Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2026-02-23 @ 6:25 AM
Study NCT ID:
NCT01465802
Status:
COMPLETED
Last Update Posted:
2019-01-09
First Post:
2011-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Of Dacomitinib (PF-00299804) In Advanced NSCLC Patients (Post Chemo Or Select First Line) To Evaluate Prophylactic Intervention On Derm And GI AEs And PRO
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Puerto Rico']}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C525726', 'term': 'dacomitinib'}, {'id': 'D004318', 'term': 'Doxycycline'}, {'id': 'D019936', 'term': 'Probiotics'}], 'ancestors': [{'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks.', 'description': 'The same event may appear as both an AE \\& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \\& non-serious in another, or 1 participant may have experienced both a serious \\& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)', 'description': 'Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).', 'otherNumAtRisk': 66, 'otherNumAffected': 65, 'seriousNumAtRisk': 66, 'seriousNumAffected': 25}, {'id': 'EG001', 'title': 'Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)', 'description': 'Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).', 'otherNumAtRisk': 66, 'otherNumAffected': 66, 'seriousNumAtRisk': 66, 'seriousNumAffected': 27}, {'id': 'EG002', 'title': 'Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)', 'description': 'Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).', 'otherNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)', 'description': 'Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks \\[range of 32 to 35 days\\]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).', 'otherNumAtRisk': 67, 'otherNumAffected': 64, 'seriousNumAtRisk': 67, 'seriousNumAffected': 22}, {'id': 'EG004', 'title': 'Cohort III (Dacomitinib 45 mg)', 'description': 'Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.', 'otherNumAtRisk': 25, 'otherNumAffected': 25, 'seriousNumAtRisk': 25, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Deafness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Cheilitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 52}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 54}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Food poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Glossodynia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Lip swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 20}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Oral mucosal erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 20}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 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acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Metabolic alkalosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Lung cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Malignant pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Non-small cell lung cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Aphasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Pleuritic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Perivascular dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Subcutaneous emphysema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Hypovolaemic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Select Dermatologic Adverse Events of Interest (SDAEI) (All Causality, All Grade) in the First 8 Weeks of Treatment by Treatment Arm for Cohort I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)', 'description': 'Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).'}, {'id': 'OG001', 'title': 'Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)', 'description': 'Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).'}], 'classes': [{'categories': [{'measurements': [{'value': '79.3', 'groupId': 'OG000', 'lowerLimit': '66.6', 'upperLimit': '88.8'}, {'value': '75.0', 'groupId': 'OG001', 'lowerLimit': '61.6', 'upperLimit': '85.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First 8 Weeks of Treatment', 'description': 'SDAEI of all causality and all grades were evaluated in participants in Cohort I. These SDAEIs included dermatitis acneiform, dry skin, exfoliative rash, nail discoloration, nail disorder, paronychia, pruritus, rash, skin exfoliation, skin fissures, skin infection, skin laceration and skin ulcer.\n\n95% confidence interval (CI) calculated using exact method based on binomial distribution.\n\nAfter protocol amendment 1, Arm C was removed from Cohort I and enrollment to Arm C was terminated. Only 7 participants were enrolled in Cohort I Arm C as a result. Given the smaller sample size, analyse of Outcome Measure 1 was not conducted in Cohort I Arm C.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable Population - included all participants who received the study treatment assigned at enrollment, but did not discontinue dacomitinib treatment less than 6 weeks from first dosing due to either disease progression or death.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With SDAEI (All Causality, Grade Greater Than or Equal to [≥] 2) in the First 8 Weeks of Treatment by Treatment Arm for Cohort I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)', 'description': 'Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).'}, {'id': 'OG001', 'title': 'Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)', 'description': 'Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).'}], 'classes': [{'categories': [{'measurements': [{'value': '46.6', 'groupId': 'OG000', 'lowerLimit': '33.3', 'upperLimit': '60.1'}, {'value': '23.2', 'groupId': 'OG001', 'lowerLimit': '13.0', 'upperLimit': '36.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First 8 Weeks of Treatment', 'description': 'SDAEI of all causality and Grade ≥2 were evaluated in participants in Cohort I. These SDAEIs included dermatitis acneiform, dry skin, exfoliative rash, nail discoloration, nail disorder, paronychia, pruritus, rash, skin exfoliation, skin fissures, skin infection, skin laceration and skin ulcer. Adverse events (AEs) were graded for severity using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, Version 4.0).\n\n95% CI calculated using exact method based on binomial distribution. After protocol amendment 1, Arm C was removed from Cohort I and enrollment to Arm C was terminated. Only 7 participants were enrolled in Cohort I Arm C as a result. Given the smaller sample size, analyse of Outcome Measure 2 was not conducted in Cohort I Arm C.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable Population'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) by Treatment Arm for Cohort I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)', 'description': 'Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).'}, {'id': 'OG001', 'title': 'Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)', 'description': 'Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).'}, {'id': 'OG002', 'title': 'Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)', 'description': 'Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).'}], 'classes': [{'title': 'Symptoms: Cycle 1 Day 8 (n=41, 42, 4)', 'categories': [{'measurements': [{'value': '2.3', 'spread': '10.12', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '10.91', 'groupId': 'OG001'}, {'value': '9.4', 'spread': '14.18', 'groupId': 'OG002'}]}]}, {'title': 'Symptoms: Cycle 1 Day 15 (n=41, 42, 3)', 'categories': [{'measurements': [{'value': '21.4', 'spread': '30.98', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '19.82', 'groupId': 'OG001'}, {'value': '30.6', 'spread': '42.56', 'groupId': 'OG002'}]}]}, {'title': 'Symptoms: Cycle 1 Day 22 (n=42, 40, 4)', 'categories': [{'measurements': [{'value': '18.0', 'spread': '25.76', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '20.45', 'groupId': 'OG001'}, {'value': '32.3', 'spread': '25.54', 'groupId': 'OG002'}]}]}, {'title': 'Symptoms: Cycle 2 Day 1 (n=41, 42, 4)', 'categories': [{'measurements': [{'value': '14.7', 'spread': '23.74', 'groupId': 'OG000'}, {'value': '6.3', 'spread': '15.38', 'groupId': 'OG001'}, {'value': '14.6', 'spread': '18.48', 'groupId': 'OG002'}]}]}, {'title': 'Symptoms: Cycle 2 Day 8 (n=42, 39, 4)', 'categories': [{'measurements': [{'value': '17.8', 'spread': '26.78', 'groupId': 'OG000'}, {'value': '9.8', 'spread': '20.00', 'groupId': 'OG001'}, {'value': '13.5', 'spread': '19.36', 'groupId': 'OG002'}]}]}, {'title': 'Symptoms: Cycle 2 Day 15 (n=37, 40, 4)', 'categories': [{'measurements': [{'value': '16.6', 'spread': '21.10', 'groupId': 'OG000'}, {'value': '9.2', 'spread': '19.54', 'groupId': 'OG001'}, {'value': '19.8', 'spread': '28.74', 'groupId': 'OG002'}]}]}, {'title': 'Symptoms: Cycle 2 Day 22 (n=35, 39, 4)', 'categories': [{'measurements': [{'value': '15.4', 'spread': '22.34', 'groupId': 'OG000'}, {'value': '12.9', 'spread': '22.72', 'groupId': 'OG001'}, {'value': '14.6', 'spread': '15.40', 'groupId': 'OG002'}]}]}, {'title': 'Symptoms: EoT (n=7, 3, 0)', 'categories': [{'measurements': [{'value': '13.1', 'spread': '32.85', 'groupId': 'OG000'}, {'value': '16.7', 'spread': '19.09', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'NA = not applicable. The number of participants completing the scale at this timepoint was 0.', 'groupId': 'OG002'}]}]}, {'title': 'Emotion: Cycle 1 Day 8 (n=41, 42, 4)', 'categories': [{'measurements': [{'value': '3.7', 'spread': '21.08', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '12.11', 'groupId': 'OG001'}, {'value': '7.3', 'spread': '14.68', 'groupId': 'OG002'}]}]}, {'title': 'Emotion: Cycle 1 Day 15 (n=41, 42, 3)', 'categories': [{'measurements': [{'value': '20.7', 'spread': '28.51', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '17.14', 'groupId': 'OG001'}, {'value': '29.8', 'spread': '45.03', 'groupId': 'OG002'}]}]}, {'title': 'Emotion: Cycle 1 Day 22 (n=42, 40, 4)', 'categories': [{'measurements': [{'value': '17.7', 'spread': '27.67', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '16.07', 'groupId': 'OG001'}, {'value': '37.7', 'spread': '32.44', 'groupId': 'OG002'}]}]}, {'title': 'Emotion: Cycle 2 Day 1 (n=41, 42, 4)', 'categories': [{'measurements': [{'value': '15.6', 'spread': '25.15', 'groupId': 'OG000'}, {'value': '6.5', 'spread': '15.25', 'groupId': 'OG001'}, {'value': '23.4', 'spread': '30.15', 'groupId': 'OG002'}]}]}, {'title': 'Emotion: Cycle 2 Day 8 (n=42, 39, 4)', 'categories': [{'measurements': [{'value': '15.1', 'spread': '25.55', 'groupId': 'OG000'}, {'value': '6.3', 'spread': '17.28', 'groupId': 'OG001'}, {'value': '21.6', 'spread': '35.76', 'groupId': 'OG002'}]}]}, {'title': 'Emotion: Cycle 2 Day 15 (n=37, 