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This open-label, randomized, parallel arm study assessed the efficacy and safety of Tarceva (erlotinib) versus gemcitabine/cisplatin combination chemotherapy as first-line treatment in patients with stage IIIB/IV non-small cell lung cancer with epidermal growth factor receptor (EGFR) mutations in their tumours. Patients were randomized to receive either Tarceva 150 mg orally daily or 3-week cycles of gemcitabine 1250 mg/m^2 intravenously (iv) on Days 1 and 8 plus cisplatin 75 mg/m^2 iv on Day 1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erlotinib | Experimental | Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity. |
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| Chemotherapy | Active Comparator | Participants received gemcitabine 1250 mg/m^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erlotinib | Drug | Erlotinib was supplied as tablets. |
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| Measure | Description | Time Frame |
|---|---|---|
| Investigator-assessed Duration of Progression-free Survival | The duration of progression-free survival was defined as the time from randomization to disease progression (PD) or death from any cause, whichever occurs first. PD was defined as: (1) At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this may include the baseline sum). The sum must also demonstrate an absolute increase of at least 5 mm. (2) An unequivocal progression of existing non-target lesions. When the patient has measurable disease, the overall tumor burden must have increased sufficiently to merit discontinuation of therapy. When the patient has only non-measurable disease, the increase in overall disease burden should be comparable in magnitude to the increase that would be required to declare PD for measurable disease. (3) The appearance of new malignant lesions. | Baseline to the data cut-off date of 20 Jul 2012 (1 year, 4 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Responders as Assessed by the Investigator | A responder was defined as a participant with either a complete response (CR) or a partial response (PR), as determined using the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. A CR was defined as: (1) The disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to < 10 mm. (2) The disappearance of all non-target lesions and normalization of tumor marker levels. All lymph nodes must be non-pathological in size (< 10 mm in the short axis). A PR was defined as: (1) At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. (2) The persistence of 1 or more non-target lesion(s) and/or maintenance of tumor marker levels above normal limits. |
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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 |
|---|---|---|---|---|---|---|
| Beijing | 100071 | China | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29654023 | Derived | Wen F, Zheng H, Zhang P, Hutton D, Li Q. OPTIMAL and ENSURE trials-based combined cost-effectiveness analysis of erlotinib versus chemotherapy for the first-line treatment of Asian patients with non-squamous non-small-cell lung cancer. BMJ Open. 2018 Apr 13;8(4):e020128. doi: 10.1136/bmjopen-2017-020128. | |
| 26105600 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Erlotinib | Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity. |
| FG001 | Chemotherapy | Participants received gemcitabine 1250 mg/m^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Chemotherapy | Drug | Cisplatin and gemcitabine were locally sourced with commercial products. |
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| Baseline to the data cut-off date of 19 Nov 2012 (1 year, 8 months) |
| Percentage of Participants With Disease Control | A participant with disease control was defined as a participant with either a complete response (CR), a partial response (PR), or stable disease (SD), as determined using RECIST v1.1. A CR was defined as the disappearance of all target lesions (TL). A PR was defined as at least a 30% decrease in the sum of the longest diameter of TLs taking as reference the Baseline sum longest diameter (SLD). 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 SLD since treatment started. For non-TLs, SD was defined as the persistence of 1 or more lesions. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the unequivocal progression of existing non-TLs. A SLD for all TLs will be calculated and reported as the Baseline SLD. | Baseline to the data cut-off date of 19 Nov 2012 (1 year, 8 months) |
| Duration of Response | Duration of response was defined as the time from the first documented complete response (CR) or partial response (PR) to the first documented disease progression (PD) or death, whichever occurs first. A CR was defined as the disappearance of all target lesions (TL). A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs taking as reference the Baseline SLD. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the unequivocal progression of existing non-TLs. | Baseline to the data cut-off date of 19 Nov 2012 (1 year, 8 months) |
| Overall Survival | Overall survival was defined as the time from the date of randomization to the date of death from any cause. | Baseline to the end of the study (3 years, 1 month) |
| Safety: Incidence of Adverse Events | 36 months |
| Quality of Life: Functional Assessment of Chronic Illness Therapy - Lung (FACIT-L) Questionnaire | approximately 21 months |
| Beijing |
| 101149 |
| China |
| Changchun | 130012 | China |
| Chongqing | 400038 | China |
| Chongqing | 400042 | China |
| Fuzhou | 350014 | China |
| Guangzhou | 510080 | China |
| Hangzhou | 310016 | China |
| Nanjing | 210002 | China |
| Shanghai | 200030 | China |
| Shanghai | 200032 | China |
| Shanghai | 200433 | China |
| Shantou | 515041 | China |
| Wuhan | 430023 | China |
| Xi'an | 710061 | China |
| Kampung Baharu Nilai | 71800 | Malaysia |
| Kelantan | 16150 | Malaysia |
| Kuala Lumpur | 50603 | Malaysia |
| Kuala Lumpur | 59100 | Malaysia |
| Kuala Pahang | 25100 | Malaysia |
| Petaling Jaya | 46150 | Malaysia |
| Petaling Jaya, Selangor | 46050 | Malaysia |
| Pulau Pinang | 11600 | Malaysia |
| Davao City | 8000 | Philippines |
| Desmarinas City | 4114 | Philippines |
| Manila | 1000 | Philippines |
| Quezon City | 1104 | Philippines |
| San Juan City | 1500 | Philippines |
| Wu YL, Zhou C, Liam CK, Wu G, Liu X, Zhong Z, Lu S, Cheng Y, Han B, Chen L, Huang C, Qin S, Zhu Y, Pan H, Liang H, Li E, Jiang G, How SH, Fernando MCL, Zhang Y, Xia F, Zuo Y. First-line erlotinib versus gemcitabine/cisplatin in patients with advanced EGFR mutation-positive non-small-cell lung cancer: analyses from the phase III, randomized, open-label, ENSURE study. Ann Oncol. 2015 Sep;26(9):1883-1889. doi: 10.1093/annonc/mdv270. Epub 2015 Jun 23. |
| Received Treatment |
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| COMPLETED |
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| NOT COMPLETED |
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Full analysis set: All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Erlotinib | Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity. |
| BG001 | Chemotherapy | Participants received gemcitabine 1250 mg/m^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| 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 |
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| 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 | Investigator-assessed Duration of Progression-free Survival | The duration of progression-free survival was defined as the time from randomization to disease progression (PD) or death from any cause, whichever occurs first. PD was defined as: (1) At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this may include the baseline sum). The sum must also demonstrate an absolute increase of at least 5 mm. (2) An unequivocal progression of existing non-target lesions. When the patient has measurable disease, the overall tumor burden must have increased sufficiently to merit discontinuation of therapy. When the patient has only non-measurable disease, the increase in overall disease burden should be comparable in magnitude to the increase that would be required to declare PD for measurable disease. (3) The appearance of new malignant lesions. | Full analysis set: All randomized participants. | Posted | Median | 95% Confidence Interval | Months | Baseline to the data cut-off date of 20 Jul 2012 (1 year, 4 months) |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Responders as Assessed by the Investigator | A responder was defined as a participant with either a complete response (CR) or a partial response (PR), as determined using the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. A CR was defined as: (1) The disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to < 10 mm. (2) The disappearance of all non-target lesions and normalization of tumor marker levels. All lymph nodes must be non-pathological in size (< 10 mm in the short axis). A PR was defined as: (1) At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. (2) The persistence of 1 or more non-target lesion(s) and/or maintenance of tumor marker levels above normal limits. | Full analysis set: All randomized participants. | Posted | Number | Percentage of responders | Baseline to the data cut-off date of 19 Nov 2012 (1 year, 8 months) |
