Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:46 PM
Study NCT ID:
NCT00769067
Status:
COMPLETED
Last Update Posted:
2015-10-07
First Post:
2008-10-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Randomized Trial Of PF-00299804 Taken Orally Versus Erlotinib Taken Orally For Treatment Of Advanced Non-Small Cell Lung Cancer That Has Progressed After One Or Two Prior Chemotherapy Regimen
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069347', 'term': 'Erlotinib Hydrochloride'}, {'id': 'C525726', 'term': 'dacomitinib'}], 'ancestors': [{'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': '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}}, 'adverseEventsModule': {'timeFrame': 'Adverse events (AEs) were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.', 'description': 'The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Erlotinib', 'description': 'Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.', 'otherNumAtRisk': 94, 'otherNumAffected': 93, 'seriousNumAtRisk': 94, 'seriousNumAffected': 30}, {'id': 'EG001', 'title': 'Dacomitinib', 'description': 'Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.', 'otherNumAtRisk': 93, 'otherNumAffected': 93, 'seriousNumAtRisk': 93, 'seriousNumAffected': 34}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cheilitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 67}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 27}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 23}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 9}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Paronychia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 18}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 27}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 17}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 20}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dermatitis acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 60}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 22}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Erythema multiforme', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Exfoliative rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 16}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Nail disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Palmar-plantar erythrodysaesthesia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 11}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 14}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Skin fissures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Infected dermal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Parotitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cachexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hypovolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Malignant pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Altered state of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pulmonary haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dermatitis acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Categorical Summary of Overall Scale Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib', 'description': 'Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.'}, {'id': 'OG001', 'title': 'Dacomitinib', 'description': 'Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.'}], 'classes': [{'title': 'Global QoL: Improved (n= 85, 85)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Global QoL: Worsened (n= 85, 85)', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'Global QoL: Stable (n= 85, 85)', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning: Improved (n= 86, 88)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning: Worsened (n= 86, 88)', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning: Stable (n= 86, 88)', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}, {'title': 'Role Functioning: Improved (n= 86, 88)', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Role Functioning: Worsened (n= 86, 88)', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'Role Functioning: Stable (n= 86, 88)', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'Cognitive Functioning: Improved (n= 86, 85)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Cognitive Functioning: Worsened (n= 86, 85)', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Cognitive Functioning: Stable (n= 86, 85)', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}, {'title': 'Emotional Functioning: Improved (n= 86, 85)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Emotional Functioning: Worsened (n= 86, 85)', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Emotional Functioning: Stable (n= 86, 85)', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'Social Functioning: Improved (n= 86, 85)', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Social Functioning: Worsened (n= 86, 85)', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Social Functioning: Stable (n= 86, 85)', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue: Improved (n= 86, 87)', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue: Worsened (n= 86, 87)', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue: Stable (n= 86, 87)', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'Pain: Improved (n= 86, 87)', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Pain: Worsened (n= 86, 87)', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'Pain: Stable (n= 86, 87)', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'Nausea and Vomiting: Improved (n= 86, 87)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Nausea and Vomiting: Worsened (n= 86, 87)', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Nausea and Vomiting: Stable (n= 86, 87)', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'Dyspnea: Improved (n= 86, 88)', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Dyspnea: Worsened (n= 86, 88)', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Dyspnea: Stable (n= 86, 88)', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'Loss of Appetite: Improved (n= 85, 87)', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Loss of Appetite: Worsened (n= 85, 87)', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}, {'title': 'Loss of Appetite: Stable (n= 85, 87)', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Insomnia: Improved (n= 86, 87)', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Insomnia: Worsened (n= 86, 87)', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'Insomnia: Stable (n= 86, 87)', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'Constipation: Improved (n= 86, 85)', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'Constipation: Worsened (n= 86, 85)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Constipation: Stable (n= 86, 85)', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea: Improved (n= 86, 85)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea: Worsened (n= 86, 85)', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea: Stable (n= 86, 85)', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Financial