40, 4)', 'categories': [{'measurements': [{'value': '13.0', 'spread': '22.70', 'groupId': 'OG000'}, {'value': '8.4', 'spread': '20.20', 'groupId': 'OG001'}, {'value': '21.0', 'spread': '40.49', 'groupId': 'OG002'}]}]}, {'title': 'Emotion: Cycle 2 Day 22 (n=35, 39, 4)', 'categories': [{'measurements': [{'value': '14.8', 'spread': '25.91', 'groupId': 'OG000'}, {'value': '12.0', 'spread': '23.73', 'groupId': 'OG001'}, {'value': '10.9', 'spread': '17.39', 'groupId': 'OG002'}]}]}, {'title': 'Emotion: EoT (n=7, 3, 0)', 'categories': [{'measurements': [{'value': '9.9', 'spread': '21.27', 'groupId': 'OG000'}, {'value': '22.2', 'spread': '21.34', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The number of participants completing the scale at this timepoint was 0.', 'groupId': 'OG002'}]}]}, {'title': 'Functioning: Cycle 1 Day 8 (n=41, 42, 4)', 'categories': [{'measurements': [{'value': '3.1', 'spread': '17.60', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '5.50', 'groupId': 'OG001'}, {'value': '-0.8', 'spread': '1.67', 'groupId': 'OG002'}]}]}, {'title': 'Functioning: Cycle 1 Day 15 (n=41, 42, 3)', 'categories': [{'measurements': [{'value': '11.1', 'spread': '21.41', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '7.47', 'groupId': 'OG001'}, {'value': '24.4', 'spread': '42.34', 'groupId': 'OG002'}]}]}, {'title': 'Functioning: Cycle 1 Day 22 (n=42, 40, 4)', 'categories': [{'measurements': [{'value': '11.7', 'spread': '21.68', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '8.86', 'groupId': 'OG001'}, {'value': '33.3', 'spread': '31.39', 'groupId': 'OG002'}]}]}, {'title': 'Functioning: Cycle 2 Day 1 (n=41, 42, 4)', 'categories': [{'measurements': [{'value': '8.5', 'spread': '21.53', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '7.72', 'groupId': 'OG001'}, {'value': '20.0', 'spread': '21.26', 'groupId': 'OG002'}]}]}, {'title': 'Functioning: Cycle 2 Day 8 (n=42, 39, 4)', 'categories': [{'measurements': [{'value': '7.0', 'spread': '18.51', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '9.52', 'groupId': 'OG001'}, {'value': '12.5', 'spread': '20.79', 'groupId': 'OG002'}]}]}, {'title': 'Functioning: Cycle 2 Day 15 (n=37, 40, 4)', 'categories': [{'measurements': [{'value': '8.3', 'spread': '22.20', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '10.58', 'groupId': 'OG001'}, {'value': '13.3', 'spread': '22.44', 'groupId': 'OG002'}]}]}, {'title': 'Functioning: Cycle 2 Day 22 (n=35, 39, 4)', 'categories': [{'measurements': [{'value': '7.8', 'spread': '22.32', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '13.78', 'groupId': 'OG001'}, {'value': '14.2', 'spread': '20.44', 'groupId': 'OG002'}]}]}, {'title': 'Functioning: EoT (n=7, 3, 0)', 'categories': [{'measurements': [{'value': '8.6', 'spread': '11.84', 'groupId': 'OG000'}, {'value': '14.4', 'spread': '25.02', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The number of participants completing the scale at this timepoint was 0.', 'groupId': 'OG002'}]}]}, {'title': 'Total: Cycle 1 Day 8 (n=41, 42, 4)', 'categories': [{'measurements': [{'value': '3.2', 'spread': '15.91', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '8.07', 'groupId': 'OG001'}, {'value': '5.3', 'spread': '9.36', 'groupId': 'OG002'}]}]}, {'title': 'Total: Cycle 1 Day 15 (n=41, 42, 3)', 'categories': [{'measurements': [{'value': '17.9', 'spread': '25.09', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '13.08', 'groupId': 'OG001'}, {'value': '28.4', 'spread': '43.52', 'groupId': 'OG002'}]}]}, {'title': 'Total: Cycle 1 Day 22 (n=42, 40, 4)', 'categories': [{'measurements': [{'value': '15.9', 'spread': '23.39', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '13.33', 'groupId': 'OG001'}, {'value': '35.0', 'spread': '29.97', 'groupId': 'OG002'}]}]}, {'title': 'Total: Cycle 2 Day 1 (n=41, 42, 4)', 'categories': [{'measurements': [{'value': '13.1', 'spread': '20.74', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '11.65', 'groupId': 'OG001'}, {'value': '20.2', 'spread': '21.75', 'groupId': 'OG002'}]}]}, {'title': 'Total: Cycle 2 Day 8 (n=42, 39, 4)', 'categories': [{'measurements': [{'value': '13.2', 'spread': '21.17', 'groupId': 'OG000'}, {'value': '6.0', 'spread': '13.49', 'groupId': 'OG001'}, {'value': '16.8', 'spread': '24.54', 'groupId': 'OG002'}]}]}, {'title': 'Total: Cycle 2 Day 15 (n=37, 40, 4)', 'categories': [{'measurements': [{'value': '12.4', 'spread': '20.39', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '14.84', 'groupId': 'OG001'}, {'value': '18.4', 'spread': '31.50', 'groupId': 'OG002'}]}]}, {'title': 'Total: Cycle 2 Day 22 (n=35, 39, 4)', 'categories': [{'measurements': [{'value': '12.7', 'spread': '21.24', 'groupId': 'OG000'}, {'value': '10.1', 'spread': '18.36', 'groupId': 'OG001'}, {'value': '12.9', 'spread': '17.22', 'groupId': 'OG002'}]}]}, {'title': 'Total: EoT (n=7, 3, 0)', 'categories': [{'measurements': [{'value': '10.3', 'spread': '18.79', 'groupId': 'OG000'}, {'value': '18.4', 'spread': '18.64', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The number of participants completing the scale at this timepoint was 0.', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'First 8 Weeks of Treatment', 'description': 'Patient Reported Outcomes (PROs) of Health Related Quality of Life (HRQoL) \\& disease/treatment-related symptoms were assessed using Dermatologic Survey (Skindex-16) that assesses "bother". It includes 3 multi-item scales: symptoms, emotions \\& functioning. Individual scaled scores \\& total scores were determined. Skindex questions were transformed to a linear scale of 0 (never bothered) to 100 (always bothered). Subscale scores are an average of non-missing questions in a given scale if greater than (\\>) 75% of total subscale questions are non-missing. The Total Score is an average of all non-missing questions in the Skindex if \\>75% of total questions are non-missing. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant.\n\nSkindex completion criteria were defined as completion of 3 out of 4 items for questions 1 to 4, 6 out of 7 items for questions 5 to 11, 4 out of 5 items for questions 12 to 16 for the visit.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PRO Skindex Analysis Population: participants that met primary endpoint analysis \\& Skindex specific criteria: a) Skindex completion criteria (as above) for initial visit \\& end of Cycle 2 or EoT visit; b) Skindex completion criteria for at least 5 of 6 visits between initial visit \\& end of Cycle 2 visit. n = number of participants completing scale.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Diarrhea AEs (All Causality, All Grade and Grade ≥2) in the First 8 Weeks of Treatment for Cohort II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)', 'description': 'Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks \\[range of 32 to 35 days\\]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).'}], 'classes': [{'title': 'All Causality, All Grade', 'categories': [{'measurements': [{'value': '83.1', 'groupId': 'OG000', 'lowerLimit': '71.0', 'upperLimit': '91.6'}]}]}, {'title': 'All Causality, Grade ≥2', 'categories': [{'measurements': [{'value': '39.0', 'groupId': 'OG000', 'lowerLimit': '26.5', 'upperLimit': '52.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First 8 Weeks of Treatment', 'description': 'Diarrhea AEs of all causality, all grade and Grade ≥2 were evaluated in participants in Cohort II. AEs were graded for severity using the NCI-CTCAE, Version 4.0.\n\n95% CI calculated using exact method based on binomial distribution.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable Population'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)', 'description': 'Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks \\[range of 32 to 35 days\\]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).'}], 'classes': [{'title': 'M/T Soreness Categories: Cycle 1 Day 8 (n=37)', 'categories': [{'measurements': [{'value': '0.8', 'spread': '2.05', 'groupId': 'OG000'}]}]}, {'title': 'M/T Soreness Categories: Cycle 1 Day 15 (n=37)', 'categories': [{'measurements': [{'value': '2.5', 'spread': '3.12', 'groupId': 'OG000'}]}]}, {'title': 'M/T Soreness Categories: Cycle 1 Day 22 (n=37)', 'categories': [{'measurements': [{'value': '2.6', 'spread': '2.97', 'groupId': 'OG000'}]}]}, {'title': 'M/T Soreness Categories: Cycle 2 Day 1 (n=37)', 'categories': [{'measurements': [{'value': '2.5', 'spread': '2.43', 'groupId': 'OG000'}]}]}, {'title': 'M/T Soreness Categories: Cycle 2 Day 8 (n=35)', 'categories': [{'measurements': [{'value': '1.9', 'spread': '2.30', 'groupId': 'OG000'}]}]}, {'title': 'M/T Soreness Categories: Cycle 2 Day 15 (n=36)', 'categories': [{'measurements': [{'value': '1.7', 'spread': '1.97', 'groupId': 'OG000'}]}]}, {'title': 'M/T Soreness Categories: Cycle 2 Day 22 (n=27)', 'categories': [{'measurements': [{'value': '1.6', 'spread': '1.85', 'groupId': 'OG000'}]}]}, {'title': 'M/T Soreness Categories: Cycle 3 Day 1 (n=19)', 'categories': [{'measurements': [{'value': '2.1', 'spread': '2.09', 'groupId': 'OG000'}]}]}, {'title': 'M/T Soreness Categories: Cycle 4 Day 1 (n=13)', 'categories': [{'measurements': [{'value': '1.7', 'spread': '2.14', 'groupId': 'OG000'}]}]}, {'title': 'M/T Soreness Categories: Cycle 5 Day 1 (n=10)', 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.29', 'groupId': 'OG000'}]}]}, {'title': 'M/T Soreness Categories: Cycle 6 Day 1 (n=8)', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.88', 'groupId': 'OG000'}]}]}, {'title': 'M/T Soreness Categories: EoT (n=30)', 'categories': [{'measurements': [{'value': '1.4', 'spread': '2.34', 'groupId': 'OG000'}]}]}, {'title': 'M/T Soreness Categories: Follow-up (n=22)', 'categories': [{'measurements': [{'value': '0.3', 'spread': '2.48', 'groupId': 'OG000'}]}]}, {'title': 'M/T Soreness Scale: Cycle 1 Day 8 (n=37)', 'categories': [{'measurements': [{'value': '1.0', 'spread': '2.00', 'groupId': 'OG000'}]}]}, {'title': 'M/T Soreness Scale: Cycle 1 Day 15 (n=37)', 'categories': [{'measurements': [{'value': '2.5', 'spread': '3.00', 'groupId': 'OG000'}]}]}, {'title': 'M/T Soreness Scale: Cycle 1 Day 22 (n=37)', 'categories': [{'measurements': [{'value': '2.2', 'spread': '2.51', 'groupId': 'OG000'}]}]}, {'title': 'M/T Soreness Scale: Cycle 2 Day 1 (n=37)', 'categories': [{'measurements': [{'value': '2.2', 'spread': '2.28', 'groupId': 'OG000'}]}]}, {'title': 'M/T Soreness Scale: Cycle 2 Day 8 (n=35)', 'categories': [{'measurements': [{'value': '1.7', 'spread': '1.97', 'groupId': 'OG000'}]}]}, {'title': 'M/T Soreness Scale: Cycle 2 Day 15 (n=36)', 'categories': [{'measurements': [{'value': '1.6', 'spread': '1.83', 'groupId': 'OG000'}]}]}, {'title': 'M/T Soreness Scale: Cycle 2 Day 22 (n=27)', 