Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2010-018476-24 | EudraCT Number |
Not provided
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This prospective, double-blind, randomized study will evaluate the safety and efficacy of two dose levels of erlotinib [Tarceva] on progression-free survival, response and disease control rates and overall survival in patients with advanced or metastatic non-small cell lung cancer (NSCLC) after failure of first-line platinum-based chemotherapy. Patients must be current smokers and not intending to stop smoking during the study. Patients will be randomized to receive either 150 mg or 300 mg of study drug as single daily oral doses. Treatment will continue until disease progression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erlotinib 150 mg | Experimental | Erlotinib 150 mg single daily oral dose until disease progression. |
|
| Erlotinib 300 mg | Experimental | Erlotinib 300 mg single daily oral dose until disease progression. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erlotinib [Tarceva] | Drug | Single daily oral dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | PFS is defined as the time from randomization to the date of first occurrence of disease progression or death. For target lesions, Progressive Disease (PD) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. | Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 Months) |
| Progression-Free Survival (PFS) at the End of Study | PFS is defined as the time from randomization to the date of first occurrence of disease progression or death. For target lesions, Progressive Disease (PD) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. | Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS defined as the time from randomization to the date of death due to any cause. | Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months) |
| Overall Response Rate (ORR) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing | 100071 | China | ||||
315 participants were randomized. 313 participants were included in the Intent-to -treat (ITT) population. The ITT population excluded 2 randomized participants: 1 participant randomized in error and 1 participant with missing source data.
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| ID | Title | Description |
|---|---|---|
| FG000 | Erlotinib 150 mg | Erlotinib 150 mg single daily oral dose until disease progression. |
| FG001 | Erlotinib 300 mg | Erlotinib 300 mg single daily oral dose until disease progression. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
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Tumor response was assessed by the investigator using computer tomography (CT) or magnetic resonance imaging (MRI) scans according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. A participant was defined as a responder if they sustained a complete response (CR) or partial response (PR) for at least 4 weeks during randomized treatment (confirmed response). Patients with no tumor assessment after the start of study treatment were to be considered as non-responders. The percentage of participants in each best response category is presented.
| Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months) |
| Disease Control Rate (DCR) | Tumor response was assessed by the investigator using computer tomography (CT) or magnetic resonance imaging (MRI) scans. Disease control rates were measured according to RECIST version 1.1 criteria. A participant was defined as having controlled disease if they sustained a Complete Response (CR) or Partial Response (PR) for at least 4 weeks during randomized treatment (confirmed response), or Stable Disease (SD) for at least 6 weeks. Patients with no tumor assessment after the start of study treatment were considered as having uncontrolled disease. The percentage of participants with Disease Control is presented. | Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months) |
| Time to Progression (TTP) | Tumor response was assessed by the investigator using computer tomography (CT) or magnetic resonance imaging (MRI) scans according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria. Time to progression (TTP) in weeks was defined as the time from randomization to the date of disease progression. Participants without event were censored at the date of the last tumor assessment when the patient was known to be progression free. | Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months) |
| Number of Participants With Adverse Events (AEs) at the End of the Study | An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events. A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. Adverse Events in the following categories are presented: Adverse Events, Serious Adverse Events, AEs leading to withdrawal from treatment and AEs leading to death. | Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months) |
| Overall Survival (OS) at the End of Study | OS defined as the time from randomization to the date of death due to any cause. | Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months) |
| Changchun |
| 130012 |
| China |
| Chengdu | 610041 | China |
| Fuzhou | 350014 | China |
| Guangzhou | 510030 | China |
| Nanjing | 210009 | China |
| Nanning | 530021 | China |
| Shanghai | 200030 | China |
| Shanghai | 200433 | China |
| Shenyang | 110001 | China |
| Tianjin | 300060 | China |
| Wuhan | 430030 | China |
| Copenhagen | 2100 | Denmark |
| Hillerød | 3400 | Denmark |
| Næstved | 4700 | Denmark |
| Roskilde | 4000 | Denmark |
| Cairo | 11796 | Egypt |
| Cairo | Egypt |
| Caen | 14076 | France |
| Limoges | 87042 | France |
| Marseille | 13915 | France |
| Paris | 75014 | France |
| Paris | 75674 | France |
| Paris | 75908 | France |
| Pontoise | 95300 | France |
| Berlin | 13125 | Germany |
| Berlin | 14165 | Germany |
| Essen | 45122 | Germany |
| Gauting | 82131 | Germany |
| Großhansdorf | 22927 | Germany |
| Hanover | 30625 | Germany |
| Hanover | 30659 | Germany |
| Immenhausen | 34376 | Germany |
| Lostau | 39291 | Germany |
| München | 81925 | Germany |
| Nuremberg | 90419 | Germany |
| Rheine | 48431 | Germany |
| Villingen-Schwenningen | 78052 | Germany |
| Wuppertal | 42283 | Germany |
| Würselen | 52146 | Germany |
| Amsterdam | 1007 MB | Netherlands |
| Breda | 4818 CK | Netherlands |
| Nieuwegein | 3435 CM | Netherlands |
| Zwolle | 8011 JW | Netherlands |
| Barcelona | Barcelona | 08035 | Spain |
| Barcelona | Barcelona | 08041 | Spain |
| Sabadell, Barcelona | Barcelona | 08208 | Spain |
| Madrid | Madrid | 28040 | Spain |
| Madrid | Madrid | 28041 | Spain |
| Málaga | Malaga | 29010 | Spain |
| Seville | Sevilla | 41013 | Spain |
| Valencia | Valencia | 46009 | Spain |
| Baden | 5404 | Switzerland |
| Basel | 4031 | Switzerland |
| Bern | 3011 | Switzerland |
| Fribourg | 1708 | Switzerland |
| Ankara | 06000 | Turkey (Türkiye) |
| Ankara | 06200 | Turkey (Türkiye) |
| Eskişehir | 26480 | Turkey (Türkiye) |
| Gaziantep | 27310 | Turkey (Türkiye) |
| Izmir | 35110 | Turkey (Türkiye) |
| Izmir | 35340 | Turkey (Türkiye) |
