Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2026-02-23 @ 8:02 PM
Study NCT ID:
NCT00548093
Status:
COMPLETED
Last Update Posted:
2019-05-21
First Post:
2007-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
PF-00299804 As A Single Agent, In Patients With Advanced Non-Small Cell Lung Cancer Who Have Failed Chemotherapy And Erlotinib
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': 'C525726', 'term': 'dacomitinib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Results for PK parameters to be assessed using nonlinear mixed effects modelling (NONMEM) are not provided because of change in planned analysis.'}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'PF-00299804 (Adenocarcinoma Histology)', 'description': "Participants with adenocarcinoma histology received PF-00299804 tablet 45 milligram (mg) orally once daily in cycles of 21 days until unacceptable toxicity, tumor progression, death, withdrawal from the study or investigator's discretion.", 'otherNumAtRisk': 50, 'otherNumAffected': 50, 'seriousNumAtRisk': 50, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'PF-00299804 (Non-adenocarcinoma Histology)', 'description': "Participants with non-adenocarcinoma histology received PF-00299804 tablet 45 mg orally once daily in cycles of 21 days until unacceptable toxicity, tumor progression, death, withdrawal from the study or investigator's discretion.", 'otherNumAtRisk': 16, 'otherNumAffected': 15, 'seriousNumAtRisk': 16, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Nodal rhythm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Blepharitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Eye discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Vitreous floaters', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Atrophic glossitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Chapped lips', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Cheilitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Diarrhoea haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Faeces discoloured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Gingival pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Glossodynia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Lip dry', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Lip ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Swollen tongue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Tongue coated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Tongue dry', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Mucous membrane disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Contrast media allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Fungal skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Nail infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Oral fungal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 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v13.1'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Skin candida', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 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'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Upper-airway cough syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Alopecia', 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'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Hypertrichosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Increased tendency to bruise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Nail disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Night sweats', 'stats': 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{'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Skin lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Non-small cell lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 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'OG000'}]}]}, {'title': 'Partial response', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Stable or No response', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}, {'title': 'Objective progression', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Indeterminate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, end of every even-numbered cycle up to end of treatment (Day 936)', 'description': 'BOR:best response recorded from treatment start until disease progression as per Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response: disappearance of all lesions. Partial Response (PR):greater than or equal to (\\>=)30% decrease in sum of longest diameters (SLDs) of target lesions (TLs) taking as reference baseline SLD. Progressive disease (PD):\\>=20% increase in SLD of TLs taking as reference smallest SLD since treatment start, or appearance of \\>=1 new lesion. Stable disease:neither shrinkage for PR nor increase for PD taking as reference smallest SLD since treatment start.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Response-evaluable population included all enrolled participants who received at least 1 dose of study treatment, with adequate baseline tumor assessment and at least 1 on-study tumor assessment after the first dosing.'}, {'type': 'SECONDARY', 'title': 'Best Overall Response (BOR) in Participants With Non-Adenocarcinoma Histology', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-00299804 (Non-adenocarcinoma Histology)', 'description': "Participants with non-adenocarcinoma histology received PF-00299804 tablet 45 mg orally once daily in cycles of 21 days until unacceptable toxicity, tumor progression, death, withdrawal from the study or investigator's discretion."}], 'classes': [{'title': 'Complete response', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Partial response', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Stable or no response', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Objective progression', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Indeterminate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, end of every even-numbered cycle up to end of treatment (Day 936)', 'description': 'BOR: best response recorded from treatment start until disease progression as per RECIST. Complete Response: disappearance of all lesions. PR: \\>=30% decrease in SLDs of TLs taking as reference baseline SLD. PD: \\>=20% increase in SLD of TLs taking as reference smallest SLD since treatment start, or appearance of \\>=1 new lesion. Stable disease: neither shrinkage for PR nor increase for PD taking as reference smallest SLD since treatment start.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Response-evaluable population included all enrolled participants who received at least 1 dose of study treatment, with adequate baseline tumor assessment and at least 1 on-study tumor assessment after the first dosing.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-00299804 (Adenocarcinoma Histology)', 'description': "Participants with adenocarcinoma histology received PF-00299804 tablet 45 milligram (mg) orally once daily in cycles of 21 days until unacceptable toxicity, tumor progression, death, withdrawal from the study or investigator's discretion."}, {'id': 'OG001', 'title': 'PF-00299804 (Non-adenocarcinoma Histology)', 'description': "Participants with non-adenocarcinoma histology received PF-00299804 tablet 45 mg orally once daily in cycles of 21 days until unacceptable toxicity, tumor progression, death, withdrawal from the study or investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '45.2', 'groupId': 'OG000', 'lowerLimit': '24.1', 'upperLimit': '66.3'}, {'value': '12.1', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, end of every even-numbered cycle up to end of treatment (Day 936)', 'description': 'Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'DR was calculated for the subgroup of participants from the response-evaluable population, with a confirmed objective tumor response (CR or PR).'}, {'type': 'SECONDARY', 'title': 'Percent Probability of Progression-free Survival (PFS) at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-00299804 (Adenocarcinoma Histology)', 'description': "Participants with adenocarcinoma histology received PF-00299804 tablet 45 milligram (mg) orally once daily in cycles of 21 days until unacceptable toxicity, tumor progression, death, withdrawal from the study or investigator's discretion."