'categories': [{'measurements': [{'value': '1.9', 'spread': '2.45', 'groupId': 'OG000'}]}]}, {'title': 'M/T Soreness Scale: Cycle 3 Day 1 (n=19)', 'categories': [{'measurements': [{'value': '2.2', 'spread': '2.81', 'groupId': 'OG000'}]}]}, {'title': 'M/T Soreness Scale: Cycle 4 Day 1 (n=13)', 'categories': [{'measurements': [{'value': '1.6', 'spread': '2.81', 'groupId': 'OG000'}]}]}, {'title': 'M/T Soreness Scale: Cycle 5 Day 1 (n=10)', 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.76', 'groupId': 'OG000'}]}]}, {'title': 'M/T Soreness Scale: Cycle 6 Day 1 (n=8)', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.35', 'groupId': 'OG000'}]}]}, {'title': 'M/T Soreness Scale: EoT (n=30)', 'categories': [{'measurements': [{'value': '1.3', 'spread': '1.78', 'groupId': 'OG000'}]}]}, {'title': 'M/T Soreness Scale: Follow-up (n=22)', 'categories': [{'measurements': [{'value': '0.5', 'spread': '1.68', 'groupId': 'OG000'}]}]}, {'title': 'Diarrhea Categories: Cycle 1 Day 8 (n=37)', 'categories': [{'measurements': [{'value': '2.1', 'spread': '2.67', 'groupId': 'OG000'}]}]}, {'title': 'Diarrhea Categories: Cycle 1 Day 15 (n=37)', 'categories': [{'measurements': [{'value': '3.2', 'spread': '2.94', 'groupId': 'OG000'}]}]}, {'title': 'Diarrhea Categories: Cycle 1 Day 22 (n=36)', 'categories': [{'measurements': [{'value': '3.9', 'spread': '3.19', 'groupId': 'OG000'}]}]}, {'title': 'Diarrhea Categories: Cycle 2 Day 1 (n=37)', 'categories': [{'measurements': [{'value': '3.0', 'spread': '2.83', 'groupId': 'OG000'}]}]}, {'title': 'Diarrhea Categories: Cycle 2 Day 8 (n=34)', 'categories': [{'measurements': [{'value': '2.2', 'spread': '3.00', 'groupId': 'OG000'}]}]}, {'title': 'Diarrhea Categories: Cycle 2 Day 15 (n=36)', 'categories': [{'measurements': [{'value': '2.1', 'spread': '3.13', 'groupId': 'OG000'}]}]}, {'title': 'Diarrhea Categories: Cycle 2 Day 22 (n=27)', 'categories': [{'measurements': [{'value': '2.7', 'spread': '3.10', 'groupId': 'OG000'}]}]}, {'title': 'Diarrhea Categories: Cycle 3 Day 1 (n=19)', 'categories': [{'measurements': [{'value': '2.8', 'spread': '2.75', 'groupId': 'OG000'}]}]}, {'title': 'Diarrhea Categories: Cycle 4 Day 1 (n=13)', 'categories': [{'measurements': [{'value': '2.3', 'spread': '3.14', 'groupId': 'OG000'}]}]}, {'title': 'Diarrhea Categories: Cycle 5 Day 1 (n=10)', 'categories': [{'measurements': [{'value': '3.8', 'spread': '3.39', 'groupId': 'OG000'}]}]}, {'title': 'Diarrhea Categories: Cycle 6 Day 1 (n=8)', 'categories': [{'measurements': [{'value': '1.9', 'spread': '2.22', 'groupId': 'OG000'}]}]}, {'title': 'Diarrhea Categories: EoT (n=30)', 'categories': [{'measurements': [{'value': '1.9', 'spread': '3.39', 'groupId': 'OG000'}]}]}, {'title': 'Diarrhea Categories: Follow-up (n=22)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.94', 'groupId': 'OG000'}]}]}, {'title': 'Diarrhea Scale: Cycle 1 Day 8 (n=37)', 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.89', 'groupId': 'OG000'}]}]}, {'title': 'Diarrhea Scale: Cycle 1 Day 15 (n=37)', 'categories': [{'measurements': [{'value': '2.4', 'spread': '2.55', 'groupId': 'OG000'}]}]}, {'title': 'Diarrhea Scale: Cycle 1 Day 22 (n=36)', 'categories': [{'measurements': [{'value': '3.0', 'spread': '2.96', 'groupId': 'OG000'}]}]}, {'title': 'Diarrhea Scale: Cycle 2 Day 1 (n=37)', 'categories': [{'measurements': [{'value': '2.5', 'spread': '2.61', 'groupId': 'OG000'}]}]}, {'title': 'Diarrhea Scale: Cycle 2 Day 8 (n=34)', 'categories': [{'measurements': [{'value': '2.0', 'spread': '2.75', 'groupId': 'OG000'}]}]}, {'title': 'Diarrhea Scale: Cycle 2 Day 15 (n=35)', 'categories': [{'measurements': [{'value': '1.7', 'spread': '2.71', 'groupId': 'OG000'}]}]}, {'title': 'Diarrhea Scale: Cycle 2 Day 22 (n=27)', 'categories': [{'measurements': [{'value': '2.0', 'spread': '2.16', 'groupId': 'OG000'}]}]}, {'title': 'Diarrhea Scale: Cycle 3 Day 1 (n=19)', 'categories': [{'measurements': [{'value': '2.4', 'spread': '2.34', 'groupId': 'OG000'}]}]}, {'title': 'Diarrhea Scale: Cycle 4 Day 1 (n=13)', 'categories': [{'measurements': [{'value': '1.8', 'spread': '2.13', 'groupId': 'OG000'}]}]}, {'title': 'Diarrhea Scale: Cycle 5 Day 1 (n=10)', 'categories': [{'measurements': [{'value': '2.7', 'spread': '2.31', 'groupId': 'OG000'}]}]}, {'title': 'Diarrhea Scale: Cycle 6 Day 1 (n=8)', 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.93', 'groupId': 'OG000'}]}]}, {'title': 'Diarrhea Scale: EoT (n=30)', 'categories': [{'measurements': [{'value': '1.6', 'spread': '2.87', 'groupId': 'OG000'}]}]}, {'title': 'Diarrhea Scale: Follow-up (n=22)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.71', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycles 1, 2, 3, 4, 5, and 6, EoT and Follow-up', 'description': 'Diarrhea severity was assessed using the modified-OMDQ. This questionnaire is comprised of 6 questions in total; however, only two items relate to diarrhea symptoms (item 5 and item 6). Symptoms scores were developed for both the full questionnaire and for the diarrhea-only questions for each completed survey. Mucositis questions were transformed to a score range of 0 to 10. Increasing OMDQ values are associated with greater symptom burden.\n\nModified OMDQ completion criteria were defined as completion of all 4 questions (questions 2, 4, 5 and 6).\n\nM/T = mouth and throat.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PRO Modified OMDQ Analysis Population; participants meeting primary endpoint analysis \\& modified OMDQ specific criteria: a) Modified OMDQ completion criteria for initial visit \\& end of Cycle 2 or EoT visit; b) Completion criteria for at least 5 of 6 visits between initial \\& end of Cycle 2 visit. n = number of participants completing scale.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With SDAEI (All Causality, All Grade) in the First 8 Weeks of Treatment for Cohort II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)', 'description': 'Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks \\[range of 32 to 35 days\\]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).'}], 'classes': [{'categories': [{'measurements': [{'value': '79.7', 'groupId': 'OG000', 'lowerLimit': '67.2', 'upperLimit': '89.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First 8 Weeks of Treatment', 'description': 'SDAEI of all causality and all grades were evaluated in participants in Cohort II. These SDAEIs included dermatitis acneiform, dry skin, exfoliative rash, nail discoloration, nail disorder, paronychia, pruritus, rash, skin exfoliation, skin fissures, skin infection, skin laceration and skin ulcer.\n\n95% CI calculated using exact method based on binomial distribution.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable Population'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With SDAEI (All Causality, Grade ≥2) in the First 8 Weeks of Treatment for Cohort II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)', 'description': 'Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks \\[range of 32 to 35 days\\]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).'}], 'classes': [{'categories': [{'measurements': [{'value': '35.6', 'groupId': 'OG000', 'lowerLimit': '23.6', 'upperLimit': '49.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First 8 Weeks of Treatment', 'description': 'SDAEI of all causality and Grade ≥2 were evaluated in participants in Cohort II. These SDAEIs included dermatitis acneiform, dry skin, exfoliative rash, nail discoloration, nail disorder, paronychia, pruritus, rash, skin exfoliation, skin fissures, skin infection, skin laceration and skin ulcer. AEs were graded for severity using the NCI-CTCAE, Version 4.0.\n\n95% CI calculated using exact method based on binomial distribution.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable Population'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)', 'description': 'Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks \\[range of 32 to 35 days\\]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).'}], 'classes': [{'title': 'Symptoms: Cycle 1 Day 8 (n=40)', 'categories': [{'measurements': [{'value': '0.1', 'spread': '8.31', 'groupId': 'OG000'}]}]}, {'title': 'Symptoms: Cycle 1 Day 15 (n=40)', 'categories': [{'measurements': [{'value': '11.4', 'spread': '21.25', 'groupId': 'OG000'}]}]}, {'title': 'Symptoms: Cycle 1 Day 22 (n=40)', 'categories': [{'measurements': [{'value': '11.4', 'spread': '18.17', 'groupId': 'OG000'}]}]}, {'title': 'Symptoms: Cycle 2 Day 1 (n=40)', 'categories': [{'measurements': [{'value': '11.4', 'spread': '19.84', 'groupId': 'OG000'}]}]}, {'title': 'Symptoms: Cycle 2 Day 8 (n=38)', 'categories': [{'measurements': [{'value': '13.5', 'spread': '20.88', 'groupId': 'OG000'}]}]}, {'title': 'Symptoms: Cycle 2 Day 15 (n=38)', 'categories': [{'measurements': [{'value': '14.7', 'spread': '17.83', 'groupId': 'OG000'}]}]}, {'title': 'Symptoms: Cycle 2 Day 22 (n=30)', 'categories': [{'measurements': [{'value': '13.6', 'spread': '16.30', 'groupId': 'OG000'}]}]}, {'title': 'Symptoms: Cycle 3 Day 1 (n=21)', 'categories': [{'measurements': [{'value': '12.7', 'spread': '19.56', 'groupId': 'OG000'}]}]}, {'title': 'Symptoms: Cycle 4 Day 1 (n=15)', 'categories': [{'measurements': [{'value': '11.9', 'spread': '18.69', 'groupId': 'OG000'}]}]}, {'title': 'Symptoms: Cycle 5 Day 1 (n=11)', 'categories': [{'measurements': [{'value': '8.0', 'spread': '22.24', 'groupId': 'OG000'}]}]}, {'title': 'Symptoms: Cycle 6 Day 1 (n=8)', 'categories': [{'measurements': [{'value': '12.0', 'spread': '32.15', 'groupId': 'OG000'}]}]}, {'title': 'Symptoms: EoT (n=33)', 'categories': [{'measurements': [{'value': '10.4', 'spread': '21.33', 'groupId': 'OG000'}]}]}, {'title': 'Symptoms: Follow-up (n=23)', 'categories': [{'measurements': [{'value': '7.1', 'spread': '23.15', 'groupId': 'OG000'}]}]}, {'title': 'Emotion: Cycle 1 Day 8 (n=40)', 'categories': [{'measurements': [{'value': '1.0', 'spread': '11.79', 'groupId': 'OG000'}]}]}, {'title': 'Emotion: Cycle 1 Day 15 (n=40)', 'categories': [{'measurements': [{'value': '8.7', 'spread': '23.57', 'groupId': 'OG000'}]}]}, {'title': 'Emotion: Cycle 1 Day 22 (n=40)', 'categories': [{'measurements': [{'value': '12.3', 'spread': '24.63', 'groupId': 'OG000'}]}]}, {'title': 'Emotion: Cycle 2 Day 1 (n=40)', 'categories': [{'measurements': [{'value': '10.2', 'spread': '21.36', 'groupId': 'OG000'}]}]}, {'title': 'Emotion: Cycle 2 Day 8 (n=38)', 'categories': [{'measurements': [{'value': '10.3', 'spread': '21.77', 'groupId': 'OG000'}]}]}, {'title': 'Emotion: Cycle 2 Day 15 (n=37)', 'categories': [{'measurements': [{'value': '13.5', 'spread': '17.10', 'groupId': 'OG000'}]}]}, {'title': 'Emotion: Cycle 2 Day 22 (n= 30)', 'categories': [{'measurements': [{'value': '12.6', 