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Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-24 @ 5:03 PM

Ignite Modification Date: 2025-12-28 @ 6:08 PM

Study NCT ID: NCT00949650

Status: COMPLETED

Last Update Posted: 2018-04-06

First Post: 2009-07-29

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: BIBW 2992 (Afatinib) Versus Chemotherapy as First Line Treatment in NSCLC With EGFR Mutation

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Mexico']}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068437', 'term': 'Pemetrexed'}, {'id': 'D000077716', 'term': 'Afatinib'}, {'id': 'D002945', 'term': 'Cisplatin'}], 'ancestors': [{'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005971', 'term': 'Glutamates'}, {'id': 'D024342', 'term': 'Amino Acids, Acidic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000600', 'term': 'Amino Acids, Dicarboxylic'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'otherDetails': "Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'First administration of trial medication until 28 days after last administration of trial medication.', 'eventGroups': [{'id': 'EG000', 'title': 'Afatinib 40 mg', 'description': 'Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.', 'otherNumAtRisk': 229, 'otherNumAffected': 229, 'seriousNumAtRisk': 229, 'seriousNumAffected': 72}, {'id': 'EG001', 'title': 'Pemetrexed/Cisplatin Chemotherapy', 'description': 'Patients received Pemetrexed 500 mg/m\\^2 lyophilised powder as intravenous infusion after Cisplatin 75 mg/m\\^2 solution for infusion as intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles.', 'otherNumAtRisk': 111, 'otherNumAffected': 108, 'seriousNumAtRisk': 111, 'seriousNumAffected': 25}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 29}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 21}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 35}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cheilitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 39}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 216}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 75}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 88}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 50}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 39}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Paronychia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 132}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 16}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 70}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 61}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 19}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 10}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 21}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hiccups', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Nasal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 20}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Dermatitis acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Nail disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Palmar-plantar erythrodysaesthesia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 145}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 11}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Skin exfoliation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Skin fissures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 14}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 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'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Acute prerenal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pulmonary artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Superior vena cava syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-Free Survival (PFS) Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Afatinib 40 mg', 'description': 'Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.'}, {'id': 'OG001', 'title': 'Pemetrexed/Cisplatin Chemotherapy', 'description': 'Patients received Pemetrexed 500 mg/m\\^2 lyophilised powder as intravenous infusion after Cisplatin 75 mg/m\\^2 solution for infusion as intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.17', 'groupId': 'OG000', 'lowerLimit': '9.63', 'upperLimit': '13.70'}, {'value': '6.90', 'groupId': 'OG001', 'lowerLimit': '5.39', 'upperLimit': '8.25'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided p-value from log-rank test stratified by EGFR mutation group and race.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '0.576', 'ciLowerLimit': '0.426', 'ciUpperLimit': '0.778', 'estimateComment': 'Afatinib 40 mg versus Pemetrexed/Cisplatin Chemotherapy.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Cox Proportional Hazard (PH) regression stratified by epidermal growth factor receptor (EGFR) mutation group and race.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression', 'description': 'PFS was defined as time from randomisation to disease progression or death whichever occured first. Assessed by central independent review according to the Response Evaluation Criteria in Solid Tumours (RECIST 1.1). Median time results from unstratified Kaplan-Meier estimates.', 'unitOfMeasure': 'Months.', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomised set (RS)'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Objective Response (OR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Afatinib 40 mg', 'description': 'Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.'