Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:27 PM
Study NCT ID:
NCT01121393
Status:
COMPLETED
Last Update Posted:
2018-12-14
First Post:
2010-04-21
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
BIBW 2992 (Afatinib) vs Gemcitabine-cisplatin in 1st Line Non-small Cell Lung Cancer (NSCLC)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['India']}, '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': 'D000077716', 'term': 'Afatinib'}], 'ancestors': [{'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic 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': 'From first administration of study medication until 28 days after the last administration of study medication up to 374 weeks', 'description': 'The treated set (TS) included all randomised patients documented to have taken at least 1 dose of study medication. Analysis of Adverse Events (AEs) was based on the concept of treatment-emergent AEs. AEs with onset after the first administration of study drug and within 28 days after the last administration were considered to be on-treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Afatinib 40 Milligram (mg)', 'description': 'Patients received Afatinib film-coated tablets 40 mg once daily (q.d.) orally with possible dose escalation to 50 mg q.d. and dose reduction to 40 mg q.d. (if applicable), 30 mg q.d., or 20 mg q.d. (according to the protocol-defined dose-escalation and dose-reduction scheme), if required. No dose increase was allowed after dose reduction. Each treatment course was planned to be 21 days. For afatinib, patients received continuous daily dosing until disease progression, unacceptable adverse events (AEs) occurred, or withdrawal of consent for any reason.', 'otherNumAtRisk': 239, 'deathsNumAtRisk': 239, 'otherNumAffected': 236, 'seriousNumAtRisk': 239, 'deathsNumAffected': 16, 'seriousNumAffected': 40}, {'id': 'EG001', 'title': 'Gemcitabine / Cisplatin Chemotherapy', 'description': 'Patients received Gemcitabine (lyophilised powder) 1000 milligram per square metre (mg/m²) as an intravenous infusion over 30 minutes on day 1 and day 8, cisplatin (solution for infusion) 75 mg/m² as an intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles; Chemotherapy could be delayed or the dose could be reduced in accordance with the guidance in the current summary of product characteristics. For gemcitabine / cisplatin, patients were to receive a maximum of 6 treatment courses unless they developed disease progression, experienced unacceptable AEs, or withdrawal of consent for any reason.', 'otherNumAtRisk': 113, 'deathsNumAtRisk': 113, 'otherNumAffected': 112, 'seriousNumAtRisk': 113, 'deathsNumAffected': 3, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 31}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 58}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 61}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 20}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 31}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 212}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 85}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 91}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 35}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Paronychia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 80}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 18}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 22}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 29}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 27}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 47}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 26}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 14}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hypoproteinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 15}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 8}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 11}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Palmar-plantar erythrodysaesthesia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 175}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Skin fissures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Multiple organ dysfunction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Central nervous system infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Meningitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Paronychia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Toxicity to various agents', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cachexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pathological fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Lung cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Malignant neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Metastases to central nervous system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Metastases to meninges', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cerebral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dysarthria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Skin disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Afatinib 40 Milligram (mg)', 'description': 'Patients received Afatinib film-coated tablets 40 mg once daily (q.d.) orally with possible dose escalation to 50 mg q.d. and dose reduction to 40 mg q.d. (if applicable), 30 mg q.d., or 20 mg q.d. (according to the protocol-defined dose-escalation and dose-reduction scheme), if required. No dose increase was allowed after dose reduction. Each treatment course was planned to be 21 days. For afatinib, patients received continuous daily dosing until disease progression, unacceptable adverse events (AEs) occurred, or withdrawal of consent for any reason.'}, {'id': 'OG001', 'title': 'Gemcitabine / Cisplatin Chemotherapy', 'description': 'Patients received Gemcitabine (lyophilised powder) 1000 milligram per square metre (mg/m²) as an intravenous infusion over 30 minutes on day 1 and day 8, cisplatin (solution for infusion) 75 mg/m² as an intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles; Chemotherapy could be delayed or the dose could be reduced in accordance with the guidance in the current summary of product characteristics. For gemcitabine / cisplatin, patients were to receive a maximum of 6 treatment courses unless they developed disease progression, experienced unacceptable AEs, or withdrawal of consent for any reason.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.01', 'groupId': 'OG000', 'lowerLimit': '9.66', 'upperLimit': '13.73'}, {'value': '5.59', 'groupId': 'OG001', 'lowerLimit': '4.67', 'upperLimit': '6.70'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'A stratified log-rank test (by the epidermal growth factor receptor (EGFR) mutation category stratification factor used at randomisation) was used to test for the effect of afatinib on PFS compared with gemcitabine / cisplatin chemotherapy.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.281', 'ciLowerLimit': '0.203', 'ciUpperLimit': '0.389', 'groupDescription': 'A Cox proportional-hazards model, stratified by EGFR mutation category was used to estimate the hazard ratio (HR) and 95% confidence interval (CI) between the 2 treatment arms.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 168', 'description': 'The primary endpoint was progression-free survival (PFS) as assessed by central independent review according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. Progression-free survival was defined as the time from randomisation to disease progression or death whichever occurs earlier. A pre-defined set of censoring rules were used for patients who did not have a PFS.\n\nOnly data collected up until the analysis cut-off date (27 December 2013) were considered. Median time results from unstratified Kaplan-Meier estimates.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The randomised set (RS) included all patients randomised to receive treatment, whether treated or not.'}, {'type': 'SECONDARY', 'title': 'Objective Response (OR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Afatinib 40 Milligram (mg)', 'description': 'Patients received Afatinib film-coated tablets 40 mg once daily (q.d.) orally with possible dose escalation to 50 mg q.d. and dose reduction to 40 mg q.d. (if applicable), 30 mg q.d., or 20 mg q.d. (according to the protocol-defined dose-escalation and dose-reduction scheme), if required. No dose increase was allowed after dose reduction. Each treatment course was planned to be 21 days. For afatinib, patients received continuous daily dosing until disease progression, unacceptable adverse events (AEs) occurred, or withdrawal of consent for any reason.'}, {'id': 'OG001', 'title': 'Gemcitabine / Cisplatin Chemotherapy', 'description': 'Patients received Gemcitabine (lyophilised powder) 1000 milligram per square metre (mg/m²) as an intravenous infusion over 30 minutes on day 1 and day 8, cisplatin (solution for infusion) 75 mg/m² as an intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles; Chemotherapy could be delayed or the dose could be reduced in accordance with the guidance in the current summary of product characteristics. For gemcitabine / cisplatin, patients were to receive a maximum of 6 treatment courses unless they developed disease progression, experienced unacceptable AEs, or withdrawal of consent for any reason.'