'spread': '19.86', 'groupId': 'OG000'}]}]}, {'title': 'Emotion: Cycle 3 Day 1 (n=21)', 'categories': [{'measurements': [{'value': '11.0', 'spread': '17.97', 'groupId': 'OG000'}]}]}, {'title': 'Emotion: Cycle 4 Day 1 (n=14)', 'categories': [{'measurements': [{'value': '11.5', 'spread': '14.65', 'groupId': 'OG000'}]}]}, {'title': 'Emotion: Cycle 5 Day 1 (n=11)', 'categories': [{'measurements': [{'value': '7.8', 'spread': '21.43', 'groupId': 'OG000'}]}]}, {'title': 'Emotion: Cycle 6 Day 1 (n=8)', 'categories': [{'measurements': [{'value': '6.8', 'spread': '22.67', 'groupId': 'OG000'}]}]}, {'title': 'Emotion: EoT (n=33)', 'categories': [{'measurements': [{'value': '8.5', 'spread': '23.38', 'groupId': 'OG000'}]}]}, {'title': 'Emotion: Follow-up (n=23)', 'categories': [{'measurements': [{'value': '7.1', 'spread': '22.74', 'groupId': 'OG000'}]}]}, {'title': 'Functioning: Cycle 1 Day 8 (n=40)', 'categories': [{'measurements': [{'value': '0.5', 'spread': '3.58', 'groupId': 'OG000'}]}]}, {'title': 'Functioning: Cycle 1 Day 15 (n=40)', 'categories': [{'measurements': [{'value': '4.3', 'spread': '13.34', 'groupId': 'OG000'}]}]}, {'title': 'Functioning: Cycle 1 Day 22 (n=40)', 'categories': [{'measurements': [{'value': '8.8', 'spread': '17.55', 'groupId': 'OG000'}]}]}, {'title': 'Functioning: Cycle 2 Day 1 (n=40)', 'categories': [{'measurements': [{'value': '7.3', 'spread': '15.25', 'groupId': 'OG000'}]}]}, {'title': 'Functioning: Cycle 2 Day 8 (n=38)', 'categories': [{'measurements': [{'value': '6.2', 'spread': '15.33', 'groupId': 'OG000'}]}]}, {'title': 'Functioning: Cycle 2 Day 15 (n=38)', 'categories': [{'measurements': [{'value': '7.0', 'spread': '11.75', 'groupId': 'OG000'}]}]}, {'title': 'Functioning: Cycle 2 Day 22 (n=30)', 'categories': [{'measurements': [{'value': '7.2', 'spread': '10.06', 'groupId': 'OG000'}]}]}, {'title': 'Functioning: Cycle 3 Day 1 (n=21)', 'categories': [{'measurements': [{'value': '5.9', 'spread': '8.09', 'groupId': 'OG000'}]}]}, {'title': 'Functioning: Cycle 4 Day 1 (n=15)', 'categories': [{'measurements': [{'value': '6.9', 'spread': '10.12', 'groupId': 'OG000'}]}]}, {'title': 'Functioning: Cycle 5 Day 1 (n=11)', 'categories': [{'measurements': [{'value': '5.5', 'spread': '12.93', 'groupId': 'OG000'}]}]}, {'title': 'Functioning: Cycle 6 Day 1 (n=8)', 'categories': [{'measurements': [{'value': '7.1', 'spread': '15.58', 'groupId': 'OG000'}]}]}, {'title': 'Functioning: EoT (n=33)', 'categories': [{'measurements': [{'value': '7.7', 'spread': '17.35', 'groupId': 'OG000'}]}]}, {'title': 'Functioning: Follow-up (n=23)', 'categories': [{'measurements': [{'value': '5.4', 'spread': '18.55', 'groupId': 'OG000'}]}]}, {'title': 'Total: Cycle 1 Day 8 (n=40)', 'categories': [{'measurements': [{'value': '0.6', 'spread': '6.83', 'groupId': 'OG000'}]}]}, {'title': 'Total: Cycle 1 Day 15 (n=40)', 'categories': [{'measurements': [{'value': '8.0', 'spread': '18.73', 'groupId': 'OG000'}]}]}, {'title': 'Total: Cycle 1 Day 22 (n=40)', 'categories': [{'measurements': [{'value': '11.0', 'spread': '19.59', 'groupId': 'OG000'}]}]}, {'title': 'Total: Cycle 2 Day 1 (n=40)', 'categories': [{'measurements': [{'value': '9.6', 'spread': '17.38', 'groupId': 'OG000'}]}]}, {'title': 'Total: Cycle 2 Day 8 (n=38)', 'categories': [{'measurements': [{'value': '9.9', 'spread': '17.79', 'groupId': 'OG000'}]}]}, {'title': 'Total: Cycle 2 Day 15 (n=38)', 'categories': [{'measurements': [{'value': '11.8', 'spread': '14.13', 'groupId': 'OG000'}]}]}, {'title': 'Total: Cycle 2 Day 22 (n=30)', 'categories': [{'measurements': [{'value': '11.2', 'spread': '14.14', 'groupId': 'OG000'}]}]}, {'title': 'Total: Cycle 3 Day 1 (n=21)', 'categories': [{'measurements': [{'value': '9.8', 'spread': '14.11', 'groupId': 'OG000'}]}]}, {'title': 'Total: Cycle 4 Day 1 (n=15)', 'categories': [{'measurements': [{'value': '10.2', 'spread': '12.49', 'groupId': 'OG000'}]}]}, {'title': 'Total: Cycle 5 Day 1 (n=11)', 'categories': [{'measurements': [{'value': '7.1', 'spread': '18.60', 'groupId': 'OG000'}]}]}, {'title': 'Total: Cycle 6 Day 1 (n=8)', 'categories': [{'measurements': [{'value': '8.2', 'spread': '22.43', 'groupId': 'OG000'}]}]}, {'title': 'Total: EoT (n=33)', 'categories': [{'measurements': [{'value': '8.7', 'spread': '19.74', 'groupId': 'OG000'}]}]}, {'title': 'Total: Follow-up (n=23)', 'categories': [{'measurements': [{'value': '6.6', 'spread': '20.52', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycles 1, 2, 3, 4, 5, and 6, EoT and Follow-up', 'description': 'PROs of HRQoL and disease/treatment-related symptoms were assessed using Dermatologic Survey (Skindex-16) that assesses "bother". It includes 3 multi-item scales: symptoms, emotions \\& functioning. Individual scaled scores \\& total scores were determined. Skindex questions were transformed to a linear scale of 0 (never bothered) to 100 (always bothered). Subscale scores are an average of non-missing questions in a given scale if \\> 75% of total subscale questions are non-missing. The Total Score is an average of all non-missing questions in the Skindex if \\>75% of total questions are non-missing. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant.\n\nSkindex completion criteria were defined as completion of 3 out of 4 items for questions 1 to 4, 6 out of 7 items for questions 5 to 11, 4 out of 5 items for questions 12 to 16 for the visit.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PRO Skindex Analysis Population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Receiving Any Concomitant Drug or Non-Drug Treatment for SDAEI, Diarrhea and Mucositis for Cohort I by Treatment Arm, Cohort II, and Cohort III', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '67', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)', 'description': 'Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).'}, {'id': 'OG001', 'title': 'Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)', 'description': 'Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).'}, {'id': 'OG002', 'title': 'Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)', 'description': 'Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).'}, {'id': 'OG003', 'title': 'Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)', 'description': 'Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks \\[range of 32 to 35 days\\]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).'}, {'id': 'OG004', 'title': 'Cohort III (Dacomitinib 45 mg)', 'description': 'Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.'}], 'classes': [{'title': 'Any Concomitant Drug', 'categories': [{'measurements': [{'value': '69.7', 'groupId': 'OG000'}, {'value': '60.6', 'groupId': 'OG001'}, {'value': '85.7', 'groupId': 'OG002'}, {'value': '82.1', 'groupId': 'OG003'}, {'value': '88.0', 'groupId': 'OG004'}]}]}, {'title': 'Any Non-Drug Treatment', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}, {'value': '16.7', 'groupId': 'OG001'}, {'value': '42.9', 'groupId': 'OG002'}, {'value': '20.9', 'groupId': 'OG003'}, {'value': '44.0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Screening to the Post-Teatment Follow-Up Visit (at least 28 days and no more than 35 days after the end of dacomitinib treatment due to progression of disease, intolerance to dacomitinib treatment, or participant withdrawal)', 'description': 'Medications used concomitantly for SDAEIs, diarrhea and mucositis were evaluated for all participants who received dacomitinib on a continuous basis with a preemptive prophylactic (Cohorts I and II) or as an interrupted dosing regimen (Cohort III).', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As Treated Population'}, {'type': 'PRIMARY', 'title': 'Mean Area Under the Plasma Concentration Time Curve From 0 to 24 Hours (AUC0-24) and From 0 to 120 Hours (AUC0-120) for Dacomitinib and Its Metabolite PF-05199265 on Cycle 1 Days 10 to 15 for Cohort III', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort III (Dacomitinib 45 mg)', 'description': 'Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.'}], 'classes': [{'title': 'Dacomitinib AUC0-24', 'categories': [{'measurements': [{'value': '1712.88', 'spread': '35', 'groupId': 'OG000'}]}]}, {'title': 'Dacomitinib AUC0-120', 'categories': [{'measurements': [{'value': '5743.60', 'spread': '32', 'groupId': 'OG000'}]}]}, {'title': 'PF-05199265 AUC0-24', 'categories': [{'measurements': [{'value': '184.62', 'spread': '139', 'groupId': 'OG000'}]}]}, {'title': 'PF-05199265 AUC0-120', 'categories': [{'measurements': [{'value': '742.32', 'spread': '129', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 10: Pre-dose and 2, 4, 6, 24, 48, 72, 96, and 120 hours post-dose (the 120 hour sample was obtained on Day 15 pre-dose).', 'description': 'AUC0-24 is the area under the plasma concentration-time curve (AUC) from time 0 to 24 hours post-dose. AUC0-120 is the AUC from time 0 to 120 hours post-dose. AUC was calculated by the linear trapezoidal method using a non-compartmental pharmacokinetic (PK) analysis.\n\nng\\*hr/mL = nanogram hours per milliliter', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Dose-Compliant participants only. Participants were considered dose-compliant when they received all planned doses at the same dose level right before sample collection.'}, {'type': 'PRIMARY', 'title': 'Mean Maximum Observed Plasma Concentrations (Cmax) for Dacomitinib and Its Metabolite PF-05199265 on Cycle 1 Days 10 to 15 for Cohort III', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort III (Dacomitinib 45 mg)', 'description': 'Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.'}], 'classes': [{'title': 'Dacomitinib Cmax', 'categories': [{'measurements': [{'value': '79.68', 'spread': '36', 'groupId': 'OG000'}]}]}, {'title': 'PF-05199265 Cmax', 'categories': [{'measurements': [{'value': '8.5176', 'spread': '137', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 10: Pre-dose and 2, 4, 6, 24, 48, 72, 96, and 120 hours post-dose (the 120 hour sample was obtained on Day 15 pre-dose).', 'description': 'Cmax was obtained from direct inspection of the data. ng/mL = nanograms per milliliter', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Dose-Compliant participants only. Participants were considered dose-compliant when they received all planned doses at the same dose level right before sample collection.'}, {'type': 'PRIMARY', 'title': 'Median Time of Occurrence of Cmax (Tmax) for Dacomitinib and Its Metabolite PF-05199265 on Cycle 1 Days 10 to 15 for Cohort III', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort III (Dacomitinib 45 mg)', 'description': 'Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.'