Difficulties: Improved (n= 85, 85)', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Financial Difficulties: Worsened (n= 85, 85)', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Financial Difficulties: Stable (n= 85, 85)', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Cycle 44 (Week 188)', 'description': 'EORTC QLQ-C30: included global health status/quality of life (QoL), functional (Fn) scales (physical, role, cognitive, emotional, and social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulties). Scores were averaged, transformed to 0-100 scale; higher score for Global Qol/Fn scales=better level of QoL/functioning or higher score for symptom scales/items=greater degree of symptoms. Overall scale change is categorized as Improved (if average scales change from baseline: for Global QoL/Fn scales \\>=10; for symptom scale/item \\<=-10), Worsened (if average scales change from baseline: for Global QoL/Fn scales \\<=-10; for symptom scale/item \\>=10), and Stable (if average scales change from baseline \\>-10 but \\<10 for Global QoL/Fn scales and symptom scale/item) and participants in each category are reported.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: all randomized participants with study drug assignment designated according to initial randomization, regardless of treatment received. "N" (number of participants analyzed): participants who completed at least 1 item at baseline. "n": participants evaluable for specified category for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Categorical Summary of Overall Scale Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib', 'description': 'Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.'}, {'id': 'OG001', 'title': 'Dacomitinib', 'description': 'Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.'}], 'classes': [{'title': 'Dyspnoea: Improved (n= 85, 87)', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Dyspnoea: Worsened (n= 85, 87)', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Dyspnoea: Stable (n= 85, 87)', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}, {'title': 'Coughing: Improved (n= 85, 87)', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'Coughing: Worsened (n= 85, 87)', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Coughing: Stable (n= 85, 87)', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Haemoptysis: Improved (n= 85, 86)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Haemoptysis: Worsened (n= 85, 86)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Haemoptysis: Stable (n= 85, 86)', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}]}, {'title': 'Sore mouth: Improved (n= 85, 87)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Sore mouth: Worsened (n= 85, 87)', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}, {'title': 'Sore mouth: Stable (n= 85, 87)', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Dysphagia: Improved (n= 85, 87)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Dysphagia: Worsened (n= 85, 87)', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'Dysphagia: Stable (n= 85, 87)', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}, {'title': 'Peripheral: Improved (n= 85, 87)', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'Peripheral: Worsened (n= 85, 87)', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Peripheral: Stable (n= 85, 87)', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'Alopecia: Improved (n= 84, 87)', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Alopecia: Worsened (n= 84, 87)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Alopecia: Stable (n= 84, 87)', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}, {'title': 'Pain in chest: Improved (n= 85, 87)', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Pain in chest: Worsened (n= 85, 87)', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Pain in chest: Stable (n= 85, 87)', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': 'Pain in arm or Shoulder: Improved (n= 85, 87)', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Pain in arm or Shoulder: Worsened (n= 85, 87)', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Pain in arm or Shoulder: Stable (n= 85, 87)', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'Pain in other parts: Improved (n= 83, 86)', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Pain in other parts: Worsened (n= 83, 86)', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Pain in other parts: Stable (n= 83, 86)', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Cycle 44 (Week 188)', '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 dyspnea 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). Scores averaged, transformed to 0-100 scale; higher symptom score = greater degree of symptoms. Overall scale change is categorized as Improved (if average scales change from baseline \\<=-10), Worsened (if average scales change from baseline \\>=10), and Stable (if average scales change from baseline \\>-10 but \\<10) and participants in each category are reported.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: all randomized participants with study drug assignment designated according to initial randomization, regardless of treatment received. "N" (number of participants analyzed): participants who completed at least 1 item at baseline. "n": participants evaluable for specified category for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Dermatology Life Quality Index (DLQI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib', 'description': 'Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.'}, {'id': 'OG001', 'title': 'Dacomitinib', 'description': 'Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.'}], 'classes': [{'title': 'C1D1 (n= 87, 91)', 'categories': [{'measurements': [{'value': '0.70', 'spread': '1.97', 'groupId': 'OG000'}, {'value': '0.88', 'spread': '2.38', 'groupId': 'OG001'}]}]}, {'title': 'C1D10-14 (n=68, 81)', 'categories': [{'measurements': [{'value': '4.35', 'spread': '6.25', 'groupId': 'OG000'}, {'value': '3.06', 'spread': '4.94', 'groupId': 'OG001'}]}]}, {'title': 'C2D1 (n= 80, 82)', 'categories': [{'measurements': [{'value': '5.16', 'spread': '6.29', 'groupId': 'OG000'}, {'value': '3.91', 'spread': '4.07', 'groupId': 'OG001'}]}]}, {'title': 'C3D1 (n= 63, 63)', 'categories': [{'measurements': [{'value': '4.08', 'spread': '5.67', 'groupId': 'OG000'}, {'value': '5.52', 'spread': '6.65', 'groupId': 'OG001'}]}]}, {'title': 'C4D1 (n= 39, 43)', 'categories': [{'measurements': [{'value': '3.97', 'spread': '4.59', 'groupId': 'OG000'}, {'value': '5.95', 'spread': '6.38', 'groupId': 'OG001'}]}]}, {'title': 'C5D1 (n= 25, 38)', 'categories': [{'measurements': [{'value': '3.56', 'spread': '3.61', 'groupId': 'OG000'}, {'value': '5.37', 'spread': '6.08', 'groupId': 'OG001'}]}]}, {'title': 'C6D1 (n= 16, 27)', 'categories': [{'measurements': [{'value': '4.13', 'spread': '4.80', 'groupId': 'OG000'}, {'value': '5.37', 'spread': '6.67', 'groupId': 'OG001'}]}]}, {'title': 'C7D1 (n= 13, 27)', 'categories': [{'measurements': [{'value': '4.38', 'spread': '4.07', 'groupId': 