}, {'id': 'OG001', 'title': 'Pemetrexed/Cisplatin Chemotherapy', 'description': 'Patients received Pemetrexed 500 mg/m\\^2 lyophilised powder as intravenous infusion after Cisplatin 75 mg/m\\^2 solution for infusion as intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '56.5', 'groupId': 'OG000', 'lowerLimit': '49.8', 'upperLimit': '63.0'}, {'value': '22.6', 'groupId': 'OG001', 'lowerLimit': '15.3', 'upperLimit': '31.3'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '4.802', 'ciLowerLimit': '2.855', 'ciUpperLimit': '8.075', 'estimateComment': 'Afatinib 40 mg-Pemetrexed/Cisplatin Chemotherapy.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic regression stratified for EGFR mutation group and race.'}], 'paramType': 'NUMBER', 'timeFrame': 'Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression', 'description': 'OR was defined as Complete Response (CR) or Partial Response (PR). Assessed by central independent review according to RECIST 1.1.', 'unitOfMeasure': 'Percentage of patients with OR.', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'RS.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Disease Control (DC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Afatinib 40 mg', 'description': 'Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.'}, {'id': 'OG001', 'title': 'Pemetrexed/Cisplatin Chemotherapy', 'description': 'Patients received Pemetrexed 500 mg/m\\^2 lyophilised powder as intravenous infusion after Cisplatin 75 mg/m\\^2 solution for infusion as intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '90.4', 'groupId': 'OG000', 'lowerLimit': '85.9', 'upperLimit': '93.9'}, {'value': '80.9', 'groupId': 'OG001', 'lowerLimit': '72.5', 'upperLimit': '87.6'}]}]}], 'analyses': [{'pValue': '0.0118', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '2.288', 'ciLowerLimit': '1.202', 'ciUpperLimit': '4.356', 'estimateComment': 'Afatinib 40 mg-Pemetrexed/Cisplatin Chemotherapy.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic regression stratified for EGFR mutation group and race.'}], 'paramType': 'NUMBER', 'timeFrame': 'Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression', 'description': 'DC was defined as a patient with OR or Stable Disease (SD). Assessed by central independent review according to the RECIST 1.1.', 'unitOfMeasure': 'Percentage of participants with DC.', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'RS.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Afatinib 40 mg', 'description': 'Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.'}, {'id': 'OG001', 'title': 'Pemetrexed/Cisplatin Chemotherapy', 'description': 'Patients received Pemetrexed 500 mg/m\\^2 lyophilised powder as intravenous infusion after Cisplatin 75 mg/m\\^2 solution for infusion as intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.16', 'groupId': 'OG000', 'lowerLimit': '24.64', 'upperLimit': '33.58'}, {'value': '28.22', 'groupId': 'OG001', 'lowerLimit': '20.73', 'upperLimit': '33.22'}]}]}], 'analyses': [{'pValue': '0.7916', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided p-value from log-rank test stratified by EGFR mutation group and race.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.3850', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '0.880', 'ciLowerLimit': '0.660', 'ciUpperLimit': '1.174', 'estimateComment': 'Afatinib 40 mg-Pemetrexed/Cisplatin Chemotherapy.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Cox PH regression stratified by EGFR mutation group and race.'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomisation to cut-off date (17MAR2017).', 'description': 'OS was defined as time from randomisation to death.', 'unitOfMeasure': 'Months.', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'RS.'}, {'type': 'SECONDARY', 'title': 'Tumour Shrinkage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Afatinib 40 mg', 'description': 'Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.'}, {'id': 'OG001', 'title': 'Pemetrexed/Cisplatin Chemotherapy', 'description': 'Patients received Pemetrexed 500 mg/m\\^2 lyophilised powder as intravenous infusion after Cisplatin 75 mg/m\\^2 solution for infusion as intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '33.19', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '43.00', 'spread': '1.59', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-9.82', 'ciLowerLimit': '-13.64', 'ciUpperLimit': '-5.99', 'estimateComment': 'Afatinib 40 mg-Pemetrexed/Cisplatin Chemotherapy.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for baseline SoD, EGFR mutation group and race.'}], 'paramType': 'MEAN', 'timeFrame': 'Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression', 'description': 'Tumour shrinkage was calculated as the minimum Sum of Diameters (SoD) of target lesions from all post-baseline tumour assessments, as read by the central independent review. The mean of these minimum values were presented after adjusting for baseline SoD, EGFR mutation group and race.', 'unitOfMeasure': 'mm.', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'RS. There were only 203 patients in the Afatinib 40 mg arm and 101 patients in the Pemetrexed/Cisplatin Chemotherapy with tumour measurements.