}], 'classes': [{'categories': [{'measurements': [{'value': '67.8', 'groupId': 'OG000', 'lowerLimit': '61.5', 'upperLimit': '73.6'}, {'value': '23.0', 'groupId': 'OG001', 'lowerLimit': '15.8', 'upperLimit': '31.4'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.572', 'ciLowerLimit': '4.522', 'ciUpperLimit': '12.679', 'groupDescription': 'A logistic regression model, stratified by EGFR mutation category was used to compare the objective response rate between the 2 treatment arms.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374', 'description': 'OR is defined as a best overall response of complete response (CR) or partial response (PR) assessed by central independent review according to RECIST version 1.1 and will be presented as the percentage of patients with OR.\n\nCR is defined as the disappearance of all target lesions and non-target lesions and no new lesions.\n\nPR is defined as at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD, non-Progressive Disease or non evaluation of all non-target lesions and no new lesions.\n\n(Exact 95% Confidence interval by Clopper and Pearson.)', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The randomised set.'}, {'type': 'SECONDARY', 'title': 'Disease Control (DC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Afatinib 40 Milligram (mg)', 'description': 'Patients received Afatinib film-coated tablets 40 mg once daily (q.d.) orally with possible dose escalation to 50 mg q.d. and dose reduction to 40 mg q.d. (if applicable), 30 mg q.d., or 20 mg q.d. (according to the protocol-defined dose-escalation and dose-reduction scheme), if required. No dose increase was allowed after dose reduction. Each treatment course was planned to be 21 days. For afatinib, patients received continuous daily dosing until disease progression, unacceptable adverse events (AEs) occurred, or withdrawal of consent for any reason.'}, {'id': 'OG001', 'title': 'Gemcitabine / Cisplatin Chemotherapy', 'description': 'Patients received Gemcitabine (lyophilised powder) 1000 milligram per square metre (mg/m²) as an intravenous infusion over 30 minutes on day 1 and day 8, cisplatin (solution for infusion) 75 mg/m² as an intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles; Chemotherapy could be delayed or the dose could be reduced in accordance with the guidance in the current summary of product characteristics. For gemcitabine / cisplatin, patients were to receive a maximum of 6 treatment courses unless they developed disease progression, experienced unacceptable AEs, or withdrawal of consent for any reason.'}], 'classes': [{'categories': [{'measurements': [{'value': '92.6', 'groupId': 'OG000', 'lowerLimit': '88.5', 'upperLimit': '95.5'}, {'value': '76.2', 'groupId': 'OG001', 'lowerLimit': '67.7', 'upperLimit': '83.5'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.843', 'ciLowerLimit': '2.039', 'ciUpperLimit': '7.240', 'groupDescription': 'stratified for EGFR mutation group', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374', 'description': 'DC is defined as a patient with objective response (OR) or stable disease (SD) assessed by central independent review according to RECIST version 1.1 and will be presented as the percentage of patients with DC.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The randomised set.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Afatinib 40 Milligram (mg)', 'description': 'Patients received Afatinib film-coated tablets 40 mg once daily (q.d.) orally with possible dose escalation to 50 mg q.d. and dose reduction to 40 mg q.d. (if applicable), 30 mg q.d., or 20 mg q.d. (according to the protocol-defined dose-escalation and dose-reduction scheme), if required. No dose increase was allowed after dose reduction. Each treatment course was planned to be 21 days. For afatinib, patients received continuous daily dosing until disease progression, unacceptable adverse events (AEs) occurred, or withdrawal of consent for any reason.'}, {'id': 'OG001', 'title': 'Gemcitabine / Cisplatin Chemotherapy', 'description': 'Patients received Gemcitabine (lyophilised powder) 1000 milligram per square metre (mg/m²) as an intravenous infusion over 30 minutes on day 1 and day 8, cisplatin (solution for infusion) 75 mg/m² as an intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles; Chemotherapy could be delayed or the dose could be reduced in accordance with the guidance in the current summary of product characteristics. For gemcitabine / cisplatin, patients were to receive a maximum of 6 treatment courses unless they developed disease progression, experienced unacceptable AEs, or withdrawal of consent for any reason.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.10', 'groupId': 'OG000', 'lowerLimit': '20.40', 'upperLimit': '27.33'}, {'value': '23.46', 'groupId': 'OG001', 'lowerLimit': '17.94', 'upperLimit': '25.56'}]}]}], 'analyses': [{'pValue': '0.4013', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'A stratified log-rank test (by the epidermal growth factor receptor (EGFR) mutation category stratification factor used at randomisation) was used to test for the effect of afatinib on OS compared with gemcitabine / cisplatin chemotherapy.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.904', 'ciLowerLimit': '0.715', 'ciUpperLimit': '1.144', 'groupDescription': 'A Cox proportional hazard model stratified (by EGFR mutation category stratification factor used at randomisation) was used to test the effect of afatinib on OS compared with gemcitabine / cisplatin chemotherapy.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomisation up to 374 weeks', 'description': 'OS is defined as the time from randomisation to death. For patients who had not died until 7 December 2017, the date they were last known to be alive was derived from patient status records, the trial completion record, radiological imaging assessments, the study treatment termination record, and the randomisation date.\n\nMedian time results from unstratified Kaplan-Meier estimates.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The randomised set.'}, {'type': 'SECONDARY', 'title': 'Time to Objective Response (OR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Afatinib 40 Milligram (mg)', 'description': 'Patients received Afatinib film-coated tablets 40 mg once daily (q.d.) orally with possible dose escalation to 50 mg q.d. and dose reduction to 40 mg q.d. (if applicable), 30 mg q.d., or 20 mg q.d. (according to the protocol-defined dose-escalation and dose-reduction scheme), if required. No dose increase was allowed after dose reduction. Each treatment course was planned to be 21 days. For afatinib, patients received continuous daily dosing until disease progression, unacceptable adverse events (AEs) occurred, or withdrawal of consent for any reason.'}, {'id': 'OG001', 'title': 'Gemcitabine / Cisplatin Chemotherapy', 'description': 'Patients received Gemcitabine (lyophilised powder) 1000 milligram per square metre (mg/m²) as an intravenous infusion over 30 minutes on day 1 and day 8, cisplatin (solution for infusion) 75 mg/m² as an intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles; Chemotherapy could be delayed or the dose could be reduced in accordance with the guidance in the current summary of product characteristics. For gemcitabine / cisplatin, patients were to receive a maximum of 6 treatment courses unless they developed disease progression, experienced unacceptable AEs, or withdrawal of consent for any reason.'}], 'classes': [{'title': 'By Week 6', 'categories': [{'measurements': [{'value': '49.2', 'groupId': 'OG000'}, {'value': '13.1', 'groupId': 'OG001'}]}]}, {'title': 'By Week 12', 'categories': [{'measurements': [{'value': '59.9', 'groupId': 'OG000'}, {'value': '19.7', 'groupId': 'OG001'}]}]}, {'title': 'By Week 18', 'categories': [{'measurements': [{'value': '64.0', 'groupId': 'OG000'}, {'value': '23.0', 'groupId': 'OG001'}]}]}, {'title': 'By Week 24', 'categories': [{'measurements': [{'value': '64.9', 'groupId': 'OG000'}, {'value': '23.0', 'groupId': 'OG001'}]}]}, {'title': 'By Week 30', 'categories': [{'measurements': [{'value': '65.7', 'groupId': 'OG000'}, {'value': '23.0', 'groupId': 'OG001'}]}]}, {'title': 'By Week 36', 'categories': [{'measurements': [{'value': '66.1', 'groupId': 'OG000'}, {'value': '23.0', 'groupId': 'OG001'}]}]}, {'title': 'By Week 42', 'categories': [{'measurements': [{'value': '66.5', 'groupId': 'OG000'}, {'value': '23.0', 'groupId': 'OG001'}]}]}, {'title': 'By Week 48', 'categories': [{'measurements': [{'value': '66.5', 'groupId': 'OG000'}, {'value': '23.0', 'groupId': 'OG001'}]}]}, {'title': 'By Week 60', 'categories': [{'measurements': [{'value': '66.9', 'groupId': 'OG000'}, {'value': '23.0', 'groupId': 'OG001'}]}]}, {'title': 'By Week 72', 'categories': [{'measurements': [{'value': '66.9', 'groupId': 'OG000'}, {'value': '23.0', 'groupId': 'OG001'}]}]}, {'title': 'By Week 84', 'categories': [{'measurements': [{'value': '66.9', 'groupId': 'OG000'}, {'value': '23.0', 'groupId': 'OG001'}]}]}, {'title': 'By Week 96', 'categories': [{'measurements': [{'value': '67.4', 'groupId': 'OG000'}, {'value': '23.0', 'groupId': 'OG001'}]}]}, {'title': 'By Week 108', 'categories': [{'measurements': [{'value': '67.4', 'groupId': 'OG000'}, {'value': '23.0', 'groupId': 'OG001'}]}]}, {'title': 'By Week 120', 'categories': [{'measurements': [{'value': '67.8', 'groupId': 'OG000'}, {'value': '23.