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This open-label, single arm study will evaluate the safety and efficacy of Tarceva (erlotinib) as first-line therapy in participants with stage IV or recurrent non-small cell lung cancer who harbour epidermal growth factor receptor (EGFR) mutations. All participants will receive Tarceva 150 mg daily orally until disease progression or unacceptable toxicity occurs. At the investigator's discretion, participants may receive Tarceva beyond disease progression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erlotinib | Experimental | Erlotinib 150 mg daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erlotinib | Drug | Erlotinib 150 mg was administered orally daily until disease progression or unacceptable toxicity. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival Per RECIST, v. 1.1 (PFS1) | PFS1 was defined as time from first dose until documented progressive disease (PD), assessed per Response Evaluation Criteria in Solid Tumors RECIST, v. 1.1, or death from any cause, whichever occurred first. PD was defined as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; and the appearance of one or more new lesions. | Approximately 68 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival Per Investigator (PFS2) | PFS2 was defined as time from first study dose to off-erlotinib progressive disease (PD), assessed by the investigator based on overall clinical evaluation. | Approximately 68 months |
| Objective Response Rate (ORR) for All Participants and Participants With EGFR Mutation E19del or L858R |
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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 |
|---|---|---|---|---|---|---|
| Princess Margaret Hospital; Oncology | Hong Kong | Hong Kong | ||||
| Queen Elizabeth Hospital; Clinical Oncology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26720423 | Derived | Park K, Yu CJ, Kim SW, Lin MC, Sriuranpong V, Tsai CM, Lee JS, Kang JH, Chan KC, Perez-Moreno P, Button P, Ahn MJ, Mok T. First-Line Erlotinib Therapy Until and Beyond Response Evaluation Criteria in Solid Tumors Progression in Asian Patients With Epidermal Growth Factor Receptor Mutation-Positive Non-Small-Cell Lung Cancer: The ASPIRATION Study. JAMA Oncol. 2016 Mar;2(3):305-12. doi: 10.1001/jamaoncol.2015.4921. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Erlotinib | Erlotinib 150 mg daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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ORR was defined as the occurrence of either a confirmed complete (CR) or a partial response (PR, as a best overall response), as determined by RECIST, v. 1.1 criteria. CR was defined as disappearance of all target lesions. PR was defined as least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. |
| Approximately 68 months |
| Disease Control Rate (DCR) for All Participants and Participants With EGFR Mutation E19del or L858R | DCR was defined as CR + PR + Stable disease (SD). CR was defined as disappearance of all target lesions. PR was defined as least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. PD was defined as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; and the appearance of one or more new lesions. | Approximately 68 months |
| Progression-free Survival for Participants With EGFR Mutation E19del or L858R Per RECIST, v. 1.1 (PFS1) | PFS1 was defined as time from first dose until documented progressive disease (PD), assessed per Response Evaluation Criteria in Solid Tumors RECIST, v. 1.1, or death from any cause, whichever occurred first. PD was defined as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; and the appearance of one or more new lesions. | Approximately 68 months |
| Overall Survival (OS) for All Participants and Participants With EGFR Mutation E19del or L858R | OS was defined as the time from baseline to the date of death from any cause. | Approximately 68 months |
| Number of Participants With Adverse Events | An adverse event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug. | Approximately 68 months |
| Correlation Between EGFR Mutations in Plasma and Clinical Outcome (ORR/PFS/OS) | This outcome measure was not assessed. | Approximately 68 months |
| Hong Kong |
| Hong Kong |
| Prince of Wales Hosp; Dept. Of Clinical Onc | Shatin | Hong Kong |
| Seoul National University Bundang Hospital | Gyeonggi-do | 13620 | South Korea |
| Gil Hospital. Gachon University | Incheon | 405-760 | South Korea |
| Asan Medical Center; Medical Oncology | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Seoul St Mary's Hospital | Seoul | 06591 | South Korea |
| Yonsei University Severance Hospital; Medical Oncology | Seoul | 120-752 | South Korea |
| Changhua Christian Hospital; Internal Medicine | Changhua | 500 | Taiwan |
| Kaohsiung Chang Gung Memorial Hospital; Dept of Internal Medicine | Kaohsiung City | 00833 | Taiwan |
| Veterans General Hospital; Internal Medicine | Kaohsiung City | 813 | Taiwan |
| China Medical University Hospital; Pulmonary and Critical Care Medicine | Taichung | 40447 | Taiwan |
| Taichung Veterans General Hospital; Dept of Internal Medicine | Taichung | 407 | Taiwan |
| National Cheng Kung Uni Hospital; Dept of Hematology and Oncology | Tainan | 704 | Taiwan |
| Chi-Mei Medical Centre; Hematology & Oncology | Tainan | 710 | Taiwan |
| National Taiwan Uni Hospital; Internal Medicine | Taipei | 100 | Taiwan |
| Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology | Taipei | 112 | Taiwan |
| Chang Gung Medical Foundation - Linkou; Chest Dept | Taoyuan | 333 | Taiwan |
| Chulalongkorn Hospital; Medical Oncology | Bangkok | 10330 | Thailand |
| Pramongkutklao Hospital; Medicine - Medical Oncology Unit | Bangkok | 10400 | Thailand |
| Songklanagarind Hospital; Department of Internal Medicine, Division of Respiratory | Songkhla | 90110 | Thailand |
| COMPLETED |
