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This observational study will evaluate the safety and efficacy of Tarceva (erlotinib) in routine clinical practice as second-line treatment in patients with recurrent or metastatic non-small dell lung cancer (NSCLC). Data will be collected from patients who have received 1 course of standard systemic chemotherapy, experienced disease progression, and who are receiveingTarceva in a second-line setting. Patients will also be followed through third-line treatment if there is disease progression on Tarceva therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erlotinib | Participants received erlotinib (Tarceva) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. The recommended daily dose of erlotinib is 150 mg orally once daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erlotinib | Drug | Erlotinib was provided in the retail versions of the product. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD) | The best overall response to treatment was determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. A CR was defined as the disappearance of all target lesions (TL) or the disappearance of all non-TLs. 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. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since treatment started for TLs and the persistence of 1 or more non-TL(s). 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 appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. For the best overall responses of CR and PR, a response was "confirmed" if a subsequent RECIST evaluation also showed a CR or PR. | Baseline to the end of the study (up to 4 years, 4 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Disease Progression | The time to disease progression was defined as the time from Baseline until disease progression as determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progressive disease 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 and/or unequivocal progression of existing non-target lesions. |
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Inclusion Criteria:
Exclusion Criteria:
- Contra-indications to treatment with Tarceva.
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Non-small cell lung cancer patients with progressive disease after first-line chemotherapy.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalst | 9300 | Belgium | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Erlotinib | Participants received erlotinib (Tarceva) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. The recommended daily dose of erlotinib is 150 mg orally once daily. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Baseline to the end of the study (up to 4 years, 4 months) |
| Progression-free Survival | Progression-free survival was defined as the time from Baseline until disease progression or death from any cause. Progressive disease was determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progressive disease 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 and/or unequivocal progression of existing non-target lesions. | Baseline to the end of the study (up to 4 years, 4 months) |
| Overall Survival | Overall survival was defined as the time from Baseline until or death from any cause | Baseline to the end of the study (up to 4 years, 4 months) |
| Change From Baseline in the Lung Cancer Symptom Scale (LCSS) Scores | Study participants and treating physicians completed the LCSS, a measure of Quality of Life (QoL), at Baseline and throughout the study. The patient LCSS measures 6 major symptoms, the Symptom Burden Index (SBI), associated with lung malignancies (3 thoracic [cough, dyspnea, haemoptysis] and 3 general symptoms [loss of appetite, fatigue, pain]) and 3 additional scores (overall symptomatic distress, interference with daily activities, global QoL), each on a 100 mm visual analogue scale (0=no impairment, 100=maximum impairment). The physician LCSS evaluates the 6 lung malignancy associated symptoms, the SBI, on an ordinal scale (100=none, 75=mild, 50=moderate, 25=marked, 0=severe). The average of the patient and physician SBI scores (6 symptoms) and the average of the patient total score (9 symptoms) ranged from 0 to 100, with a higher patient and a lower physician score indicating more impairment. A negative patient and a positive physician change score indicates improvement. | Baseline to the end of the study (up to 4 years, 4 months) |
| Percentage of Participants Who Developed Rash | At each study visit, the presence of skin rash was graded using the Common Toxicity Criteria (CTC), with grade 0 = no rash, grade 1 = mild, grade 2 = moderate, grade 3 = severe, and grade 4 = life threatening or disabling rash. Reported is the percentage of participants who developed a grade ≥ 1 rash. | Baseline to the end of the study (up to 4 years, 4 months) |
| Antwerp |
| 2020 |
| Belgium |
| Arlon | 6700 | Belgium |
| Bonheiden | 2820 | Belgium |
| Bouge | 5004 | Belgium |
| Boussu | 7360 | Belgium |
| Brussels | 1020 | Belgium |
| Brussels | 1050 | Belgium |
| Brussels | 1180 | Belgium |
| Brussels | 1200 | Belgium |
| Charleroi | 6000 | Belgium |
| Chimay | 6460 | Belgium |
| Duffel | 2570 | Belgium |
| Edegem | 2650 | Belgium |
| Frameries | 7080 | Belgium |
| Genk | 3600 | Belgium |
| Gilly | 6060 | Belgium |
| Hasselt | 3500 | Belgium |
| Leuven | 3000 | Belgium |
| Liège | 4000 | Belgium |
| Marche-en-Famenne | 5411 | Belgium |
| Mons | 7000 | Belgium |
| Namur | 5000 | Belgium |
| Ostend | 8400 | Belgium |
| Ottignies | 1340 | Belgium |
| Roeselare | 8800 | Belgium |
| Seraing | 4100 | Belgium |
| Sint-Niklaas | 9100 | Belgium |
| Tournai | 7500 | Belgium |
| Turnhout | 2300 | Belgium |
| Verviers | 4800 | Belgium |
| Vilvoorde | 1800 | Belgium |
| Wilrijk | 2610 | Belgium |
| Differdange | 4602 | Luxembourg |
| Esch-alzette | Luxembourg |
| Luxembourg | 1210 | Luxembourg |
| COMPLETED |
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| NOT COMPLETED |
|
|