'OG000'}, {'value': '4.93', 'spread': '6.54', 'groupId': 'OG001'}]}]}, {'title': 'C8D1 (n= 11, 24)', 'categories': [{'measurements': [{'value': '4.64', 'spread': '3.14', 'groupId': 'OG000'}, {'value': '5.33', 'spread': '6.23', 'groupId': 'OG001'}]}]}, {'title': 'C9D1 (n= 11, 19)', 'categories': [{'measurements': [{'value': '3.82', 'spread': '3.34', 'groupId': 'OG000'}, {'value': '4.84', 'spread': '5.76', 'groupId': 'OG001'}]}]}, {'title': 'C10D1 (n= 11, 17)', 'categories': [{'measurements': [{'value': '3.36', 'spread': '3.04', 'groupId': 'OG000'}, {'value': '5.88', 'spread': '7.37', 'groupId': 'OG001'}]}]}, {'title': 'C11D1 (n= 10, 15)', 'categories': [{'measurements': [{'value': '5.60', 'spread': '5.13', 'groupId': 'OG000'}, {'value': '6.73', 'spread': '7.57', 'groupId': 'OG001'}]}]}, {'title': 'C12D1 (n= 7, 14)', 'categories': [{'measurements': [{'value': '6.71', 'spread': '5.62', 'groupId': 'OG000'}, {'value': '5.50', 'spread': '6.99', 'groupId': 'OG001'}]}]}, {'title': 'C13D1 (n= 7, 13)', 'categories': [{'measurements': [{'value': '5.57', 'spread': '4.08', 'groupId': 'OG000'}, {'value': '5.08', 'spread': '7.90', 'groupId': 'OG001'}]}]}, {'title': 'C14D1 (n= 6, 12)', 'categories': [{'measurements': [{'value': '6.00', 'spread': '3.95', 'groupId': 'OG000'}, {'value': '6.00', 'spread': '7.35', 'groupId': 'OG001'}]}]}, {'title': 'C15D1 (n= 6, 12)', 'categories': [{'measurements': [{'value': '4.67', 'spread': '3.78', 'groupId': 'OG000'}, {'value': '5.92', 'spread': '7.40', 'groupId': 'OG001'}]}]}, {'title': 'C16D1 (n= 5, 11)', 'categories': [{'measurements': [{'value': '5.40', 'spread': '3.91', 'groupId': 'OG000'}, {'value': '5.36', 'spread': '8.18', 'groupId': 'OG001'}]}]}, {'title': 'C17D1 (n= 4, 11)', 'categories': [{'measurements': [{'value': '5.00', 'spread': '4.24', 'groupId': 'OG000'}, {'value': '5.55', 'spread': '7.85', 'groupId': 'OG001'}]}]}, {'title': 'C18D1 (n= 4, 10)', 'categories': [{'measurements': [{'value': '3.00', 'spread': '2.16', 'groupId': 'OG000'}, {'value': '7.30', 'spread': '9.08', 'groupId': 'OG001'}]}]}, {'title': 'C19D1 (n= 4, 9)', 'categories': [{'measurements': [{'value': '4.50', 'spread': '2.38', 'groupId': 'OG000'}, {'value': '7.22', 'spread': '7.73', 'groupId': 'OG001'}]}]}, {'title': 'C20D1 (n= 2, 10)', 'categories': [{'measurements': [{'value': '3.50', 'spread': '3.54', 'groupId': 'OG000'}, {'value': '6.50', 'spread': '8.57', 'groupId': 'OG001'}]}]}, {'title': 'C21D1 (n= 2, 9)', 'categories': [{'measurements': [{'value': '3.50', 'spread': '2.12', 'groupId': 'OG000'}, {'value': '7.33', 'spread': '7.76', 'groupId': 'OG001'}]}]}, {'title': 'C22D1 (n= 1, 7)', 'categories': [{'measurements': [{'value': '1.00', 'spread': 'NA', 'comment': 'No measure of dispersion calculated as there is only 1 participant (n=1)', 'groupId': 'OG000'}, {'value': '2.14', 'spread': '3.67', 'groupId': 'OG001'}]}]}, {'title': 'C23D1 (n= 1, 7)', 'categories': [{'measurements': [{'value': '1.00', 'spread': 'NA', 'comment': 'No measure of dispersion calculated as there is only 1 participant (n=1)', 'groupId': 'OG000'}, {'value': '3.71', 'spread': '3.99', 'groupId': 'OG001'}]}]}, {'title': 'C24D1 (n= 1, 7)', 'categories': [{'measurements': [{'value': '3.00', 'spread': 'NA', 'comment': 'No measure of dispersion calculated as there is only 1 participant (n=1)', 'groupId': 'OG000'}, {'value': '2.57', 'spread': '4.08', 'groupId': 'OG001'}]}]}, {'title': 'C25D1 (n= 1, 6)', 'categories': [{'measurements': [{'value': '8.00', 'spread': 'NA', 'comment': 'No measure of dispersion calculated as there is only 1 participant (n=1)', 'groupId': 'OG000'}, {'value': '2.83', 'spread': '4.45', 'groupId': 'OG001'}]}]}, {'title': 'C26D1 (n= 0, 6)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No measure of dispersion calculated as there are no participants (n=0)', 'groupId': 'OG000'}, {'value': '2.67', 'spread': '4.13', 'groupId': 'OG001'}]}]}, {'title': 'C27D1 (n= 0, 6)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No measure of dispersion calculated as there are no participants (n=0)', 'groupId': 'OG000'}, {'value': '3.33', 'spread': '3.98', 'groupId': 'OG001'}]}]}, {'title': 'C28D1 (n= 0, 6)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No measure of dispersion calculated as there are no participants (n=0)', 'groupId': 'OG000'}, {'value': '3.17', 'spread': '3.82', 'groupId': 'OG001'}]}]}, {'title': 'C29D1 (n= 0, 6)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No measure of dispersion calculated as there are no participants (n=0)', 'groupId': 'OG000'}, {'value': '5.33', 'spread': '4.59', 'groupId': 'OG001'}]}]}, {'title': 'C30D1 (n= 0, 5)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No measure of dispersion calculated as there are no participants (n=0)', 'groupId': 'OG000'}, {'value': '4.20', 'spread': '5.12', 'groupId': 'OG001'}]}]}, {'title': 'C31D1 (n= 0, 5)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No measure of dispersion calculated as there are no participants (n=0)', 'groupId': 'OG000'}, {'value': '4.20', 'spread': '4.97', 'groupId': 'OG001'}]}]}, {'title': 'C32D1 (n= 0, 4)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No measure of dispersion calculated as there are no participants (n=0)', 'groupId': 'OG000'}, {'value': '2.75', 'spread': '2.50', 'groupId': 'OG001'}]}]}, {'title': 'C33D1 (n= 0, 4)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No measure of dispersion calculated as there are no participants (n=0)', 'groupId': 'OG000'}, {'value': '3.00', 'spread': '2.94', 'groupId': 'OG001'}]}]}, {'title': 'C34D1 (n= 0, 2)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No measure of dispersion calculated as there are no participants (n=0)', 'groupId': 'OG000'}, {'value': '4.00', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': 'C35D1 (n= 0, 2)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No measure of dispersion calculated as there are no participants (n=0)', 'groupId': 'OG000'}, {'value': '12.50', 'spread': '13.44', 'groupId': 'OG001'}]}]}, {'title': 'C36D1 (n= 0, 2)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No measure of dispersion calculated as there are no participants (n=0)', 'groupId': 'OG000'}, {'value': '1.50', 'spread': '2.12', 'groupId': 'OG001'}]}]}, {'title': 'C37D1 (n= 0, 2)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No measure of dispersion calculated as there are no participants (n=0)', 'groupId': 'OG000'}, {'value': '1.50', 'spread': '2.12', 'groupId': 'OG001'}]}]}, {'title': 'C38D1 (n= 0, 2)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No measure of dispersion calculated as there are no participants (n=0)', 'groupId': 'OG000'}, {'value': '0.50', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'C39D1 (n= 0, 2)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No measure of dispersion calculated as there are no participants (n=0)', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'C40D1 (n= 0, 2)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No measure of dispersion calculated as there are no participants (n=0)', 'groupId': 'OG000'}, {'value': '0.50', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'C41D1 (n= 0, 2)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No measure of dispersion calculated as there are no participants (n=0)', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'C42D1 (n= 0, 2)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No measure of dispersion calculated as there are no participants (n=0)', 'groupId': 'OG000'}, {'value': '0.50', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'C43D1 (n= 0, 1)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No measure of dispersion calculated as there are no participants (n=0)', 'groupId': 'OG000'}, {'value': '3.00', 'spread': 'NA', 'comment': 'No measure of dispersion calculated as there are no participants (n=0)', 'groupId': 'OG001'}]}]}, {'title': 'C44D1 (n= 0, 0)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No measure of dispersion calculated as there are no participants (n=0)', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No measure of dispersion calculated as there are no participants (n=0)', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle (C) 1 Day (D) 1 (baseline), C1D10-14, D1 of subsequent cycles up to C44', 'description': "DLQI: 10-item questionnaire to measure how much the participant's skin problem has impacted their life over the previous week on following 6 domains: symptoms/feelings (2 questions), daily activities (2 questions), leisure (2 questions), work/school (1 question), personal relationships (2 questions), and treatment (1 question). All questions were answered on a 4-point Likert scale ranging from 0 (not at all/not relevant) to 3 (very much/prevented work or studying). The DLQI total evaluable score was calculated by summing the score of each question and ranged from 0 to 30, where higher scores indicated more quality of life impairment.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants with study drug assignment designated according to initial randomization, regardless of treatment received. Here "N" (number of participants analyzed) signifies participants evaluable for this measure; "n" signifies participants evaluable for specified category for each arm, respectively.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Kirsten Rat Sarcoma (KRAS) and Epidermal Growth Factor Receptor (EGFR) Status and EGFR T790M Mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib', 'description': 'Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.'}, {'id': 'OG001', 'title': 'Dacomitinib', 'description': 'Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.'}], 'classes': [{'title': 'EGFR Status: Wild Type', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}, {'title': 'EGFR Status: Mutant', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'EGFR T790M Mutation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'EGFR Status: Unknown', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'KRAS Status: Wild Type', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}, {'title': 'KRAS Status: Mutant', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'KRAS Status: Unknown', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'Tumor tissue were analyzed at a sponsor-designated laboratory to investigate KRAS and EGFR status (wild type or mutated). Participants who did not provide samples for central laboratory analysis confirmation were classified as "unknown". Additionally blood specimens were analyzed at a sponsor-designated laboratory for T790M mutation in EGFR.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants with study drug assignment designated according to initial randomization, regardless of treatment received. The participants under the category EGFR T790M Mutation are already included in the EGFR Mutant category.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Soluble Protein Biomarkers Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib', 'description': 'Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.'}, {'id': 'OG001', 'title': 'Dacomitinib', 'description': 'Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.'}], 'classes': [{'title': 'EGFR, C1D1 (n= 65, 66)', 'categories': [{'measurements': [{'value': '49.88', 'spread': '7.513', 'groupId': 'OG000'}, {'value': '49.44', 'spread': '9.286', 'groupId': 'OG001'}]}]}, {'title': 'EGFR, C2D1 (n= 76, 73)', 'categories': [{'measurements': [{'value': '48.87', 'spread': '6.985', 'groupId': 'OG000'}, {'value': '41.29', 'spread': '8.132', 'groupId': 'OG001'}]}]}, {'title': 'EGFR, C3D1 (n= 43, 53)', 'categories': [{'measurements': [{'value': '51.28', 'spread': '6.925', 'groupId': 'OG000'}, {'value': '42.39', 'spread': '8.072', 'groupId': 'OG001'}]}]}, {'title': 'EGFR, C4D1 (n= 26, 39)', 'categories': [{'measurements': [{'value': '49.49', 'spread': '8.41', 'groupId': 'OG000'}, {'value': '41.9', 'spread': '8.793', 'groupId': 'OG001'}]}]}, {'title': 'EGFR, C5D1 (n= 16, 29)', 'categories': [{'measurements': [{'value': '48.58', 'spread': '5.801', 'groupId': 'OG000'}, {'value': '41.97', 'spread': '7.974', 'groupId': 'OG001'}]}]}, {'title': 'EGFR, C6D1 (n= 15, 27)', 'categories': [{'measurements': [{'value': '50.32', 'spread': '7.073', 'groupId': 'OG000'}, {'value': '42.82', 'spread': '8.014', 'groupId': 'OG001'}]}]}, {'title': 'EGFR, C7D1 (n= 13, 26)', 'categories': [{'measurements': [{'value': '52.16', 'spread': '7.449', 'groupId': 'OG000'}, {'value': '43.16', 'spread': '9.13', 'groupId': 'OG001'}]}]}, {'title': 'EGFR, C8D1 (n= 10, 21)', 'categories': [{'measurements': [{'value': '54.74', 'spread': '10.73', 'groupId': 'OG000'}, {'value': '44.78', 'spread': '9.673', 'groupId': 'OG001'}]}]}, {'title': 'EGFR, C9D1 (n= 8, 17)', 'categories': [{'measurements': [{'value': '55.38', 'spread': '12.888', 'groupId': 'OG000'}, {'value': '47.89', 'spread': '10.854', 'groupId': 'OG001'}]}]}, {'title': 'EGFR, C10D1 (n= 10, 17)', 'categories': [{'measurements': [{'value': '54.57', 'spread': '9.244', 'groupId': 'OG000'}, {'value': '48.12', 'spread': '13.105', 'groupId': 'OG001'}]}]}, {'title': 'EGFR, C11D1 (n= 7, 14)', 'categories': [{'measurements': [{'value': '59.63', 'spread': '14.624', 'groupId': 'OG000'}, {'value': '50.9', 'spread': '13.667', 'groupId': 'OG001'}]}]}, {'title': 'EGFR, C12D1 (n= 6, 13)', 'categories': [{'measurements': [{'value': '57.65', 'spread': '11.503', 'groupId': 'OG000'}, {'value': '52.39', 'spread': '12.976', 'groupId': 'OG001'}]}]}, {'title': 'HER2, C1D1 (n= 65,66)', 'categories': [{'measurements': [{'value': '10.89', 'spread': '15.44', 'groupId': 'OG000'}, {'value': '8.39', 'spread': '2.05', 'groupId': 'OG001'}]}]}, {'title': 'HER2, C2D1 (n= 76,73)', 'categories': [{'measurements': [{'value': '9.17', 'spread': '4.946', 'groupId': 'OG000'}, {'value': '6.42', 'spread': '2.12', 'groupId': 'OG001'}]}]}, {'title': 'HER2, C3D1 (n= 43,53)', 'categories': [{'measurements': [{'value': '9.26', 'spread': '6.383', 'groupId': 'OG000'}, {'value': '6.17', 'spread': '1.703', 'groupId': 'OG001'}]}]}, {'title': 'HER2, C4D1 (n= 26,39)', 'categories': [{'measurements': [{'value': '9.51', 'spread': '6.958', 'groupId': 'OG000'}, {'value': '6.29', 'spread': '1.716', 'groupId': 'OG001'}]}]}, {'title': 'HER2, C5D1 (n= 16,29)', 'categories': [{'measurements': [{'value': '7.7', 'spread': '1.79', 'groupId': 'OG000'}, {'value': '5.96', 'spread': '1.342', 'groupId': 'OG001'}]}]}, {'title': 'HER2, C6D1 (n= 15,27)', 'categories': [{'measurements': [{'value': '7.45', 'spread': '2.414', 'groupId': 'OG000'}, {'value': '6.34', 'spread': '1.428', 'groupId': 'OG001'}]}]}, {'title': 'HER2, C7D1 (n= 13,26)', 'categories': [{'measurements': [{'value': '8.07', 'spread': '2.262', 'groupId': 'OG000'}, {'value': '6.47', 'spread': '1.773', 'groupId': 'OG001'}]}]}, {'title': 'HER2, C8D1 (n= 10,21)', 'categories': [{'measurements': [{'value': '7.28', 'spread': '1.279', 'groupId': 'OG000'}, {'value': '7.15', 'spread': '3.168', 'groupId': 'OG001'}]}]}, {'title': 'HER2, C9D1 (n= 8,17)', 'categories': [{'measurements': [{'value': '7.32', 'spread': '1.204', 'groupId': 'OG000'}, {'value': '6.87', 'spread': '2.205', 'groupId': 'OG001'}]}]}, {'title': 'HER2, C10D1 (n= 10,17)', 'categories': [{'measurements': [{'value': '7.49', 'spread': '1.618', 'groupId': 'OG000'}, {'value': '7.25', 'spread': '2.883', 'groupId': 'OG001'}]}]}, {'title': 'HER2, C11D1 (n= 7,14)', 'categories': [{'measurements': [{'value': '7.76', 'spread': '1.735', 'groupId': 'OG000'}, {'value': '6.56', 'spread': '1.333', 'groupId': 'OG001'}]}]}, {'title': 'HER2, C12D1 (n= 6,13)', 'categories': [{'measurements': [{'value': '7.15', 'spread': '1.57', 'groupId': 'OG000'}, {'value': '6.57', 'spread': '1.587', 'groupId': 'OG001'}]}]}, {'title': 'E-cadherin, C1D1 (n= 65,66)', 'categories': [{'measurements': [{'value': '51.71', 'spread': '14.63', 'groupId': 'OG000'}, {'value': '56.13', 'spread': '22.694', 'groupId': 'OG001'}]}]}, {'title': 'E-cadherin, C2D1 (n= 76,73)', 'categories': [{'measurements': [{'value': '41.46', 'spread': '14.982', 'groupId': 'OG000'}, {'value': '45.4', 'spread': '18.149', 'groupId': 'OG001'}]}]}, {'title': 'E-cadherin, C3D1 (n= 43,53)', 'categories': [{'measurements': [{'value': '42.58', 'spread': '13.284', 'groupId': 'OG000'}, {'value': '42.28', 'spread': '17.81', 'groupId': 'OG001'}]}]}, {'title': 'E-cadherin, C4D1 (n= 26,39)', 'categories': [{'measurements': [{'value': '40.51', 'spread': '12.384', 'groupId': 'OG000'}, {'value': '40.15', 'spread': '16.105', 'groupId': 'OG001'}]}]}, {'title': 'E-cadherin, C5D1 (n= 16,29)', 'categories': [{'measurements': [{'value': '37.58', 'spread': '9.951', 'groupId': 'OG000'}, {'value': '38.15', 'spread': '10.913', 'groupId': 'OG001'}]}]}, {'title': 'E-cadherin, C6D1 (n= 15,27)', 'categories': [{'measurements': [{'value': '36.78', 'spread': '7.695', 'groupId': 'OG000'}, {'value': '39.16', 'spread': '10.301', 'groupId': 'OG001'}]}]}, {'title': 'E-cadherin, C7D1 (n= 13,26)', 'categories': [{'measurements': [{'value': '38.33', 'spread': '9.675', 'groupId': 'OG000'}, {'value': '39.47', 'spread': '11.977', 'groupId': 'OG001'}]}]}, {'title': 'E-cadherin, C8D1 (n= 10,21)', 'categories': [{'measurements': [{'value': '43.6', 'spread': '11.661', 'groupId': 'OG000'}, {'value': '40.94', 'spread': '13.698', 'groupId': 'OG001'}]}]}, {'title': 'E-cadherin, C9D1 (n= 8,17)', 'categories': [{'measurements': [{'value': '40.26', 'spread': '8.146', 'groupId': 'OG000'}, {'value': '38.97', 'spread': '12.517', 'groupId': 'OG001'}]}]}, {'title': 'E-cadherin, C10D1 (n= 10,17)', 'categories': [{'measurements': [{'value': '40.29', 'spread': '15.742', 'groupId': 'OG000'}, {'value': '45.85', 'spread': '12.244', 'groupId': 'OG001'}]}]}, {'title': 'E-cadherin, C11D1 (n= 7,14)', 'categories': [{'measurements': [{'value': '35.9', 'spread': '9.239', 'groupId': 'OG000'}, {'value': '39.44', 'spread': '8.968', 'groupId': 'OG001'}]}]}, {'title': 'E-cadherin, C12D1 (n= 6,13)', 'categories': [{'measurements': [{'value': '35.48', 'spread': '8.637', 'groupId': 'OG000'}, {'value': '40.3', 'spread': '12.433', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle (C) 1 Day (D) 1 (baseline), D1 of each subsequent cycle up to end of treatment (up to 121 weeks)', 'description': 'Blood specimens were analyzed at a sponsor-designated laboratory for analysis of shed proteins/receptors related to Human Epidermal Growth Factor Receptor (HER) signaling (EGFR, HER-2, Epithelial-cadherin \\[E-cadherin\\]). The data collection after C12D1 was not performed, as there were too few participants across both treatment arms after C12D1.', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Biomarker analysis population: participants who received \\>=1 dose and had baseline samples submitted as per Institutional Review Board/Independent Ethics Committee approval and participant consent. "N"(number of participants analyzed): participants evaluable for this measure; "n": participants evaluable at each time-point for each arm respectively.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Trough Plasma Concentration (Ctrough) of Dacomitinib (PF-00299804)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dacomitinib', 'description': 'Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.'}], 'classes': [{'title': 'C1D10-14 (n= 63)', 'categories': [{'measurements': [{'value': '71.94', 'spread': '37.496', 'groupId': 'OG000'}]}]}, {'title': 'C2D1 (n= 60)', 'categories': [{'measurements': [{'value': '65.50', 'spread': '33.292', 'groupId': 'OG000'}]}]}, {'title': 'C3D1 (n= 44)', 'categories': [{'measurements': [{'value': '59.28', 'spread': '30.089', 'groupId': 'OG000'}]}]}, {'title': 'C4D1 (n= 31)', 'categories': [{'measurements': [{'value': '57.79', 'spread': '26.206', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'C1D10-14, C2D1, C3D1, C4D1', 'description': 'Only participants from "Dacomitinib" treatment arm were planned to be analyzed for this outcome.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) analysis population: all participants who received \\>=1 dose of study medication, with treatment assignments designated according to actual study treatment received, and from whom at least 1 PK sample was obtained. Here "n" signifies participants who were evaluable at specified time-point.'}, {'type': 'PRIMARY', 'title': 'Progression-Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib', 'description': 'Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.'}, {'id': 'OG001', 'title': 'Dacomitinib', 'description': 'Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000', 'lowerLimit': '7.9', 'upperLimit': '11.7'}, {'value': '12.4', 'groupId': 'OG001', 'lowerLimit': '8.1', 'upperLimit': '16.1'}]}]}], 'analyses': [{'pValue': '0.012', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.657', 'ciLowerLimit': '0.472', 'ciUpperLimit': '0.914', 'pValueComment': '2-Sided.', 'estimateComment': 'The estimated HR was for the Dacomitinib arm versus the Erlotinib arm.', 'groupDescription': 'Total 128 events (progression/death) provided 80% power to detect a hazard ratio (HR) of 1.45 (Erlotinib versus Dacomitinib arm) with 1-sided alpha=0.10.This represented a 45% improvement in true median PFS.