Erlotinib or Placebo Following Chemoradiotherapy (Chemo/R... | NCT00153803

Name	Class
Sanofi	INDUSTRY
Genentech, Inc.	INDUSTRY

Label	Type	Description	Intervention Names
1	Experimental	Erlotinib (Tarceva) 150mg: Erlotinib 150mg orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events, death or completion of 3 years of therapy.	Drug: Erlotinib (tarceva)
2	Placebo Comparator	Matched Placebo: Matched placebo orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events death or completion of 3 years of therapy.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Erlotinib (tarceva)	Drug	Erlotinib 150mg orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events, death or completion of 3 years of therapy.

Measure	Description	Time Frame
Progression Free Survival	Progression Free Survival is defined as time from randomization until documented disease progression or death from any cause. The Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.0) was used to determine disease progression. Irradiated target lesions were considered non-measurable disease. Symptomatic radiographic changes of irradiated non-measurable disease required pathologically confirmation or positive FDG-PET scan 6 months following completion of concurrent chemoradiation to be considered locoregional disease progression. Global deterioration of health status requiring discontinuation of treatment without objective evidence of progression was considered distant disease progression.	5 years

Measure	Description	Time Frame
Overall Survival		From date of randomization until the date of death from any cause, assessed up to 50 months
Percent of Participants Surviving 3 Years		36 months

Name	Affiliation	Role
James R Rigas, MD	Norris Cotton Cancer Center	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Birmingham Hematology and Oncology Associates, LLC		Birmingham	Alabama	35235	United States
Oncology Specialties, P.C.

ID	Title	Description
FG000	Tarceva	Tarceva 150mg Erlotinib (tarceva): Erlotinib 150mg orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events, death or completion of 3 years of therapy.
FG001	Placebo

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Progression Free Survival

Progression Free Survival is defined as time from randomization until documented disease progression or death from any cause. The Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.0) was used to determine disease progression. Irradiated target lesions were considered non-measurable disease. Symptomatic radiographic changes of irradiated non-measurable disease required pathologically confirmation or positive FDG-PET scan 6 months following completion of concurrent chemoradiation to be considered locoregional disease progression. Global deterioration of health status requiring discontinuation of treatment without objective evidence of progression was considered distant disease progression.

NA = not available; The data cannot be located/provided due to the PI leaving the institution.

Posted

Median

Full Range

Months

5 years

ID	Title	Description
OG000	Tarceva	Tarceva 150mg Erlotinib (tarceva): Erlotinib 150mg orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events, death or completion of 3 years of therapy.
OG001	Placebo	Matched Placebo Placebo: Matched placebo orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events death or completion of 3 years of therapy.

Units	Counts
Participants	OG000118 OG001117

Title

Denominators

Categories

Title	Measurements
	OG0007.4(NA to NA)Data could not be found; The data cannot be located/provided due to the PI leaving the institution. OG0018.1(NA to NA)Data could not be found; The data cannot be located/provided due to the PI leaving the institution.

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		0.165		Hazard Ratio (HR)	0.93			2-Sided	95	0.65	1.33					Superiority

Secondary

Overall Survival

NA = not available; The data cannot be located/provided due to the PI leaving the institution.

Posted

Median

Full Range

Months

From date of randomization until the date of death from any cause, assessed up to 50 months

ID	Title	Description
OG000	Tarceva	Tarceva 150mg Erlotinib (tarceva): Erlotinib 150mg orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events, death or completion of 2 years of therapy.
OG001	Placebo	Matched Placebo Placebo: Matched placebo orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events death or completion of 3 years of therapy.

Units	Counts
Participants	OG000

Secondary

Percent of Participants Surviving 3 Years

Posted

Number

percentage of participants

36 months

ID	Title	Description
OG000	Tarceva	Tarceva 150mg Erlotinib (tarceva): Erlotinib 150mg orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events, death or completion of 3 years of therapy.
OG001	Placebo	Matched Placebo Placebo: Matched placebo orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events death or completion of 3 years of therapy.