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Afatinib 40 mg', 'description': 'Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.'}, {'id': 'OG001', 'title': 'Pemetrexed/Cisplatin Chemotherapy', 'description': 'Patients received Pemetrexed 500 mg/m\\^2 lyophilised powder as intravenous infusion after Cisplatin 75 mg/m\\^2 solution for infusion as intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles.'}], 'classes': [{'title': 'Change from baseline at lowest value', 'categories': [{'measurements': [{'value': '-3.95', 'spread': '3.91', 'groupId': 'OG000'}, {'value': '-2.68', 'spread': '2.90', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline at last value', 'categories': [{'measurements': [{'value': '-1.19', 'spread': '5.36', 'groupId': 'OG000'}, {'value': '-0.29', 'spread': '4.02', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and throughout the trial until progression (every 3 weeks), up to 28 months.', 'description': 'Because the PFS was longer for patients in the Afatinib arm than for patients in the chemotherapy arm, the period of data collection for ECOG status and body weight continued for a longer time in the Afatinib arm.', 'unitOfMeasure': 'Kg.', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'RS. Only patients with baseline and at least one post-baseline assessment were included.'}, {'type': 'SECONDARY', 'title': 'Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Afatinib 40 mg', 'description': 'Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.'}, {'id': 'OG001', 'title': 'Pemetrexed/Cisplatin Chemotherapy', 'description': 'Patients received Pemetrexed 500 mg/m\\^2 lyophilised powder as intravenous infusion after Cisplatin 75 mg/m\\^2 solution for infusion as intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles.'}], 'classes': [{'title': 'ECOG PS 0 (last value)', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}, {'title': 'ECOG PS 1 (last value)', 'categories': [{'measurements': [{'value': '138', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}]}, {'title': 'ECOG PS 2 (last value)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Throughout the trial until progression (every 3 weeks), up to 28 months.', 'description': "ECOG PS measured on 6 point scale to assess participant's performance status. 0=Fully active, able to carry on all pre-disease activities without restriction.\n\n1. Restricted in physically strenuous activity, but ambulatory and able to carry out light or sedentary work.\n2. Ambulatory (\\>50 percent of waking hours), capable of all self-care, unable to carry out any work activities.\n3. Capable of only limited self-care, confined to bed or chair more than 50 percent of waking hours.\n4. Completely disabled, cannot carry on any self-care, totally confined to bed or chair.\n5. Dead.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'RS. Only patients with baseline and at least one post-baseline assessment were included.'}, {'type': 'SECONDARY', 'title': 'Health Related Quality of Life (HRQOL): Time to Deterioration in Coughing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Afatinib 40 mg', 'description': 'Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.'}, {'id': 'OG001', 'title': 'Pemetrexed/Cisplatin Chemotherapy', 'description': 'Patients received Pemetrexed 500 mg/m\\^2 lyophilised powder as intravenous infusion after Cisplatin 75 mg/m\\^2 solution for infusion as intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.97', 'comment': 'As only 82 patients (35.7 percent) in the Afatinib 40 mg deteriorated, the upper limit of Confidence Interval (CI) was not estimable.', 'groupId': 'OG000', 'lowerLimit': '19.22', 'upperLimit': 'NA'}, {'value': '8.02', 'comment': 'As only 44 patients (38.3 percent) in the Pemetrexed/Cisplatin Chemotherapy deteriorated, the upper limit of the CI was not estimable.', 'groupId': 'OG001', 'lowerLimit': '4.44', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.0062', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided p-value from log-rank test stratified by EGFR mutation group and race.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.2133', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '0.589', 'ciLowerLimit': '0.401', 'ciUpperLimit': '0.866', 'estimateComment': 'Afatinib 40 mg vs. Pemetrexed/Cisplatin Chemotherapy, if HR\\<1 then favours Afatinib 40 mg.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Cox PH regression stratified by EGFR mutation group and race.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Throughout the trial until progression (every 3 weeks).', 'description': 'HRQOL was measured by European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire C30 (QLQ-C30) and its lung cancer specific module LC13 (QLQ-LC13). Analysis for cough is based on QLQ-LC13 question 1. Time to deterioration was defined as the time from randomisation to a score increased (worsened) by at least 10 points from baseline (0-100 point scale). Patients were considered deteriorated at time of death. Median time results from unstratified Kaplan-Meier estimates.', 'unitOfMeasure': 'Months.', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'RS.'