}, {'id': 'OG001', 'title': 'PF-00299804 (Non-adenocarcinoma Histology)', 'description': "Participants with non-adenocarcinoma histology received PF-00299804 tablet 45 mg orally once daily in cycles of 21 days until unacceptable toxicity, tumor progression, death, withdrawal from the study or investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '24.3', 'groupId': 'OG000', 'lowerLimit': '12.4', 'upperLimit': '38.4'}, {'value': '8.0', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '29.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 6 months after the start of study medication', 'description': 'Probability of being event free (event defined as PD or death due to any cause) at 6 months after the first dose of study treatment. PFS was defined as the time from the first dosing date to the date of first documentation of progression or death due to any cause, whichever occurs first. PFS was calculated as (first event date (if not reached, censored at the last known event-free date) minus first dosing date plus 1). Documentation of progression was determined from objective disease assessment based on RECIST v1.0 criteria. PD was defined as at least a 20% increase in the sum of the longest diameters of the target lesions taking as a reference the smallest sum of the longest diameters recorded since treated started or the appearance of 1 or more new lesions.', 'unitOfMeasure': 'percent chance of being event-free', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'As-enrolled population included all participants who were enrolled in the study.'}, {'type': 'SECONDARY', 'title': 'Percent Probability of Overall Survival at Months 6 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-00299804 (Adenocarcinoma Histology)', 'description': "Participants with adenocarcinoma histology received PF-00299804 tablet 45 milligram (mg) orally once daily in cycles of 21 days until unacceptable toxicity, tumor progression, death, withdrawal from the study or investigator's discretion."}, {'id': 'OG001', 'title': 'PF-00299804 (Non-adenocarcinoma Histology)', 'description': "Participants with non-adenocarcinoma histology received PF-00299804 tablet 45 mg orally once daily in cycles of 21 days until unacceptable toxicity, tumor progression, death, withdrawal from the study or investigator's discretion."}], 'classes': [{'title': 'Month 6', 'categories': [{'measurements': [{'value': '71.5', 'groupId': 'OG000', 'lowerLimit': '56.7', 'upperLimit': '82.1'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '24.5', 'upperLimit': '71.0'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '46.3', 'groupId': 'OG000', 'lowerLimit': '31.4', 'upperLimit': '59.9'}, {'value': '21.9', 'groupId': 'OG001', 'lowerLimit': '5.6', 'upperLimit': '44.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Months 6, 12', 'description': 'Probability of being alive at 6 and 12 months after the first dose of study medication.', 'unitOfMeasure': 'percent chance of being alive', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'As-enrolled population included all participants who were enrolled in the study.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to 24 Hours [AUC (0-24)]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-00299804 (Adenocarcinoma Histology)', 'description': "Participants with adenocarcinoma histology received PF-00299804 tablet 45 milligram (mg) orally once daily in cycles of 21 days until unacceptable toxicity, tumor progression, death, withdrawal from the study or investigator's discretion."}, {'id': 'OG001', 'title': 'PF-00299804 (Non-adenocarcinoma Histology)', 'description': "Participants with non-adenocarcinoma histology received PF-00299804 tablet 45 mg orally once daily in cycles of 21 days until unacceptable toxicity, tumor progression, death, withdrawal from the study or investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '390.8', 'spread': '165.24', 'groupId': 'OG000'}, {'value': '397.9', 'spread': '258.11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0.5-2, 3-5, 6-8, 22-26 hours post dose on Day 1 of Cycle 1', 'description': 'The pharmacokinetic (PK) samples collected between 22-26 hours post dose on Day 1 of Cycle 1 were within the pre-specified time window for the 24-hour post dose sample and were used for calculation of AUC (0-24) on Day 1 of Cycle 1.', 'unitOfMeasure': 'nanogram*hour per milliliter (ng*hr/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PK concentration population included all enrolled participants who received at least 1 dose of study treatment and had at least 1 measured plasma concentration. Here, 'N' (overall number of participants analyzed) signifies those participants who were evaluable for the measure."}, {'type': 'SECONDARY', 'title': 'Maximum Observed Plasma Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-00299804 (Adenocarcinoma Histology)', 'description': "Participants with adenocarcinoma histology received PF-00299804 tablet 45 milligram (mg) orally once daily in cycles of 21 days until unacceptable toxicity, tumor progression, death, withdrawal from the study or investigator's discretion."}, {'id': 'OG001', 'title': 'PF-00299804 (Non-adenocarcinoma Histology)', 'description': "Participants with non-adenocarcinoma histology received PF-00299804 tablet 45 mg orally once daily in cycles of 21 days until unacceptable toxicity, tumor progression, death, withdrawal from the study or investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '22.61', 'spread': '10.315', 'groupId': 'OG000'}, {'value': '25.49', 'spread': '22.533', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0.5-2, 3-5, 6-8, 22-26 hours post dose on Day 1 of Cycle 1', 'unitOfMeasure': 'nanogram per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PK concentration population included all enrolled participants who received at least 1 dose of study treatment and had at least 1 measured plasma concentration. Here, 'N' signifies those participants who were evaluable for the measure."}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Observed Plasma Concentration (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-00299804 (Adenocarcinoma Histology)', 'description': "Participants with adenocarcinoma histology received PF-00299804 tablet 45 milligram (mg) orally once daily in cycles of 21 days until unacceptable toxicity, tumor progression, death, withdrawal from the study or investigator's discretion."}, {'id': 'OG001', 'title': 'PF-00299804 (Non-adenocarcinoma Histology)', 'description': "Participants with non-adenocarcinoma histology received PF-00299804 tablet 45 mg orally once daily in cycles of 21 days until unacceptable toxicity, tumor progression, death, withdrawal from the study or investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '6.08', 'groupId': 'OG000', 'lowerLimit': '3.00', 'upperLimit': '25.1'}, {'value': '6.17', 'groupId': 'OG001', 'lowerLimit': '5.00', 'upperLimit': '25.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0.5-2, 3-5, 6-8, 22-26 hours post dose on Day 1 of Cycle 1', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "PK concentration population included all enrolled participants who received at least 1 dose of study treatment and had at least 1 measured plasma concentration. Here, 'N' signifies those participants who were evaluable for the measure."}, {'type': 'SECONDARY', 'title': 'Human Epidermal Growth Factor-2 (HER-2) and Epidermal Growth Factor Receptor (EGFR) Levels in Serum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-00299804 (Adenocarcinoma Histology)', 'description': "Participants with adenocarcinoma histology received PF-00299804 tablet 45 milligram (mg) orally once daily in cycles of 21 days until unacceptable toxicity, tumor progression, death, withdrawal from the study or investigator's discretion."}, {'id': 'OG001', 'title': 'PF-00299804 (Non-adenocarcinoma Histology)', 'description': "Participants with non-adenocarcinoma histology received PF-00299804 tablet 45 mg orally once daily in cycles of 21 days until unacceptable toxicity, tumor progression, death, withdrawal from the study or investigator's discretion."