\n\nHR and 95% confidence interval estimated from stratified Cox Regression;2-sided p-value was based on stratified log-rank test with epidermal growth factor receptor (EGFR) status, Kirsten Rat Sarcoma status (KRAS), baseline Eastern Cooperative Oncology Group (ECOG) as stratification factors', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for the stratification factors: EGFR status, KRAS status and baseline ECOG performance status.', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline until disease progression or death, assessed at Cycle 2, 3, 4, 5, 6, thereafter every other cycle up to end of treatment (121 weeks), followed by every 8 weeks >284 weeks', 'description': 'PFS: Time in weeks from randomization to date of objective disease progression or death due to any cause, whichever occurred first. PFS was calculated as (first event date or last known event-free date \\[if the event date unavailable\\] minus the date of randomization plus 1) divided by 7. Objective progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST), as at least 20 percent (%) increase in the sum of longest dimensions (LDs) of target lesions, taking as reference the smallest sum of LD recorded since the treatment started and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population included all randomized participants with study drug assignment designated according to initial randomization, regardless of treatment received.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Objective Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib', 'description': 'Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.'}, {'id': 'OG001', 'title': 'Dacomitinib', 'description': 'Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '12.0'}, {'value': '17.0', 'groupId': 'OG001', 'lowerLimit': '10.1', 'upperLimit': '26.2'}]}]}], 'analyses': [{'pValue': '0.011', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': '2-Sided.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Unadjusted.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline until disease progression or death, assessed at Cycle 2, 3, 4, 5, 6, thereafter every other cycle up to end of treatment (121 weeks), followed by every 8 weeks >284 weeks', 'description': 'Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.0. CR: disappearance of all target and non-target lesions. PR: at least 30 % decrease in sum of the LDs of target lesion, taking as reference the baseline sum LD. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants with study drug assignment designated according to initial randomization, regardless of treatment received.'}, {'type': 'SECONDARY', 'title': 'Best Overall Response (BOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib', 'description': 'Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.'}, {'id': 'OG001', 'title': 'Dacomitinib', 'description': 'Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.'}], 'classes': [{'title': 'Complete Response', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Partial Response', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Stable/No Response', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'Objective Progression', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Indeterminate', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline until disease progression or death, assessed at Cycle 2, 3, 4, 5, 6, thereafter every other cycle up to end of treatment (121 weeks), followed by every 8 weeks >284 weeks', 'description': 'Number of participants with BOR according to RECIST version 1.0: CR= disappearance of all target and non-target lesions. PR= at least 30% decrease in sum of LDs of target lesion, taking as reference baseline sum LD. Stable/no response= neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of LDs since treatment started. Objective progression= at least a 20% increase in sum of LDs of target lesions, taking as reference the smallest sum of LDs recorded since treatment started and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants with study drug assignment designated according to initial randomization, regardless of treatment received.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib', 'description': 'Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.'}, {'id': 'OG001', 'title': 'Dacomitinib', 'description': 'Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.'}], 'classes': [{'categories': [{'measurements': [{'value': '40.1', 'groupId': 'OG000', 'lowerLimit': '24.7', 'upperLimit': '72.0'}, {'value': '71.9', 'groupId': 'OG001', 'lowerLimit': '23.6', 'upperLimit': '112.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline until disease progression or death, assessed at Cycle 2, 3, 4, 5, 6, thereafter every other cycle up to end of treatment (121 weeks), followed by every 8 weeks >284 weeks', 'description': 'Time in weeks from first documentation of objective tumor response to objective tumor progression or symptomatic deterioration or death due to any cause, whichever occurred first. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or symptomatic deterioration or death due to any cause or last known progression-free date \\[if none of the event dates available\\] minus the date of the first CR or PR \\[which ever occurred first\\] 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': 'Analysis population included sub-set of participants from ITT population who had a confirmed objective tumor response (CR or PR).'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib', 'description': 'Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.'}, {'id': 'OG001', 'title': 'Dacomitinib', 'description': 'Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.'}], 'classes': [{'categories': [{'measurements': [{'value': '32.3', 'groupId': 'OG000', 'lowerLimit': '24.0', 'upperLimit': '40.3'}, {'value': '41.4', 'groupId': 'OG001', 'lowerLimit': '30.4', 'upperLimit': '48.1'}]}]}], 'analyses': [{'pValue': '0.252', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.822', 'ciLowerLimit': '0.587', 'ciUpperLimit': '1.151', 'pValueComment': '2-Sided.', 'estimateComment': 'The estimated HR was for the Dacomitinib arm versus the Erlotinib arm.', 'groupDescription': 'HR and its 95% confidence interval were estimated from stratified Cox Regression and 2-sided p-value was based on the stratified log-rank test with EGFR status, KRAS status and baseline ECOG as stratification factors.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted by stratification factors: EGFR status, KRAS status and baseline ECOG performance status.', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline until end of treatment (15 August 2014); followed up every 8 weeks after discontinuation from study treatment.', 'description': 'Time in weeks from randomization to date of death due to any cause. OS was calculated as (the death date or last known alive date (if death date unavailable) minus the date of randomization plus 1) divided by 7.', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants with study drug assignment designated according to initial randomization, regardless of treatment received.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Erlotinib', 'description': 'Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.'