Units	Counts
Participants	OG000

Secondary

Serious Adverse Event Profile Relating to Death, Disability, Life-threatening, Hospitalization, and Impairment/Damage for Concurrent Chemoradiation

Number of participants with treatment-related serious adverse events (SAEs) observed in each SAE category for each arm relating to death, disability, life-threatening, hospitalization, and impairment/damage is reported. For participants with multiple SAEs, the SAE report having the strongest relationship to study drug is summarized.

Posted

Count of Participants

Participants

18 months

ID	Title	Description
OG000	Tarceva	Tarceva 150mg Erlotinib (tarceva): Erlotinib 150mg orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events, death or completion of 3 years of therapy.
OG001	Placebo	Matched Placebo Placebo: Matched placebo orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events death or completion of 3 years of therapy.

Units	Counts
Participants

Secondary

Serious Adverse Event Profile Relating to Death, Disability, Life-threatening, Hospitalization, and Impairment/Damage for Erlotinib and Placebo

Posted

Count of Participants

Participants

18 months

ID	Title	Description
OG000	Tarceva	Tarceva 150mg Erlotinib (tarceva): Erlotinib 150mg orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events, death or completion of 3 years of therapy.
OG001	Placebo	Matched Placebo Placebo: Matched placebo orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events death or completion of 3 years of therapy.