}], 'classes': [{'title': 'EGFR: C1D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.25', 'spread': '14.86', 'groupId': 'OG000'}, {'value': '57.28', 'spread': '15.36', 'groupId': 'OG001'}]}]}, {'title': 'EGFR: C2D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45.89', 'spread': '12.42', 'groupId': 'OG000'}, {'value': '51.05', 'spread': '11.35', 'groupId': 'OG001'}]}]}, {'title': 'EGFR: C3D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44.91', 'spread': '11.43', 'groupId': 'OG000'}, {'value': '46.79', 'spread': '7.64', 'groupId': 'OG001'}]}]}, {'title': 'EGFR: C4D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46.26', 'spread': '11.7', 'groupId': 'OG000'}, {'value': '46.72', 'spread': '9.01', 'groupId': 'OG001'}]}]}, {'title': 'EGFR: C5D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45.35', 'spread': '11.32', 'groupId': 'OG000'}, {'value': '51.2', 'spread': '9.76', 'groupId': 'OG001'}]}]}, {'title': 'EGFR: C6D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.71', 'spread': '12.01', 'groupId': 'OG000'}, {'value': '66.52', 'spread': '20.19', 'groupId': 'OG001'}]}]}, {'title': 'EGFR: C7D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52.85', 'spread': '15.6', 'groupId': 'OG000'}, {'value': '44.29', 'spread': '9.55', 'groupId': 'OG001'}]}]}, {'title': 'EGFR: C8D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.27', 'spread': '17.05', 'groupId': 'OG000'}, {'value': '55.93', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG001'}]}]}, {'title': 'EGFR: C9D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.68', 'spread': '11.41', 'groupId': 'OG000'}]}]}, {'title': 'EGFR: C10D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.45', 'spread': '11.58', 'groupId': 'OG000'}]}]}, {'title': 'HER2: C1D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.69', 'spread': '4.18', 'groupId': 'OG000'}, {'value': '9.57', 'spread': '10.27', 'groupId': 'OG001'}]}]}, {'title': 'HER2: C2D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.2', 'spread': '3.28', 'groupId': 'OG000'}, {'value': '9.39', 'spread': '9.18', 'groupId': 'OG001'}]}]}, {'title': 'HER2: C3D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.21', 'spread': '2.31', 'groupId': 'OG000'}, {'value': '6.46', 'spread': '2.92', 'groupId': 'OG001'}]}]}, {'title': 'HER2: C4D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.22', 'spread': '2.25', 'groupId': 'OG000'}, {'value': '6.6', 'spread': '2.44', 'groupId': 'OG001'}]}]}, {'title': 'HER2: C5D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.02', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '8.38', 'spread': '3.54', 'groupId': 'OG001'}]}]}, {'title': 'HER2: C6D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.74', 'spread': '4.55', 'groupId': 'OG000'}, {'value': '9.9', 'spread': '7.34', 'groupId': 'OG001'}]}]}, {'title': 'HER2: C7D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.95', 'spread': '2.46', 'groupId': 'OG000'}, {'value': '6.7', 'spread': '0.42', 'groupId': 'OG001'}]}]}, {'title': 'HER2: C8D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.61', 'spread': '2.95', 'groupId': 'OG000'}, {'value': '11.7', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG001'}]}]}, {'title': 'HER2: C9D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.23', 'spread': '11.66', 'groupId': 'OG000'}]}]}, {'title': 'HER2: C10D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.00', 'spread': '2.67', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline [pre-dose on Cycle 1 Day 1 (C1D1)], then pre-dose on Day 1 of each cycle, end of treatment (Day 936)', 'description': 'Human epidermal growth factor receptor 2 (HER2) is a transmembrane protein that plays a pivotal role in growth factor signal transduction and epidermal growth factor receptor (EGFR) is a cell surface protein that binds to epidermal growth factor. Levels of the HER-2 and EGFR extracellular domains in serum were assessed by enzyme-linked immunosorbent assay (ELISA).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The pharmacodynamic population was defined as members of the ITT (as enrolled) population who had baseline samples submitted per Institutional Review Board (IRB) / Independent Ethics Committee (IEC) approval and participant consent. Here, 'number analyzed' signifies participants evaluable at each time point for each arm respectively."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Human Epidermal Growth Factor Family (HER-Family) and Kirsten Rat Sarcoma (KRAS) Gene Mutation Status From Free Tumor Deoxy- Ribonucleic Acid (DNA) in Blood at Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-00299804 (Adenocarcinoma Histology)', 'description': "Participants with adenocarcinoma histology received PF-00299804 tablet 45 milligram (mg) orally once daily in cycles of 21 days until unacceptable toxicity, tumor progression, death, withdrawal from the study or investigator's discretion."}, {'id': 'OG001', 'title': 'PF-00299804 (Non-adenocarcinoma Histology)', 'description': "Participants with non-adenocarcinoma histology received PF-00299804 tablet 45 mg orally once daily in cycles of 21 days until unacceptable toxicity, tumor progression, death, withdrawal from the study or investigator's discretion."}], 'classes': [{'title': 'KRAS mutation: Wild-type', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'KRAS mutation: Mutant', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'KRAS mutation: Unknown', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'HER-2 mutation: Wild-type', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'HER-2 mutation: Mutant', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HER-2 mutation: Unknown', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening', 'description': 'HER-family is a family of transmembrane protein that plays a pivotal role in growth factor signal transduction and Kirsten Rat Sarcoma (KRAS) gene is an oncogene that encodes a small guanosine triphosphatase (GTPase) transductor protein called KRAS. The mutation status of HER and KRAS genes in tumor DNA present in plasma was determined using a polymerase chain reaction (PCR)-based assay. The gene that is most common in a particular natural population is known as the wild type. Any form of the gene other than the wild type is known as a mutant form. Number of participants with HER-Family and KRAS gene mutation were classified as: wild type, mutant and unknown.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As-enrolled population included all participants who were enrolled in the study.'}, {'type': 'SECONDARY', 'title': 'European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-00299804 (Adenocarcinoma Histology)', 'description': "Participants with adenocarcinoma histology received PF-00299804 tablet 45 milligram (mg) orally once daily in cycles of 21 days until unacceptable toxicity, tumor progression, death, withdrawal from the study or investigator's discretion."}, {'id': 'OG001', 'title': 'PF-00299804 (Non-adenocarcinoma Histology)', 'description': "Participants with non-adenocarcinoma histology received PF-00299804 tablet 45 mg orally once daily in cycles of 21 days until unacceptable toxicity, tumor progression, death, withdrawal from the study or investigator's discretion."}], 'classes': [{'title': 'C1D1: GHS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65.83', 'spread': '24.99', 'groupId': 'OG000'}, {'value': '60.56', 'spread': '25.87', 'groupId': 'OG001'}]}]}, {'title': 'C1D1: Physical functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '74.70', 'spread': '22.17', 'groupId': 'OG000'}, {'value': '70.22', 'spread': '27.24', 'groupId': 'OG001'}]}]}, {'title': 'C1D1: Role functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.67', 'spread': '33.46', 'groupId': 'OG000'}, {'value': '74.44', 'spread': '32.04', 'groupId': 'OG001'}]}]}, {'title': 'C1D1: Emotional Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77.72', 'spread': '23.87', 'groupId': 'OG000'}, {'value': '77.22', 'spread': '16.51', 'groupId': 'OG001'}]}]}, {'title': 'C1D1: Cognitive Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '81.33', 'spread': '24.89', 'groupId': 'OG000'}, {'value': '76.67', 'spread': '28.73', 'groupId': 'OG001'}]}]}, {'title': 'C1D1: Social Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76.33', 'spread': '30.69', 'groupId': 'OG000'}, {'value': '67.78', 'spread': '26.33', 'groupId': 'OG001'}]}]}, {'title': 'C1D1: Fatigue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.44', 'spread': '25.99', 'groupId': 'OG000'}, {'value': '44.44', 'spread': '26.89', 'groupId': 'OG001'}]}]}, {'title': 