}, {'type': 'SECONDARY', 'title': 'HRQOL: Time to Deterioration in Dyspnoea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Afatinib 40 mg', 'description': 'Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.'}, {'id': 'OG001', 'title': 'Pemetrexed/Cisplatin Chemotherapy', 'description': 'Patients received Pemetrexed 500 mg/m\\^2 lyophilised powder as intravenous infusion after Cisplatin 75 mg/m\\^2 solution for infusion as intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.41', 'groupId': 'OG000', 'lowerLimit': '5.59', 'upperLimit': '15.93'}, {'value': '2.86', 'groupId': 'OG001', 'lowerLimit': '2.17', 'upperLimit': '4.90'}]}]}], 'analyses': [{'pValue': '0.0129', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided p-value from log-rank test stratified by EGFR mutation group and race.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0078', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '0.680', 'ciLowerLimit': '0.499', 'ciUpperLimit': '0.927', 'estimateComment': 'Afatinib 40 mg vs. Pemetrexed/Cisplatin Chemotherapy, if HR\\<1 then favours Afatinib 40 mg.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Cox PH regression stratified by EGFR mutation group and race.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Throughout the trial until progression (every 3 weeks).', 'description': 'HRQOL was measured by EORTC QLQ-C30 and its lung cancer specific module QLQ-LC13. Analysis for dyspnoea is based on composite of QLQ-LC13 questions 3-5. Time to deterioration was defined as the time from randomisation to a score increased (worsened) by at least 10 points from baseline (0-100 point scale). Patients were considered deteriorated at time of death. Median time results from unstratified Kaplan-Meier estimates.', 'unitOfMeasure': 'Months.', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'RS.'}, {'type': 'SECONDARY', 'title': 'HRQOL: Time to Deterioration in Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Afatinib 40 mg', 'description': 'Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.'}, {'id': 'OG001', 'title': 'Pemetrexed/Cisplatin Chemotherapy', 'description': 'Patients received Pemetrexed 500 mg/m\\^2 lyophilised powder as intravenous infusion after Cisplatin 75 mg/m\\^2 solution for infusion as intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.17', 'groupId': 'OG000', 'lowerLimit': '2.79', 'upperLimit': '5.59'}, {'value': '3.09', 'groupId': 'OG001', 'lowerLimit': '2.17', 'upperLimit': '3.98'}]}]}], 'analyses': [{'pValue': '0.1882', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided p-value from log-rank test stratified by EGFR mutation group and race.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0427', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '0.826', 'ciLowerLimit': '0.618', 'ciUpperLimit': '1.104', 'estimateComment': 'Afatinib 40 mg vs. Pemetrexed/Cisplatin Chemotherapy, if HR\\<1 then favours Afatinib 40 mg.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Cox PH regression stratified by EGFR mutation group and race.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Throughout the trial until progression (every 3 weeks).', 'description': 'HRQOL was measured by EORTC QLQ-C30 and its lung cancer specific module QLQ-LC13. Analysis for pain is based on composite of QLQ-C30 questions 9 and 19. Time to deterioration was defined as the time from randomisation to a score increased (worsened) by at least 10 points from baseline (0-100 point scale). Patients were considered deteriorated at time of death. Median time results from unstratified Kaplan-Meier estimates.', 'unitOfMeasure': 'Months.', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'RS.'}, {'type': 'SECONDARY', 'title': 'Trough Plasma Concentrations of Afatinib at Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '165', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Afatinib 20 mg', 'description': 'Patients received Afatinib monotherapy 20 mg film-coated tablets orally once daily after a dose reduction.'}, {'id': 'OG001', 'title': 'Afatinib 30 mg', 'description': 'Patients received Afatinib monotherapy 30 mg film-coated tablets orally once daily after a dose reduction.'}, {'id': 'OG002', 'title': 'Afatinib 40 mg', 'description': 'Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.'}, {'id': 'OG003', 'title': 'Afatinib 50 mg', 'description': 'Patients received Afatinib monotherapy 50 mg film-coated tablets orally once daily after a dose escalation.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.8', 'spread': '36.6', 'groupId': 'OG001'}, {'value': '28.0', 'spread': '85.0', 'groupId': 'OG002'}, {'value': '29.9', 'spread': '46.1', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 22.', 'description': 'Trough plasma concentrations of Afatinib at Day 22 (course 2, visit 1) after multiple daily dosing of 40 mg Afatinib and after dose escalation to 50 mg or dose reduction to 30 mg or 20 mg.', 'unitOfMeasure': 'ng/mL.', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from the treated set with evaluable data and who had at least 1 valid Afatinib plasma concentration available on this time point.'}, {'type': 'SECONDARY', 'title': 'Trough Plasma Concentrations of Afatinib at Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Afatinib 20 mg', 'description': 'Patients received Afatinib monotherapy 20 mg film-coated tablets orally once daily after a dose reduction.'