}, {'id': 'FG001', 'title': 'Dacomitinib', 'description': 'Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}, {'groupId': 'FG001', 'numSubjects': '94'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}, {'comment': 'One participant was not treated: refused treatment for reason other than an adverse event (AE).', 'groupId': 'FG001', 'numSubjects': '93'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}, {'groupId': 'FG001', 'numSubjects': '94'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '89'}, {'groupId': 'FG001', 'numSubjects': '86'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Study terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '188', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Erlotinib', 'description': 'Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.'}, {'id': 'BG001', 'title': 'Dacomitinib', 'description': 'Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.1', 'spread': '12.0', 'groupId': 'BG000'}, {'value': '59.9', 'spread': '9.5', 'groupId': 'BG001'}, {'value': '60.0', 'spread': '10.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-treat (ITT) population included all randomized participants with study drug assignment designated according to initial randomization, regardless of treatment received.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 188}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'dispFirstSubmitDate': '2011-11-15', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-22', 'studyFirstSubmitDate': '2008-10-07', 'dispFirstSubmitQcDate': '2011-11-15', 'resultsFirstSubmitDate': '2015-07-27', 'studyFirstSubmitQcDate': '2008-10-07', 'dispFirstPostDateStruct': {'date': '2011-11-21', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-10-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-07-27', 'studyFirstPostDateStruct': {'date': '2008-10-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-08-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants With Kirsten Rat Sarcoma (KRAS) and Epidermal Growth Factor Receptor (EGFR) Status and EGFR T790M Mutation', 'timeFrame': 'Baseline', 'description': 'Tumor tissue were analyzed at a sponsor-designated laboratory to investigate KRAS and EGFR status (wild type or mutated). Participants who did not provide samples for central laboratory analysis confirmation were classified as "unknown". Additionally blood specimens were analyzed at a sponsor-designated laboratory for T790M mutation in EGFR.'}, {'measure': 'Soluble Protein Biomarkers Level', 'timeFrame': 'Cycle (C) 1 Day (D) 1 (baseline), D1 of each subsequent cycle up to end of treatment (up to 121 weeks)', 'description': 'Blood specimens were analyzed at a sponsor-designated laboratory for analysis of shed proteins/receptors related to Human Epidermal Growth Factor Receptor (HER) signaling (EGFR, HER-2, Epithelial-cadherin \\[E-cadherin\\]). The data collection after C12D1 was not performed, as there were too few participants across both treatment arms after C12D1.'}, {'measure': 'Trough Plasma Concentration (Ctrough) of Dacomitinib (PF-00299804)', 'timeFrame': 'C1D10-14, C2D1, C3D1, C4D1', 'description': 'Only participants from "Dacomitinib" treatment arm were planned to be analyzed for this outcome.'}], 'primaryOutcomes': [{'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'Baseline until disease progression or death, assessed at Cycle 2, 3, 4, 5, 6, thereafter every other cycle up to end of treatment (121 weeks), followed by every 8 weeks >284 weeks', 'description': 'PFS: Time in weeks from randomization to date of objective disease progression or death due to any cause, whichever occurred first. PFS was calculated as (first event date or last known event-free date \\[if the event date unavailable\\] minus the date of randomization plus 1) divided by 7. Objective progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST), as at least 20 percent (%) increase in the sum of longest dimensions (LDs) of target lesions, taking as reference the smallest sum of LD recorded since the treatment started and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.'}], 'secondaryOutcomes': [{'measure': 'Categorical Summary of Overall Scale Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)', 'timeFrame': 'Baseline up to Cycle 44 (Week 188)', 'description': 'EORTC QLQ-C30: included global health status/quality of life (QoL), functional (Fn) scales (physical, role, cognitive, emotional, and social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulties). Scores were averaged, transformed to 0-100 scale; higher score for Global Qol/Fn scales=better level of QoL/functioning or higher score for symptom scales/items=greater degree of symptoms. Overall scale change is categorized as Improved (if average scales change from baseline: for Global QoL/Fn scales \\>=10; for symptom scale/item \\<=-10), Worsened (if average scales change from baseline: for Global QoL/Fn scales \\<=-10; for symptom scale/item \\>=10), and Stable (if average scales change from baseline \\>-10 but \\<10 for Global QoL/Fn scales and symptom scale/item) and participants in each category are reported.'}, {'measure': 'Categorical Summary of Overall Scale Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13)', 'timeFrame': 'Baseline up to Cycle 44 (Week 188)', '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 dyspnea 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). Scores averaged, transformed to 0-100 scale; higher symptom score = greater degree of symptoms. Overall scale change is categorized as Improved (if average scales change from baseline \\<=-10), Worsened (if average scales change from baseline \\>=10), and Stable (if average scales change from baseline \\>-10 but \\<10) and participants in each category are reported.'}, {'measure': 'Dermatology Life Quality Index (DLQI)', 'timeFrame': 'Cycle (C) 1 Day (D) 1 (baseline), C1D10-14, D1 of subsequent cycles up to C44', 'description': "DLQI: 10-item questionnaire to measure how much the participant's skin problem has impacted their life over the previous week on following 6 domains: symptoms/feelings (2 questions), daily activities (2 questions), leisure (2 questions), work/school (1 question), personal relationships (2 questions), and treatment (1 question). All questions were answered on a 4-point Likert scale ranging from 0 (not at all/not relevant) to 3 (very much/prevented work or studying). The DLQI total evaluable score was calculated by summing the score of each question and ranged from 0 to 30, where higher scores indicated more quality of life impairment."}, {'measure': 'Percentage of Participants With Objective Response', 'timeFrame': 'Baseline until disease progression or death, assessed at Cycle 2, 3, 4, 5, 6, thereafter every other cycle up to end of treatment (121 weeks), followed by every 8 weeks >284 weeks', 'description': 'Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.0. CR: disappearance of all target and non-target lesions. PR: at least 30 % decrease in sum of the LDs of target lesion, taking as reference the baseline sum LD. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response.'