Per-protocol population: All enrolled participants who started erlotinib therapy and did not violate the study protocol.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort | Participants in the observational cohort received second-line therapy with Tarceva. At the time of discontinuation of Tarceva, a third-line chemotherapy or best supportive care were initiated as appropriate. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | 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 | Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD) | The best overall response to treatment was determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. A CR was defined as the disappearance of all target lesions (TL) or the disappearance of all non-TLs. 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. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since treatment started for TLs and the persistence of 1 or more non-TL(s). 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 appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. For the best overall responses of CR and PR, a response was "confirmed" if a subsequent RECIST evaluation also showed a CR or PR. | Per-protocol population: All enrolled participants who started erlotinib therapy and did not violate the study protocol. Only participants with an evaluable response were included in the analysis. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline to the end of the study (up to 4 years, 4 months) |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Time to Disease Progression | The time to disease progression was defined as the time from Baseline until disease progression as determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progressive disease 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 and/or unequivocal progression of existing non-target lesions. | Per-protocol population: All enrolled participants who started erlotinib therapy and did not violate the study protocol. Only participants with an evaluable response were included in the analysis. | Posted | Median | 95% Confidence Interval | Months | Baseline to the end of the study (up to 4 years, 4 months) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival | Progression-free survival was defined as the time from Baseline until disease progression or death from any cause. Progressive disease was determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progressive disease 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 and/or unequivocal progression of existing non-target lesions. | Per-protocol population: All enrolled participants who started erlotinib therapy and did not violate the study protocol. Only participants with an evaluable response were included in the analysis. | Posted | Median | 95% Confidence Interval | Months | Baseline to the end of the study (up to 4 years, 4 months) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival was defined as the time from Baseline until or death from any cause | Per-protocol population: All enrolled participants who started erlotinib therapy and did not violate the study protocol. | Posted | Median | 95% Confidence Interval | Months | Baseline to the end of the study (up to 4 years, 4 months) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Lung Cancer Symptom Scale (LCSS) Scores | Study participants and treating physicians completed the LCSS, a measure of Quality of Life (QoL), at Baseline and throughout the study. The patient LCSS measures 6 major symptoms, the Symptom Burden Index (SBI), associated with lung malignancies (3 thoracic [cough, dyspnea, haemoptysis] and 3 general symptoms [loss of appetite, fatigue, pain]) and 3 additional scores (overall symptomatic distress, interference with daily activities, global QoL), each on a 100 mm visual analogue scale (0=no impairment, 100=maximum impairment). The physician LCSS evaluates the 6 lung malignancy associated symptoms, the SBI, on an ordinal scale (100=none, 75=mild, 50=moderate, 25=marked, 0=severe). The average of the patient and physician SBI scores (6 symptoms) and the average of the patient total score (9 symptoms) ranged from 0 to 100, with a higher patient and a lower physician score indicating more impairment. A negative patient and a positive physician change score indicates improvement. | Per-protocol population: All enrolled participants who started erlotinib therapy and did not violate the study protocol. Only participants with LCSS scores were included in the analysis. | Posted | Mean | 95% Confidence Interval | Units on a scale | Baseline to the end of the study (up to 4 years, 4 months) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Developed Rash | At each study visit, the presence of skin rash was graded using the Common Toxicity Criteria (CTC), with grade 0 = no rash, grade 1 = mild, grade 2 = moderate, grade 3 = severe, and grade 4 = life threatening or disabling rash. Reported is the percentage of participants who developed a grade ≥ 1 rash. | Per-protocol population: All enrolled participants who started erlotinib therapy and did not violate the study protocol. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline to the end of the study (up to 4 years, 4 months) |
|
|
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Safety analysis population: All participants who received at least 1 dose of erlotinib.
The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
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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 (Tarceva) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. The recommended daily dose of erlotinib is 150 mg orally once daily. Erlotinib: Erlotinib was provided in the retail versions of the product. | 210 | 347 | 0 | 347 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Eye disorder | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Gastrointestinal perforation | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Pain | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Bronchitis bacterial | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Listeria sepsis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Drug toxicity | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Radiation pneumonitis | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| General physical condition abnormal | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Hypernatraemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Lymphangiosis carcinomatosa | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
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| Metastases to peritoneum | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
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| Pyogenic granuloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Small intestine carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
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| Coma | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Epilepsy | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Loss of consciousness | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Nervous system disorder | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Hypercapnia | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Aortic thrombosis | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Arterial thrombosis limb | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
Not provided
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 | Hoffman-LaRoche | 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
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| Title | Measurements |
|---|---|
|
| Progressive disease |
|
|
|
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| Units | Counts |
|---|---|
| Participants |
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