}, {'id': 'OG001', 'title': 'Afatinib 30 mg', 'description': 'Patients received Afatinib monotherapy 30 mg film-coated tablets orally once daily after a dose reduction.'}, {'id': 'OG002', 'title': 'Afatinib 40 mg', 'description': 'Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.'}, {'id': 'OG003', 'title': 'Afatinib 50 mg', 'description': 'Patients received Afatinib monotherapy 50 mg film-coated tablets orally once daily after a dose escalation.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.0', 'spread': '82.4', 'groupId': 'OG001'}, {'value': '25.8', 'spread': '69.5', 'groupId': 'OG002'}, {'value': '29.6', 'spread': '79.2', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 29.', 'description': 'Trough plasma concentrations of Afatinib at day 29 (course 2, visit 2) after multiple daily dosing of 40 mg Afatinib and after dose escalation to 50 mg or dose reduction to 30 mg or 20 mg.', 'unitOfMeasure': 'ng/mL.', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from the treated set with evaluable data and who had at least 1 valid Afatinib plasma concentration available on this time point.'}, {'type': 'SECONDARY', 'title': 'Trough Plasma Concentrations of Afatinib at Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Afatinib 20 mg', 'description': 'Patients received Afatinib monotherapy 20 mg film-coated tablets orally once daily after a dose reduction.'}, {'id': 'OG001', 'title': 'Afatinib 30 mg', 'description': 'Patients received Afatinib monotherapy 30 mg film-coated tablets orally once daily after a dose reduction.'}, {'id': 'OG002', 'title': 'Afatinib 40 mg', 'description': 'Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.'}, {'id': 'OG003', 'title': 'Afatinib 50 mg', 'description': 'Patients received Afatinib monotherapy 50 mg film-coated tablets orally once daily after a dose escalation.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.4', 'spread': '260', 'groupId': 'OG000'}, {'value': '24.7', 'spread': '63.9', 'groupId': 'OG001'}, {'value': '23.5', 'spread': '66.2', 'groupId': 'OG002'}, {'value': '27.5', 'spread': '64.4', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 43.', 'description': 'Trough plasma concentrations of Afatinib at Day 43 (course 3, visit 1) after multiple daily dosing of 40 mg Afatinib and after dose escalation to 50 mg or dose reduction to 30 mg or 20 mg.', 'unitOfMeasure': 'ng/mL.', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from the treated set with evaluable data and who had at least 1 valid Afatinib plasma concentration available on this time point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Afatinib 40 mg', 'description': 'Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.'}, {'id': 'FG001', 'title': 'Pemetrexed/Cisplatin Chemotherapy', 'description': 'Patients received Pemetrexed 500 mg/m\\^2 lyophilised powder as intravenous infusion after Cisplatin 75 mg/m\\^2 solution for infusion as intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Treated patients.', 'groupId': 'FG000', 'numSubjects': '230'}, {'comment': 'Treated patients.', 'groupId': 'FG001', 'numSubjects': '115'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'On treatment at the cut-off date 17MAR2017.', 'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '230'}, {'groupId': 'FG001', 'numSubjects': '115'}]}], 'dropWithdraws': [{'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '188'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'Completed 6 courses of chemotherapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'Other Adverse Event (AE)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Refusal to continue medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Other not specified above', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Two-arm, randomised (2:1 ratio), open-label, active-controlled, parallel-group comparison. 345 patients were randomised, 5 patients were not treated: 4 patients were not eligible for treatment and 1 patient in the chemotherapy arm refused to take study medication.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '345', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Afatinib 40 mg', 'description': 'Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.'}, {'id': 'BG001', 'title': 'Pemetrexed/Cisplatin Chemotherapy', 'description': 'Patients received Pemetrexed 500 mg/m\\^2 lyophilised powder as intravenous infusion after Cisplatin 75 mg/m\\^2 solution for infusion as intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.5', 'spread': '10.1', 'groupId': 'BG000'}, {'value': '59.9', 'spread': '10.0', 'groupId': 'BG001'}, {'value': '60.3', 'spread': '10.