}], 'classes': [{'title': 'Dacomitinib Tmax', 'categories': [{'measurements': [{'value': '5.850', 'spread': '53', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '24.30'}]}]}, {'title': 'PF-05199265 Tmax', 'categories': [{'measurements': [{'value': '5.980', 'spread': '126', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '24.30'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1 Day 10: Pre-dose and 2, 4, 6, 24, 48, 72, 96, and 120 hours post-dose (the 120 hour sample was obtained on Day 15 pre-dose).', 'description': 'Tmax was obtained from direct inspection of the data as the time of first occurence of Cmax.', 'unitOfMeasure': 'hours (hr)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Dose-Compliant participants only. Participants were considered dose-compliant when they received all planned doses at the same dose level right before sample collection.'}, {'type': 'SECONDARY', 'title': 'Mean AUC From 0 to the End of the Dosing Interval (AUC0-tau) for Dacomitinib and Its Metabolite PF-05199265 on Cycle 2 Day 1 for Cohort I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)', 'description': 'Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).'}, {'id': 'OG001', 'title': 'Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)', 'description': 'Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).'}, {'id': 'OG002', 'title': 'Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)', 'description': 'Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).'}], 'classes': [{'title': 'Dacomitinib AUC0-tau', 'categories': [{'measurements': [{'value': '1801.96', 'spread': '59', 'groupId': 'OG000'}, {'value': '1869.23', 'spread': '37', 'groupId': 'OG001'}, {'value': '1412.42', 'spread': '63', 'groupId': 'OG002'}]}]}, {'title': 'PF-05199265 AUC0-tau', 'categories': [{'measurements': [{'value': '164.520', 'spread': '89', 'groupId': 'OG000'}, {'value': '112.306', 'spread': '139', 'groupId': 'OG001'}, {'value': '366.933', 'spread': '107', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 2 Day 1: pre-dose and at 2, 4, 6, and 24 hours post-dose', 'description': 'AUCtau was the AUC from time 0 to the end of the dosing interval, where the dosing interval was 24 hours. AUCtau was calculated by the linear/log trapezoidal method using a non-compartmental PK analysis.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Dose-Compliant participants only. Participants were considered dose-compliant when they received at least 14 consecutive doses at the same dose level right before sample collection.\n\nNumber of participants analyzed is the number of participants contributing to the summary statistics.'}, {'type': 'SECONDARY', 'title': 'Mean Cmax for Dacomitinib and Its Metabolite PF-05199265 on Cycle 2 Day 1 for Cohort I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)', 'description': 'Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).'}, {'id': 'OG001', 'title': 'Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)', 'description': 'Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).'}, {'id': 'OG002', 'title': 'Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)', 'description': 'Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).'}], 'classes': [{'title': 'Dacomitinib Cmax', 'categories': [{'measurements': [{'value': '88.15', 'spread': '57', 'groupId': 'OG000'}, {'value': '89.79', 'spread': '36', 'groupId': 'OG001'}, {'value': '98.08', 'spread': '89', 'groupId': 'OG002'}]}]}, {'title': 'PF-05199265 Cmax', 'categories': [{'measurements': [{'value': '7.7426', 'spread': '80', 'groupId': 'OG000'}, {'value': '5.2901', 'spread': '141', 'groupId': 'OG001'}, {'value': '8.8545', 'spread': '260', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 2 Day 1: pre-dose and at 2, 4, 6, and 24 hours post-dose', 'description': 'Cmax was obtained from direct inspection of the data.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Dose-Compliant participants only. Participants were considered dose-compliant when they received at least 14 consecutive doses at the same dose level right before sample collection.\n\nNumber of participants analyzed is the number of participants contributing to the summary statistics.'}, {'type': 'SECONDARY', 'title': 'Median Tmax for Dacomitinib and Its Metabolite PF-05199265 on Cycle 2 Day 1 for Cohort I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)', 'description': 'Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).'}, {'id': 'OG001', 'title': 'Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)', 'description': 'Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).'}, {'id': 'OG002', 'title': 'Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)', 'description': 'Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).'}], 'classes': [{'title': 'Dacomitinib Tmax', 'categories': [{'measurements': [{'value': '4.000', 'spread': '67', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '24.00'}, {'value': '6.000', 'spread': '67', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '24.30'}, {'value': '6.580', 'spread': '108', 'groupId': 'OG002', 'lowerLimit': '4.02', 'upperLimit': '22.20'}]}]}, {'title': 'PF-05199265 Tmax', 'categories': [{'measurements': [{'value': '4.050', 'spread': '82', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '24.10'}, {'value': '4.020', 'spread': '125', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '24.30'}, {'value': '6.580', 'spread': '105', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '22.20'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 2 Day 1: pre-dose and at 2, 4, 6, and 24 hours post-dose', 'description': 'Tmax was obtained from direct inspection of the data as the time of first occurence of Cmax.', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Dose-Compliant participants only. Participants were considered dose-compliant when they received at least 14 consecutive doses at the same dose level right before sample collection.\n\nNumber of participants analyzed is the number of participants contributing to the summary statistics.'}, {'type': 'SECONDARY', 'title': 'Mean Apparent Clearance (CL/F) for Dacomitinib on Cycle 2 Day 1 for Cohort I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)', 'description': 'Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).'}, {'id': 'OG001', 'title': 'Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)', 'description': 'Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).'}, {'id': 'OG002', 'title': 'Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)', 'description': 'Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).'}], 'classes': [{'categories': [{'measurements': [{'value': '29.94', 'spread': '85', 'groupId': 'OG000'}, {'value': '24.07', 'spread': '37', 'groupId': 'OG001'}, {'value': '34.24', 'spread': '45', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 2 Day 1: pre-dose and at 2, 4, 6, and 24 hours post-dose', 'description': 'CL/F was calculated as dose/AUCtau.', 'unitOfMeasure': 'Liters per hour', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Dose-Compliant participants only. Participants were considered dose-compliant when they received at least 14 consecutive doses at the same dose level right before sample collection.\n\nNumber of participants analyzed is the number of participants contributing to the summary statistics.'}, {'type': 'SECONDARY', 'title': 'Mean Plasma Trough Concentrations (Ctrough) for Dacomitinib by Visit for Cohorts I, II and III', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)', 'description': 'Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).'}, {'id': 'OG001', 'title': 'Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)', 'description': 'Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).'}, {'id': 'OG002', 'title': 'Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)', 'description': 'Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).'}, {'id': 'OG003', 'title': 'Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)', 'description': 'Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks \\[range of 32 to 35 days\\]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).'}, {'id': 'OG004', 'title': 'Cohort III (Dacomitinib 45 mg)', 'description': 'Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.'}], 'classes': [{'title': 'Cycle 3 Day 1 (n=13, 15, 3, 14, 15)', 'categories': [{'measurements': [{'value': '65.477', 'spread': '50', 'groupId': 'OG000'}, {'value': '65.063', 'spread': '55', 'groupId': 'OG001'}, {'value': '56.212', 'spread': '46', 'groupId': 'OG002'}, {'value': '66.338', 'spread': '58', 'groupId': 'OG003'}, {'value': '55.780', 'spread': '40', 'groupId': 'OG004'}]}]}, {'title': 'Cycle 4 Day 1 (n=8, 7, 2, 5, 13)', 'categories': [{'measurements': [{'value': '61.592', 'spread': '36', 'groupId': 'OG000'}, {'value': '67.109', 'spread': '29', 'groupId': 'OG001'}, {'value': '65.466', 'spread': '49', 'groupId': 'OG002'}, {'value': '71.116', 'spread': '49', 'groupId': 'OG003'}, {'value': '55.644', 'spread': '42', 'groupId': 'OG004'}]}]}, {'title': 'Cycle 5 Day 1 (n=3, 6, 2, 3, 12)', 'categories': [{'measurements': [{'value': '89.970', 'spread': '38', 'groupId': 'OG000'}, {'value': '68.012', 'spread': '39', 'groupId': 'OG001'}, {'value': '69.649', 'spread': '63', 'groupId': 'OG002'}, {'value': '66.082', 'spread': '33', 'groupId': 'OG003'}, {'value': '53.116', 'spread': '44', 'groupId': 'OG004'}]}]}, {'title': 'Cycle 6 Day 1 (n=2, 5, 1, 2, 10)', 'categories': [{'measurements': [{'value': '15.578', 'spread': '1208', 'groupId': 'OG000'}, {'value': '72.856', 'spread': '47', 'groupId': 'OG001'}, {'value': '46.000', 'spread': 'NA', 'comment': 'Geometric mean coefficient of variation is not calculable as n=1.', 'groupId': 'OG002'}, {'value': '9.201', 'spread': '3760', 'groupId': 'OG003'}, {'value': '52.603', 'spread': '52', 'groupId': 'OG004'}]}]}, {'title': 'Cycle 7 Day 1 (n=2, 1, 1, 1, 8)', 'categories': [{'measurements': [{'value': '59.086', 'spread': '47', 'groupId': 'OG000'}, {'value': '40.900', 'spread': 'NA', 'comment': 'Geometric mean coefficient of variation is not calculable as n=1.', 'groupId': 'OG001'}, {'value': '59.900', 'spread': 'NA', 'comment': 'Geometric mean coefficient of variation is not calculable as n=1.', 'groupId': 'OG002'}, {'value': '42.600', 'spread': 'NA', 'comment': 'Geometric mean coefficient of variation is not calculable as n=1.', 'groupId': 'OG003'}, {'value': '55.685', 'spread': '21', 'groupId': 'OG004'}]}]}, {'title': 'Cycle 8 Day 1 (n=2, 2, 1, 2, 8)', 'categories': [{'measurements': [{'value': '61.430', 'spread': '90', 'groupId': 'OG000'}, {'value': '58.988', 'spread': '31', 'groupId': 'OG001'}, {'value': '47.00', 'spread': 'NA', 'comment': 'Geometric mean coefficient of variation is not calculable as n=1.', 'groupId': 'OG002'}, {'value': '64.296', 'spread': '35', 'groupId': 'OG003'}, {'value': '51.559', 'spread': '24', 'groupId': 'OG004'}]}]}, {'title': 'Cycle 9 Day 1 (n=2, 2, 1, 2, 6)', 'categories': [{'measurements': [{'value': '64.747', 'spread': '72', 'groupId': 'OG000'}, {'value': '58.928', 'spread': '31', 'groupId': 'OG001'}, {'value': '46.000', 'spread': 'NA', 'comment': 'Geometric mean coefficient of variation is not calculable as n=1.', 'groupId': 'OG002'}, {'value': '64.115', 'spread': '30', 'groupId': 'OG003'}, {'value': '44.865', 'spread': '50', 'groupId': 'OG004'}]}]}, {'title': 'Cycle 10 Day 1 (n=1, 2, 1, 2, 4)', 'categories': [{'measurements': [{'value': '51.400', 'spread': 'NA', 'comment': 'Geometric mean coefficient of variation is not calculable as n=1.', 'groupId': 'OG000'}, {'value': '54.041', 'spread': '48', 'groupId': 'OG001'}, {'value': '58.800', 'spread': 'NA', 'comment': 'Geometric mean coefficient of variation is not calculable as n=1.', 'groupId': 'OG002'}, {'value': '71.695', 'spread': '26', 'groupId': 'OG003'}, {'value': '55.362', 'spread': '32', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cohorts I to III: Pre-dose on Day 1 of Cycle 3 to 10.', 'description': 'Ctrough was the pre-dose plasma concentration of dacomitinib at steady state obtained from direct inspection of the data.