Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-01-07 @ 5:21 PM
Study NCT ID:
NCT00531934
Status:
COMPLETED
Last Update Posted:
2015-02-25
First Post:
2007-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Management of Tarceva - Induced Rash in Patients With Non-Small Cell Lung Cancer.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069347', 'term': 'Erlotinib Hydrochloride'}], 'ancestors': [{'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': 'genentech@druginfo.com', 'phone': '800-821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann- LaRoche'}, 'certainAgreement': {'otherDetails': "The study being conducted under this agreement is part of the overall study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the study, but after the first publication or presentation that involves the overall study. Sponsor may request that confidential information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events (AEs) were recorded continuously until 30 days after the last treatment administration.', 'eventGroups': [{'id': 'EG000', 'title': 'Erlotinib + Doxycycline', 'description': "Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.", 'otherNumAtRisk': 73, 'otherNumAffected': 71, 'seriousNumAtRisk': 73, 'seriousNumAffected': 18}, {'id': 'EG001', 'title': 'Erlotinib', 'description': 'Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.', 'otherNumAtRisk': 74, 'otherNumAffected': 69, 'seriousNumAtRisk': 74, 'seriousNumAffected': 24}], 'otherEvents': [{'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 58}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Paronychia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypertrichosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nail disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Intertrigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hyperkeratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Ingrowing nail', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Skin discolouration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 34}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Aphthous stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Abdominal rigidity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Aerophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Faecaloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Gingival bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Gingival hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Gingival pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Glossitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Haematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hiatus hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Salivary hypersecretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Subileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Xerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 30}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Catheter site inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hyperthermia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fungal skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Oral fungal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Staphylococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Bronchitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Bronchopulmonary aspergillosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Central line infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Conjunctivitis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fungal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, 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disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Adrenal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Vulvovaginal dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'seriousEvents': [{'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Colonic obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Staphylococcal skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Intracranial pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Lung disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Bronchitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Xerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Oesophageal achalasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With at Least One Skin Rash (Folliculitis) of Any Grade During the First 4 Months of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib + Doxycycline', 'description': "Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline."}, {'id': 'OG001', 'title': 'Erlotinib', 'description': 'Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '71.2', 'groupId': 'OG000'}, {'value': '80.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.175', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Days 0, 14, 28 and Months 2, 3, and 4', 'description': 'Description of skin rash (folliculitis, including erythema, papulo-pustules, nodule, and crust) was according to Common Terminology Criteria for Adverse Events (CTCAE) version 3 scale. Medical pictures of the face (front and sides views) systematically, and of any region presenting with skin lesions were obtained. The pictures were reviewed by a centralized committee of evaluation.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; data for 1 participant in the erlotinib treatment group were missing.'}, {'type': 'SECONDARY', 'title': 'Number of Skin Rash (Folliculitis) Events During the First 4 Months of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib + Doxycycline', 'description': "Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline."}, {'id': 'OG001', 'title': 'Erlotinib', 'description': 'Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 0, 14, 28 and Months 2, 3, and 4', 'description': 'A cutaneous rash as folliculitis can be defined with several types including erythema, papulo-pustular and nodules.', 'unitOfMeasure': 'rash events', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Skin Rash (Folliculitis) During the First 4 Months of Treatment By Type', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib + Doxycycline', 'description': "Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline."}, {'id': 'OG001', 'title': 'Erlotinib', 'description': 'Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.'}], 'classes': [{'title': 'Erythema', 'categories': [{'measurements': [{'value': '55.8', 'groupId': 'OG000'}, {'value': '70.7', 'groupId': 'OG001'}]}]}, {'title': 'Papulo-pustule', 'categories': [{'measurements': [{'value': '65.4', 'groupId': 'OG000'}, {'value': '72.4', 'groupId': 'OG001'}]}]}, {'title': 'Nodule', 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Crust', 'categories': [{'measurements': [{'value': '9.6', 'groupId': 'OG000'}, {'value': '25.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 0, 14, 28 and Months 2, 3, and 4', 'description': 'A cutaneous rash as folliculitis can be defined with several types including erythema, papulo-pustule, nodule, and crust.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Skin Rash (Folliculitis) During the First 4 Months of Treatment By Maximal Intensity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib + Doxycycline', 'description': "Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline."}, {'id': 'OG001', 'title': 'Erlotinib', 'description': 'Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.'}], 'classes': [{'title': 'Grade 1', 'categories': [{'measurements': [{'value': '61.5', 'groupId': 'OG000'}, {'value': '18.6', 'groupId': 'OG001'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '34.6', 'groupId': 'OG000'}, {'value': '62.7', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}, {'value': '18.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Erlotinib + doxycycline vs Erlotinib: Grade 3 intensity skin rash (folliculitis)', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Days 0, 14, 28 and Months 2, 3, and 4', 'description': 'Intensity of skin rashes was classified according to CTCAE grading. Grade 1 equals (=) Macular or papular eruption or erythema without associated symptoms; Grade 2=Macular or papular eruption or erythema with pruritus or other associated symptoms; localized desquamation or other lesions covering less than (\\<)50 percent (%) of body surface area (BSA); Grade 3=Severe, generalized erythroderma or macular, papular, or vesicular eruption; desquamation.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; only participants with an adverse event of skin rash (folliculitis) during the first 4 months were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With at Least One Skin Rash (Folliculitis) of Any Grade After the First 4 Months of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib + Doxycycline', 'description': "Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline."}, {'id': 'OG001', 'title': 'Erlotinib', 'description': 'Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}, {'value': '1.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Months 7, 10, and 12', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Skin Rash (Folliculitis) Events After the First 4 Months of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib + Doxycycline', 'description': "Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline."}, {'id': 'OG001', 'title': 'Erlotinib', 'description': 'Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Months 7, 10, and 12', 'description': 'A cutaneous rash as folliculitis can be defined with several types including erythema, papulo-pustular and nodules.', 'unitOfMeasure': 'rash events', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Skin Rash (Folliculitis) After the First 4 Months of Treatment By Type', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib + Doxycycline', 'description': "Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline."}, {'id': 'OG001', 'title': 'Erlotinib', 'description': 'Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.'}], 'classes': [{'title': 'Erythema', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Papulo-pustule', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Nodule', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Crust', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Months 7, 10, and 12', 'description': 'A cutaneous rash as folliculitis can be defined with several types including erythema, papulo-pustule, nodule, and crust.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Skin Rash (Folliculitis) After the First 4 Months of Treatment By Intensity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib + Doxycycline', 'description': "Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline."}, {'id': 'OG001', 'title': 'Erlotinib', 'description': 'Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.'}], 'classes': [{'title': 'Initial intensity: Grade 1', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Maximal intensity: Grade 1', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Months 7, 10, and 12', 'description': 'Intensity of skin rashes was classified according to CTCAE grading. Grade 1=Macular or papular eruption or erythema without associated symptoms; Grade 2=Macular or papular eruption or erythema with pruritus or other associated symptoms; localized desquamation or other lesions covering \\<50% of BSA; Grade 3=Severe, generalized erythroderma or macular, papular, or vesicular eruption; desquamation.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Time Free From Skin Rash (Folliculitis) During the First 4 Months of Treatment - Number of Participants With an Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib + Doxycycline', 'description': "Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline."}, {'id': 'OG001', 'title': 'Erlotinib', 'description': 'Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 0, 14, 28 and Months 2, 3, and 4', 'description': 'Period without occurrence was determined as the number of days from the first dose of medication until the first appearance of folliculitis, analyzed using Kaplan-Meier analysis.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Time Free From Skin Rash (Folliculitis) During the First 4 Months of Treatment - Time to Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib + Doxycycline', 'description': "Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline."}, {'id': 'OG001', 'title': 'Erlotinib', 'description': 'Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '22'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '8', 'upperLimit': '16'}]}]}], 'analyses': [{'pValue': '0.143', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.763', 'ciLowerLimit': '0.525', 'ciUpperLimit': '1.109', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Days 0, 14, 28 and Months 2, 3, and 4', 'description': 'Period without occurrence was determined as the number of days from the first dose of medication until the first appearance of folliculitis, analyzed using Kaplan-Meier analysis.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Estimated to be Event Free at 4 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib + Doxycycline', 'description': "Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline."}, {'id': 'OG001', 'title': 'Erlotinib', 'description': 'Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.7', 'groupId': 'OG000'}, {'value': '11.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 0, 14, 28 and Months 2, 3, and 4', 'description': 'Percentage of participants estimated to be without skin rash (folliculitis) at 4 months.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Time Free From Skin Rash (Folliculitis) During the Whole Treatment Period - Number of Participants With an Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib + Doxycycline', 'description': "Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline."}, {'id': 'OG001', 'title': 'Erlotinib', 'description': 'Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12', 'description': 'Period without occurrence was determined as the number of days from the first dose of medication until the first appearance of folliculitis, analyzed using Kaplan-Meier analysis.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Time Free From Skin Rash (Folliculitis) During the Whole Treatment Period - Time to Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib + Doxycycline', 'description': "Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline."}, {'id': 'OG001', 'title': 'Erlotinib', 'description': 'Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '22'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '8', 'upperLimit': '16'}]}]}], 'analyses': [{'pValue': '0.153', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.769', 'ciLowerLimit': '0.529', 'ciUpperLimit': '1.116', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12', 'description': 'Period without occurrence was determined as the number of days from the first dose of medication until the first appearance of folliculitis, analyzed using Kaplan-Meier analysis.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Estimated to be Event Free at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib + Doxycycline', 'description': "Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline."}, {'id': 'OG001', 'title': 'Erlotinib', 'description': 'Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.8', 'groupId': 'OG000'}, {'value': '11.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12', 'description': 'Percentage of participants estimated to be without skin rash (folliculitis) at 12 months.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Duration of Skin Rash (Folliculitis) During the First 4 Months of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib + Doxycycline', 'description': "Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline."}, {'id': 'OG001', 'title': 'Erlotinib', 'description': 'Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '59.6', 'spread': '35.9', 'groupId': 'OG000'}, {'value': '60.6', 'spread': '33.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 0, 14, 28 and Months 2, 3, and 4', 'description': 'If the cutaneous rash was ongoing at the last visit or Month 4, the duration of cutaneous rash was calculated between start of folliculitis and Visit Month 4 or premature withdrawal visit or death.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population; only participants with an event (folliculitis) were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Duration of Skin Rash (Folliculitis) During the Whole Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib + Doxycycline', 'description': "Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline."}, {'id': 'OG001', 'title': 'Erlotinib', 'description': 'Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '86.7', 'spread': '81.1', 'groupId': 'OG000'}, {'value': '99.3', 'spread': '90.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12', 'description': 'If the end of cutaneous rash was missing, the duration of cutaneous rash was calculated between start of folliculitis and last evaluation date.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population; only participants with an event (folliculitis) were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Other Skin Lesions of Any Grade During the First 4 Months of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib + Doxycycline', 'description': "Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline."}, {'id': 'OG001', 'title': 'Erlotinib', 'description': 'Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '39.7', 'groupId': 'OG000'}, {'value': '42.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 0, 14, 28 and Months 2, 3, and 4', 'description': 'Other skin lesions included presence or absence of xerosis and paronychia.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Other Skin Lesions During the First 4 Months of Treatment By Type', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib + Doxycycline', 'description': "Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline."}, {'id': 'OG001', 'title': 'Erlotinib', 'description': 'Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.'}], 'classes': [{'title': 'Xerosis', 'categories': [{'measurements': [{'value': '37.0', 'groupId': 'OG000'}, {'value': '41.1', 'groupId': 'OG001'}]}]}, {'title': 'Paronychia', 'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000'}, {'value': '8.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 0, 14, 28 and Months 2, 3, and 4', 'description': 'Other skin lesions included xerosis and paronychia.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Other Skin Lesions During the First 4 Months of Treatment By Maximal Intensity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib + Doxycycline', 'description': "Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline."}, {'id': 'OG001', 'title': 'Erlotinib', 'description': 'Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.'}], 'classes': [{'title': 'Grade 1', 'categories': [{'measurements': [{'value': '69.0', 'groupId': 'OG000'}, {'value': '29.0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '24.1', 'groupId': 'OG000'}, {'value': '51.6', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '6.9', 'groupId': 'OG000'}, {'value': '16.1', 'groupId': 'OG001'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Erlotinib + doxycycline vs Erlotinib: Grade 3', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Days 0, 14, 28 and Months 2, 3, and 4', 'description': 'Other skin lesions included xerosis and paronychia. Intensity was classified according to CTCAE grading. Grade 1=Macular or papular eruption or erythema without associated symptoms; Grade 2=Macular or papular eruption or erythema with pruritus or other associated symptoms; localized desquamation or other lesions covering \\<50% of BSA; Grade 3=Severe, generalized erythroderma or macular, papular, or vesicular eruption; desquamation; Grade 4=Generalized exfoliative, ulcerative, or bullous dermatitis. If a participant had several skin lesions, the maximal intensity was taken into account.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; only participants with an adverse event classified as other skin lesion during the first 4 months were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Erlotinib Dose Reduction by Reason for Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib + Doxycycline', 'description': "Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline."}, {'id': 'OG001', 'title': 'Erlotinib', 'description': 'Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.'}], 'classes': [{'title': 'Adverse event', 'categories': [{'measurements': [{'value': '80.0', 'groupId': 'OG000'}, {'value': '85.7', 'groupId': 'OG001'}]}]}, {'title': "Investigator's decision", 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2.4', 'groupId': 'OG001'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '11.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12', 'description': 'Erlotinib dose adjustment was done in case of toxicity occurrence. Keratitis, diarrhea, interstitial lung disease, and other toxic occurrences determined erlotinib dose reduction. If erlotinib was previously discontinued for skin rash or diarrhea of Grade 2 and if these symptoms of Grade 2 recurred OR if the symptoms were intolerable for the participants, erlotinib was discontinued until recovery/Grade 1 then the dose was reduced of one level of 50 mg.