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '147', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '224', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '166', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '249', 'groupId': 'BG002'}]}]}, {'title': 'Non-Asian', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Race (Asian/non-Asian) was a stratification factor.', 'unitOfMeasure': 'Participants'}, {'title': 'Epidermal Growth Factor Receptor (EGFR) mutation group', 'classes': [{'title': 'EGFR mutation category: L858R', 'categories': [{'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}]}]}, {'title': 'EGFR mutation category: Deletion Exon 19', 'categories': [{'measurements': [{'value': '112', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '169', 'groupId': 'BG002'}]}]}, {'title': 'EGFR mutation category: Other', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'EGFR mutation group (L858R/Deletion Exon 19/Other) was a stratification factor.', 'unitOfMeasure': 'Participants'}, {'title': 'Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)', 'classes': [{'title': 'ECOG PS 0 (baseline)', 'categories': [{'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}]}, {'title': 'ECOG PS 1 (baseline)', 'categories': [{'measurements': [{'value': '138', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '211', 'groupId': 'BG002'}]}]}, {'title': 'ECOG PS 2 (baseline)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': "ECOG PS measured on 6 point scale to assess participant's performance status. 0=Fully active, able to carry on all pre-disease activities without restriction.\n\n1. Restricted in physically strenuous activity, but ambulatory and able to carry out light or sedentary work.\n2. Ambulatory (\\>50 percent of waking hours), capable of all self-care, unable to carry out any work activities.\n3. Capable of only limited self-care, confined to bed or chair more than 50 percent of waking hours.\n4. Completely disabled, cannot carry on any self-care, totally confined to bed or chair.\n5. Dead.", 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Randomised Set (RS): The randomised set includes all patients who were randomised to receive treatment, whether treated or not.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 345}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-03-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-09', 'studyFirstSubmitDate': '2009-07-29', 'resultsFirstSubmitDate': '2013-08-08', 'studyFirstSubmitQcDate': '2009-07-29', 'lastUpdatePostDateStruct': {'date': '2018-04-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-10-25', 'studyFirstPostDateStruct': {'date': '2009-07-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-Free Survival (PFS) Time', 'timeFrame': 'Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression', 'description': 'PFS was defined as time from randomisation to disease progression or death whichever occured first. Assessed by central independent review according to the Response Evaluation Criteria in Solid Tumours (RECIST 1.1). Median time results from unstratified Kaplan-Meier estimates.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Patients With Objective Response (OR)', 'timeFrame': 'Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression', 'description': 'OR was defined as Complete Response (CR) or Partial Response (PR). Assessed by central independent review according to RECIST 1.1.'}, {'measure': 'Percentage of Participants With Disease Control (DC)', 'timeFrame': 'Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression', 'description': 'DC was defined as a patient with OR or Stable Disease (SD). Assessed by central independent review according to the RECIST 1.1.'}, {'measure': 'Overall Survival (OS) Time', 'timeFrame': 'From randomisation to cut-off date (17MAR2017).', 'description': 'OS was defined as time from randomisation to death.'}, {'measure': 'Tumour Shrinkage', 'timeFrame': 'Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression', 'description': 'Tumour shrinkage was calculated as the minimum Sum of Diameters (SoD) of target lesions from all post-baseline tumour assessments, as read by the central independent review. The mean of these minimum values were presented after adjusting for baseline SoD, EGFR mutation group and race.'}, {'measure': 'Change From Baseline in Body Weight', 'timeFrame': 'Baseline and throughout the trial until progression (every 3 weeks), up to 28 months.', 'description': 'Because the PFS was longer for patients in the Afatinib arm than for patients in the chemotherapy arm, the period of data collection for ECOG status and body weight continued for a longer time in the Afatinib arm.'}, {'measure': 'Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)', 'timeFrame': 'Throughout the trial until progression (every 3 weeks), up to 28 months.', 'description': "ECOG PS measured on 6 point scale to assess participant's performance status. 0=Fully active, able to carry on all pre-disease activities without restriction.\n\n1. Restricted in physically strenuous activity, but ambulatory and able to carry out light or sedentary work.\n2. Ambulatory (\\>50 percent of waking hours), capable of all self-care, unable to carry out any work activities.\n3. Capable of only limited self-care, confined to bed or chair more than 50 percent of waking hours.\n4. Completely disabled, cannot carry on any self-care, totally confined to bed or chair.\n5. Dead."}, {'measure': 'Health Related Quality of Life (HRQOL): Time to Deterioration in Coughing', 'timeFrame': 'Throughout the trial until progression (every 3 weeks).', 'description': 'HRQOL was measured by European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire C30 (QLQ-C30) and its lung cancer specific module LC13 (QLQ-LC13). Analysis for cough is based on QLQ-LC13 question 1. Time to deterioration was defined as the time from randomisation to a score increased (worsened) by at least 10 points from baseline (0-100 point scale). Patients were considered deteriorated at time of death. Median time results from unstratified Kaplan-Meier estimates.'