'C1D1: Nausea, vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.33', 'spread': '18.10', 'groupId': 'OG000'}, {'value': '10.00', 'spread': '17.59', 'groupId': 'OG001'}]}]}, {'title': 'C1D1: Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.33', 'spread': '32.24', 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'0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C30D1: Dyspnoea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C30D1: Insomnia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C30D1: Appetite loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C30D1: Constipation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C30D1: Diarrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C30D1: Financial difficulties', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C31D1: GHS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '83.33', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C31D1: Physical functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C31D1: Role functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 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[{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C31D1: Fatigue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C31D1: Nausea, vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C31D1: 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'C31D1: Appetite loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C31D1: Constipation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C31D1: Diarrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C31D1: Financial difficulties', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C32D1: GHS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '83.33', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C32D1: Physical functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one 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'0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C32D1: Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C32D1: Dyspnoea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C32D1: Insomnia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C32D1: Appetite loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C32D1: Constipation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C32D1: Diarrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 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'OG000'}]}]}, {'title': 'C33D1: Diarrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C33D1: Financial difficulties', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C34D1: GHS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '83.33', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was 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'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C34D1: Nausea, vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C34D1: Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C34D1: Dyspnoea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 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[{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C34D1: Diarrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C34D1: Financial difficulties', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C35D1: GHS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '83.33', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C35D1: Physical functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C35D1: Role functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C35D1: Emotional Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': 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[{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C38D1: Appetite loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C38D1: Constipation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C38D1: Diarrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 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vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C39D1: Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C39D1: Dyspnoea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C39D1: Insomnia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C39D1: Appetite loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C39D1: Constipation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C39D1: Diarrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C39D1: Financial difficulties', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C40D1: GHS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '83.33', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C40D1: Physical functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C40D1: Role functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C40D1: Emotional Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C40D1: Cognitive Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C40D1: Social Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C40D1: Fatigue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C40D1: Nausea, vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C40D1: Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C40D1: Dyspnoea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C40D1: Insomnia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C40D1: Appetite loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C40D1: Constipation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C40D1: Diarrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C40D1: Financial difficulties', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C41D1: GHS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '83.33', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C41D1: Physical functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C41D1: Role functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C41D1: Emotional Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C41D1: Cognitive Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C41D1: Social Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C41D1: Fatigue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C41D1: Nausea, vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C41D1: Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C41D1: Dyspnoea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C41D1: Insomnia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C41D1: Appetite loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C41D1: Constipation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C41D1: Diarrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C41D1: Financial difficulties', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C42D1: GHS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '83.33', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C42D1: Physical functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C42D1: Role functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C42D1: Emotional Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C42D1: Cognitive Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C42D1: Social Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C42D1: Fatigue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C42D1: Nausea, vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C42D1: Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C42D1: Dyspnoea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C42D1: Insomnia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C42D1: Appetite loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C42D1: Constipation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C42D1: Diarrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C42D1: Financial difficulties', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C43D1: GHS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '83.33', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C43D1: Physical functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C43D1: Role functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C43D1: Emotional Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C43D1: Cognitive Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C43D1: Social Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C43D1: Fatigue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C43D1: Nausea, vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C43D1: Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C43D1: Dyspnoea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C43D1: Insomnia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C43D1: Appetite loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C43D1: Constipation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C43D1: Diarrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C43D1: Financial difficulties', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (C1D1), C2D1 thereafter every subsequent cycle up to C43', 'description': "EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status (GHS), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "As-enrolled population included all participants who were enrolled in the study. Here, 'N' signifies those participants who were evaluable for the measure and 'number analyzed' signifies participants evaluable at each time point for each arm respectively."