| Konya | 42050 | Turkey (Türkiye) |
| Safety Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-treat Population included all randomized participants. 2 participants were excluded from analysis: 1 participant randomized in error and 1 participant with missing source data.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Erlotinib 150 mg | Erlotinib 150 mg single daily oral dose until disease progression. |
| BG001 | Erlotinib 300 mg | Erlotinib 300 mg single daily oral dose until disease progression. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 (PFS) | PFS is defined as the time from randomization to the date of first occurrence of disease progression or death. For target lesions, Progressive Disease (PD) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. | Intent-to-treat Population included all randomized participants. 2 participants were excluded from analysis: 1 participant randomized in error and 1 participant with missing source data. | Posted | Median | 95% Confidence Interval | weeks | Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 Months) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS defined as the time from randomization to the date of death due to any cause. | Intent-to-treat Population included all randomized participants. 2 participants were excluded from analysis: 1 participant randomized in error and 1 participant with missing source data. | Posted | Median | 95% Confidence Interval | months | Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Response Rate (ORR) | Tumor response was assessed by the investigator using computer tomography (CT) or magnetic resonance imaging (MRI) scans according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. A participant was defined as a responder if they sustained a complete response (CR) or partial response (PR) for at least 4 weeks during randomized treatment (confirmed response). Patients with no tumor assessment after the start of study treatment were to be considered as non-responders. The percentage of participants in each best response category is presented. | Intent-to-treat Population included all randomized participants. 2 participants were excluded from analysis: 1 participant randomized in error and 1 participant with missing source data. | Posted | Number | 95% Confidence Interval | percentage of participants | Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) | Tumor response was assessed by the investigator using computer tomography (CT) or magnetic resonance imaging (MRI) scans. Disease control rates were measured according to RECIST version 1.1 criteria. A participant was defined as having controlled disease if they sustained a Complete Response (CR) or Partial Response (PR) for at least 4 weeks during randomized treatment (confirmed response), or Stable Disease (SD) for at least 6 weeks. Patients with no tumor assessment after the start of study treatment were considered as having uncontrolled disease. The percentage of participants with Disease Control is presented. | Intent-to-treat Population included all randomized participants. 2 participants were excluded from analysis: 1 participant randomized in error and 1 participant with missing source data. | Posted | Number | 95% Confidence Interval | percentage of participants | Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Progression (TTP) | Tumor response was assessed by the investigator using computer tomography (CT) or magnetic resonance imaging (MRI) scans according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria. Time to progression (TTP) in weeks was defined as the time from randomization to the date of disease progression. Participants without event were censored at the date of the last tumor assessment when the patient was known to be progression free. | Intent-to-treat Population included all randomized participants. 2 participants were excluded from analysis: 1 participant randomized in error and 1 participant with missing source data. | Posted | Median | 95% Confidence Interval | weeks | Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events (AEs) at the End of the Study | An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events. A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. Adverse Events in the following categories are presented: Adverse Events, Serious Adverse Events, AEs leading to withdrawal from treatment and AEs leading to death. | Safety population included all randomized participants who received at least one dose of study drug. | Posted | Number | participants | Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Progression-Free Survival (PFS) at the End of Study | PFS is defined as the time from randomization to the date of first occurrence of disease progression or death. For target lesions, Progressive Disease (PD) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. | Intent-to-treat Population included all randomized participants. 2 participants were excluded from analysis: 1 participant randomized in error and 1 participant with missing source data. | Posted | Median | 95% Confidence Interval | weeks | Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) at the End of Study | OS defined as the time from randomization to the date of death due to any cause. | Intent-to-treat Population included all randomized participants. 2 participants were excluded from analysis: 1 participant randomized in error and 1 participant with missing source data. | Posted | Median | 95% Confidence Interval | months | Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months) |
|
|
Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months)
Safety population: All participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Erlotinib 150 mg | Erlotinib 150 mg single daily oral dose until disease progression. | 29 | 154 | 115 | 154 | ||
| EG001 | Erlotinib 300 mg | Erlotinib 300 mg single daily oral dose until disease progression. | 35 | 158 | 128 | 158 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Lower respiratory tract infection bacterial | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Hydropneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Death | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Arteriospasm coronary | Cardiac disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Intracardiac thrombus | Cardiac disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Hypoxic-ischaemic encephalopathy | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Renal failure chronic | Renal and urinary disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.1) | Systematic Assessment |
| |
| Pericardial effusion malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.1) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA (16.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genetech@druginfo.com |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069347 | Erlotinib Hydrochloride |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
|
| Participants |
|
|
| Counts |
|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Participants |
|
|
|
|