}, {'measure': 'HRQOL: Time to Deterioration in Dyspnoea', 'timeFrame': 'Throughout the trial until progression (every 3 weeks).', 'description': 'HRQOL was measured by EORTC QLQ-C30 and its lung cancer specific module QLQ-LC13. Analysis for dyspnoea is based on composite of QLQ-LC13 questions 3-5. Time to deterioration was defined as the time from randomisation to a score increased (worsened) by at least 10 points from baseline (0-100 point scale). Patients were considered deteriorated at time of death. Median time results from unstratified Kaplan-Meier estimates.'}, {'measure': 'HRQOL: Time to Deterioration in Pain', 'timeFrame': 'Throughout the trial until progression (every 3 weeks).', 'description': 'HRQOL was measured by EORTC QLQ-C30 and its lung cancer specific module QLQ-LC13. Analysis for pain is based on composite of QLQ-C30 questions 9 and 19. Time to deterioration was defined as the time from randomisation to a score increased (worsened) by at least 10 points from baseline (0-100 point scale). Patients were considered deteriorated at time of death. Median time results from unstratified Kaplan-Meier estimates.'}, {'measure': 'Trough Plasma Concentrations of Afatinib at Day 22', 'timeFrame': 'Day 22.', 'description': 'Trough plasma concentrations of Afatinib at Day 22 (course 2, visit 1) after multiple daily dosing of 40 mg Afatinib and after dose escalation to 50 mg or dose reduction to 30 mg or 20 mg.'}, {'measure': 'Trough Plasma Concentrations of Afatinib at Day 29', 'timeFrame': 'Day 29.', 'description': 'Trough plasma concentrations of Afatinib at day 29 (course 2, visit 2) after multiple daily dosing of 40 mg Afatinib and after dose escalation to 50 mg or dose reduction to 30 mg or 20 mg.'}, {'measure': 'Trough Plasma Concentrations of Afatinib at Day 43', 'timeFrame': 'Day 43.', 'description': 'Trough plasma concentrations of Afatinib at Day 43 (course 3, visit 1) after multiple daily dosing of 40 mg Afatinib and after dose escalation to 50 mg or dose reduction to 30 mg or 20 mg.'}]}, 'conditionsModule': {'conditions': ['Carcinoma, Non-Small-Cell Lung', 'Adenocarcinoma']}, 'referencesModule': {'references': [{'pmid': '37235976', 'type': 'DERIVED', 'citation': "Sequist LV, Yang JC, Yamamoto N, O'Byrne K, Hirsh V, Mok T, Geater SL, Orlov S, Tsai CM, Boyer M, Su WC, Bennouna J, Kato T, Gorbunova V, Lee KH, Shah R, Massey D, Zazulina V, Shahidi M, Schuler M. Phase III Study of Afatinib or Cisplatin Plus Pemetrexed in Patients With Metastatic Lung Adenocarcinoma With EGFR Mutations. J Clin Oncol. 2023 Jun 1;41(16):2869-2876. doi: 10.1200/JCO.22.02547."}, {'pmid': '29653820', 'type': 'DERIVED', 'citation': "Wu YL, Sequist LV, Tan EH, Geater SL, Orlov S, Zhang L, Lee KH, Tsai CM, Kato T, Barrios CH, Schuler M, Hirsh V, Yamamoto N, O'Byrne K, Boyer M, Mok T, Peil B, Marten A, Chih-Hsin Yang J, Paz-Ares L, Park K. Afatinib as First-line Treatment of Older Patients With EGFR Mutation-Positive Non-Small-Cell Lung Cancer: Subgroup Analyses of the LUX-Lung 3, LUX-Lung 6, and LUX-Lung 7 Trials. Clin Lung Cancer. 2018 Jul;19(4):e465-e479. doi: 10.1016/j.cllc.2018.03.009. Epub 2018 Mar 17."}, {'pmid': '27601237', 'type': 'DERIVED', 'citation': "Yang JC, Sequist LV, Zhou C, Schuler M, Geater SL, Mok T, Hu CP, Yamamoto N, Feng J, O'Byrne K, Lu S, Hirsh V, Huang Y, Sebastian M, Okamoto I, Dickgreber N, Shah R, Marten A, Massey D, Wind S, Wu YL. Effect of dose adjustment on the safety and efficacy of afatinib for EGFR mutation-positive lung adenocarcinoma: post hoc analyses of the randomized LUX-Lung 3 and 6 trials. Ann Oncol. 2016 Nov;27(11):2103-2110. doi: 10.1093/annonc/mdw322. Epub 2016 Sep 6."}, {'pmid': '26823294', 'type': 'DERIVED', 'citation': "Schuler M, Wu YL, Hirsh V, O'Byrne K, Yamamoto N, Mok T, Popat S, Sequist LV, Massey D, Zazulina V, Yang JC. First-Line Afatinib versus Chemotherapy in Patients with Non-Small Cell Lung Cancer and Common Epidermal Growth Factor Receptor Gene Mutations and Brain Metastases. J Thorac Oncol. 2016 Mar;11(3):380-90. doi: 10.1016/j.jtho.2015.11.014. Epub 2016 Jan 25."}, {'pmid': '26094656', 'type': 'DERIVED', 'citation': 'Kato T, Yoshioka H, Okamoto I, Yokoyama A, Hida T, Seto T, Kiura K, Massey D, Seki Y, Yamamoto N. Afatinib versus cisplatin plus pemetrexed in Japanese patients with advanced non-small cell lung cancer harboring activating EGFR mutations: Subgroup analysis of LUX-Lung 3. Cancer Sci. 2015 Sep;106(9):1202-11. doi: 10.1111/cas.12723. Epub 2015 Jul 25.'}, {'pmid': '26051236', 'type': 'DERIVED', 'citation': 'Yang JC, Sequist LV, Geater SL, Tsai CM, Mok TS, Schuler M, Yamamoto N, Yu CJ, Ou SH, Zhou C, Massey D, Zazulina V, Wu YL. Clinical activity of afatinib in patients with advanced non-small-cell lung cancer harbouring uncommon EGFR mutations: a combined post-hoc analysis of LUX-Lung 2, LUX-Lung 3, and LUX-Lung 6. Lancet Oncol. 2015 Jul;16(7):830-8. doi: 10.1016/S1470-2045(15)00026-1. Epub 2015 Jun 4.'