}, {'measure': 'Best Overall Response (BOR)', 'timeFrame': 'Baseline until disease progression or death, assessed at Cycle 2, 3, 4, 5, 6, thereafter every other cycle up to end of treatment (121 weeks), followed by every 8 weeks >284 weeks', 'description': 'Number of participants with BOR according to RECIST version 1.0: CR= disappearance of all target and non-target lesions. PR= at least 30% decrease in sum of LDs of target lesion, taking as reference baseline sum LD. Stable/no response= neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of LDs since treatment started. Objective progression= at least a 20% increase in sum of LDs of target lesions, taking as reference the smallest sum of LDs recorded since treatment started and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.'}, {'measure': 'Duration of Response (DR)', 'timeFrame': 'Baseline until disease progression or death, assessed at Cycle 2, 3, 4, 5, 6, thereafter every other cycle up to end of treatment (121 weeks), followed by every 8 weeks >284 weeks', 'description': 'Time in weeks from first documentation of objective tumor response to objective tumor progression or symptomatic deterioration or death due to any cause, whichever occurred first. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or symptomatic deterioration or death due to any cause or last known progression-free date \\[if none of the event dates available\\] minus the date of the first CR or PR \\[which ever occurred first\\] that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Baseline until end of treatment (15 August 2014); followed up every 8 weeks after discontinuation from study treatment.', 'description': 'Time in weeks from randomization to date of death due to any cause. OS was calculated as (the death date or last known alive date (if death date unavailable) minus the date of randomization plus 1) divided by 7.'}]}, 'conditionsModule': {'keywords': ['Lung cancer', 'advanced', 'second or third line'], 'conditions': ['Non-small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '26768165', 'type': 'DERIVED', 'citation': "Ramalingam SS, O'Byrne K, Boyer M, Mok T, Janne PA, Zhang H, Liang J, Taylor I, Sbar EI, Paz-Ares L. Dacomitinib versus erlotinib in patients with EGFR-mutated advanced nonsmall-cell lung cancer (NSCLC): pooled subset analyses from two randomized trials. Ann Oncol. 2016 Mar;27(3):423-9. doi: 10.1093/annonc/mdv593. Epub 2016 Jan 13."}]}, 'descriptionModule': {'briefSummary': 'This study will compare PF-00299804 given orally on continuous schedule to the approved drug, erlotinib, in patients whose non-small cell lung cancer has progressed after chemotherapy; patients will be randomized to receive one of these drugs, and followed for efficacy and tolerance of each.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* advanced measurable Non-Small Cell Lung Cancer (NSCLC);\n* progressed after 1-2 prior chemotherapy;\n* Eastern Cooperative Oncology Group (ECOG) 0-2;\n* tissue available for future KRAS/ EGFR testing\n\nExclusion Criteria:\n\n* prior Epidermal Growth Factor Receptor (EGFR) targeted therapy;\n* active or untreated Central Nervous System (CNS) metastases;'}, 'identificationModule': {'nctId': 'NCT00769067', 'briefTitle': 'A Randomized Trial Of PF-00299804 Taken Orally Versus Erlotinib Taken Orally For Treatment Of Advanced Non-Small Cell Lung Cancer That Has Progressed After One Or Two Prior Chemotherapy Regimen', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Randomized Phase 2 Trial Of Pf-00299804 Versus Erlotinib For The Treatment Of Advanced Non-small Cell Lung Cancer After Failure Of At Least One Prior Chemotherapy Regimen', 'orgStudyIdInfo': {'id': 'A7471028'}, 'secondaryIdInfos': [{'id': '2008-005235-14', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'interventionNames': ['Drug: Erlotinib']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'interventionNames': ['Drug: PF-00299804']}], 'interventions': [{'name': 'Erlotinib', 'type': 'DRUG', 'description': 'Continuous oral dosing at 150 mg daily.', 'armGroupLabels': ['A']}, {'name': 'PF-00299804', 'type': 'DRUG', 'description': 'Continuous oral dosing at 45mg daily', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35661', 'city': 'Muscle Shoals', 'state': 'Alabama', 'country': 'United States', 'facility': 'Northwest Alabama Cancer Center', 'geoPoint': {'lat': 34.74481, 'lon': -87.66753}}, {'zip': '90640', 'city': 'Montebello', 'state': 'California', 'country': 'United States', 'facility': 'Agajanian Institute of Oncology and Hematology', 'geoPoint': {'lat': 34.00946, 'lon': -118.10535}}, {'zip': '06610', 'city': 'Bridgeport', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Bridgeport Hospital', 'geoPoint': {'lat': 41.17923, 'lon': -73.18945}}, {'zip': '06856', 'city': 'Norwalk', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Wittingham Cancer Center @ Norwalk Hospital', 'geoPoint': {'lat': 41.1176, 'lon': -73.4079}}, {'zip': '06708', 'city': 'Waterbury', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Medical Oncology & Hematology, P.C.', 'geoPoint': {'lat': 41.55815, 'lon': -73.0515}}, {'zip': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Winship Cancer Institute at Grady Health Systems', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30322-1013', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Winship Cancer Institute, Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Winship Cancer Institute at Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Winship Cancer Institute of Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Winship Cancer Institute, Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30901', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Augusta Oncology Associates, P.C.', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '30909', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Augusta Oncology Associates, PC', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '31904', 'city': 'Columbus', 'state': 'Georgia', 'country': 'United States', 'facility': 'John B. 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Hospital Santa Rita', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '90610-000', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital Sao Lucas da PUCRS', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '14784-400', 'city': 'Barretos', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'FUNDACAO PIO XII Hospital de Cancer de Barretos', 'geoPoint': {'lat': -20.55722, 'lon': -48.56778}}, {'zip': '01246-000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira - ICESP', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': 'V5Z 4E6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'BC Cancer Agency - Vancouver Centre', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'L4M 6M2', 'city': 'Barrie', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Royal Victoria Hospital', 'geoPoint': {'lat': 44.40011, 'lon': -79.66634}}, {'zip': 'L1G 2B9', 'city': 'Oshawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'RSM Durham Regional Cancer Centre - 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