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Assessment Type	Notes	Statistical Information
Hemoglobin	Blood and lymphatic system disorders	Systematic Assessment		EG0000 events0 affected118 at risk EG0010 events0 affected117 at risk EG0021 events1 affected77 at risk EG0030 events0 affected75 at risk
Atrial fibrillation	Cardiac disorders	Systematic Assessment	Supraventricular and nodal arrhythmia	EG0002 events2 affected118 at risk EG0011 events1 affected117 at risk EG0020 events0 affected77 at risk EG003
Cardiac Arrhythmia	Cardiac disorders	Systematic Assessment		EG0001 events1 affected118 at risk EG0010 events0 affected117 at risk EG0020 events0 affected77 at risk EG003
Cardiac General	Cardiac disorders	Systematic Assessment	Cardiac General	EG0000 events0 affected118 at risk EG0011 events1 affected117 at risk EG0022 events2 affected77 at risk EG003
Cardiac ischemia/infarction	Cardiac disorders	Systematic Assessment	Cardiac ischemia/infarction	EG0000 events0 affected118 at risk EG0011 events1 affected117 at risk EG0021 events1 affected77 at risk EG003
Hypotension	Cardiac disorders	Systematic Assessment		EG0000 events0 affected118 at risk EG0011 events1 affected117 at risk EG0020 events0 affected77 at risk EG003
Paroxysmal Atrial Tachycardia	Cardiac disorders	Systematic Assessment		EG0000 events0 affected118 at risk EG0010 events0 affected117 at risk EG0021 events1 affected77 at risk EG003
Ventricular fibrillation	Cardiac disorders	Systematic Assessment	Ventricular arrhythmia	EG0000 events0 affected118 at risk EG0011 events1 affected117 at risk EG0020 events0 affected77 at risk EG003
Colitis	Gastrointestinal disorders	Systematic Assessment		EG0000 events0 affected118 at risk EG0010 events0 affected117 at risk EG0021 events1 affected77 at risk EG003
Dehydration	Gastrointestinal disorders	Systematic Assessment		EG0002 events2 affected118 at risk EG0012 events2 affected117 at risk EG0020 events0 affected77 at risk EG003
Dysphagia (difficulty swallowing)	Gastrointestinal disorders	Systematic Assessment		EG0000 events0 affected118 at risk EG0011 events1 affected117 at risk EG0020 events0 affected77 at risk EG003
Esophagitis	Gastrointestinal disorders	Systematic Assessment		EG0004 events4 affected118 at risk EG0012 events2 affected117 at risk EG0020 events0 affected77 at risk EG003
Fistula, Esophagus	Gastrointestinal disorders	Systematic Assessment		EG0000 events0 affected118 at risk EG0010 events0 affected117 at risk EG0020 events0 affected77 at risk EG003
Gastritis	Gastrointestinal disorders	Systematic Assessment	Gastritis (including bile reflux gastritis)	EG0000 events0 affected118 at risk EG0011 events1 affected117 at risk EG0020 events0 affected77 at risk EG003
Gastrointestinal - Other	Gastrointestinal disorders	Systematic Assessment		EG0001 events1 affected118 at risk EG0010 events0 affected117 at risk EG0020 events0 affected77 at risk EG003
Mucositis/stomatitis	Gastrointestinal disorders	Systematic Assessment	Mucositis/stomatitis (functional/symptomatic) Esophagus	EG0000 events0 affected118 at risk EG0012 events2 affected117 at risk EG0020 events0 affected77 at risk EG003
Perforation, GIColon	Gastrointestinal disorders	Systematic Assessment	GI/Colon Perforation	EG0000 events0 affected118 at risk EG0011 events1 affected117 at risk EG0020 events0 affected77 at risk EG003
Vomiting	Gastrointestinal disorders	Systematic Assessment		EG0001 events1 affected118 at risk EG0010 events0 affected117 at risk EG0020 events0 affected77 at risk EG003
Constitutional Symptoms - Fatigue	General disorders	Systematic Assessment	Fatigue (asthenia, lethargy, malaise)	EG0001 events1 affected118 at risk EG0010 events0 affected117 at risk EG0020 events0 affected77 at risk EG003
Constitutional Symptoms - Fever	General disorders	Systematic Assessment	Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10eFever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)9/L)	EG0000 events0 affected118 at risk EG0011 events1 affected117 at risk EG0020 events0 affected77 at risk EG003