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Disease Control | A participant with disease control was defined as a participant with either a complete response (CR), a partial response (PR), or stable disease (SD), as determined using RECIST v1.1. A CR was defined as the disappearance of all target lesions (TL). A PR was defined as at least a 30% decrease in the sum of the longest diameter of TLs taking as reference the Baseline sum longest diameter (SLD). 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 SLD since treatment started. For non-TLs, SD was defined as the persistence of 1 or more lesions. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the unequivocal progression of existing non-TLs. A SLD for all TLs will be calculated and reported as the Baseline SLD. | Full analysis set: All randomized participants. | Posted | Number | Percentage of participants | Baseline to the data cut-off date of 19 Nov 2012 (1 year, 8 months) |
| |||||||||||||||||||||||||||||||
| Secondary | Duration of Response | Duration of response was defined as the time from the first documented complete response (CR) or partial response (PR) to the first documented disease progression (PD) or death, whichever occurs first. A CR was defined as the disappearance of all target lesions (TL). A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs taking as reference the Baseline SLD. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the unequivocal progression of existing non-TLs. | Full analysis set: All randomized participants. Only participants who had a complete response or partial response were included in the analysis. | Posted | Median | 95% Confidence Interval | Months | Baseline to the data cut-off date of 19 Nov 2012 (1 year, 8 months) |
| ||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival was defined as the time from the date of randomization to the date of death from any cause. | Full analysis set: All randomized participants. | Posted | Median | 95% Confidence Interval | Months | Baseline to the end of the study (3 years, 1 month) |
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| Secondary | Safety: Incidence of Adverse Events | Not Posted | 36 months | ||||||||||||||||||||||||||||||||||||
| Secondary | Quality of Life: Functional Assessment of Chronic Illness Therapy - Lung (FACIT-L) Questionnaire | Not Posted | approximately 21 months |
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Safety analysis set: All participants who had received at least 1 dose of study medication.
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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 | Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity. | 22 | 110 | 99 | 110 | ||
| EG001 | Chemotherapy | Participants received gemcitabine 1250 mg/m^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first. | 16 | 104 | 96 | 104 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA (14.1) | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (14.1) | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
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| Abscess limb | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
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| Gastrointestinal infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
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| Haemorrhoid infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
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| Localised infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
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| Nail bed infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
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| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
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| Small intestinal haemorrhage | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
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| Thrombosis | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
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| Pericardial effusion | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
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| Femur fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
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| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
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| Blood glucose increased | Investigations | MedDRA (14.1) | Systematic Assessment |
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| Platelet count decreased | Investigations | MedDRA (14.1) | Systematic Assessment |
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| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
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| Bone erosion | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
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| Chest pain | General disorders | MedDRA (14.1) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Atrial septal defect | Congenital, familial and genetic disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Systematic Assessment |
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| Spinal cord compression | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
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| Bipolar disorder | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
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| Haemorrhoid operation | Surgical and medical procedures | MedDRA (14.1) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
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| Mouth ulceration | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA (14.1) | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA (14.1) | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA (14.1) | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (14.1) | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
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| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA (14.1) | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA (14.1) | Systematic Assessment |
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| Platelet count decreased | Investigations | MedDRA (14.1) | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA (14.1) | Systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA (14.1) | Systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA (14.1) | Systematic Assessment |
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| Haemoglobin decreased | Investigations | MedDRA (14.1) | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (14.1) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (14.1) | Systematic Assessment |
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| Chest discomfort | General disorders | MedDRA (14.1) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
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| Paronychia | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
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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 | genentech@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 |
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| ID | Term |
|---|---|
| D000069347 | Erlotinib Hydrochloride |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D013812 | Therapeutics |
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| Male |
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| Units | Counts |
|---|
| Participants |
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