\n\nNumber of participants analyzed is the total number of participants in the treatment group in the indicated population, n is the number of participants contributing to the summary statistics.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Dose-Compliant participants only. Participants were considered dose-compliant when they received at least 14 consecutive doses at the same dose level right before sample collection in Cohorts I, II and III.'}, {'type': 'SECONDARY', 'title': 'Mean Plasma Ctrough for PF-05199265 by Visit for Cohorts I, II and III', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)', 'description': 'Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).'}, {'id': 'OG001', 'title': 'Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)', 'description': 'Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).'}, {'id': 'OG002', 'title': 'Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)', 'description': 'Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).'}, {'id': 'OG003', 'title': 'Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)', 'description': 'Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks \\[range of 32 to 35 days\\]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).'}, {'id': 'OG004', 'title': 'Cohort III (Dacomitinib 45 mg)', 'description': 'Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.'}], 'classes': [{'title': 'Cycle 3 Day 1 (n=13, 15, 3, 14, 15)', 'categories': [{'measurements': [{'value': '6.988', 'spread': '60', 'groupId': 'OG000'}, {'value': '4.653', 'spread': '133', 'groupId': 'OG001'}, {'value': '10.220', 'spread': '11', 'groupId': 'OG002'}, {'value': '7.814', 'spread': '59', 'groupId': 'OG003'}, {'value': '9.967', 'spread': '149', 'groupId': 'OG004'}]}]}, {'title': 'Cycle 4 Day 1 (n=8, 7, 2, 5, 13)', 'categories': [{'measurements': [{'value': '5.555', 'spread': '71', 'groupId': 'OG000'}, {'value': '5.271', 'spread': '242', 'groupId': 'OG001'}, {'value': '8.522', 'spread': '15', 'groupId': 'OG002'}, {'value': '6.848', 'spread': '82', 'groupId': 'OG003'}, {'value': '11.759', 'spread': '113', 'groupId': 'OG004'}]}]}, {'title': 'Cycle 5 Day 1 (n=3, 6, 2, 3, 12)', 'categories': [{'measurements': [{'value': '4.356', 'spread': '55', 'groupId': 'OG000'}, {'value': '4.989', 'spread': '58', 'groupId': 'OG001'}, {'value': '8.522', 'spread': '10', 'groupId': 'OG002'}, {'value': '5.850', 'spread': '115', 'groupId': 'OG003'}, {'value': '10.510', 'spread': '124', 'groupId': 'OG004'}]}]}, {'title': 'Cycle 6 Day 1 (n=2, 5, 1, 2, 10)', 'categories': [{'measurements': [{'value': '5.020', 'spread': '70', 'groupId': 'OG000'}, {'value': '6.523', 'spread': '123', 'groupId': 'OG001'}, {'value': '8.150', 'spread': 'NA', 'comment': 'Geometric mean coefficient of variation is not calculable as n=1.', 'groupId': 'OG002'}, {'value': '1.261', 'spread': '937', 'groupId': 'OG003'}, {'value': '7.844', 'spread': '125', 'groupId': 'OG004'}]}]}, {'title': 'Cycle 7 Day 1 (n=2, 1, 1, 1, 8)', 'categories': [{'measurements': [{'value': '4.850', 'spread': '49', 'groupId': 'OG000'}, {'value': '23.900', 'spread': 'NA', 'comment': 'Geometric mean coefficient of variation is not calculable as n=1.', 'groupId': 'OG001'}, {'value': '8.560', 'spread': 'NA', 'comment': 'Geometric mean coefficient of variation is not calculable as n=1.', 'groupId': 'OG002'}, {'value': '6.680', 'spread': 'NA', 'comment': 'Geometric mean coefficient of variation is not calculable as n=1.', 'groupId': 'OG003'}, {'value': '8.203', 'spread': '105', 'groupId': 'OG004'}]}]}, {'title': 'Cycle 8 Day 1 (n=2, 2, 1, 2, 8)', 'categories': [{'measurements': [{'value': '5.349', 'spread': '54', 'groupId': 'OG000'}, {'value': '6.085', 'spread': '476', 'groupId': 'OG001'}, {'value': '10.100', 'spread': 'NA', 'comment': 'Geometric mean coefficient of variation is not calculable as n=1.', 'groupId': 'OG002'}, {'value': '10.844', 'spread': '38', 'groupId': 'OG003'}, {'value': '8.205', 'spread': '117', 'groupId': 'OG004'}]}]}, {'title': 'Cycle 9 Day 1 (n=2, 2, 1, 2, 6)', 'categories': [{'measurements': [{'value': '4.271', 'spread': '34', 'groupId': 'OG000'}, {'value': '6.448', 'spread': '612', 'groupId': 'OG001'}, {'value': '9.720', 'spread': 'NA', 'comment': 'Geometric mean coefficient of variation is not calculable as n=1.', 'groupId': 'OG002'}, {'value': '9.159', 'spread': '58', 'groupId': 'OG003'}, {'value': '6.963', 'spread': '88', 'groupId': 'OG004'}]}]}, {'title': 'Cycle 10 Day 1 (n=1, 2, 1, 2, 4)', 'categories': [{'measurements': [{'value': '3.460', 'spread': 'NA', 'comment': 'Geometric mean coefficient of variation is not calculable as n=1.', 'groupId': 'OG000'}, {'value': '6.892', 'spread': '305', 'groupId': 'OG001'}, {'value': '10.700', 'spread': 'NA', 'comment': 'Geometric mean coefficient of variation is not calculable as n=1.', 'groupId': 'OG002'}, {'value': '9.442', 'spread': '26', 'groupId': 'OG003'}, {'value': '6.364', 'spread': '154', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cohorts I to III: Pre-dose on Day 1 of Cycle 3 to 10.', 'description': 'Ctrough was the pre-dose plasma concentration of the dacomitinib metabolite PF-05199265 at steady state obtained from direct inspection of the data.\n\nNumber of participants analyzed is the total number of participants in the treatment group in the indicated population, n is the number of participants contributing to the summary statistics.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Dose-Compliant participants only. Participants were considered dose-compliant when they received at least 14 consecutive doses at the same dose level right before sample collection in Cohorts I, II and III.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)', 'description': 'Open-label dacomitinib 45 milligram (mg) tablets orally (PO) taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).'}, {'id': 'FG001', 'title': 'Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)', 'description': 'Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).'}, {'id': 'FG002', 'title': 'Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)', 'description': 'Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05 percent (%) applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).'}, {'id': 'FG003', 'title': 'Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)', 'description': 'Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks \\[range of 32 to 35 days\\]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).'}, {'id': 'FG004', 'title': 'Cohort III (Dacomitinib 45 mg)', 'description': 'Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '66'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'comment': 'An additional 5 participants were enrolled in Cohort II but not treated.', 'groupId': 'FG003', 'numSubjects': '67'}, {'groupId': 'FG004', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '38'}, {'groupId': 'FG004', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '29'}, {'groupId': 'FG004', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Study terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Reason not specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}, {'value': '231', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)', 'description': 'Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).'}, {'id': 'BG001', 'title': 'Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)', 'description': 'Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).'}, {'id': 'BG002', 'title': 'Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)', 'description': 'Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).'}, {'id': 'BG003', 'title': 'Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)', 'description': 'Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks \\[range of 32 to 35 days\\]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).'}, {'id': 'BG004', 'title': 'Cohort III (Dacomitinib 45 mg)', 'description': 'Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.0', 'spread': '10.38', 'groupId': 'BG000'}, {'value': '64.4', 'spread': '10.55', 'groupId': 'BG001'}, {'value': '61.3', 'spread': '7.67', 'groupId': 'BG002'}, {'value': '66.0', 'spread': '9.63', 'groupId': 'BG003'}, {'value': '64.2', 'spread': '14.29', 'groupId': 'BG004'}, {'value': '64.9', 'spread': '10.59', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '109', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '122', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'As Treated Population - included all participants who received at least 1 dose of study treatment assigned at enrollment.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 236}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'dispFirstSubmitDate': '2015-12-14', 'completionDateStruct': {'date': '2015-05-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-20', 'studyFirstSubmitDate': '2011-10-20', 'dispFirstSubmitQcDate': '2015-12-14', 'resultsFirstSubmitDate': '2016-04-15', 'studyFirstSubmitQcDate': '2011-11-02', 'dispFirstPostDateStruct': {'date': '2016-01-14', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2019-01-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-07-07', 'studyFirstPostDateStruct': {'date': '2011-11-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-08-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Select Dermatologic Adverse Events of Interest (SDAEI) (All Causality, All Grade) in the First 8 Weeks of Treatment by Treatment Arm for Cohort I', 'timeFrame': 'First 8 Weeks of Treatment', 'description': 'SDAEI of all causality and all grades were evaluated in participants in Cohort I. These SDAEIs included dermatitis acneiform, dry skin, exfoliative rash, nail discoloration, nail disorder, paronychia, pruritus, rash, skin exfoliation, skin fissures, skin infection, skin laceration and skin ulcer.