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; only participants that discontinued or interrupted erlotinib were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Doxycycline Dose Reduction by Reason for Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib + Doxycycline', 'description': "Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline."}, {'id': 'OG001', 'title': 'Erlotinib', 'description': 'Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.'}], 'classes': [{'title': 'Adverse event', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12', 'description': "Occurrence of folliculitis-type skin rash of Grade greater than or equal to (≥)2 led to dose modification. Continuation of treatment with doxycycline after occurrence of folliculitis-type skin rash of Grade ≥2 was upon the investigator's opinion.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; only participants that discontinued or interrupted doxycycline were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Global Disease Control by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib + Doxycycline', 'description': "Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline."}, {'id': 'OG001', 'title': 'Erlotinib', 'description': 'Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.'}], 'classes': [{'title': 'Month 2 (n=34,33)', 'categories': [{'measurements': [{'value': '88.2', 'groupId': 'OG000'}, {'value': '93.9', 'groupId': 'OG001'}]}]}, {'title': 'Month 4 (n=19,25)', 'categories': [{'measurements': [{'value': '89.5', 'groupId': 'OG000'}, {'value': '80.0', 'groupId': 'OG001'}]}]}, {'title': 'Month 7 (n=11,17)', 'categories': [{'measurements': [{'value': '72.7', 'groupId': 'OG000'}, {'value': '76.5', 'groupId': 'OG001'}]}]}, {'title': 'Month 10 (n=7,12)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '66.7', 'groupId': 'OG001'}]}]}, {'title': 'Month 12 (n=7,10)', 'categories': [{'measurements': [{'value': '71.4', 'groupId': 'OG000'}, {'value': '40.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Months 2, 4, 7, 10, and 12', 'description': 'Disease control was determined according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria for evaluation and was defined as participants with either complete response (CR), partial response (PR), or stable disease (SD).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; number (n) = number of participants analyzed for the specified parameter at a given visit.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants by Best Global Response Under Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib + Doxycycline', 'description': "Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline."}, {'id': 'OG001', 'title': 'Erlotinib', 'description': 'Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.'}], 'classes': [{'title': 'PR', 'categories': [{'measurements': [{'value': '15.5', 'groupId': 'OG000'}, {'value': '10.3', 'groupId': 'OG001'}]}]}, {'title': 'SD', 'categories': [{'measurements': [{'value': '36.2', 'groupId': 'OG000'}, {'value': '48.3', 'groupId': 'OG001'}]}]}, {'title': 'Progression', 'categories': [{'measurements': [{'value': '48.3', 'groupId': 'OG000'}, {'value': '41.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12', 'description': 'Response was determined according to the RECIST criteria for evaluation and was defined as participants with either CR, PR, SD, or progression. No CR was reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival (PFS) - Percentage of Participants With an Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib + Doxycycline', 'description': "Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline."}, {'id': 'OG001', 'title': 'Erlotinib', 'description': 'Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '91.8', 'groupId': 'OG000'}, {'value': '87.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12', 'description': 'PFS was defined by the time between first intake of treatment with erlotinib and disease progression or death for any cause; estimated using Kaplan-Meier method.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival (PFS) - Time to Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib + Doxycycline', 'description': "Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline."}, {'id': 'OG001', 'title': 'Erlotinib', 'description': 'Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '63.0', 'groupId': 'OG000', 'lowerLimit': '56.0', 'upperLimit': '107.0'}, {'value': '70.0', 'groupId': 'OG001', 'lowerLimit': '56.0', 'upperLimit': '107.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12', 'description': 'PFS was defined by the time between first intake of treatment with erlotinib and disease progression or death for any cause; estimated using Kaplan-Meier method.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Estimated to be Progression Free at 4 and 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib + Doxycycline', 'description': "Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline."}, {'id': 'OG001', 'title': 'Erlotinib', 'description': 'Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.'}], 'classes': [{'title': '4 Months', 'categories': [{'measurements': [{'value': '30.1', 'groupId': 'OG000'}, {'value': '31.0', 'groupId': 'OG001'}]}]}, {'title': '12 Months', 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000'}, {'value': '10.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Months 4 and 12', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) - Percentage of Participants With an Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib + Doxycycline', 'description': "Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline."}, {'id': 'OG001', 'title': 'Erlotinib', 'description': 'Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '71.2', 'groupId': 'OG000'}, {'value': '67.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12', 'description': 'OS was defined by the time between first intake of treatment with erlotinib and death for any cause; analyzed using Kaplan-Meier method.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) - Time to Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib + Doxycycline', 'description': "Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline."}, {'id': 'OG001', 'title': 'Erlotinib', 'description': 'Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '227.0', 'groupId': 'OG000', 'lowerLimit': '153.0', 'upperLimit': '282.0'}, {'value': '251.0', 'groupId': 'OG001', 'lowerLimit': '152.0', 'upperLimit': '336.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12', 'description': 'OS was defined by the time between first intake of treatment with erlotinib and death for any cause; analyzed using Kaplan-Meier method.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Estimated to be Alive at 4 and 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib + Doxycycline', 'description': "Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline."}, {'id': 'OG001', 'title': 'Erlotinib', 'description': 'Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.'}], 'classes': [{'title': '4 Months', 'categories': [{'measurements': [{'value': '68.5', 'groupId': 'OG000'}, {'value': '69.7', 'groupId': 'OG001'}]}]}, {'title': '12 Months', 'categories': [{'measurements': [{'value': '27.1', 'groupId': 'OG000'}, {'value': '33.