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374', 'description': 'OR is defined as a best of overall response of complete response (CR) or partial response (PR) assessed by central independent review according to RECIST version 1.1.\n\nFor patients with an objective response, time to objective response was defined as the time from randomisation to the first objective response.\n\nOutcome data are the percentage of patients with OR by each scheduled tumour assessment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The RS included all patients randomised to receive treatment, whether treated or not.'}, {'type': 'SECONDARY', 'title': 'Duration of Objective Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Afatinib 40 Milligram (mg)', 'description': 'Patients received Afatinib film-coated tablets 40 mg once daily (q.d.) orally with possible dose escalation to 50 mg q.d. and dose reduction to 40 mg q.d. (if applicable), 30 mg q.d., or 20 mg q.d. (according to the protocol-defined dose-escalation and dose-reduction scheme), if required. No dose increase was allowed after dose reduction. Each treatment course was planned to be 21 days. For afatinib, patients received continuous daily dosing until disease progression, unacceptable adverse events (AEs) occurred, or withdrawal of consent for any reason.'}, {'id': 'OG001', 'title': 'Gemcitabine / Cisplatin Chemotherapy', 'description': 'Patients received Gemcitabine (lyophilised powder) 1000 milligram per square metre (mg/m²) as an intravenous infusion over 30 minutes on day 1 and day 8, cisplatin (solution for infusion) 75 mg/m² as an intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles; Chemotherapy could be delayed or the dose could be reduced in accordance with the guidance in the current summary of product characteristics. For gemcitabine / cisplatin, patients were to receive a maximum of 6 treatment courses unless they developed disease progression, experienced unacceptable AEs, or withdrawal of consent for any reason.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.72', 'groupId': 'OG000', 'lowerLimit': '8.34', 'upperLimit': '12.45'}, {'value': '4.27', 'groupId': 'OG001', 'lowerLimit': '2.76', 'upperLimit': '5.75'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374', 'description': 'OR is defined as a best of overall response of complete response (CR) or partial response (PR) assessed by central independent review according to RECIST version 1.1.\n\nFor patients with an objective response, duration of objective response was defined as the time from the first objective response to disease progression or death whichever occurs earlier. A pre-defined set of censoring rules were used for patients who did not progress/die. The Median values are Kaplan-Meier estimates.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Randomised set with an objective response.'}, {'type': 'SECONDARY', 'title': 'Duration of Disease Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Afatinib 40 Milligram (mg)', 'description': 'Patients received Afatinib film-coated tablets 40 mg once daily (q.d.) orally with possible dose escalation to 50 mg q.d. and dose reduction to 40 mg q.d. (if applicable), 30 mg q.d., or 20 mg q.d. (according to the protocol-defined dose-escalation and dose-reduction scheme), if required. No dose increase was allowed after dose reduction. Each treatment course was planned to be 21 days. For afatinib, patients received continuous daily dosing until disease progression, unacceptable adverse events (AEs) occurred, or withdrawal of consent for any reason.'}, {'id': 'OG001', 'title': 'Gemcitabine / Cisplatin Chemotherapy', 'description': 'Patients received Gemcitabine (lyophilised powder) 1000 milligram per square metre (mg/m²) as an intravenous infusion over 30 minutes on day 1 and day 8, cisplatin (solution for infusion) 75 mg/m² as an intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles; Chemotherapy could be delayed or the dose could be reduced in accordance with the guidance in the current summary of product characteristics. For gemcitabine / cisplatin, patients were to receive a maximum of 6 treatment courses unless they developed disease progression, experienced unacceptable AEs, or withdrawal of consent for any reason.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.07', 'groupId': 'OG000', 'lowerLimit': '9.69', 'upperLimit': '13.80'}, {'value': '5.65', 'groupId': 'OG001', 'lowerLimit': '5.49', 'upperLimit': '6.93'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374', 'description': 'For patients with disease control, duration of disease control was defined as the time from randomisation to progression or death whichever occurs first. A pre-defined set of censoring rules were used for patients who did not progress/die. The Median values are Kaplan-Meier estimates.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The randomised set with disease control.'}, {'type': 'SECONDARY', 'title': 'Tumour Shrinkage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Afatinib 40 Milligram (mg)', 'description': 'Patients received Afatinib film-coated tablets 40 mg once daily (q.d.) orally with possible dose escalation to 50 mg q.d. and dose reduction to 40 mg q.d. (if applicable), 30 mg q.d., or 20 mg q.d. (according to the protocol-defined dose-escalation and dose-reduction scheme), if required. No dose increase was allowed after dose reduction. Each treatment course was planned to be 21 days. For afatinib, patients received continuous daily dosing until disease progression, unacceptable adverse events (AEs) occurred, or withdrawal of consent for any reason.'}, {'id': 'OG001', 'title': 'Gemcitabine / Cisplatin Chemotherapy', 'description': 'Patients received Gemcitabine (lyophilised powder) 1000 milligram per square metre (mg/m²) as an intravenous infusion over 30 minutes on day 1 and day 8, cisplatin (solution for infusion) 75 mg/m² as an intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles; Chemotherapy could be delayed or the dose could be reduced in accordance with the guidance in the current summary of product characteristics. For gemcitabine / cisplatin, patients were to receive a maximum of 6 treatment courses unless they developed disease progression, experienced unacceptable AEs, or withdrawal of consent for any reason.'}], 'classes': [{'categories': [{'measurements': [{'value': '33.41', 'spread': '0.99', 'groupId': 'OG000'}, {'value': '47.06', 'spread': '1.45', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.64', 'ciLowerLimit': '-17.10', 'ciUpperLimit': '-10.19', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.76', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'adjusted for baseline sum of diameters and EGFR mutation group'}], 'paramType': 'MEAN', 'timeFrame': 'Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374', 'description': 'Tumour shrinkage is calculated as the minimum post-baseline sum of longest diameters of target lesions (longest for non-nodal lesions, short axis for nodal lesions) (SLD), as assessed by central independent review. The mean of these minimum values are presented after adjusting for baseline sum of longest diameters and EGFR mutation category. Only data collected up until the analysis cut-off date (27 Dec 2013) were considered. A negative value means the smallest post-baseline SLD was smaller than baseline (decreased since baseline); a positive value means tumor size increased since baseline.\n\nThe means are adjusted for baseline sum of lesions and EGFR mutation category.', 'unitOfMeasure': 'millimetre (mm)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The randomised set. There were ony 220 patients in the Afatinib arm and 101 patients in the Gemcitabine / Cisplatin arm with baseline and post-baseline target lesion measurements.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Afatinib 40 Milligram (mg)', 'description': 'Patients received Afatinib film-coated tablets 40 mg once daily (q.d.) orally with possible dose escalation to 50 mg q.d. and dose reduction to 40 mg q.d. (if applicable), 30 mg q.d., or 20 mg q.d. (according to the protocol-defined dose-escalation and dose-reduction scheme), if required. No dose increase was allowed after dose reduction. Each treatment course was planned to be 21 days. For afatinib, patients received continuous daily dosing until disease progression, unacceptable adverse events (AEs) occurred, or withdrawal of consent for any reason.'}, {'id': 'OG001', 'title': 'Gemcitabine / Cisplatin Chemotherapy', 'description': 'Patients received Gemcitabine (lyophilised powder) 1000 milligram per square metre (mg/m²) as an intravenous infusion over 30 minutes on day 1 and day 8, cisplatin (solution for infusion) 75 mg/m² as an intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles; Chemotherapy could be delayed or the dose could be reduced in accordance with the guidance in the current summary of product characteristics. For gemcitabine / cisplatin, patients were to receive a maximum of 6 treatment courses unless they developed disease progression, experienced unacceptable AEs, or withdrawal of consent for any reason.'