\n\n95% confidence interval (CI) calculated using exact method based on binomial distribution.\n\nAfter protocol amendment 1, Arm C was removed from Cohort I and enrollment to Arm C was terminated. Only 7 participants were enrolled in Cohort I Arm C as a result. Given the smaller sample size, analyse of Outcome Measure 1 was not conducted in Cohort I Arm C.'}, {'measure': 'Percentage of Participants With SDAEI (All Causality, Grade Greater Than or Equal to [≥] 2) in the First 8 Weeks of Treatment by Treatment Arm for Cohort I', 'timeFrame': 'First 8 Weeks of Treatment', 'description': 'SDAEI of all causality and Grade ≥2 were evaluated in participants in Cohort I. These SDAEIs included dermatitis acneiform, dry skin, exfoliative rash, nail discoloration, nail disorder, paronychia, pruritus, rash, skin exfoliation, skin fissures, skin infection, skin laceration and skin ulcer. Adverse events (AEs) were graded for severity using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, Version 4.0).\n\n95% CI calculated using exact method based on binomial distribution. After protocol amendment 1, Arm C was removed from Cohort I and enrollment to Arm C was terminated. Only 7 participants were enrolled in Cohort I Arm C as a result. Given the smaller sample size, analyse of Outcome Measure 2 was not conducted in Cohort I Arm C.'}, {'measure': 'Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) by Treatment Arm for Cohort I', 'timeFrame': 'First 8 Weeks of Treatment', 'description': 'Patient Reported Outcomes (PROs) of Health Related Quality of Life (HRQoL) \\& disease/treatment-related symptoms were assessed using Dermatologic Survey (Skindex-16) that assesses "bother". It includes 3 multi-item scales: symptoms, emotions \\& functioning. Individual scaled scores \\& total scores were determined. Skindex questions were transformed to a linear scale of 0 (never bothered) to 100 (always bothered). Subscale scores are an average of non-missing questions in a given scale if greater than (\\>) 75% of total subscale questions are non-missing. The Total Score is an average of all non-missing questions in the Skindex if \\>75% of total questions are non-missing. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant.\n\nSkindex completion criteria were defined as completion of 3 out of 4 items for questions 1 to 4, 6 out of 7 items for questions 5 to 11, 4 out of 5 items for questions 12 to 16 for the visit.'}, {'measure': 'Percentage of Participants With Diarrhea AEs (All Causality, All Grade and Grade ≥2) in the First 8 Weeks of Treatment for Cohort II', 'timeFrame': 'First 8 Weeks of Treatment', 'description': 'Diarrhea AEs of all causality, all grade and Grade ≥2 were evaluated in participants in Cohort II. AEs were graded for severity using the NCI-CTCAE, Version 4.0.\n\n95% CI calculated using exact method based on binomial distribution.'}, {'measure': 'Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II', 'timeFrame': 'Cycles 1, 2, 3, 4, 5, and 6, EoT and Follow-up', 'description': 'Diarrhea severity was assessed using the modified-OMDQ. This questionnaire is comprised of 6 questions in total; however, only two items relate to diarrhea symptoms (item 5 and item 6). Symptoms scores were developed for both the full questionnaire and for the diarrhea-only questions for each completed survey. Mucositis questions were transformed to a score range of 0 to 10. Increasing OMDQ values are associated with greater symptom burden.\n\nModified OMDQ completion criteria were defined as completion of all 4 questions (questions 2, 4, 5 and 6).\n\nM/T = mouth and throat.'}, {'measure': 'Percentage of Participants With SDAEI (All Causality, All Grade) in the First 8 Weeks of Treatment for Cohort II', 'timeFrame': 'First 8 Weeks of Treatment', 'description': 'SDAEI of all causality and all grades were evaluated in participants in Cohort II. These SDAEIs included dermatitis acneiform, dry skin, exfoliative rash, nail discoloration, nail disorder, paronychia, pruritus, rash, skin exfoliation, skin fissures, skin infection, skin laceration and skin ulcer.\n\n95% CI calculated using exact method based on binomial distribution.'}, {'measure': 'Percentage of Participants With SDAEI (All Causality, Grade ≥2) in the First 8 Weeks of Treatment for Cohort II', 'timeFrame': 'First 8 Weeks of Treatment', 'description': 'SDAEI of all causality and Grade ≥2 were evaluated in participants in Cohort II. These SDAEIs included dermatitis acneiform, dry skin, exfoliative rash, nail discoloration, nail disorder, paronychia, pruritus, rash, skin exfoliation, skin fissures, skin infection, skin laceration and skin ulcer. AEs were graded for severity using the NCI-CTCAE, Version 4.0.\n\n95% CI calculated using exact method based on binomial distribution.'}, {'measure': 'Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II', 'timeFrame': 'Cycles 1, 2, 3, 4, 5, and 6, EoT and Follow-up', 'description': 'PROs of HRQoL and disease/treatment-related symptoms were assessed using Dermatologic Survey (Skindex-16) that assesses "bother". It includes 3 multi-item scales: symptoms, emotions \\& functioning. Individual scaled scores \\& total scores were determined. Skindex questions were transformed to a linear scale of 0 (never bothered) to 100 (always bothered). Subscale scores are an average of non-missing questions in a given scale if \\> 75% of total subscale questions are non-missing. The Total Score is an average of all non-missing questions in the Skindex if \\>75% of total questions are non-missing. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant.\n\nSkindex completion criteria were defined as completion of 3 out of 4 items for questions 1 to 4, 6 out of 7 items for questions 5 to 11, 4 out of 5 items for questions 12 to 16 for the visit.'}, {'measure': 'Mean Area Under the Plasma Concentration Time Curve From 0 to 24 Hours (AUC0-24) and From 0 to 120 Hours (AUC0-120) for Dacomitinib and Its Metabolite PF-05199265 on Cycle 1 Days 10 to 15 for Cohort III', 'timeFrame': 'Cycle 1 Day 10: Pre-dose and 2, 4, 6, 24, 48, 72, 96, and 120 hours post-dose (the 120 hour sample was obtained on Day 15 pre-dose).', 'description': 'AUC0-24 is the area under the plasma concentration-time curve (AUC) from time 0 to 24 hours post-dose. AUC0-120 is the AUC from time 0 to 120 hours post-dose. AUC was calculated by the linear trapezoidal method using a non-compartmental pharmacokinetic (PK) analysis.\n\nng\\*hr/mL = nanogram hours per milliliter'}, {'measure': 'Mean Maximum Observed Plasma Concentrations (Cmax) for Dacomitinib and Its Metabolite PF-05199265 on Cycle 1 Days 10 to 15 for Cohort III', 'timeFrame': 'Cycle 1 Day 10: Pre-dose and 2, 4, 6, 24, 48, 72, 96, and 120 hours post-dose (the 120 hour sample was obtained on Day 15 pre-dose).', 'description': 'Cmax was obtained from direct inspection of the data. ng/mL = nanograms per milliliter'}, {'measure': 'Median Time of Occurrence of Cmax (Tmax) for Dacomitinib and Its Metabolite PF-05199265 on Cycle 1 Days 10 to 15 for Cohort III', 'timeFrame': 'Cycle 1 Day 10: Pre-dose and 2, 4, 6, 24, 48, 72, 96, and 120 hours post-dose (the 120 hour sample was obtained on Day 15 pre-dose).', 'description': 'Tmax was obtained from direct inspection of the data as the time of first occurence of Cmax.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Receiving Any Concomitant Drug or Non-Drug Treatment for SDAEI, Diarrhea and Mucositis for Cohort I by Treatment Arm, Cohort II, and Cohort III', 'timeFrame': 'Screening to the Post-Teatment Follow-Up Visit (at least 28 days and no more than 35 days after the end of dacomitinib treatment due to progression of disease, intolerance to dacomitinib treatment, or participant withdrawal)', 'description': 'Medications used concomitantly for SDAEIs, diarrhea and mucositis were evaluated for all participants who received dacomitinib on a continuous basis with a preemptive prophylactic (Cohorts I and II) or as an interrupted dosing regimen (Cohort III).'}, {'measure': 'Mean AUC From 0 to the End of the Dosing Interval (AUC0-tau) for Dacomitinib and Its Metabolite PF-05199265 on Cycle 2 Day 1 for Cohort I', 'timeFrame': 'Cycle 2 Day 1: pre-dose and at 2, 4, 6, and 24 hours post-dose', 'description': 'AUCtau was the AUC from time 0 to the end of the dosing interval, where the dosing interval was 24 hours. AUCtau was calculated by the linear/log trapezoidal method using a non-compartmental PK analysis.'}, {'measure': 'Mean Cmax for Dacomitinib and Its Metabolite PF-05199265 on Cycle 2 Day 1 for Cohort I', 'timeFrame': 'Cycle 2 Day 1: pre-dose and at 2, 4, 6, and 24 hours post-dose', 'description': 'Cmax was obtained from direct inspection of the data.'}, {'measure': 'Median Tmax for Dacomitinib and Its Metabolite PF-05199265 on Cycle 2 Day 1 for Cohort I', 'timeFrame': 'Cycle 2 Day 1: pre-dose and at 2, 4, 6, and 24 hours post-dose', 'description': 'Tmax was obtained from direct inspection of the data as the time of first occurence of Cmax.'}, {'measure': 'Mean Apparent Clearance (CL/F) for Dacomitinib on Cycle 2 Day 1 for Cohort I', 'timeFrame': 'Cycle 2 Day 1: pre-dose and at 2, 4, 6, and 24 hours post-dose', 'description': 'CL/F was calculated as dose/AUCtau.'}, {'measure': 'Mean Plasma Trough Concentrations (Ctrough) for Dacomitinib by Visit for Cohorts I, II and III', 'timeFrame': 'Cohorts I to III: Pre-dose on Day 1 of Cycle 3 to 10.', 'description': 'Ctrough was the pre-dose plasma concentration of dacomitinib at steady state obtained from direct inspection of the data.\n\nNumber of participants analyzed is the total number of participants in the treatment group in the indicated population, n is the number of participants contributing to the summary statistics.'}, {'measure': 'Mean Plasma Ctrough for PF-05199265 by Visit for Cohorts I, II and III', 'timeFrame': 'Cohorts I to III: Pre-dose on Day 1 of Cycle 3 to 10.', 'description': 'Ctrough was the pre-dose plasma concentration of the dacomitinib metabolite PF-05199265 at steady state obtained from direct inspection of the data.\n\nNumber of participants analyzed is the total number of participants in the treatment group in the indicated population, n is the number of participants contributing to the summary statistics.