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Months 4 and 12', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Dermatology Life Quality Index (DLQI) Global Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib + Doxycycline', 'description': "Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline."}, {'id': 'OG001', 'title': 'Erlotinib', 'description': 'Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.'}], 'classes': [{'title': 'Baseline (n=67,69)', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'Day 14 (n=63,62)', 'categories': [{'measurements': [{'value': '1.7', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '4.3', 'groupId': 'OG001'}]}]}, {'title': 'Day 28 (n=60,56)', 'categories': [{'measurements': [{'value': '1.7', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '4.0', 'groupId': 'OG001'}]}]}, {'title': 'Month 2 (n=35,37)', 'categories': [{'measurements': [{'value': '2.3', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '5.3', 'groupId': 'OG001'}]}]}, {'title': 'Month 3 (n=29,27)', 'categories': [{'measurements': [{'value': '1.7', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '3.7', 'groupId': 'OG001'}]}]}, {'title': 'Month 4 (n=19,24)', 'categories': [{'measurements': [{'value': '1.6', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '3.5', 'groupId': 'OG001'}]}]}, {'title': 'Endpoint (n=65,63)', 'categories': [{'measurements': [{'value': '2.0', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '4.8', 'groupId': 'OG001'}]}]}, {'title': 'Change at Endpoint (n=35,37)', 'categories': [{'measurements': [{'value': '1.9', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '4.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Days 14 and 28 and Months 2, 3, and 4', 'description': "Quality of life was assessed by participant's responses to a DLQI questionnaire. The DLQI is a 10-item questionnaire assessing quality of life; questions were assessed on a 4-point scale (0=not at all; 1=a little; 2=a lot; and 3=very much). The DLQI was calculated by summing the score of each question resulting in a maximum of 30 (extremely large effect on participant's life) and a minimum of 0 (no effect at all on participant's life). The higher the score, the more quality of life is impaired. Analysis was performed by visit well as at the last available value after baseline (Endpoint); change from baseline to endpoint was also determined.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population; n=number of participants assessed for the specified parameter at a given visit.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants by DLQI Global Score Classification of Disease Effect on Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib + Doxycycline', 'description': "Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline."}, {'id': 'OG001', 'title': 'Erlotinib', 'description': 'Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.'}], 'classes': [{'title': 'Baseline, no effect (n=67,69)', 'categories': [{'measurements': [{'value': '98.5', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '97.1', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'Baseline, small effect (n=67,69)', 'categories': [{'measurements': [{'value': '1.5', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '4.3', 'groupId': 'OG001'}]}]}, {'title': 'Day 14, no effect (n=63,62)', 'categories': [{'measurements': [{'value': '69.8', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '41.9', 'spread': '4.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 14, small effect (n=63,62)', 'categories': [{'measurements': [{'value': '27.0', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '30.6', 'spread': '4.8', 'groupId': 'OG001'}]}]}, {'title': 'Day 14, moderate effect (n=63,62)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '21.0', 'spread': '5.3', 'groupId': 'OG001'}]}]}, {'title': 'Day 14, very large effect (n=63,62)', 'categories': [{'measurements': [{'value': '1.6', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '6.5', 'spread': '3.7', 'groupId': 'OG001'}]}]}, {'title': 'Day 14, extremely large effect (n=63,62)', 'categories': [{'measurements': [{'value': '1.6', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '3.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 28, no effect (n=60,56)', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '41.1', 'groupId': 'OG001'}]}]}, {'title': 'Day 28, small effect (n=60,56)', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}, {'value': '35.7', 'groupId': 'OG001'}]}]}, {'title': 'Day 28, moderate effect (n=60,56)', 'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000'}, {'value': '19.6', 'groupId': 'OG001'}]}]}, {'title': 'Day 28, very large effect (n=60,56)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'Day 28, extremely large effect (n=60,56)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'Month 2, no effect (n=35,37)', 'categories': [{'measurements': [{'value': '65.7', 'groupId': 'OG000'}, {'value': '40.5', 'groupId': 'OG001'}]}]}, {'title': 'Month 2, small effect (n=35,37)', 'categories': [{'measurements': [{'value': '22.9', 'groupId': 'OG000'}, {'value': '27.0', 'groupId': 'OG001'}]}]}, {'title': 'Month 2, moderate effect (n=35,37)', 'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000'}, {'value': '21.6', 'groupId': 'OG001'}]}]}, {'title': 'Month 2, very large effect (n=35,37)', 'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000'}, {'value': '8.1', 'groupId': 'OG001'}]}]}, {'title': 'Month 2, extremely large effect (n=35,37)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '2.7', 'groupId': 'OG001'}]}]}, {'title': 'Month 3, no effect (n=29,27)', 'categories': [{'measurements': [{'value': '69.0', 'groupId': 'OG000'}, {'value': '37.0', 'groupId': 'OG001'}]}]}, {'title': 'Month 3, small effect (n=29,27)', 'categories': [{'measurements': [{'value': '27.6', 'groupId': 'OG000'}, {'value': '44.4', 'groupId': 'OG001'}]}]}, {'title': 'Month 3, moderate effect (n=29,27)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '11.1', 'groupId': 'OG001'}]}]}, {'title': 'Month 3, very large effect (n=29,27)', 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000'}, {'value': '7.4', 'groupId': 'OG001'}]}]}, {'title': 'Month 4, no effect (n=19,24)', 'categories': [{'measurements': [{'value': '78.9', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}]}]}, {'title': 'Month 4, small effect (n=19,24)', 'categories': [{'measurements': [{'value': '15.8', 'groupId': 'OG000'}, {'value': '41.7', 'groupId': 'OG001'}]}]}, {'title': 'Month 4, very large effect (n=19,24)', 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000'}, {'value': '8.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Days 14 and 28 and Months 2, 3, and 4', 'description': "Quality of life was assessed by participant's responses to a DLQI questionnaire. The DLQI is a 10-item questionnaire assessing quality of life; questions were assessed on a 4-point scale (0=not at all; 1=a little; 2=a lot; and 3=very much). The DLQI was calculated by summing the score of each question resulting in a maximum of 30 (extremely large effect on participant's life) and a minimum of 0 (no effect at all on participant's life). The higher the score, the more quality of life is impaired. The DLQI global score was classified into 5 levels: 0-1 (no effect at all), 2-5 (small effect), 6-10 (moderate effect), 11-20 (very large effect) and 21-30 (extremely large effect).", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population; n=number of participants assessed for the specified parameter at a given visit.'