Constitutional Symptoms- Other	General disorders	Systematic Assessment		EG0002 events2 affected118 at risk EG0010 events0 affected117 at risk EG0020 events0 affected77 at risk EG003
Hemorrhage - Respiratory tract NOS	General disorders	Systematic Assessment	Hemorrhage, pulmonary/upper respiratory/ Respiratory tract None otherwise specified (NOS)	EG0000 events0 affected118 at risk EG0010 events0 affected117 at risk EG0021 events1 affected77 at risk EG003
Hemorrhage, GI Lower	General disorders	Systematic Assessment		EG0000 events0 affected118 at risk EG0011 events1 affected117 at risk EG0020 events0 affected77 at risk EG003
Hemorrhage, pulmonary/upper respiratory - Bronchopulmonary	General disorders	Systematic Assessment	Hemorrhage, pulmonary/upper respiratory Bronchopulmonary	EG0000 events0 affected118 at risk EG0011 events1 affected117 at risk EG0020 events0 affected77 at risk EG003
Hemorrhage, pulmonary/upper respiratory- Lung	General disorders	Systematic Assessment	Hemorrhage, pulmonary/upper respiratory- Lung	EG0001 events1 affected118 at risk EG0010 events0 affected117 at risk EG0020 events0 affected77 at risk EG003
Hemorrhage/Bleeding - Other	General disorders	Systematic Assessment		EG0001 events1 affected118 at risk EG0010 events0 affected117 at risk EG0020 events0 affected77 at risk EG003
Pain - Abdomen NOS	General disorders	Systematic Assessment	None otherwise specified (NOW)	EG0000 events0 affected118 at risk EG0010 events0 affected117 at risk EG0021 events1 affected77 at risk EG003
Pain - Bone	General disorders	Systematic Assessment		EG0000 events0 affected118 at risk EG0010 events0 affected117 at risk EG0022 events2 affected77 at risk EG003
Pain - Joint	General disorders	Systematic Assessment		EG0001 events1 affected118 at risk EG0010 events0 affected117 at risk EG0020 events0 affected77 at risk EG003
Pain - Other	General disorders	Systematic Assessment		EG0000 events0 affected118 at risk EG0010 events0 affected117 at risk EG0022 events2 affected77 at risk EG003
Pain- Chest/thorax	General disorders	Systematic Assessment		EG0000 events0 affected118 at risk EG0011 events1 affected117 at risk EG0020 events0 affected77 at risk EG003
Allergic Reaction	Immune system disorders	Systematic Assessment	Allergic reaction/hypersensitivity (including drug fever)	EG0001 events1 affected118 at risk EG0011 events1 affected117 at risk EG0020 events0 affected77 at risk EG003
Colitis, Infectious	Infections and infestations	Systematic Assessment	example: Clostridium difficile	EG0000 events0 affected118 at risk EG0010 events0 affected117 at risk EG0020 events0 affected77 at risk EG003
Febrile neutropenia	Infections and infestations	Systematic Assessment	Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infection)(ANC <1.0 x 10e9/L, fever >=38.5 degrees C)	EG0001 events1 affected118 at risk EG0010 events0 affected117 at risk EG0020 events0 affected77 at risk EG003
Infection - Blood	Infections and infestations	Systematic Assessment	Infection with normal ANC or Grade 1 or 2 neutrophils Blood	EG0001 events1 affected118 at risk EG0010 events0 affected117 at risk EG0020 events0 affected77 at risk EG003
Infection - Foreign body	Infections and infestations	Systematic Assessment	Infection with normal ANC or Grade 1 or 2 neutrophils Foreign body (e.g., graft, implant, prosthesis, stent)	EG0001 events1 affected118 at risk EG0010 events0 affected117 at risk EG0022 events2 affected77 at risk EG003
Infection - Lung	Infections and infestations	Systematic Assessment	Infection with normal ANC or Grade 1 or 2 neutrophils Lung (pneumonia)	EG0001 events1 affected118 at risk EG0010 events0 affected117 at risk EG0024 events4 affected77 at risk EG003
Infection - Other	Infections and infestations	Systematic Assessment		EG0002 events2 affected118 at risk EG0011 events1 affected117 at risk EG0025 events5 affected77 at risk EG003