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| NOT COMPLETED |
|
|
Of the 208 participants who were enrolled in the study, one participant was excluded from the baseline analysis population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Erlotinib | Erlotinib 150 mg daily |
| 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 Per RECIST, v. 1.1 (PFS1) | PFS1 was defined as time from first dose until documented progressive disease (PD), assessed per Response Evaluation Criteria in Solid Tumors RECIST, v. 1.1, or death from any cause, whichever occurred first. PD was defined as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; and the appearance of one or more new lesions. | The per protocol population included participants who had EGFR mutations confirmed by a study-designated central laboratory. | Posted | Median | 95% Confidence Interval | months | Approximately 68 months |
|
|
| |||||||||||||||||||||||||
| Secondary | Progression-free Survival Per Investigator (PFS2) | PFS2 was defined as time from first study dose to off-erlotinib progressive disease (PD), assessed by the investigator based on overall clinical evaluation. | The per protocol population included participants who had EGFR mutations confirmed by a study-designated central laboratory. Data are reported for evaluable participants. | Posted | Median | 95% Confidence Interval | months | Approximately 68 months |
|
| ||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) for All Participants and Participants With EGFR Mutation E19del or L858R | ORR was defined as the occurrence of either a confirmed complete (CR) or a partial response (PR, as a best overall response), as determined by RECIST, v. 1.1 criteria. CR was defined as disappearance of all target lesions. PR was defined as least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. | The per protocol population included participants who had EGFR mutations confirmed by a study-designated central laboratory. Data are reported for evaluable participants. | Posted | Number | 95% Confidence Interval | percentage of participants | Approximately 68 months |
|
| ||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) for All Participants and Participants With EGFR Mutation E19del or L858R | DCR was defined as CR + PR + Stable disease (SD). CR was defined as disappearance of all target lesions. PR was defined as least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. PD was defined as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; and the appearance of one or more new lesions. | The per protocol population included participants who had EGFR mutations confirmed by a study-designated central laboratory. Data are reported for evaluable participants. | Posted | Number | 95% Confidence Interval | percentage of participants | Approximately 68 months |
|
| ||||||||||||||||||||||||||
| Secondary | Progression-free Survival for Participants With EGFR Mutation E19del or L858R Per RECIST, v. 1.1 (PFS1) | PFS1 was defined as time from first dose until documented progressive disease (PD), assessed per Response Evaluation Criteria in Solid Tumors RECIST, v. 1.1, or death from any cause, whichever occurred first. PD was defined as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; and the appearance of one or more new lesions. | The per protocol population included participants who had EGFR mutations confirmed by a study-designated central laboratory. Data are reported for evaluable participants. | Posted | Median | 95% Confidence Interval | months | Approximately 68 months |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) for All Participants and Participants With EGFR Mutation E19del or L858R | OS was defined as the time from baseline to the date of death from any cause. | The per protocol population included participants who had EGFR mutations confirmed by a study-designated central laboratory. Data are reported for evaluable participants. | Posted | Median | 95% Confidence Interval | months | Approximately 68 months |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events | An adverse event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug. | The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment. | Posted | Number | participants | Approximately 68 months |
|
| |||||||||||||||||||||||||||
| Secondary | Correlation Between EGFR Mutations in Plasma and Clinical Outcome (ORR/PFS/OS) | This outcome measure was not assessed. | Data were not collected. | Posted | Approximately 68 months |
|
|
Approximately 68 months
The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Erlotinib | Erlotinib 150 mg daily | 59 | 207 | 206 | 207 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Dengue fever | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Infective exacerbation of bronchiectasis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Parainfluenzae virus infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Staphylococcal scalded skin syndrome | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Compression fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Pneumoconiosis | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Neuritis cranial | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Speech disorder | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Superior vena cava syndrome | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Subcutaneous emphysema | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA 19.1 | Systematic Assessment |
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| Pelvic pain | Reproductive system and breast disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 19.1 | 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 | 1-800-821-8590 | genentech@druginfo.com |
| 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
|
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| All Participants |
|
| ||||
| EGFR Mutation E19del or L858R |
|
|
|