}], 'classes': [{'title': 'Change from baseline at lowest value', 'categories': [{'measurements': [{'value': '-3.03', 'spread': '3.99', 'groupId': 'OG000'}, {'value': '-1.52', 'spread': '3.65', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline at last value', 'categories': [{'measurements': [{'value': '-0.76', 'spread': '4.79', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '4.52', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 374 weeks.', 'description': 'The change from baseline to the lowest and the last body weight recorded or during the the study.', 'unitOfMeasure': 'kilogram (kg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The randomised set. Data only presented for a patient with a baseline and at least on post-baseline assessment of weight.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Afatinib 40 Milligram (mg)', 'description': 'Patients received Afatinib film-coated tablets 40 mg once daily (q.d.) orally with possible dose escalation to 50 mg q.d. and dose reduction to 40 mg q.d. (if applicable), 30 mg q.d., or 20 mg q.d. (according to the protocol-defined dose-escalation and dose-reduction scheme), if required. No dose increase was allowed after dose reduction. Each treatment course was planned to be 21 days. For afatinib, patients received continuous daily dosing until disease progression, unacceptable adverse events (AEs) occurred, or withdrawal of consent for any reason.'}, {'id': 'OG001', 'title': 'Gemcitabine / Cisplatin Chemotherapy', 'description': 'Patients received Gemcitabine (lyophilised powder) 1000 milligram per square metre (mg/m²) as an intravenous infusion over 30 minutes on day 1 and day 8, cisplatin (solution for infusion) 75 mg/m² as an intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles; Chemotherapy could be delayed or the dose could be reduced in accordance with the guidance in the current summary of product characteristics. For gemcitabine / cisplatin, patients were to receive a maximum of 6 treatment courses unless they developed disease progression, experienced unacceptable AEs, or withdrawal of consent for any reason.'}], 'classes': [{'title': 'ECOG PS 0 (baseline) 0 (last value)', 'categories': [{'measurements': [{'value': '11.4', 'groupId': 'OG000'}, {'value': '21.8', 'groupId': 'OG001'}]}]}, {'title': 'ECOG PS 1 (baseline) 0 (last value)', 'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000'}, {'value': '3.6', 'groupId': 'OG001'}]}]}, {'title': 'ECOG PS 0 (baseline) 1 (last value)', 'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000'}, {'value': '14.5', 'groupId': 'OG001'}]}]}, {'title': 'ECOG PS 1 (baseline) 1 (last value)', 'categories': [{'measurements': [{'value': '67.5', 'groupId': 'OG000'}, {'value': '51.8', 'groupId': 'OG001'}]}]}, {'title': 'ECOG PS 0 (baseline) 2 (last value)', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'ECOG PS 1 (baseline) 2 (last value)', 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'ECOG PS 0 (baseline) 3 (last value)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'ECOG PS 1 (baseline) 3 (last value)', 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000'}, {'value': '4.5', 'groupId': 'OG001'}]}]}, {'title': 'ECOG PS 0 (baseline) 4 (last value)', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'ECOG PS 1 (baseline) 4 (last value)', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 374 weeks.', 'description': "The last ECOG performance score category recorded during the study. Outcome data are the percentage of patients with an shift of ECOG performance status from baseline to the last ECOG performance status.\n\nECOG 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 selfcare, unable to carry out any work activities;\n3. Capable of only limited self care, confined to bed or chair more then 50 percent of waking hours;\n4. Completely disabled, cannot carry on any selfcare, totally confined to bed or chair;\n5. Dead", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The randomised set. Data only presented for patients with a baseline and at least one post-baseline assessment of ECOG status.'}, {'type': 'SECONDARY', 'title': 'Health Related Quality of Life (HRQOL): Time of Deterioration in Coughing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Afatinib 40 Milligram (mg)', 'description': 'Patients received Afatinib film-coated tablets 40 mg once daily (q.d.) orally with possible dose escalation to 50 mg q.d. and dose reduction to 40 mg q.d. (if applicable), 30 mg q.d., or 20 mg q.d. (according to the protocol-defined dose-escalation and dose-reduction scheme), if required. No dose increase was allowed after dose reduction. Each treatment course was planned to be 21 days. For afatinib, patients received continuous daily dosing until disease progression, unacceptable adverse events (AEs) occurred, or withdrawal of consent for any reason.'}, {'id': 'OG001', 'title': 'Gemcitabine / Cisplatin Chemotherapy', 'description': 'Patients received Gemcitabine (lyophilised powder) 1000 milligram per square metre (mg/m²) as an intravenous infusion over 30 minutes on day 1 and day 8, cisplatin (solution for infusion) 75 mg/m² as an intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles; Chemotherapy could be delayed or the dose could be reduced in accordance with the guidance in the current summary of product characteristics. For gemcitabine / cisplatin, patients were to receive a maximum of 6 treatment courses unless they developed disease progression, experienced unacceptable AEs, or withdrawal of consent for any reason.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.05', 'comment': 'As only 84 patients (34.7 percent) in Afatinib 40mg deteriorated, the upper limit of the confidence interval was not estimable.', 'groupId': 'OG000', 'lowerLimit': '17.45', 'upperLimit': 'NA'}, {'value': '10.28', 'comment': 'As only 39 patients (32.0 percent) in Gemcitabine / Cisplatin deteriorated, the upper limit of the confidence interval was not estimable.', 'groupId': 'OG001', 'lowerLimit': '4.63', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'A stratified log-rank test (by the epidermal growth factor receptor (EGFR) mutation category stratification factor used at randomisation) was used to test for the effect of afatinib on HRQOL compared with gemcitabine / cisplatin chemotherapy.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.458', 'ciLowerLimit': '0.303', 'ciUpperLimit': '0.692', 'groupDescription': 'Cox proportional hazard model stratified by EGFR mutation group', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 374 weeks.', 'description': 'HRQOL as measured by standardised questionnaires (EuropeanOrganisation for Research and Treatment of Cancer (EORTC)) quality of life questionaires (OLQ-C30) and its lung cancer module (QLQ-LC13). Analysis for cough: QLQ-LC13, question 1.\n\nTime to deterioration was defined as the time from randomisation to a score increase (i.e. worsened) of at least 10 points from baseline (0 to 100 point scale). Patients without deterioration (including those with disease progression) were censored at the date of the last available HRQOL assessment; patients without post-baseline assessments were censored at the date of randomisation. Patients were considered as having deteriorated at the time of death. The median is Kaplan-Meier estimates.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The randomised set.'}, {'type': 'SECONDARY', 'title': 'Health Related Quality of Life (HRQOL): Time of Deterioration in Dyspnoea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Afatinib 40 Milligram (mg)', 'description': 'Patients received Afatinib film-coated tablets 40 mg once daily (q.d.) orally with possible dose escalation to 50 mg q.d. and dose reduction to 40 mg q.d. (if applicable), 30 mg q.d., or 20 mg q.d. (according to the protocol-defined dose-escalation and dose-reduction scheme), if required. No dose increase was allowed after dose reduction. Each treatment course was planned to be 21 days. For afatinib, patients received continuous daily dosing until disease progression, unacceptable adverse events (AEs) occurred, or withdrawal of consent for any reason.'}, {'id': 'OG001', 'title': 'Gemcitabine / Cisplatin Chemotherapy', 'description': 'Patients received Gemcitabine (lyophilised powder) 1000 milligram per square metre (mg/m²) as an intravenous infusion over 30 minutes on day 1 and day 8, cisplatin (solution for infusion) 75 mg/m² as an intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles; Chemotherapy could be delayed or the dose could be reduced in accordance with the guidance in the current summary of product characteristics. For gemcitabine / cisplatin, patients were to receive a maximum of 6 treatment courses unless they developed disease progression, experienced unacceptable AEs, or withdrawal of consent for any reason.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.66', 'groupId': 'OG000', 'lowerLimit': '4.76', 'upperLimit': '11.17'}, {'value': '1.68', 'groupId': 'OG001', 'lowerLimit': '1.38', 'upperLimit': '3.15'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'A stratified log-rank test (by the epidermal growth factor receptor (EGFR) mutation category stratification factor used at randomisation) was used to test for the effect of afatinib on HRQOL compared with gemcitabine / cisplatin chemotherapy.