}, {'type': 'SECONDARY', 'title': 'European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-00299804 (Adenocarcinoma Histology)', 'description': "Participants with adenocarcinoma histology received PF-00299804 tablet 45 milligram (mg) orally once daily in cycles of 21 days until unacceptable toxicity, tumor progression, death, withdrawal from the study or investigator's discretion."}, {'id': 'OG001', 'title': 'PF-00299804 (Non-adenocarcinoma Histology)', 'description': "Participants with non-adenocarcinoma histology received PF-00299804 tablet 45 mg orally once daily in cycles of 21 days until unacceptable toxicity, tumor progression, death, withdrawal from the study or investigator's discretion."}], 'classes': [{'title': 'C1D1: Dyspnoea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.85', 'spread': '22.84', 'groupId': 'OG000'}, {'value': '26.98', 'spread': '21.67', 'groupId': 'OG001'}]}]}, {'title': 'C1D1: Coughing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.33', 'spread': '30.12', 'groupId': 'OG000'}, {'value': '33.33', 'spread': '25.20', 'groupId': 'OG001'}]}]}, {'title': 'C1D1: Hemoptysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.00', 'spread': '10.45', 'groupId': 'OG000'}, {'value': '4.44', 'spread': '11.73', 'groupId': 'OG001'}]}]}, {'title': 'C1D1: Sore mouth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.33', 'spread': '10.10', 'groupId': 'OG000'}, {'value': '6.67', 'spread': '18.69', 'groupId': 'OG001'}]}]}, {'title': 'C1D1: Dysphagia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.67', 'spread': '9.13', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'C1D1: Peripheral neuropathy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.00', 'spread': '18.13', 'groupId': 'OG000'}, {'value': '13.33', 'spread': '24.56', 'groupId': 'OG001'}]}]}, {'title': 'C1D1: Alopecia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.16', 'spread': '25.94', 'groupId': 'OG000'}, {'value': '22.22', 'spread': '37.09', 'groupId': 'OG001'}]}]}, {'title': 'C1D1: Chest pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.67', 'spread': '27.07', 'groupId': 'OG000'}, {'value': '20.00', 'spread': '30.34', 'groupId': 'OG001'}]}]}, {'title': 'C1D1: Arm pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.00', 'spread': '30.12', 'groupId': 'OG000'}, {'value': '17.78', 'spread': '33.01', 'groupId': 'OG001'}]}]}, {'title': 'C1D1: Other pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32.00', 'spread': '32.96', 'groupId': 'OG000'}, {'value': '37.78', 'spread': '33.01', 'groupId': 'OG001'}]}]}, {'title': 'C2D1: Dyspnoea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.69', 'spread': '20.02', 'groupId': 'OG000'}, {'value': '26.85', 'spread': '23.43', 'groupId': 'OG001'}]}]}, {'title': 'C2D1: Coughing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.70', 'spread': '19.45', 'groupId': 'OG000'}, {'value': '33.33', 'spread': '24.62', 'groupId': 'OG001'}]}]}, {'title': 'C2D1: Hemoptysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.27', 'spread': '8.50', 'groupId': 'OG000'}, {'value': '5.56', 'spread': '12.97', 'groupId': 'OG001'}]}]}, {'title': 'C2D1: Sore mouth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.36', 'spread': '32.00', 'groupId': 'OG000'}, {'value': '27.78', 'spread': '23.92', 'groupId': 'OG001'}]}]}, {'title': 'C2D1: Dysphagia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.58', 'spread': '14.13', 'groupId': 'OG000'}, {'value': '11.11', 'spread': '16.41', 'groupId': 'OG001'}]}]}, {'title': 'C2D1: Peripheral neuropathy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.12', 'spread': '20.45', 'groupId': 'OG000'}, {'value': '13.89', 'spread': '22.29', 'groupId': 'OG001'}]}]}, {'title': 'C2D1: Alopecia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.06', 'spread': '20.68', 'groupId': 'OG000'}, {'value': '8.33', 'spread': '15.08', 'groupId': 'OG001'}]}]}, {'title': 'C2D1: Chest pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.61', 'spread': '21.29', 'groupId': 'OG000'}, {'value': '13.89', 'spread': '17.16', 'groupId': 'OG001'}]}]}, {'title': 'C2D1: Arm pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.39', 'spread': '20.83', 'groupId': 'OG000'}, {'value': '19.44', 'spread': '38.82', 'groupId': 'OG001'}]}]}, {'title': 'C2D1: Other pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.76', 'spread': '26.29', 'groupId': 'OG000'}, {'value': '16.67', 'spread': '30.15', 'groupId': 'OG001'}]}]}, {'title': 'C3D1: Dyspnoea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.37', 'spread': '23.69', 'groupId': 'OG000'}, {'value': '18.52', 'spread': '14.47', 'groupId': 'OG001'}]}]}, {'title': 'C3D1: Coughing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.08', 'spread': '20.45', 'groupId': 'OG000'}, {'value': '41.67', 'spread': '25.13', 'groupId': 'OG001'}]}]}, {'title': 'C3D1: Hemoptysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.67', 'spread': '7.36', 'groupId': 'OG000'}, {'value': '5.56', 'spread': '12.97', 'groupId': 'OG001'}]}]}, {'title': 'C3D1: Sore mouth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.00', 'spread': '31.85', 'groupId': 'OG000'}, {'value': '16.67', 'spread': '22.47', 'groupId': 'OG001'}]}]}, {'title': 'C3D1: Dysphagia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.67', 'spread': '24.52', 'groupId': 'OG000'}, {'value': '11.11', 'spread': '21.71', 'groupId': 'OG001'}]}]}, {'title': 'C3D1: Peripheral neuropathy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 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[{'measurements': [{'value': '8.33', 'spread': '16.45', 'groupId': 'OG000'}, {'value': '25.00', 'spread': '32.18', 'groupId': 'OG001'}]}]}, {'title': 'C3D1: Other pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.08', 'spread': '26.66', 'groupId': 'OG000'}, {'value': '33.33', 'spread': '30.43', 'groupId': 'OG001'}]}]}, {'title': 'C4D1: Dyspnoea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.81', 'spread': '16.08', 'groupId': 'OG000'}, {'value': '31.94', 'spread': '26.85', 'groupId': 'OG001'}]}]}, {'title': 'C4D1: Coughing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.79', 'spread': '20.96', 'groupId': 'OG000'}, {'value': '41.67', 'spread': '23.57', 'groupId': 'OG001'}]}]}, {'title': 'C4D1: Hemoptysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.56', 'spread': '9.06', 'groupId': 'OG000'}, {'value': '4.17', 'spread': '11.79', 'groupId': 'OG001'}]}]}, {'title': 'C4D1: Sore mouth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.23', 'spread': '19.26', 'groupId': 'OG000'}, {'value': '20.83', 'spread': '24.80', 'groupId': 'OG001'}]}]}, {'title': 'C4D1: Dysphagia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.69', 'spread': '14.32', 'groupId': 'OG000'}, {'value': '16.67', 'spread': '30.86', 'groupId': 'OG001'}]}]}, {'title': 'C4D1: Peripheral neuropathy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.23', 'spread': '28.55', 'groupId': 'OG000'}, {'value': '25.00', 'spread': '15.43', 'groupId': 'OG001'}]}]}, {'title': 'C4D1: Alopecia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.41', 'spread': '21.12', 'groupId': 'OG000'}, {'value': '4.17', 'spread': '11.79', 'groupId': 'OG001'}]}]}, {'title': 'C4D1: Chest pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.85', 'spread': '10.86', 'groupId': 'OG000'}, {'value': '20.83', 'spread': '30.54', 'groupId': 'OG001'}]}]}, {'title': 