}, {'type': 'SECONDARY', 'title': 'Quality of Life Score as Assessed by Visual Analog Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib + Doxycycline', 'description': "Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline."}, {'id': 'OG001', 'title': 'Erlotinib', 'description': 'Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.'}], 'classes': [{'title': 'Baseline (n=64,68)', 'categories': [{'measurements': [{'value': '81.4', 'spread': '23.7', 'groupId': 'OG000'}, {'value': '87.8', 'spread': '19.6', 'groupId': 'OG001'}]}]}, {'title': 'Day 14 (n=62,63)', 'categories': [{'measurements': [{'value': '68.8', 'spread': '26.6', 'groupId': 'OG000'}, {'value': '51.0', 'spread': '34.5', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 14 (n=59,61)', 'categories': [{'measurements': [{'value': '-16.2', 'spread': '28.5', 'groupId': 'OG000'}, {'value': '-39.2', 'spread': '37.8', 'groupId': 'OG001'}]}]}, {'title': 'Day 28 (n=59,56)', 'categories': [{'measurements': [{'value': '66.5', 'spread': '27.2', 'groupId': 'OG000'}, {'value': '54.8', 'spread': '27.0', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 28 (n=55,54)', 'categories': [{'measurements': [{'value': '-15.5', 'spread': '28.8', 'groupId': 'OG000'}, {'value': '-35.1', 'spread': '27.8', 'groupId': 'OG001'}]}]}, {'title': 'Month 2 (n=36,36)', 'categories': [{'measurements': [{'value': '68.9', 'spread': '22.8', 'groupId': 'OG000'}, {'value': '52.6', 'spread': '27.4', 'groupId': 'OG001'}]}]}, {'title': 'Month 3 (n=28,27)', 'categories': [{'measurements': [{'value': '63.5', 'spread': '21.4', 'groupId': 'OG000'}, {'value': '56.1', 'spread': '31.7', 'groupId': 'OG001'}]}]}, {'title': 'Month 4 (n=18,24)', 'categories': [{'measurements': [{'value': '71.8', 'spread': '20.9', 'groupId': 'OG000'}, {'value': '59.9', 'spread': '29.7', 'groupId': 'OG001'}]}]}, {'title': 'Endpoint (n=65,64)', 'categories': [{'measurements': [{'value': '64.0', 'spread': '26.6', 'groupId': 'OG000'}, {'value': '58.3', 'spread': '30.8', 'groupId': 'OG001'}]}]}, {'title': 'Change at Endpoint (n=60,62)', 'categories': [{'measurements': [{'value': '-18.1', 'spread': '27.7', 'groupId': 'OG000'}, {'value': '-30.4', 'spread': '31.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Days 14 and 28, and Months 2, 3, and 4', 'description': "Quality of life was assessed by participant's responses to a VAS questionnaire - (evaluation of satisfaction with skin status). VAS was measured on a 100 millimeter (mm) scale where 0 = not at all satisfied and 100 = very satisfied. Participants were asked to mark the line corresponding to their satisfaction at each visit and the distance from the left edge was measured. A negative change from baseline indicates improvement. Analysis was performed by visit well as at the last available value after baseline (Endpoint).", 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; n=number of participants assessed for the specified parameter at a given visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Erlotinib Plus (+) Doxycycline', 'description': "Participants received erlotinib 150 milligrams per day (mg/day), tablets, orally (PO) until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline."}, {'id': 'FG001', 'title': 'Erlotinib', 'description': 'Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '74'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '63'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '147', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Erlotinib + Doxycycline', 'description': "Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline."}, {'id': 'BG001', 'title': 'Erlotinib', 'description': 'Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.5', 'spread': '10.6', 'groupId': 'BG000'}, {'value': '64.2', 'spread': '11.1', 'groupId': 'BG001'}, {'value': '63.8', 'spread': '10.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-Treat population (ITT): all randomized participants who received at least\n\n1 dose of erlotinib.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 147}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-05', 'studyFirstSubmitDate': '2007-09-18', 'resultsFirstSubmitDate': '2014-06-23', 'studyFirstSubmitQcDate': '2007-09-18', 'lastUpdatePostDateStruct': {'date': '2015-02-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-08-25', 'studyFirstPostDateStruct': {'date': '2007-09-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With at Least One Skin Rash (Folliculitis) of Any Grade During the First 4 Months of Treatment', 'timeFrame': 'Days 0, 14, 28 and Months 2, 3, and 4', 'description': 'Description of skin rash (folliculitis, including erythema, papulo-pustules, nodule, and crust) was according to Common Terminology Criteria for Adverse Events (CTCAE) version 3 scale. Medical pictures of the face (front and sides views) systematically, and of any region presenting with skin lesions were obtained. The pictures were reviewed by a centralized committee of evaluation.'}], 'secondaryOutcomes': [{'measure': 'Number of Skin Rash (Folliculitis) Events During the First 4 Months of Treatment', 'timeFrame': 'Days 0, 14, 28 and Months 2, 3, and 4', 'description': 'A cutaneous rash as folliculitis can be defined with several types including erythema, papulo-pustular and nodules.'}, {'measure': 'Percentage of Participants With Skin Rash (Folliculitis) During the First 4 Months of Treatment By Type', 'timeFrame': 'Days 0, 14, 28 and Months 2, 3, and 4', 'description': 'A cutaneous rash as folliculitis can be defined with several types including erythema, papulo-pustule, nodule, and crust.'}, {'measure': 'Percentage of Participants With Skin Rash (Folliculitis) During the First 4 Months of Treatment By Maximal Intensity', 'timeFrame': 'Days 0, 14, 28 and Months 2, 3, and 4', 'description': 'Intensity of skin rashes was classified according to CTCAE grading. Grade 1 equals (=) Macular or papular eruption or erythema without associated symptoms; Grade 2=Macular or papular eruption or erythema with pruritus or other associated symptoms; localized desquamation or other lesions covering less than (\\<)50 percent (%) of body surface area (BSA); Grade 3=Severe, generalized erythroderma or macular, papular, or vesicular eruption; desquamation.'}, {'measure': 'Percentage of Participants With at Least One Skin Rash (Folliculitis) of Any Grade After the First 4 Months of Treatment', 'timeFrame': 'Months 7, 10, and 12'}, {'measure': 'Number of Skin Rash (Folliculitis) Events After the First 4 Months of Treatment', 'timeFrame': 'Months 7, 10, and 12', 'description': 'A cutaneous rash as folliculitis can be defined with several types including erythema, papulo-pustular and nodules.'}, {'measure': 'Number of Participants With Skin Rash (Folliculitis) After the First 4 Months of Treatment By Type', 'timeFrame': 'Months 7, 10, and 12', 'description': 'A cutaneous rash as folliculitis can be defined with several types including erythema, papulo-pustule, nodule, and crust.'