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.534', 'ciLowerLimit': '0.394', 'ciUpperLimit': '0.724', 'groupDescription': 'Cox proportional hazard model stratified by EGFR mutation group', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 374 weeks.', 'description': 'HRQOL as measured by OLQ-C30 and its lung cancer module (QLQ-LC13). Analysis for dyspnoea: composite of QLQ-LC13, questions 3 to 5; individual item from QLQ-C30, question 8.\n\nTime to deterioration was defined as the time from randomisation to a score increase (i.e. worsened) of at least 10 points from baseline (0 to 100 point scale). Patients without deterioration (including those with disease progression) were censored at the date of the last available HRQOL assessment; patients without post-baseline assessments were censored at the date of randomisation. Patients were considered as having deteriorated at the time of death. The median is Kaplan-Meier estimates.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The randomised set.'}, {'type': 'SECONDARY', 'title': 'Health Related Quality of Life (HRQOL): Time of Deterioration in Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Afatinib 40 Milligram (mg)', 'description': 'Patients received Afatinib film-coated tablets 40 mg once daily (q.d.) orally with possible dose escalation to 50 mg q.d. and dose reduction to 40 mg q.d. (if applicable), 30 mg q.d., or 20 mg q.d. (according to the protocol-defined dose-escalation and dose-reduction scheme), if required. No dose increase was allowed after dose reduction. Each treatment course was planned to be 21 days. For afatinib, patients received continuous daily dosing until disease progression, unacceptable adverse events (AEs) occurred, or withdrawal of consent for any reason.'}, {'id': 'OG001', 'title': 'Gemcitabine / Cisplatin Chemotherapy', 'description': 'Patients received Gemcitabine (lyophilised powder) 1000 milligram per square metre (mg/m²) as an intravenous infusion over 30 minutes on day 1 and day 8, cisplatin (solution for infusion) 75 mg/m² as an intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles; Chemotherapy could be delayed or the dose could be reduced in accordance with the guidance in the current summary of product characteristics. For gemcitabine / cisplatin, patients were to receive a maximum of 6 treatment courses unless they developed disease progression, experienced unacceptable AEs, or withdrawal of consent for any reason.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.93', 'groupId': 'OG000', 'lowerLimit': '4.21', 'upperLimit': '10.38'}, {'value': '3.38', 'groupId': 'OG001', 'lowerLimit': '1.77', 'upperLimit': '5.29'}]}]}], 'analyses': [{'pValue': '0.0220', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'A stratified log-rank test (by the epidermal growth factor receptor (EGFR) mutation category stratification factor used at randomisation) was used to test for the effect of afatinib on HRQOL compared with gemcitabine / cisplatin chemotherapy.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.699', 'ciLowerLimit': '0.511', 'ciUpperLimit': '0.956', 'groupDescription': 'Cox proportional hazard model stratified by EGFR mutation group', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 374 weeks.', 'description': 'HRQOL as measured by OLQ-C30 and its lung cancer module QLQ-LC13. Analysis for pain: composite of QLQ-C30, questions 9 and 19; individual items from QLQ-LC13, questions 10, 11 and 12.\n\nTime to deterioration was defined as the time from randomisation to a score increase (i.e. worsened) of at least 10 points from baseline (0 to 100 point scale). Patients without deterioration (including those with disease progression) were censored at the date of the last available HRQOL assessment; patients without post-baseline assessments were censored at the date of randomisation. Patients were considered as having deteriorated at the time of death. The median is Kaplan-Meier estimates.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The randomised set.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics of Afatinib at Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Afatinib 30mg q.d.', 'description': 'Patients receiving Afatinib 30mg once daily (q.d.) orally after a dose reduction.'}, {'id': 'OG001', 'title': 'Afatinib 40mg q.d.', 'description': 'Patients receiving Afatinib 40mg once daily (q.d.) orally'}, {'id': 'OG002', 'title': 'Afatinib 50mg q.d.', 'description': 'Patients receiving Afatinib 50mg once daily (q.d.) orally after a dose escalation.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.7', 'spread': '109', 'groupId': 'OG000'}, {'value': '23.1', 'spread': '65.1', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 22 (course 2, visit 1)', 'description': 'Outcome data are the trough plasma concentrations of afatinib at day 22 after multiple daily dosing of 40mg afatinib and after dose escalation to 50mg or dose reduction to 30mg afatinib (no patient dose reduced to 20mg during the Pharmacokinetics (PK) assessment period).', 'unitOfMeasure': 'nanogram/millilitre (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who had at least 1 afatinib dose and who had at least 1 valid afatinib plasma concentration available.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics of Afatinib at Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Afatinib 30mg q.d.', 'description': 'Patients receiving Afatinib 30mg once daily (q.d.) after a dose reduction.'}, {'id': 'OG001', 'title': 'Afatinib 40mg q.d.', 'description': 'Patients receiving Afatinib 40mg once daily (q.d.)'}, {'id': 'OG002', 'title': 'Afatinib 50mg q.d.', 'description': 'Patients receiving Afatinib 50mg once daily (q.d.) after a dose escalation.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.5', 'spread': '90.3', 'groupId': 'OG000'}, {'value': '23.8', 'spread': '70.6', 'groupId': 'OG001'}, {'value': '22.8', 'spread': '60.8', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 29 (course 2, visit 2)', 'description': 'Outcome data are the trough plasma concentrations of afatinib at day 29 after multiple daily dosing of 40mg afatinib and after dose escalation to 50mg or dose reduction to 30mg afatinib (no patient dose reduced to 20mg during the PK assessment period).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who had at least 1 afatinib dose and who had at least 1 valid afatinib plasma concentration available.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics of Afatinib at Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Afatinib 30mg q.d.', 'description': 'Patients receiving Afatinib 30mg once daily (q.d.) after a dose reduction.'}, {'id': 'OG001', 'title': 'Afatinib 40mg q.d.', 'description': 'Patients receiving Afatinib 40mg once daily (q.d.)'}, {'id': 'OG002', 'title': 'Afatinib 50mg q.d.', 'description': 'Patients receiving Afatinib 50mg once daily (q.d.) after a dose escalation.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.5', 'spread': '52.9', 'groupId': 'OG000'}, {'value': '22.1', 'spread': '67.4', 'groupId': 'OG001'}, {'value': '22.9', 'spread': '62.5', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 43 (course 3, visit 1)', 'description': 'Outcome data are the trough plasma concentrations of afatinib at day 43 after multiple daily dosing of 40mg afatinib and after dose escalation to 50mg or dose reduction to 30mg afatinib (no patient dose reduced to 20mg during the PK assessment period).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who had at least 1 afatinib dose and who had at least 1 valid afatinib plasma concentration available.'}, {'type': 'SECONDARY', 'title': 'Safety of Afatinib as Indicated by Intensity and Incidence of Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Afatinib 40 Milligram (mg)', 'description': 'Patients received Afatinib film-coated tablets 40 mg once daily (q.d.) orally with possible dose escalation to 50 mg q.d. and dose reduction to 40 mg q.d. (if applicable), 30 mg q.d., or 20 mg q.d. (according to the protocol-defined dose-escalation and dose-reduction scheme), if required. No dose increase was allowed after dose reduction. Each treatment course was planned to be 21 days. For afatinib, patients received continuous daily dosing until disease progression, unacceptable adverse events (AEs) occurred, or withdrawal of consent for any reason.'}, {'id': 'OG001', 'title': 'Gemcitabine / Cisplatin Chemotherapy', 'description': 'Patients received Gemcitabine (lyophilised powder) 1000 milligram per square metre (mg/m²) as an intravenous infusion over 30 minutes on day 1 and day 8, cisplatin (solution for infusion) 75 mg/m² as an intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles; Chemotherapy could be delayed or the dose could be reduced in accordance with the guidance in the current summary of product characteristics. For gemcitabine / cisplatin, patients were to receive a maximum of 6 treatment courses unless they developed disease progression, experienced unacceptable AEs, or withdrawal of consent for any reason.'}], 'classes': [{'title': 'CTCAE Grade 1', 'categories': [{'measurements': [{'value': '13.8', 'groupId': 'OG000'}, {'value': '8.0', 'groupId': 'OG001'}]}]}, {'title': 'CTCAE Grade 2', 'categories': [{'measurements': [{'value': '36.0', 'groupId': 'OG000'}, {'value': '29.2', 'groupId': 'OG001'}]}]}, {'title': 'CTCAE Grade 3', 'categories': [{'measurements': [{'value': '39.3', 'groupId': 'OG000'}, {'value': '38.1', 'groupId': 'OG001'}]}]}, {'title': 'CTCAE Grade 4', 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000'}, {'value': '21.2', 'groupId': 'OG001'}]}]}, {'title': 'CTCAE Grade 5', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}, {'value': '2.