'C4D1: Arm pain', 'denoms': [{'units': 'Participants', 'counts': 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'categories': [{'measurements': [{'value': '25.64', 'spread': '17.15', 'groupId': 'OG000'}, {'value': '42.86', 'spread': '16.27', 'groupId': 'OG001'}]}]}, {'title': 'C5D1: Hemoptysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.28', 'spread': '6.54', 'groupId': 'OG000'}, {'value': '4.76', 'spread': '12.60', 'groupId': 'OG001'}]}]}, {'title': 'C5D1: Sore mouth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.23', 'spread': '25.25', 'groupId': 'OG000'}, {'value': '23.81', 'spread': '25.20', 'groupId': 'OG001'}]}]}, {'title': 'C5D1: Dysphagia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.69', 'spread': '17.15', 'groupId': 'OG000'}, {'value': '14.29', 'spread': '26.23', 'groupId': 'OG001'}]}]}, {'title': 'C5D1: Peripheral neuropathy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.67', 'spread': '27.08', 'groupId': 'OG000'}, {'value': '19.05', 'spread': '17.82', 'groupId': 'OG001'}]}]}, {'title': 'C5D1: Alopecia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.97', 'spread': '22.23', 'groupId': 'OG000'}, {'value': '9.52', 'spread': '16.27', 'groupId': 'OG001'}]}]}, {'title': 'C5D1: Chest pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.97', 'spread': '17.78', 'groupId': 'OG000'}, {'value': '9.52', 'spread': '16.27', 'groupId': 'OG001'}]}]}, {'title': 'C5D1: Arm pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.26', 'spread': '22.65', 'groupId': 'OG000'}, {'value': '23.81', 'spread': '37.09', 'groupId': 'OG001'}]}]}, {'title': 'C5D1: Other pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.33', 'spread': '30.25', 'groupId': 'OG000'}, {'value': '33.33', 'spread': '38.49', 'groupId': 'OG001'}]}]}, {'title': 'C6D1: Dyspnoea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.90', 'spread': '23.84', 'groupId': 'OG000'}, {'value': '20.00', 'spread': '14.49', 'groupId': 'OG001'}]}]}, {'title': 'C6D1: Coughing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.78', 'spread': '20.61', 'groupId': 'OG000'}, {'value': '20.00', 'spread': '18.26', 'groupId': 'OG001'}]}]}, {'title': 'C6D1: Hemoptysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.70', 'spread': '10.78', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'C6D1: Sore mouth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.22', 'spread': '22.87', 'groupId': 'OG000'}, {'value': '26.67', 'spread': '27.89', 'groupId': 'OG001'}]}]}, {'title': 'C6D1: Dysphagia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': 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'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C43D1: Sore mouth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'C43D1: Dysphagia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C43D1: Peripheral neuropathy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C43D1: Alopecia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C43D1: Chest pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C43D1: Arm pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C43D1: Other pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (C1D1), C2D1 thereafter every subsequent cycle up to C43', 'description': 'QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprised 1 multi-item scale for dyspnoea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain). Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "As-enrolled population included all participants who were enrolled in the study. Here, 'N' signifies those participants who were evaluable for the measure and 'number analyzed' signifies participants evaluable at each time point for each arm respectively."}, {'type': 'SECONDARY', 'title': 'Dermatology Life Quality Index (DLQI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-00299804 (Adenocarcinoma Histology)', 'description': "Participants with adenocarcinoma histology received PF-00299804 tablet 45 milligram (mg) orally once daily in cycles of 21 days until unacceptable toxicity, tumor progression, death, withdrawal from the study or investigator's discretion."}, {'id': 'OG001', 'title': 'PF-00299804 (Non-adenocarcinoma Histology)', 'description': "Participants with non-adenocarcinoma histology received PF-00299804 tablet 45 mg orally once daily in cycles of 21 days until unacceptable toxicity, tumor progression, death, withdrawal from the study or investigator's discretion."}], 'classes': [{'title': 'C1D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.38', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '0.80', 'spread': '1.52', 'groupId': 'OG001'}]}]}, {'title': 'C2D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.34', 'spread': '4.37', 'groupId': 'OG000'}, {'value': '2.08', 'spread': '2.22', 'groupId': 'OG001'}]}]}, {'title': 'C3D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.08', 'spread': '4.31', 'groupId': 'OG000'}, {'value': '3.08', 'spread': '3.99', 'groupId': 'OG001'}]}]}, {'title': 'C4D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.56', 'spread': '3.62', 'groupId': 'OG000'}, {'value': '5.13', 'spread': '5.06', 'groupId': 'OG001'}]}]}, {'title': 'C5D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.67', 'spread': '4.12', 'groupId': 'OG000'}, {'value': '6.00', 'spread': '7.62', 'groupId': 'OG001'}]}]}, {'title': 'C6D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.39', 'spread': '4.65', 'groupId': 'OG000'}, {'value': '6.00', 'spread': '6.40', 'groupId': 'OG001'}]}]}, {'title': 'C7D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.00', 'spread': '5.28', 'groupId': 'OG000'}, {'value': '5.00', 'spread': '6.06', 'groupId': 'OG001'}]}]}, {'title': 'C8D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.31', 'spread': '3.57', 'groupId': 'OG000'}, {'value': '3.67', 'spread': '3.21', 'groupId': 'OG001'}]}]}, {'title': 'C9D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.78', 'spread': '2.49', 'groupId': 'OG000'}, {'value': '2.50', 'spread': '3.54', 'groupId': 'OG001'}]}]}, {'title': 'C10D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.22', 'spread': '2.54', 'groupId': 'OG000'}, {'value': '8.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG001'}]}]}, {'title': 'C11D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.78', 'spread': '3.35', 'groupId': 'OG000'}]}]}, {'title': 'C12D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.00', 'spread': '3.95', 'groupId': 'OG000'}]}]}, {'title': 'C13D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.00', 'spread': '3.65', 'groupId': 'OG000'}]}]}, {'title': 'C14D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.50', 'spread': '0.71', 'groupId': 'OG000'}]}]}, {'title': 'C15D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.00', 'spread': '1.41', 'groupId': 'OG000'}]}]}, {'title': 'C16D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'C17D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.50', 'spread': '0.71', 'groupId': 'OG000'}]}]}, {'title': 'C18D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.50', 'spread': '0.71', 'groupId': 'OG000'}]}]}, {'title': 'C19D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.00', 'spread': '1.41', 'groupId': 'OG000'}]}]}, {'title': 'C20D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.50', 'spread': '0.71', 'groupId': 'OG000'}]}]}, {'title': 'C21D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.00', 'spread': '1.41', 'groupId': 'OG000'}]}]}, {'title': 'C22D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.00', 'spread': '1.41', 'groupId': 'OG000'}]}]}, {'title': 'C23D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.00', 'spread': '11.31', 'groupId': 'OG000'}]}]}, {'title': 'C24D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.00', 'spread': '1.41', 'groupId': 'OG000'}]}]}, {'title': 'C25D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'C26D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C27D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C29D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C30D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C31D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C32D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C33D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C34D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C35D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C36D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C37D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C38D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C39D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C40D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C41D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C42D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'C43D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (C1D1), C2D1 thereafter every subsequent cycle up to C43', 'description': "Self-administered questionnaire to measure health-related quality of life (QoL) of adult participants suffering from skin disease; 10 questions concerning participants' perception of impact of their disease over last week encompassing aspects such as symptoms or feelings, daily activities, leisure, work or school, personal relationships and treatment. Questions scored on a 4-point Likert scale: 0 (not relevant), 1 (a little), 2 (a lot), and 3 (very much). Scores of individual questions (0-3) were added to yield a total score (0-30); higher score = greater impairment of participant's QoL.