}, {'pmid': '25589191', 'type': 'DERIVED', 'citation': "Yang JC, Wu YL, Schuler M, Sebastian M, Popat S, Yamamoto N, Zhou C, Hu CP, O'Byrne K, Feng J, Lu S, Huang Y, Geater SL, Lee KY, Tsai CM, Gorbunova V, Hirsh V, Bennouna J, Orlov S, Mok T, Boyer M, Su WC, Lee KH, Kato T, Massey D, Shahidi M, Zazulina V, Sequist LV. Afatinib versus cisplatin-based chemotherapy for EGFR mutation-positive lung adenocarcinoma (LUX-Lung 3 and LUX-Lung 6): analysis of overall survival data from two randomised, phase 3 trials. Lancet Oncol. 2015 Feb;16(2):141-51. doi: 10.1016/S1470-2045(14)71173-8. Epub 2015 Jan 12."}, {'pmid': '23816967', 'type': 'DERIVED', 'citation': "Yang JC, Hirsh V, Schuler M, Yamamoto N, O'Byrne KJ, Mok TS, Zazulina V, Shahidi M, Lungershausen J, Massey D, Palmer M, Sequist LV. Symptom control and quality of life in LUX-Lung 3: a phase III study of afatinib or cisplatin/pemetrexed in patients with advanced lung adenocarcinoma with EGFR mutations. J Clin Oncol. 2013 Sep 20;31(27):3342-50. doi: 10.1200/JCO.2012.46.1764. Epub 2013 Jul 1."}, {'pmid': '23816960', 'type': 'DERIVED', 'citation': "Sequist LV, Yang JC, Yamamoto N, O'Byrne K, Hirsh V, Mok T, Geater SL, Orlov S, Tsai CM, Boyer M, Su WC, Bennouna J, Kato T, Gorbunova V, Lee KH, Shah R, Massey D, Zazulina V, Shahidi M, Schuler M. Phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations. J Clin Oncol. 2013 Sep 20;31(27):3327-34. doi: 10.1200/JCO.2012.44.2806. Epub 2013 Jul 1."}]}, 'descriptionModule': {'briefSummary': 'This randomised, open label phase III trial will be performed in patients with adenocarcinoma of the lung with tumours harbouring an Epidermal Growth Factor Receptor activating mutation. The objectives of the trial are to compare the efficacy of single agent BIBW 2992, Arm A, with Pemetrexed/Cisplatin chemotherapy, Arm B, as first line treatment for this group of patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Pathologically confirmed diagnosis of Stage IIIB (with cytologically proven pleural effusion or pericardial effusion) or Stage IV adenocarcinoma of the lung. Patients with mixed histology are eligible if adenocarcinoma is the predominant histology.\n* Epidermal Growth Factor Receptor mutation detected by central laboratory analysis of tumour biopsy material.\n* Measurable disease according to RECIST 1.1.\n* Eastern Cooperative Oncology Group score of 0 or 1.\n* Age \\>/= 18 years.\n* Life expectancy of at least three months.\n* Written informed consent that is consistent with International Conference on Harmonisation-Good Clinical Practice guidelines.\n\nExclusion criteria:\n\n* Prior chemotherapy for relapsed and/or metastatic NSCLC. Neoadjuvant/adjuvant chemotherapy is permitted if at least 12 months has elapsed between the end of chemotherapy and randomisation.\n* Prior treatment with Epidermal Growth Factor Receptor targeting small molecules or antibodies.\n* Radiotherapy or surgery (other than biopsy) within 4 weeks prior to randomisation.\n* Active brain metastases\n* Any other current malignancy or malignancy diagnosed within the past five years\n* Known pre-existing interstitial lung disease.\n* Significant or recent acute gastrointestinal disorders with diarrhoea as a major symptom.\n* History or presence of clinically relevant cardiovascular abnormalities.\n* Any other concomitant serious illness or organ system dysfunction.\n* Adequate absolute neutrophil count and platelet count\n* Adequate liver and kidney function\n* Active hepatitis B infection, active hepatitis C infection or known HIV carrier.'}, 'identificationModule': {'nctId': 'NCT00949650', 'briefTitle': 'BIBW 2992 (Afatinib) Versus Chemotherapy as First Line Treatment in NSCLC With EGFR Mutation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Randomised, Open-label, Phase III Study of BIBW 2992 Versus Chemotherapy as First-line Treatment for Patients With Stage IIIB or IV Adenocarcinoma of the Lung Harbouring an EGFR Activating Mutation', 'orgStudyIdInfo': {'id': '1200.32'}, 'secondaryIdInfos': [{'id': '2008-005615-18', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BIBW 2992', 'description': 'BIBW 2992 tablet once daily until progression', 'interventionNames': ['Drug: BIBW 2992']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cisplatin/Pemetrexed', 'description': 'Cisplatin and Pemetrexed IV once every 3 weeks for up to 6 cycles', 'interventionNames': ['Drug: Pemetrexed', 'Drug: Cisplatin']}], 'interventions': [{'name': 'Pemetrexed', 'type': 'DRUG', 'description': 'Pemetrexed IV given once every 3 weeks for up to 6 cycles', 'armGroupLabels': ['Cisplatin/Pemetrexed']}, {'name': 'BIBW 2992', 'type': 'DRUG', 'description': 'BIBW 2992 once daily until progression', 'armGroupLabels': ['BIBW 2992']}, {'name': 'Cisplatin', 'type': 'DRUG', 'description': 'Cisplatin IV given once every 3 weeks for up to 6 cycles', 'armGroupLabels': ['Cisplatin/Pemetrexed']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72703', 'city': 'Fayetteville', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Highlands Oncology Group', 'geoPoint': {'lat': 36.06258, 'lon': -94.15743}}, {'zip': '90640', 'city': 'Montebello', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Trials and Research Associates Inc', 'geoPoint': {'lat': 34.00946, 'lon': -118.10535}}, {'zip': '33179', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Innovative Medical Research of South Florida', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '70072', 'city': 'Marrero', 'state': 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