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first administration of study medication up to 28 days after the last administration of study medication up to 374 weeks.', 'description': 'Safety of Afatinib as indicated by intensity and incidence of adverse events graded according to the US National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Presented as the percentage of patients with an Adverse Events during the on-treatment period by highest CTCAE grade.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The treated set (TS) included all randomised patients who were documented to have taken at least 1 dose of study medication (i.e. afatinib or gemcitabine / cisplatin). Patients were allocated according to the treatment actually received.'}, {'type': 'SECONDARY', 'title': 'Changes in Safety Laboratory Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Afatinib 40 Milligram (mg)', 'description': 'Patients received Afatinib film-coated tablets 40 mg once daily (q.d.) orally with possible dose escalation to 50 mg q.d. and dose reduction to 40 mg q.d. (if applicable), 30 mg q.d., or 20 mg q.d. (according to the protocol-defined dose-escalation and dose-reduction scheme), if required. No dose increase was allowed after dose reduction. Each treatment course was planned to be 21 days. For afatinib, patients received continuous daily dosing until disease progression, unacceptable adverse events (AEs) occurred, or withdrawal of consent for any reason.'}, {'id': 'OG001', 'title': 'Gemcitabine / Cisplatin Chemotherapy', 'description': 'Patients received Gemcitabine (lyophilised powder) 1000 milligram per square metre (mg/m²) as an intravenous infusion over 30 minutes on day 1 and day 8, cisplatin (solution for infusion) 75 mg/m² as an intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles; Chemotherapy could be delayed or the dose could be reduced in accordance with the guidance in the current summary of product characteristics. For gemcitabine / cisplatin, patients were to receive a maximum of 6 treatment courses unless they developed disease progression, experienced unacceptable AEs, or withdrawal of consent for any reason.'}], 'classes': [{'title': 'Potassium CTCAE grade 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'no corresponding rules defined', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'no corresponding rules defined', 'groupId': 'OG001'}]}]}, {'title': 'Potassium CTCAE grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000'}, {'value': '15.6', 'groupId': 'OG001'}]}]}, {'title': 'Potassium CTCAE grade 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000'}, {'value': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'AST CTCAE grade 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000'}, {'value': '1.9', 'groupId': 'OG001'}]}]}, {'title': 'AST CTCAE grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000'}, {'value': '1.9', 'groupId': 'OG001'}]}]}, {'title': 'AST CTCAE grade 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'ALT CTCAE grade 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.1', 'groupId': 'OG000'}, {'value': '5.6', 'groupId': 'OG001'}]}]}, {'title': 'ALT CTCAE grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000'}, {'value': '1.9', 'groupId': 'OG001'}]}]}, {'title': 'ALT CTCAE grade 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine CTCAE grade 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000'}, {'value': '2.8', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine CTCAE grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine CTCAE grade 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine Kinase CTCAE grade 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000'}, {'value': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine Kinase CTCAE grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine Kinase CTCAE grade 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first administration of study medication up to 28 days after the last administration of study medication up to 374 weeks.', 'description': 'Outcome data presented are the percentage of patients by worst CTCAE grade (only Grades 2 to 4 presented) on treatment for the following laboratory parameters: Potassium, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine and Creatine Kinase.\n\nFor Potassium; only CTCAE grades resulting from hypokalemia (low values) are presented.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set (TS) included all randomised patients who were documented to have taken at least 1 dose of study medication. Patients were allocated according to the treatment actually received. Patients with a baseline and at least one on-treatment assessment of the parameter are of interest.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Afatinib 40 Milligram (mg)', 'description': 'Patients received Afatinib film-coated tablets 40 mg once daily (q.d.) orally with possible dose escalation to 50 mg q.d. and dose reduction to 40 mg q.d. (if applicable), 30 mg q.d., or 20 mg q.d. (according to the protocol-defined dose-escalation and dose-reduction scheme), if required. No dose increase was allowed after dose reduction. Each treatment course was planned to be 21 days. For afatinib, patients received continuous daily dosing until disease progression, unacceptable adverse events (AEs) occurred, or withdrawal of consent for any reason.'}, {'id': 'FG001', 'title': 'Gemcitabine / Cisplatin Chemotherapy', 'description': 'Patients received Gemcitabine (lyophilised powder) 1000 milligram per square metre (mg/m²) as an intravenous infusion over 30 minutes on day 1 and day 8, cisplatin (solution for infusion) 75 mg/m² as an intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles; Chemotherapy could be delayed or the dose could be reduced in accordance with the guidance in the current summary of product characteristics. For gemcitabine / cisplatin, patients were to receive a maximum of 6 treatment courses unless they developed disease progression, experienced unacceptable AEs, or withdrawal of consent for any reason.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Randomised', 'groupId': 'FG000', 'numSubjects': '242'}, {'comment': 'Randomised', 'groupId': 'FG001', 'numSubjects': '122'}]}, {'type': 'Treated', 'achievements': [{'comment': 'Treated', 'groupId': 'FG000', 'numSubjects': '239'}, {'comment': 'Treated', 'groupId': 'FG001', 'numSubjects': '113'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'At the time of data cut-off for last-patient out (07 December 2017)', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Completed 6 courses of chemotherapy', 'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '242'}, {'groupId': 'FG001', 'numSubjects': '84'}]}], 'dropWithdraws': [{'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '201'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'Other Adverse events', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'Non-compliant with protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Refused cont. medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Other than listed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Two-arm, randomised (2:1 ratio), open-label, active-controlled, parallel-group comparison of afatinib versus gemcitabine / cisplatin chemotherapy.', 'preAssignmentDetails': 'All patients were screened for eligibility to participate in the trial. Patients attended a specialist sites which ensured that they met all strictly implemented inclusion/exclusion criteria. Patients were not to be entered to trial treatment if any one of the specific entry criteria was violated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '364', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Afatinib 40 Milligram (mg)', 'description': 'Patients received Afatinib film-coated tablets 40 mg once daily (q.d.) orally with possible dose escalation to 50 mg q.d. and dose reduction to 40 mg q.d. (if applicable), 30 mg q.d., or 20 mg q.d. (according to the protocol-defined dose-escalation and dose-reduction scheme), if required. No dose increase was allowed after dose reduction. Each treatment course was planned to be 21 days. For afatinib, patients received continuous daily dosing until disease progression, unacceptable adverse events (AEs) occurred, or withdrawal of consent for any reason.'}, {'id': 'BG001', 'title': 'Gemcitabine / Cisplatin Chemotherapy', 'description': 'Patients received Gemcitabine (lyophilised powder) 1000 milligram per square metre (mg/m²) as an intravenous infusion over 30 minutes on day 1 and day 8, cisplatin (solution for infusion) 75 mg/m² as an intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles; Chemotherapy could be delayed or the dose could be reduced in accordance with the guidance in the current summary of product characteristics. For gemcitabine / cisplatin, patients were to receive a maximum of 6 treatment courses unless they developed disease progression, experienced unacceptable AEs, or withdrawal of consent for any reason.