}, {'measure': 'Number of Participants With Skin Rash (Folliculitis) After the First 4 Months of Treatment By Intensity', 'timeFrame': 'Months 7, 10, and 12', 'description': 'Intensity of skin rashes was classified according to CTCAE grading. Grade 1=Macular or papular eruption or erythema without associated symptoms; Grade 2=Macular or papular eruption or erythema with pruritus or other associated symptoms; localized desquamation or other lesions covering \\<50% of BSA; Grade 3=Severe, generalized erythroderma or macular, papular, or vesicular eruption; desquamation.'}, {'measure': 'Time Free From Skin Rash (Folliculitis) During the First 4 Months of Treatment - Number of Participants With an Event', 'timeFrame': 'Days 0, 14, 28 and Months 2, 3, and 4', 'description': 'Period without occurrence was determined as the number of days from the first dose of medication until the first appearance of folliculitis, analyzed using Kaplan-Meier analysis.'}, {'measure': 'Time Free From Skin Rash (Folliculitis) During the First 4 Months of Treatment - Time to Event', 'timeFrame': 'Days 0, 14, 28 and Months 2, 3, and 4', 'description': 'Period without occurrence was determined as the number of days from the first dose of medication until the first appearance of folliculitis, analyzed using Kaplan-Meier analysis.'}, {'measure': 'Percentage of Participants Estimated to be Event Free at 4 Months', 'timeFrame': 'Days 0, 14, 28 and Months 2, 3, and 4', 'description': 'Percentage of participants estimated to be without skin rash (folliculitis) at 4 months.'}, {'measure': 'Time Free From Skin Rash (Folliculitis) During the Whole Treatment Period - Number of Participants With an Event', 'timeFrame': 'Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12', 'description': 'Period without occurrence was determined as the number of days from the first dose of medication until the first appearance of folliculitis, analyzed using Kaplan-Meier analysis.'}, {'measure': 'Time Free From Skin Rash (Folliculitis) During the Whole Treatment Period - Time to Event', 'timeFrame': 'Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12', 'description': 'Period without occurrence was determined as the number of days from the first dose of medication until the first appearance of folliculitis, analyzed using Kaplan-Meier analysis.'}, {'measure': 'Percentage of Participants Estimated to be Event Free at 12 Months', 'timeFrame': 'Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12', 'description': 'Percentage of participants estimated to be without skin rash (folliculitis) at 12 months.'}, {'measure': 'Duration of Skin Rash (Folliculitis) During the First 4 Months of Treatment', 'timeFrame': 'Days 0, 14, 28 and Months 2, 3, and 4', 'description': 'If the cutaneous rash was ongoing at the last visit or Month 4, the duration of cutaneous rash was calculated between start of folliculitis and Visit Month 4 or premature withdrawal visit or death.'}, {'measure': 'Duration of Skin Rash (Folliculitis) During the Whole Treatment Period', 'timeFrame': 'Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12', 'description': 'If the end of cutaneous rash was missing, the duration of cutaneous rash was calculated between start of folliculitis and last evaluation date.'}, {'measure': 'Percentage of Participants With Other Skin Lesions of Any Grade During the First 4 Months of Treatment', 'timeFrame': 'Days 0, 14, 28 and Months 2, 3, and 4', 'description': 'Other skin lesions included presence or absence of xerosis and paronychia.'}, {'measure': 'Percentage of Participants With Other Skin Lesions During the First 4 Months of Treatment By Type', 'timeFrame': 'Days 0, 14, 28 and Months 2, 3, and 4', 'description': 'Other skin lesions included xerosis and paronychia.'}, {'measure': 'Percentage of Participants With Other Skin Lesions During the First 4 Months of Treatment By Maximal Intensity', 'timeFrame': 'Days 0, 14, 28 and Months 2, 3, and 4', 'description': 'Other skin lesions included xerosis and paronychia. Intensity was classified according to CTCAE grading. Grade 1=Macular or papular eruption or erythema without associated symptoms; Grade 2=Macular or papular eruption or erythema with pruritus or other associated symptoms; localized desquamation or other lesions covering \\<50% of BSA; Grade 3=Severe, generalized erythroderma or macular, papular, or vesicular eruption; desquamation; Grade 4=Generalized exfoliative, ulcerative, or bullous dermatitis. If a participant had several skin lesions, the maximal intensity was taken into account.'}, {'measure': 'Percentage of Participants With Erlotinib Dose Reduction by Reason for Reduction', 'timeFrame': 'Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12', 'description': 'Erlotinib dose adjustment was done in case of toxicity occurrence. Keratitis, diarrhea, interstitial lung disease, and other toxic occurrences determined erlotinib dose reduction. If erlotinib was previously discontinued for skin rash or diarrhea of Grade 2 and if these symptoms of Grade 2 recurred OR if the symptoms were intolerable for the participants, erlotinib was discontinued until recovery/Grade 1 then the dose was reduced of one level of 50 mg.'}, {'measure': 'Percentage of Participants With Doxycycline Dose Reduction by Reason for Reduction', 'timeFrame': 'Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12', 'description': "Occurrence of folliculitis-type skin rash of Grade greater than or equal to (≥)2 led to dose modification. Continuation of treatment with doxycycline after occurrence of folliculitis-type skin rash of Grade ≥2 was upon the investigator's opinion."}, {'measure': 'Percentage of Participants With Global Disease Control by Visit', 'timeFrame': 'Months 2, 4, 7, 10, and 12', 'description': 'Disease control was determined according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria for evaluation and was defined as participants with either complete response (CR), partial response (PR), or stable disease (SD).'}, {'measure': 'Percentage of Participants by Best Global Response Under Treatment', 'timeFrame': 'Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12', 'description': 'Response was determined according to the RECIST criteria for evaluation and was defined as participants with either CR, PR, SD, or progression. No CR was reported.'}, {'measure': 'Progression-Free Survival (PFS) - Percentage of Participants With an Event', 'timeFrame': 'Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12', 'description': 'PFS was defined by the time between first intake of treatment with erlotinib and disease progression or death for any cause; estimated using Kaplan-Meier method.'}, {'measure': 'Progression-Free Survival (PFS) - Time to Event', 'timeFrame': 'Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12', 'description': 'PFS was defined by the time between first intake of treatment with erlotinib and disease progression or death for any cause; estimated using Kaplan-Meier method.'}, {'measure': 'Percentage of Participants Estimated to be Progression Free at 4 and 12 Months', 'timeFrame': 'Months 4 and 12'}, {'measure': 'Overall Survival (OS) - Percentage of Participants With an Event', 'timeFrame': 'Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12', 'description': 'OS was defined by the time between first intake of treatment with erlotinib and death for any cause; analyzed using Kaplan-Meier method.'