Infection - Wound	Infections and infestations	Systematic Assessment	Infection with normal ANC or Grade 1 or 2 neutrophils Wound	EG0000 events0 affected118 at risk EG0011 events1 affected117 at risk EG0020 events0 affected77 at risk EG003
Hyperglycemia	Metabolism and nutrition disorders	Systematic Assessment		EG0000 events0 affected118 at risk EG0011 events1 affected117 at risk EG0020 events0 affected77 at risk EG003
Fracture	Musculoskeletal and connective tissue disorders	Systematic Assessment		EG0000 events0 affected118 at risk EG0011 events1 affected117 at risk EG0020 events0 affected77 at risk EG003
Musculoskeletal / Soft Tissue - Other	Musculoskeletal and connective tissue disorders	Systematic Assessment	Musculoskeletal / Soft Tissue - Other	EG0000 events0 affected118 at risk EG0010 events0 affected117 at risk EG0021 events1 affected77 at risk EG003
Cerebrovascular Ischemia	Nervous system disorders	Systematic Assessment		EG0000 events0 affected118 at risk EG0011 events1 affected117 at risk EG0020 events0 affected77 at risk EG003
Confusion	Nervous system disorders	Systematic Assessment		EG0001 events1 affected118 at risk EG0010 events0 affected117 at risk EG0020 events0 affected77 at risk EG003
Dizziness	Nervous system disorders	Systematic Assessment		EG0000 events0 affected118 at risk EG0011 events1 affected117 at risk EG0020 events0 affected77 at risk EG003
Neurology - Other	Nervous system disorders	Systematic Assessment		EG0000 events0 affected118 at risk EG0010 events0 affected117 at risk EG0021 events1 affected77 at risk EG003
Somnolence/depressed level of consciousness	Nervous system disorders	Systematic Assessment		EG0001 events1 affected118 at risk EG0010 events0 affected117 at risk EG0020 events0 affected77 at risk EG003
Obstruction - Ureter	Renal and urinary disorders	Systematic Assessment		EG0000 events0 affected118 at risk EG0010 events0 affected117 at risk EG0021 events1 affected77 at risk EG003
Dyspnea (shortness of breath)	Respiratory, thoracic and mediastinal disorders	Systematic Assessment		EG0000 events0 affected118 at risk EG0012 events2 affected117 at risk EG0022 events2 affected77 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	Systematic Assessment		EG0000 events0 affected118 at risk EG0011 events1 affected117 at risk EG0020 events0 affected77 at risk EG003
Pleural effusion (non-malignant)	Respiratory, thoracic and mediastinal disorders	Systematic Assessment		EG0000 events0 affected118 at risk EG0010 events0 affected117 at risk EG0021 events1 affected77 at risk EG003
Pneumonitis/pulmonary infiltrates	Respiratory, thoracic and mediastinal disorders	Systematic Assessment		EG0001 events1 affected118 at risk EG0012 events2 affected117 at risk EG0024 events4 affected77 at risk EG003
Upper Respiratory - Other	Respiratory, thoracic and mediastinal disorders	Systematic Assessment		EG0003 events3 affected118 at risk EG0013 events3 affected117 at risk EG0023 events3 affected77 at risk EG003
Skin - Other	Skin and subcutaneous tissue disorders	Systematic Assessment		EG0001 events1 affected118 at risk EG0010 events0 affected117 at risk EG0020 events0 affected77 at risk EG003
Wound complication, non-infectious	Skin and subcutaneous tissue disorders	Systematic Assessment		EG0000 events0 affected118 at risk EG0011 events1 affected117 at risk EG0020 events0 affected77 at risk EG003
Intra-operative Injury - Other	Surgical and medical procedures	Systematic Assessment		EG0000 events0 affected118 at risk EG0010 events0 affected117 at risk EG0020 events0 affected77 at risk EG003
Thrombosis/embolism (vascular access-related)	Vascular disorders	Systematic Assessment		EG0001 events1 affected118 at risk EG0010 events0 affected117 at risk EG0021 events1 affected77 at risk EG003
Thrombosis/thrombus/embolism	Vascular disorders	Systematic Assessment		EG0003 events3 affected118 at risk EG0014 events4 affected117 at risk EG0022 events2 affected77 at risk EG003
Vascular - Other	Vascular disorders	Systematic Assessment		EG0001 events1 affected118 at risk EG0010 events0 affected117 at risk EG0020 events0 affected77 at risk EG003