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['non-small cell lung cancer', 'advanced', 'previously treated'], 'conditions': ['Non Small Cell Lung Cancer (NSCLC)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A7471042&StudyName=Study%20Of%20Dacomitinib%20%28PF-00299804%29%20In%20Advanced%20NSCLC%20Patients%20%28Post%20Chemo%20Or%20Select%20First%20Line%29%20To%20Evaluate%20Prophylactic%20Interventio', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'To assess the impact of prophylactic treatment on the incidence of adverse events in advanced NSCLC patients (post chemotherapy) treated with dacomitinib daily as a single agent. To assess the impact of an interrupted dacomitinib dosing schedule in Cycle 1 on the incidence of adverse events in first-line advanced NSCLC patients with an EGFR mutation (HER-1 mutation, HER-2 mutation or HER-2 amplification).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Advanced Non-Small Cell Lung Cancer (NSCLC).\n* For Cohort I and Cohort II, advanced NSCLC patients must have received at least one prior regimen of systemic therapy which includes at least one standard chemotherapy for advanced NSCLC and who have failed (ie, progressed or intolerant due to toxicity which precludes further treatment) standard therapy for advanced or metastatic disease. To be considered intolerant to treatment, a patient must have received at least two cycles to be considered previously treated.\n* For Cohort III, advanced NSCLC patients must not have received prior systemic treatment for their advanced disease and require a known EGFR (HER-1) mutation, HER-2 mutation or HER-2 amplification. Cohort III patients could have received prior adjuvant chemotherapy for Stage I-III disease or combined modality chemotherapy-radiation for Stage IIIA disease is allowed if treatment completed\\>12 months prior to enrollment.\n* All cohorts, patients must have evidence of disease; however, measurable disease is not required to enroll.\n* Eastern Cooperative Oncology Group (ECOG) Performance status 0-2\n* Estimated creatinine clearance ≥15 mL/min.\n\nExclusion Criteria:\n\n* Prior treatment with an EGFR-targeted or HER-targeted agent (all cohorts).\n* Chemotherapy, radiotherapy, biological or investigational agents within 2 weeks of baseline disease assessments (all cohorts).\n* Patients with known diffuse interstitial lung disease (all cohorts).\n* Investigational therapy as only treatment for advanced NSCLC without administration of an approved chemotherapy for advanced NSCLC (for Cohort I and Cohort II)'}, 'identificationModule': {'nctId': 'NCT01465802', 'acronym': 'ARCHER 1042', 'briefTitle': 'Study Of Dacomitinib (PF-00299804) In Advanced NSCLC Patients (Post Chemo Or Select First Line) To Evaluate Prophylactic Intervention On Derm And GI AEs And PRO', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'ARCHER 1042: A PHASE 2 STUDY OF DACOMITINIB IN ADVANCED NON-SMALL CELL LUNG CANCER (POST-CHEMOTHERAPY OR SELECT FIRST LINE PATIENTS) TO EVALUATE PROPHYLACTIC INTERVENTION ON DERMATOLOGIC AND GASTROINTESTINAL ADVERSE EVENTS AND PATIENT REPORTED OUTCOMES', 'orgStudyIdInfo': {'id': 'A7471042'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort I', 'description': 'Arm A: Dacomitinib 45 mg orally daily on a continuous schedule until disease progression, toxicity, death or withdrawal of consent Doxycycline placebo orally BID for 4 weeks Arm B: Dacomitinib 45 mg orally daily on a continuous schedule until disease progression, toxicity, death or withdrawal of consent Doxycycline 100 mg orally BID for 4 weeks', 'interventionNames': ['Drug: Dacomitinib', 'Drug: Doxycycline']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort II', 'description': 'Dacomitinib 45 mg orally daily on a continuous schedule until disease progression, toxicity, death or withdrawal of consent Topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks VSL#3 probiotic 4 capsules orally daily or 1 sachet orally daily for up to 5 weeks (starting between Day minus 7 to Day minus 4 and continuing through Day 28)', 'interventionNames': ['Drug: Dacomitinib', 'Drug: Probiotic', 'Drug: Alclometasone cream']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort III', 'description': 'Cohort III is an interrupted dosing schedule of dacomitinib in the first cycle only', 'interventionNames': ['Drug: Dacomitinib']}], 'interventions': [{'name': 'Dacomitinib', 'type': 'DRUG', 'description': 'Dacomitinib 45 mg orally daily on a continuous schedule until disease progression, toxicity, death or withdrawal of consent', 'armGroupLabels': ['Cohort I', 'Cohort II']}, {'name': 'Dacomitinib', 'type': 'DRUG', 'description': 'Dacomitinib 45 mg orally daily on a continuous schedule for the first 10 days in Cycle 1, followed by 4 days off treatment, followed by continuous daily dosing until disease progression, toxicity, death or withdrawal of consent', 'armGroupLabels': ['Cohort III']}, {'name': 'Doxycycline', 'type': 'DRUG', 'description': 'Doxycycline or Doxycycline placebo BID for 4 weeks', 'armGroupLabels': ['Cohort I']}, {'name': 'Probiotic', 'type': 'DRUG', 'description': 'VSL#3 probiotic 4 capsules orally daily or 1 sachet orally daily for up to 5 weeks (starting between Day minus 7 to Day minus 4 and continuing through Day 28)', 'armGroupLabels': ['Cohort II']}, {'name': 'Alclometasone cream', 'type': 'DRUG', 'description': 'Topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks', 'armGroupLabels': ['Cohort II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'St. Jude Heritage Healthcare', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '92604', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Hematology Oncology', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'UC San Diego Medical Center - La Jolla', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'UC San Diego Moores Cancer Center - Investigational Drug Services', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'UC San Diego Moores Cancer Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90095-7349', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Drug Management Only: UCLA West Medical Pharmacy', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Drug Management Only: UCLA West Medical Pharmacy Attn: Steven L. 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Hillcrest', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '93401', 'city': 'San Luis Obispo', 'state': 'California', 'country': 'United States', 'facility': 'Coastal Integrative Cancer Care', 'geoPoint': {'lat': 35.28275, 'lon': -120.65962}}, {'zip': '93105', 'city': 'Santa Barbara', 'state': 'California', 'country': 'United States', 'facility': 'SANSUM Clinic', 'geoPoint': {'lat': 34.42083, 'lon': -119.69819}}, {'zip': '93150', 'city': 'Santa Barbara', 'state': 'California', 'country': 'United States', 'facility': 'Cancer Center of Santa Barbara with SANSUM Clinic', 'geoPoint': {'lat': 34.42083, 'lon': -119.69819}}, {'zip': '93454', 'city': 'Santa Maria', 'state': 'California', 'country': 'United States', 'facility': 'Central Coast Medical Oncology Corporation', 'geoPoint': {'lat': 34.95303, 'lon': -120.43572}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Hematology Oncology', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Santa Monica Medical Center & Orthopaedic Hospital', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '93463', 'city': 'Solvang', 'state': 'California', 'country': 'United States', 'facility': 'Cancer Center of Santa Barbara with SANSUM Clinic', 'geoPoint': {'lat': 34.59582, 'lon': -120.13765}}, {'zip': '91030', 'city': 'South Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope South Pasadena Cancer Center', 'geoPoint': {'lat': 34.11612, 'lon': -118.15035}}, {'zip': '91355', 'city': 'Valencia', 'state': 'California', 'country': 'United States', 'facility': 'UCLA/Santa Clarita Valley Cancer Center', 'geoPoint': {'lat': 34.44361, 'lon': -118.60953}}, {'zip': '91361', 'city': 'Westlake Village', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Cancer Center', 'geoPoint': {'lat': 34.14584, 'lon': -118.80565}}, {'zip': '80205', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Kaiser Permanente Colorado - Franklin', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '81501', 'city': 'Grand Junction', 'state': 'Colorado', 'country': 'United States', 'facility': "St. Mary's Hospital Regional Cancer Center", 'geoPoint': {'lat': 39.06387, 'lon': -108.55065}}, {'zip': '80026', 'city': 'Lafayette', 'state': 'Colorado', 'country': 'United States', 'facility': 'Kaiser Permanente Colorado - Rock Creek', 'geoPoint': {'lat': 39.9936, 'lon': -105.08971}}, {'zip': '80124', 'city': 'Lonetree', 'state': 'Colorado', 'country': 'United States', 'facility': 'Kaiser Permanente Colorado - Lonetree', 'geoPoint': {'lat': 37.16806, 'lon': -107.17282}}, {'zip': '33308', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Michael and Dianne Bienes Comprehensive Cancer Center, Holy Cross Hospital', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33021', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Memorial Cancer Institute', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '32024', 'city': 'Lake City', 'state': 'Florida', 'country': 'United States', 'facility': 'Cancer Care of North Florida, PA', 'geoPoint': {'lat': 30.18968, 'lon': -82.63929}}, {'zip': '33028', 'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'Memorial West Cancer Institute', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'zip': '30607', 'city': 'Athens', 'state': 'Georgia', 'country': 'United States', 'facility': 'University Cancer & Blood Center, LLC', 'geoPoint': {'lat': 33.96095, 'lon': -83.37794}}, {'zip': '31404', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'Summit Cancer Care,PC', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '31405', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'Summit Cancer Care, PC', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center, Division of Hematology & Oncology', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Ships Drugs to: Emmanuel Semmes, RPh (or Ami Patel, Pharm D) University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '61615', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'Illinois CancerCare, P.C.', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '67208', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '67214', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '48183', 'city': 'Brownstown', 'state': 'Michigan', 'country': 'United States', 'facility': 'Josephine Ford Cancer Center-Downriver'}, {'zip': '48126', 'city': 'Dearborn', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Medical Center - 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