}, {'measure': 'Overall Survival (OS) - Time to Event', 'timeFrame': 'Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12', 'description': 'OS was defined by the time between first intake of treatment with erlotinib and death for any cause; analyzed using Kaplan-Meier method.'}, {'measure': 'Percentage of Participants Estimated to be Alive at 4 and 12 Months', 'timeFrame': 'Months 4 and 12'}, {'measure': 'Dermatology Life Quality Index (DLQI) Global Score', 'timeFrame': 'Baseline, Days 14 and 28 and Months 2, 3, and 4', 'description': "Quality of life was assessed by participant's responses to a DLQI questionnaire. The DLQI is a 10-item questionnaire assessing quality of life; questions were assessed on a 4-point scale (0=not at all; 1=a little; 2=a lot; and 3=very much). The DLQI was calculated by summing the score of each question resulting in a maximum of 30 (extremely large effect on participant's life) and a minimum of 0 (no effect at all on participant's life). The higher the score, the more quality of life is impaired. Analysis was performed by visit well as at the last available value after baseline (Endpoint); change from baseline to endpoint was also determined."}, {'measure': 'Percentage of Participants by DLQI Global Score Classification of Disease Effect on Quality of Life', 'timeFrame': 'Baseline, Days 14 and 28 and Months 2, 3, and 4', 'description': "Quality of life was assessed by participant's responses to a DLQI questionnaire. The DLQI is a 10-item questionnaire assessing quality of life; questions were assessed on a 4-point scale (0=not at all; 1=a little; 2=a lot; and 3=very much). The DLQI was calculated by summing the score of each question resulting in a maximum of 30 (extremely large effect on participant's life) and a minimum of 0 (no effect at all on participant's life). The higher the score, the more quality of life is impaired. The DLQI global score was classified into 5 levels: 0-1 (no effect at all), 2-5 (small effect), 6-10 (moderate effect), 11-20 (very large effect) and 21-30 (extremely large effect)."}, {'measure': 'Quality of Life Score as Assessed by Visual Analog Scale (VAS)', 'timeFrame': 'Baseline, Days 14 and 28, and Months 2, 3, and 4', 'description': "Quality of life was assessed by participant's responses to a VAS questionnaire - (evaluation of satisfaction with skin status). VAS was measured on a 100 millimeter (mm) scale where 0 = not at all satisfied and 100 = very satisfied. Participants were asked to mark the line corresponding to their satisfaction at each visit and the distance from the left edge was measured. A negative change from baseline indicates improvement. Analysis was performed by visit well as at the last available value after baseline (Endpoint)."}]}, 'conditionsModule': {'conditions': ['Non-Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This 2 arm study will evaluate the management of Tarceva-induced skin rash in patients with non-small cell lung cancer who have failed first-line chemotherapy for advanced disease. Eligible patients will be randomized to receive a)doxycycline 100mg po daily or b)no preventative treatment; all patients will receive Tarceva 150mg/kg po daily. The anticipated time on study treatment is until disease progression or intolerable toxicity, and the target sample size is 100-500 individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients, 18-75 years of age;\n* confirmed non-small cell lung cancer;\n* failure after first line chemotherapy for advanced disease, and scheduled for second line therapy with Tarceva.\n\nExclusion Criteria:\n\n* rash of any etiology at study entry;\n* history of significant heart disease;\n* any other malignancies (other than adequately treated squamous cell skin cancer, or in situ cancer of the cervix);\n* history of allergic reactions to tetracyclines.'}, 'identificationModule': {'nctId': 'NCT00531934', 'briefTitle': 'A Study of Management of Tarceva - Induced Rash in Patients With Non-Small Cell Lung Cancer.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Randomized, Open Label Study to Evaluate the Effect of Doxycycline on Tarceva-induced Skin Rash in Patients With Non-small Cell Lung Cancer After Failure of First Line Chemotherapy', 'orgStudyIdInfo': {'id': 'ML20829'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Doxycline', 'Drug: erlotinib [Tarceva]']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: erlotinib [Tarceva]']}], 'interventions': [{'name': 'Doxycline', 'type': 'DRUG', 'description': '100mg po daily', 'armGroupLabels': ['1']}, {'name': 'erlotinib [Tarceva]', 'type': 'DRUG', 'description': '150mg po daily', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06600', 'city': 'Antibes', 'country': 'France', 'geoPoint': {'lat': 43.58127, 'lon': 7.12487}}, {'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '33300', 'city': 'Bordeaux', 'country': 'France', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '29200', 'city': 'Brest', 'country': 'France', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '14076', 'city': 'Caen', 'country': 'France', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '71100', 'city': 'Chalon-sur-Saône', 'country': 'France', 'geoPoint': {'lat': 46.78112, 'lon': 4.85372}}, {'zip': '28018', 'city': 'Chartres', 'country': 'France', 'geoPoint': {'lat': 48.44685, 'lon': 1.48925}}, {'zip': '83007', 'city': 'Draguignan', 'country': 'France', 'geoPoint': {'lat': 43.53692, 'lon': 6.46458}}, {'zip': '05007', 'city': 'Gap', 'country': 'France', 'geoPoint': {'lat': 44.55858, 'lon': 6.07868}}, {'zip': '69400', 'city': 'Gleizé', 'country': 'France', 'geoPoint': {'lat': 45.98916, 'lon': 4.69708}}, {'zip': '87042', 'city': 'Limoges', 'country': 'France', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '57038', 'city': 'Metz', 'country': 'France', 'geoPoint': {'lat': 49.11911, 'lon': 6.17269}}, {'zip': '30900', 'city': 'Nîmes', 'country': 'France', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '75116', 'city': 'Paris', 'country': 'France', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75674', 'city': 'Paris', 'country': 'France', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75679', 'city': 'Paris', 'country': 'France', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '66000', 'city': 'Perpignan', 'country': 'France', 'geoPoint': {'lat': 42.69764, 'lon': 2.89541}}, {'zip': '24000', 'city': 'Périgueux', 'country': 'France', 'geoPoint': {'lat': 45.18691, 'lon': 0.71439}}, {'zip': '69495', 'city': 'Pierre-Bénite', 'country': 'France', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '95300', 'city': 'Pontoise', 'country': 'France', 'geoPoint': {'lat': 49.05, 'lon': 2.1}}, {'zip': '35033', 'city': 'Rennes', 'country': 'France', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '76000', 'city': 'Rouen', 'country': 'France', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '37044', 'city': 'Tours', 'country': 'France', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'zip': '56017', 'city': 'Vannes', 'country': 'France', 'geoPoint': {'lat': 47.65688, 'lon': -2.76205}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}