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "As-enrolled population included all participants who were enrolled in the study. Here, 'N' signifies those participants who were evaluable for the measure and 'number analyzed' signifies participants evaluable at each time point for each arm respectively."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Progression-free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-00299804 (Adenocarcinoma Histology)', 'description': "Participants with adenocarcinoma histology received PF-00299804 tablet 45 milligram (mg) orally once daily in cycles of 21 days up to 1 year or until unacceptable toxicity, tumor progression, death or investigator's discretion."}, {'id': 'OG001', 'title': 'PF-00299804 (Non-adenocarcinoma Histology)', 'description': "Participants with non-adenocarcinoma histology received PF-00299804 tablet 45 mg orally once daily in cycles of 21 days up to 1 year or until unacceptable toxicity, tumor progression, death or investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '24.3', 'groupId': 'OG000', 'lowerLimit': '12.4', 'upperLimit': '38.4'}, {'value': '8.0', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '29.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6', 'description': 'PFS is defined as time in weeks from randomization to the first documentation of objective tumor progression or death due to any cause. PFS was calculated as = (first event date minus randomization date plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \\[PD\\]), or from adverse event (AE) data (where the outcome was "Death").', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'As-enrolled population included all participants who were enrolled in the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PF-00299804 (Adenocarcinoma Histology)', 'description': "Participants with adenocarcinoma histology received PF-00299804 tablet 45 milligram (mg) orally once daily in cycles of 21 days until unacceptable toxicity, tumor progression, death, withdrawal from the study or investigator's discretion."}, {'id': 'FG001', 'title': 'PF-00299804 (Non-adenocarcinoma Histology)', 'description': "Participants with non-adenocarcinoma histology received PF-00299804 tablet 45 mg orally once daily in cycles of 21 days until unacceptable toxicity, tumor progression, death, withdrawal from the study or investigator's discretion."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Objective progression or relapse', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Completed post-treatment follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'PF-00299804 (Adenocarcinoma Histology)', 'description': "Participants with adenocarcinoma histology received PF-00299804 tablet 45 milligram (mg) orally once daily in cycles of 21 days until unacceptable toxicity, tumor progression, death, withdrawal from the study or investigator's discretion."}, {'id': 'BG001', 'title': 'PF-00299804 (Non-adenocarcinoma Histology)', 'description': "Participants with non-adenocarcinoma histology received PF-00299804 tablet 45 mg orally once daily in cycles of 21 days until unacceptable toxicity, tumor progression, death, withdrawal from the study or investigator's discretion."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.7', 'spread': '9.3', 'groupId': 'BG000'}, {'value': '65.0', 'spread': '10.7', 'groupId': 'BG001'}, {'value': '61.7', 'spread': '9.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'dispFirstSubmitDate': '2011-06-03', 'completionDateStruct': {'date': '2012-06-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-20', 'studyFirstSubmitDate': '2007-10-19', 'dispFirstSubmitQcDate': '2011-06-03', 'resultsFirstSubmitDate': '2019-02-07', 'studyFirstSubmitQcDate': '2007-10-19', 'dispFirstPostDateStruct': {'date': '2011-06-16', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2019-05-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-05-20', 'studyFirstPostDateStruct': {'date': '2007-10-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-03-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best Overall Response (BOR) in Participants With Adenocarcinoma Histology', 'timeFrame': 'Baseline, end of every even-numbered cycle up to end of treatment (Day 936)', 'description': 'BOR:best response recorded from treatment start until disease progression as per Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response: disappearance of all lesions. Partial Response (PR):greater than or equal to (\\>=)30% decrease in sum of longest diameters (SLDs) of target lesions (TLs) taking as reference baseline SLD. Progressive disease (PD):\\>=20% increase in SLD of TLs taking as reference smallest SLD since treatment start, or appearance of \\>=1 new lesion. Stable disease:neither shrinkage for PR nor increase for PD taking as reference smallest SLD since treatment start.'}], 'secondaryOutcomes': [{'measure': 'Best Overall Response (BOR) in Participants With Non-Adenocarcinoma Histology', 'timeFrame': 'Baseline, end of every even-numbered cycle up to end of treatment (Day 936)', 'description': 'BOR: best response recorded from treatment start until disease progression as per RECIST. Complete Response: disappearance of all lesions. PR: \\>=30% decrease in SLDs of TLs taking as reference baseline SLD. PD: \\>=20% increase in SLD of TLs taking as reference smallest SLD since treatment start, or appearance of \\>=1 new lesion. Stable disease: neither shrinkage for PR nor increase for PD taking as reference smallest SLD since treatment start.'}, {'measure': 'Duration of Response (DR)', 'timeFrame': 'Baseline, end of every even-numbered cycle up to end of treatment (Day 936)', 'description': 'Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.'}, {'measure': 'Percent Probability of Progression-free Survival (PFS) at Month 6', 'timeFrame': 'Up to 6 months after the start of study medication', 'description': 'Probability of being event free (event defined as PD or death due to any cause) at 6 months after the first dose of study treatment. PFS was defined as the time from the first dosing date to the date of first documentation of progression or death due to any cause, whichever occurs first. PFS was calculated as (first event date (if not reached, censored at the last known event-free date) minus first dosing date plus 1). Documentation of progression was determined from objective disease assessment based on RECIST v1.0 criteria. PD was defined as at least a 20% increase in the sum of the longest diameters of the target lesions taking as a reference the smallest sum of the longest diameters recorded since treated started or the appearance of 1 or more new lesions.'}, {'measure': 'Percent Probability of Overall Survival at Months 6 and 12', 'timeFrame': 'Months 6, 12', 'description': 'Probability of being alive at 6 and 12 months after the first dose of study medication.'}, {'measure': 'Area Under the Curve From Time Zero to 24 Hours [AUC (0-24)]', 'timeFrame': '0.5-2, 3-5, 6-8, 22-26 hours post dose on Day 1 of Cycle 1', 'description': 'The pharmacokinetic (PK) samples collected between 22-26 hours post dose on Day 1 of Cycle 1 were within the pre-specified time window for the 24-hour post dose sample and were used for calculation of AUC (0-24) on Day 1 of Cycle 1.'