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '364', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '56.7', 'spread': '11.2', 'groupId': 'BG000'}, {'value': '55.6', 'spread': '10.1', 'groupId': 'BG001'}, {'value': '56.4', 'spread': '10.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Treated Set'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '364', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '155', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '238', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Epidermal growth factor receptor (EGFR)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '364', 'groupId': 'BG002'}]}], 'categories': [{'title': 'L858R (L858R alone and L858R + Deletion Exon 19)', 'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}]}, {'title': 'Deletion Exon 19 (alone)', 'measurements': [{'value': '124', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '186', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', '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': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '364', 'groupId': 'BG002'}]}], 'categories': [{'title': 'ECOG PS 0 (baseline)', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}, {'title': 'ECOG PS 1 (baseline)', 'measurements': [{'value': '194', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '275', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', '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; 1=Restricted in physically strenuous activity, but ambulatory and able to carry out light or sedentary work; 2=Ambulatory (\\>50 percent of waking hours), capable of all selfcare, unable to carry out any work activities; 3=Capable of only limited self care, confined to bed or chair more then 50 percent of waking hours; 4=Completely disabled, cannot carry on any selfcare, totally confined to bed or chair; 5=Dead", 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The randomised set (RS) included all patients randomised to receive treatment, whether treated or not.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2013-10-16', 'size': 1275902, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-11-21T23:53', 'hasProtocol': True}, {'date': '2012-12-05', 'size': 273868, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-11-21T23:53', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 364}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2017-11-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-13', 'studyFirstSubmitDate': '2010-04-21', 'resultsFirstSubmitDate': '2014-12-27', 'studyFirstSubmitQcDate': '2010-05-11', 'lastUpdatePostDateStruct': {'date': '2018-12-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-01-23', 'studyFirstPostDateStruct': {'date': '2010-05-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free Survival', 'timeFrame': 'Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 168', 'description': 'The primary endpoint was progression-free survival (PFS) as assessed by central independent review according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. Progression-free survival was defined as the time from randomisation to disease progression or death whichever occurs earlier. A pre-defined set of censoring rules were used for patients who did not have a PFS.\n\nOnly data collected up until the analysis cut-off date (27 December 2013) were considered. Median time results from unstratified Kaplan-Meier estimates.'}], 'secondaryOutcomes': [{'measure': 'Objective Response (OR)', 'timeFrame': 'Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374', 'description': 'OR is defined as a best overall response of complete response (CR) or partial response (PR) assessed by central independent review according to RECIST version 1.1 and will be presented as the percentage of patients with OR.\n\nCR is defined as the disappearance of all target lesions and non-target lesions and no new lesions.\n\nPR is defined as at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD, non-Progressive Disease or non evaluation of all non-target lesions and no new lesions.\n\n(Exact 95% Confidence interval by Clopper and Pearson.)'}, {'measure': 'Disease Control (DC)', 'timeFrame': 'Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374', 'description': 'DC is defined as a patient with objective response (OR) or stable disease (SD) assessed by central independent review according to RECIST version 1.1 and will be presented as the percentage of patients with DC.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From randomisation up to 374 weeks', 'description': 'OS is defined as the time from randomisation to death. For patients who had not died until 7 December 2017, the date they were last known to be alive was derived from patient status records, the trial completion record, radiological imaging assessments, the study treatment termination record, and the randomisation date.\n\nMedian time results from unstratified Kaplan-Meier estimates.'}, {'measure': 'Time to Objective Response (OR)', 'timeFrame': 'Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374', 'description': 'OR is defined as a best of overall response of complete response (CR) or partial response (PR) assessed by central independent review according to RECIST version 1.1.\n\nFor patients with an objective response, time to objective response was defined as the time from randomisation to the first objective response.\n\nOutcome data are the percentage of patients with OR by each scheduled tumour assessment.'}, {'measure': 'Duration of Objective Response', 'timeFrame': 'Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374', 'description': 'OR is defined as a best of overall response of complete response (CR) or partial response (PR) assessed by central independent review according to RECIST version 1.1.\n\nFor patients with an objective response, duration of objective response was defined as the time from the first objective response to disease progression or death whichever occurs earlier. A pre-defined set of censoring rules were used for patients who did not progress/die. The Median values are Kaplan-Meier estimates.'}, {'measure': 'Duration of Disease Control', 'timeFrame': 'Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374', 'description': 'For patients with disease control, duration of disease control was defined as the time from randomisation to progression or death whichever occurs first. A pre-defined set of censoring rules were used for patients who did not progress/die. The Median values are Kaplan-Meier estimates.'}, {'measure': 'Tumour Shrinkage', 'timeFrame': 'Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374', 'description': 'Tumour shrinkage is calculated as the minimum post-baseline sum of longest diameters of target lesions (longest for non-nodal lesions, short axis for nodal lesions) (SLD), as assessed by central independent review. The mean of these minimum values are presented after adjusting for baseline sum of longest diameters and EGFR mutation category. Only data collected up until the analysis cut-off date (27 Dec 2013) were considered. A negative value means the smallest post-baseline SLD was smaller than baseline (decreased since baseline); a positive value means tumor size increased since baseline.\n\nThe means are adjusted for baseline sum of lesions and EGFR mutation category.'}, {'measure': 'Change From Baseline in Body Weight', 'timeFrame': 'Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 374 weeks.', 'description': 'The change from baseline to the lowest and the last body weight recorded or during the the study.'}, {'measure': 'Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)', 'timeFrame': 'Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 374 weeks.', 'description': "The last ECOG performance score category recorded during the study. Outcome data are the percentage of patients with an shift of ECOG performance status from baseline to the last ECOG performance status.\n\nECOG 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 selfcare, unable to carry out any work activities;\n3. Capable of only limited self care, confined to bed or chair more then 50 percent of waking hours;\n4. Completely disabled, cannot carry on any selfcare, totally confined to bed or chair;\n5. Dead"}, {'measure': 'Health Related Quality of Life (HRQOL): Time of Deterioration in Coughing', 'timeFrame': 'Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 374 weeks.', 'description': 'HRQOL as measured by standardised questionnaires (EuropeanOrganisation for Research and Treatment of Cancer (EORTC)) quality of life questionaires (OLQ-C30) and its lung cancer module (QLQ-LC13). Analysis for cough: QLQ-LC13, question 1.\n\nTime to deterioration was defined as the time from randomisation to a score increase (i.e. worsened) of at least 10 points from baseline (0 to 100 point scale). Patients without deterioration (including those with disease progression) were censored at the date of the last available HRQOL assessment; patients without post-baseline assessments were censored at the date of randomisation. Patients were considered as having deteriorated at the time of death. The median is Kaplan-Meier estimates.'