Other Adverse Events

Term	Organ System	Assessment Type	Notes	Statistical Information
Allergic reaction	Immune system disorders	Systematic Assessment	Allergic reaction/hypersensitivity (including drug fever)	EG0001 events1 affected118 at risk EG0010 events0 affected117 at risk EG0020 events0 affected77 at risk EG0030 events0 affected75 at risk
Hemoglobin	Blood and lymphatic system disorders	Systematic Assessment		EG0001 events1 affected118 at risk EG0011 events1 affected117 at risk EG0020 events0 affected77 at risk EG003
Atrial fibrillation	Cardiac disorders	Systematic Assessment	Supraventricular and nodal arrhythmia Atrial fibrillation	EG0000 events0 affected118 at risk EG0011 events1 affected117 at risk EG0020 events0 affected77 at risk EG003
Cardiac General - Other	Cardiac disorders	Systematic Assessment		EG0001 events1 affected118 at risk EG0010 events0 affected117 at risk EG0020 events0 affected77 at risk EG003
Constitutional symptoms - Fever	General disorders	Systematic Assessment	Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)	EG0001 events1 affected118 at risk EG0010 events0 affected117 at risk EG0021 events1 affected77 at risk EG003
Skin - Other	Skin and subcutaneous tissue disorders	Systematic Assessment		EG0000 events0 affected118 at risk EG0011 events1 affected117 at risk EG0020 events0 affected77 at risk EG003
Constipation	Gastrointestinal disorders	Systematic Assessment		EG0001 events1 affected118 at risk EG0010 events0 affected117 at risk EG0020 events0 affected77 at risk EG003
Dehydration	Gastrointestinal disorders	Systematic Assessment		EG0000 events0 affected118 at risk EG0011 events1 affected117 at risk EG0020 events0 affected77 at risk EG003
Esophagitis	Gastrointestinal disorders	Systematic Assessment		EG0001 events1 affected118 at risk EG0010 events0 affected117 at risk EG0020 events0 affected77 at risk EG003
Gastrointestinal - Other	Gastrointestinal disorders	Systematic Assessment		EG0001 events1 affected118 at risk EG0010 events0 affected117 at risk EG0020 events0 affected77 at risk EG003
Nausea	Gastrointestinal disorders	Systematic Assessment		EG0001 events1 affected118 at risk EG0010 events0 affected117 at risk EG0020 events0 affected77 at risk EG003
Infection - Other	Infections and infestations	Systematic Assessment		EG0000 events0 affected118 at risk EG0011 events1 affected117 at risk EG0020 events0 affected77 at risk EG003
Fracture	Musculoskeletal and connective tissue disorders	Systematic Assessment		EG0000 events0 affected118 at risk EG0011 events1 affected117 at risk EG0021 events1 affected77 at risk EG003
Extrapyramidal/involuntary movement/restlessness	Nervous system disorders	Systematic Assessment		EG0000 events0 affected118 at risk EG0011 events1 affected117 at risk EG0020 events0 affected77 at risk EG003
Pain - Chest/Thorax	General disorders	Systematic Assessment		EG0002 events2 affected118 at risk EG0010 events0 affected117 at risk EG0020 events0 affected77 at risk EG003
Pain - Other	General disorders	Systematic Assessment		EG0001 events1 affected118 at risk EG0010 events0 affected117 at risk EG0020 events0 affected77 at risk EG003
Pneumonitis/pulmonary infiltrates	Respiratory, thoracic and mediastinal disorders	Systematic Assessment		EG0000 events0 affected118 at risk EG0011 events1 affected117 at risk EG0020 events0 affected77 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	Systematic Assessment		EG0001 events1 affected118 at risk EG0010 events0 affected117 at risk EG0020 events0 affected77 at risk EG003
Desquamation	Skin and subcutaneous tissue disorders	Systematic Assessment		EG0000 events0 affected118 at risk EG0010 events0 affected117 at risk EG0021 events1 affected77 at risk EG003
Pancreatitis	Hepatobiliary disorders	Systematic Assessment		EG0000 events0 affected118 at risk EG0010 events0 affected117 at risk EG0021 events1 affected77 at risk EG003
Pain - Abdomen NOS	General disorders	Systematic Assessment	None otherwise specified (NOS)	EG0000 events0 affected118 at risk EG0010 events0 affected117 at risk EG0021 events1 affected77 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment		EG0000 events0 affected118 at risk EG0010 events0 affected117 at risk EG0021 events1 affected77 at risk EG003
Upper respiratory - other	Respiratory, thoracic and mediastinal disorders	Systematic Assessment		EG0000 events0 affected118 at risk EG0010 events0 affected117 at risk EG0021 events1 affected77 at risk EG003
Embolism	Vascular disorders	Systematic Assessment	Thrombosis/ thrombus/ embolism	EG0000 events0 affected118 at risk EG0010 events0 affected117 at risk EG0021 events1 affected77 at risk EG003

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

ID	Title	Description
BG000	Tarceva	Tarceva 150mg Erlotinib (tarceva): Erlotinib 150mg orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events, death or completion of 3 years of therapy.
BG001	Placebo	Matched Placebo Placebo: Matched placebo orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events death or completion of 3 years of therapy.
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	Chemoradiation Before Tarceva		26	118	36	118	12	118
EG001	Chemoradiation Before Placebo		27	117	38	117	8	117
EG002	Tarceva	Tarceva 150mg Erlotinib (tarceva): Erlotinib 150mg orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events, death or completion of 3 years of therapy.	43	77	39	77	8	77
EG003	Placebo	Matched Placebo Placebo: Matched placebo orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events death or completion of 3 years of therapy.	40	75	23	75	0	75