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax)', 'timeFrame': '0.5-2, 3-5, 6-8, 22-26 hours post dose on Day 1 of Cycle 1'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax)', 'timeFrame': '0.5-2, 3-5, 6-8, 22-26 hours post dose on Day 1 of Cycle 1'}, {'measure': 'Human Epidermal Growth Factor-2 (HER-2) and Epidermal Growth Factor Receptor (EGFR) Levels in Serum', 'timeFrame': 'Baseline [pre-dose on Cycle 1 Day 1 (C1D1)], then pre-dose on Day 1 of each cycle, end of treatment (Day 936)', 'description': 'Human epidermal growth factor receptor 2 (HER2) is a transmembrane protein that plays a pivotal role in growth factor signal transduction and epidermal growth factor receptor (EGFR) is a cell surface protein that binds to epidermal growth factor. Levels of the HER-2 and EGFR extracellular domains in serum were assessed by enzyme-linked immunosorbent assay (ELISA).'}, {'measure': 'Number of Participants With Human Epidermal Growth Factor Family (HER-Family) and Kirsten Rat Sarcoma (KRAS) Gene Mutation Status From Free Tumor Deoxy- Ribonucleic Acid (DNA) in Blood at Screening', 'timeFrame': 'Screening', 'description': 'HER-family is a family of transmembrane protein that plays a pivotal role in growth factor signal transduction and Kirsten Rat Sarcoma (KRAS) gene is an oncogene that encodes a small guanosine triphosphatase (GTPase) transductor protein called KRAS. The mutation status of HER and KRAS genes in tumor DNA present in plasma was determined using a polymerase chain reaction (PCR)-based assay. The gene that is most common in a particular natural population is known as the wild type. Any form of the gene other than the wild type is known as a mutant form. Number of participants with HER-Family and KRAS gene mutation were classified as: wild type, mutant and unknown.'}, {'measure': 'European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score', 'timeFrame': 'Baseline (C1D1), C2D1 thereafter every subsequent cycle up to C43', 'description': "EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status (GHS), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms."}, {'measure': 'European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score', 'timeFrame': 'Baseline (C1D1), C2D1 thereafter every subsequent cycle up to C43', 'description': 'QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprised 1 multi-item scale for dyspnoea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain). Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.'}, {'measure': 'Dermatology Life Quality Index (DLQI) Score', 'timeFrame': 'Baseline (C1D1), C2D1 thereafter every subsequent cycle up to C43', 'description': "Self-administered questionnaire to measure health-related quality of life (QoL) of adult participants suffering from skin disease; 10 questions concerning participants' perception of impact of their disease over last week encompassing aspects such as symptoms or feelings, daily activities, leisure, work or school, personal relationships and treatment. Questions scored on a 4-point Likert scale: 0 (not relevant), 1 (a little), 2 (a lot), and 3 (very much). Scores of individual questions (0-3) were added to yield a total score (0-30); higher score = greater impairment of participant's QoL."}, {'measure': 'Percentage of Participants With Progression-free Survival (PFS)', 'timeFrame': 'Month 6', 'description': 'PFS is defined as time in weeks from randomization to the first documentation of objective tumor progression or death due to any cause. PFS was calculated as = (first event date minus randomization date plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \\[PD\\]), or from adverse event (AE) data (where the outcome was "Death").'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['non-small cell lung cancer', 'advanced', 'previously treated'], 'conditions': ['Carcinoma, Non Small Cell Lung']}, 'referencesModule': {'references': [{'pmid': '24501009', 'type': 'DERIVED', 'citation': "Reckamp KL, Giaccone G, Camidge DR, Gadgeel SM, Khuri FR, Engelman JA, Koczywas M, Rajan A, Campbell AK, Gernhardt D, Ruiz-Garcia A, Letrent S, Liang J, Taylor I, O'Connell JP, Janne PA. A phase 2 trial of dacomitinib (PF-00299804), an oral, irreversible pan-HER (human epidermal growth factor receptor) inhibitor, in patients with advanced non-small cell lung cancer after failure of prior chemotherapy and erlotinib. Cancer. 2014 Apr 15;120(8):1145-54. doi: 10.1002/cncr.28561. Epub 2014 Feb 5."}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A7471002&StudyName=PF-00299804%20As%20A%20Single%20Agent%2C%20In%20Patients%20With%20Advanced%20Non-Small%20Cell%20Lung%20Cancer%20%20Who%20Have%20Failed%20Chemotherapy%20And%20Erlotinib', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'To assess the antitumor efficacy measured by the objective response rate of oral PF-00299804 taken daily, as single agent in patients with advanced NSCLC who failed at least one chemotherapy + erlotinib.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Advanced Non-Small Cell Lung Cancer (NSCLC)\n* Prior treatment with and failure of at least one regimen of chemotherapy and erlotinib.\n* Prior treatment with no more than two chemotherapy regimens, including adjuvant or combined modality treatment.\n* Measurable disease .\n* Eastern Cooperative Oncology Group (ECOG) Performance status 0-2\n* Tissue available for KRAS/ EGFR testing\n* Creatinine clearance \\> 40 cc/min or serum creat \\< 1.5 x ULN\n\nExclusion Criteria:\n\n* Chemotherapy\n* Radiotherapy\n* Biological or investigational agents within 4 weeks of baseline disease assessment.\n* Patients who lack of tolerance of erlotinib therapy.'}, 'identificationModule': {'nctId': 'NCT00548093', 'briefTitle': 'PF-00299804 As A Single Agent, In Patients With Advanced Non-Small Cell Lung Cancer Who Have Failed Chemotherapy And Erlotinib', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 2, OPEN-LABEL, TWO ARM TRIAL TO EVALUATE THE EFFICACY OF PF-00299804 IN PATIENTS WITH ADVANCED NSCLC AFTER FAILURE OF AT LEAST ONE PRIOR CHEMOTHERAPY REGIMEN AND FAILURE OF PRIOR TREATMENT WITH ERLOTINIB', 'orgStudyIdInfo': {'id': 'A7471002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'descriptive: adenocarcinoma histology', 'interventionNames': ['Drug: PF-00299804']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'descriptive: non-adenocarcinoma histology', 'interventionNames': ['Drug: PF-00299804']}], 'interventions': [{'name': 'PF-00299804', 'type': 'DRUG', 'description': 'PF-00299804 orally at 45 mg daily, on continuous schedule', 'armGroupLabels': ['1']}, {'name': 'PF-00299804', 'type': 'DRUG', 'description': 'PF-00299804 orally at 45 mg daily, on continuous schedule', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '91105', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Medical Group', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '91030', 'city': 'South Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope South Pasadena Cancer Center', 'geoPoint': {'lat': 34.11612, 'lon': -118.15035}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Lions Eye Institute', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Hospital, Anschutz Cancer Pavilion', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Hospital, Anschutz Inpatient Pavilion', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Hospital', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Grady Health Systems', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emery University Hospital Midtown', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory Clinic', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Winship Cancer Institute', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'CCR, National Cancer Institute', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Karmanos Cancer Institute/Wayne State University', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48334', 'city': 'Farmington Hills', 'state': 'Michigan', 'country': 'United States', 'facility': 'Lawrence and Idell Weisberg Cancer Treatment Center', 'geoPoint': {'lat': 42.48531, 'lon': -83.37716}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'url': 'https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests', 'ipdSharing': 'YES', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}