}, {'measure': 'Health Related Quality of Life (HRQOL): Time of Deterioration in Dyspnoea', 'timeFrame': 'Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 374 weeks.', 'description': 'HRQOL as measured by OLQ-C30 and its lung cancer module (QLQ-LC13). Analysis for dyspnoea: composite of QLQ-LC13, questions 3 to 5; individual item from QLQ-C30, question 8.\n\nTime to deterioration was defined as the time from randomisation to a score increase (i.e. worsened) of at least 10 points from baseline (0 to 100 point scale). Patients without deterioration (including those with disease progression) were censored at the date of the last available HRQOL assessment; patients without post-baseline assessments were censored at the date of randomisation. Patients were considered as having deteriorated at the time of death. The median is Kaplan-Meier estimates.'}, {'measure': 'Health Related Quality of Life (HRQOL): Time of Deterioration in Pain', 'timeFrame': 'Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 374 weeks.', 'description': 'HRQOL as measured by OLQ-C30 and its lung cancer module QLQ-LC13. Analysis for pain: composite of QLQ-C30, questions 9 and 19; individual items from QLQ-LC13, questions 10, 11 and 12.\n\nTime to deterioration was defined as the time from randomisation to a score increase (i.e. worsened) of at least 10 points from baseline (0 to 100 point scale). Patients without deterioration (including those with disease progression) were censored at the date of the last available HRQOL assessment; patients without post-baseline assessments were censored at the date of randomisation. Patients were considered as having deteriorated at the time of death. The median is Kaplan-Meier estimates.'}, {'measure': 'Pharmacokinetics of Afatinib at Day 22', 'timeFrame': 'Day 22 (course 2, visit 1)', 'description': 'Outcome data are the trough plasma concentrations of afatinib at day 22 after multiple daily dosing of 40mg afatinib and after dose escalation to 50mg or dose reduction to 30mg afatinib (no patient dose reduced to 20mg during the Pharmacokinetics (PK) assessment period).'}, {'measure': 'Pharmacokinetics of Afatinib at Day 29', 'timeFrame': 'Day 29 (course 2, visit 2)', 'description': 'Outcome data are the trough plasma concentrations of afatinib at day 29 after multiple daily dosing of 40mg afatinib and after dose escalation to 50mg or dose reduction to 30mg afatinib (no patient dose reduced to 20mg during the PK assessment period).'}, {'measure': 'Pharmacokinetics of Afatinib at Day 43', 'timeFrame': 'Day 43 (course 3, visit 1)', 'description': 'Outcome data are the trough plasma concentrations of afatinib at day 43 after multiple daily dosing of 40mg afatinib and after dose escalation to 50mg or dose reduction to 30mg afatinib (no patient dose reduced to 20mg during the PK assessment period).'}, {'measure': 'Safety of Afatinib as Indicated by Intensity and Incidence of Adverse Events', 'timeFrame': 'From first administration of study medication up to 28 days after the last administration of study medication up to 374 weeks.', 'description': 'Safety of Afatinib as indicated by intensity and incidence of adverse events graded according to the US National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Presented as the percentage of patients with an Adverse Events during the on-treatment period by highest CTCAE grade.'}, {'measure': 'Changes in Safety Laboratory Parameters', 'timeFrame': 'From first administration of study medication up to 28 days after the last administration of study medication up to 374 weeks.', 'description': 'Outcome data presented are the percentage of patients by worst CTCAE grade (only Grades 2 to 4 presented) on treatment for the following laboratory parameters: Potassium, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine and Creatine Kinase.\n\nFor Potassium; only CTCAE grades resulting from hypokalemia (low values) are presented.'}]}, 'conditionsModule': {'conditions': ['Carcinoma, Non-Small-Cell Lung', 'Adenocarcinoma']}, 'referencesModule': {'references': [{'pmid': '30584317', 'type': 'DERIVED', 'citation': 'Wu YL, Xu CR, Hu CP, Feng J, Lu S, Huang Y, Li W, Hou M, Shi JH, Marten A, Fan J, Peil B, Zhou C. Afatinib versus gemcitabine/cisplatin for first-line treatment of Chinese patients with advanced non-small-cell lung cancer harboring EGFR mutations: subgroup analysis of the LUX-Lung 6 trial. Onco Targets Ther. 2018 Nov 30;11:8575-8587. doi: 10.2147/OTT.S160358. eCollection 2018.'}, {'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': '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': '24439929', 'type': 'DERIVED', 'citation': 'Wu YL, Zhou C, Hu CP, Feng J, Lu S, Huang Y, Li W, Hou M, Shi JH, Lee KY, Xu CR, Massey D, Kim M, Shi Y, Geater SL. Afatinib versus cisplatin plus gemcitabine for first-line treatment of Asian patients with advanced non-small-cell lung cancer harbouring EGFR mutations (LUX-Lung 6): an open-label, randomised phase 3 trial. Lancet Oncol. 2014 Feb;15(2):213-22. doi: 10.1016/S1470-2045(13)70604-1. Epub 2014 Jan 15.'}]}, 'descriptionModule': {'briefSummary': 'To investigate the efficacy and safety of BIBW 2992 compared to standard first-line chemotherapy in patients with stage IIIB or IV adenocarcinoma of the lung harbouring an EGFR activating mutation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. pathologically confirmed diagnosis of stage IIIB or stage IV adenocarcinoma of the Lung\n2. EGFR(Epidermal Growth Factor Receptor) mutation detected by central laboratory analysis of tumor biopsy material\n3. Measurable disease according to Response Evaluation Criteria in Solid Tumours (RECIST)1.1\n4. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.\n5. Age\\>=18 years\n6. life expectancy of at least three months\n7. Written informed consent that is consistent with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) guidelines.\n\nExclusion criteria:\n\n1. Prior chemotherapy for relapsed and/or metastatic NSCLC.\n2. Prior treatment with EGFR targeting small molecules or antibodies.\n3. Radiotherapy or surgery(other than biopsy) within 4 weeks prior to randomization\n4. Active brain metastases\n5. Any other current malignancy or malignancy diagnosed within the past 5 years\n6. Known pre-existing interstitial lung disease\n7. Significant or recent acute gastrointestinal disorders with diarrhoea as a a major symptoms.\n8. History or presence of clinically relevant cardiovascular abnormalities\n9. Cardiac left ventricular function with resting ejection fraction of less than 50%.\n10. Any other concomitant serious illness or organ system dysfunction which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the test drug.\n11. Absolute neutrophil count(ANC)\\<1500/mm3\n12. Platelet count\\<100,000/mm3\n13. Creatinine clearance\\<60ml/min or serum creatinine\\>1.5 times Upper Limit of Normal (ULN).\n14. Bilirubin\\>1.5 times ULN\n15. Aspartate Amino Transferase (AST) or Alanine Amino Transferase (ALT) \\> 3 times ULN\n16. Women of childbearing potential, or men who are able to father a child, unwilling to use a medically acceptable method of contraception during the trial\n17. Pregnancy of breast-feeding\n18. Patients unable to comply with the protocol\n19. Active hepatitis B infection, active hepatitis C infection or known HIV(Human Immunodeficiency Virus) carrier.\n20. Known or suspected active drug or alcohol abuse.\n21. requirement for treatment with any of the prohibited concomitant medications listed in section 4.2.2\n22. Any contraindications for therapy with gemcitabine/cisplatin\n23. Known hypersensitivity to BIBW2992 or the excipient of any of the trial drugs\n24. Use of any investigational drug within 4 weeks of randomization.'}, 'identificationModule': {'nctId': 'NCT01121393', 'briefTitle': 'BIBW 2992 (Afatinib) vs Gemcitabine-cisplatin in 1st Line Non-small Cell Lung Cancer (NSCLC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'LUX-Lung 6: A Randomized, 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': '1200.34'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A BIBW 2992', 'description': 'Patients receive a tablet of BIBW 2992 daily until progression or unacceptable toxicity', 'interventionNames': ['Drug: BIBW 2992']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm B Chemotherapy', 'description': 'Patients receive Gemcitabine and Cisplatin, maximum is 6 courses', 'interventionNames': ['Drug: Gemcitabine+Cisplatin']}], 'interventions': [{'name': 'Gemcitabine+Cisplatin', 'type': 'DRUG', 'description': 'Gemcitabine d1,8, Cisplatin d1, 21 days as a course, up to 6 courses.', 'armGroupLabels': ['Arm B Chemotherapy']}, {'name': 'BIBW 2992', 'type': 'DRUG', 'description': 'starting dose is 40 mg, in the event of no or minimal drug-related adverse events after one course, the dose will be increased to 50mg. in the event of certain drug related Adverse Event (AE), dose reduction will be increments of 10 mg, with the lowest dose being 20mg.', 'armGroupLabels': ['Arm A BIBW 2992']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100020', 'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Chao-Yang Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100071', 'city': 'Beijing', 'country': 'China', 'facility': '307 Hospital of PLA', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100730', 'city': 'Beijing', 'country': 'China', 'facility': 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