Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2025-12-25 @ 5:02 PM
Study NCT ID:
NCT00153803
Status:
COMPLETED
Last Update Posted:
2019-09-06
First Post:
2005-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Erlotinib or Placebo Following Chemoradiotherapy (Chemo/RT) in Stage III Non-Small Cell Lung Cancer (NSCLC)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069347', 'term': 'Erlotinib Hydrochloride'}], 'ancestors': [{'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Cancer.Research.Nurse@Dartmouth.edu', 'title': 'Clinical Research Office', 'organization': 'Dartmouth-Hitchcock Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'The intent-to-treat population included 235 eligible randomized patients to the erlotinib arm (n = 118) or placebo arm (n = 117); 245 randomized, 10 became ineligible prior to any treatment. Patients were evaluated with a medical history, physical exam, laboratory studies, and toxicity assessment starting at 1st dose, every 4 weeks for 2 months, then every 8-12 weeks until treatment discontinuation. Participants were evaluated, on average, for 6 months, and through study completion up to 3 years', 'description': 'Common Toxicities are reported. Adverse events (Serious, Other Adverse Events) are reporting for only those participants who are included in the intent-to-treat population .This study used the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 3.0 for grading and reporting of toxicities and adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Chemoradiation Before Tarceva', 'otherNumAtRisk': 118, 'deathsNumAtRisk': 118, 'otherNumAffected': 12, 'seriousNumAtRisk': 118, 'deathsNumAffected': 26, 'seriousNumAffected': 36}, {'id': 'EG001', 'title': 'Chemoradiation Before Placebo', 'otherNumAtRisk': 117, 'deathsNumAtRisk': 117, 'otherNumAffected': 8, 'seriousNumAtRisk': 117, 'deathsNumAffected': 27, 'seriousNumAffected': 38}, {'id': 'EG002', 'title': 'Tarceva', 'description': 'Tarceva 150mg\n\nErlotinib (tarceva): Erlotinib 150mg orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events, death or completion of 3 years of therapy.', 'otherNumAtRisk': 77, 'deathsNumAtRisk': 77, 'otherNumAffected': 8, 'seriousNumAtRisk': 77, 'deathsNumAffected': 43, 'seriousNumAffected': 39}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Matched Placebo\n\nPlacebo: Matched placebo orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events death or completion of 3 years of therapy.', 'otherNumAtRisk': 75, 'deathsNumAtRisk': 75, 'otherNumAffected': 0, 'seriousNumAtRisk': 75, 'deathsNumAffected': 40, 'seriousNumAffected': 23}], 'otherEvents': [{'term': 'Allergic reaction', 'notes': 'Allergic reaction/hypersensitivity (including drug fever)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemoglobin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial fibrillation', 'notes': 'Supraventricular and nodal arrhythmia Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac General - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constitutional symptoms - Fever', 'notes': 'Fever (in the absence of neutropenia, where neutropenia is defined as ANC \\<1.0 x 10e9/L)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Esophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Extrapyramidal/involuntary movement/restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain - Chest/Thorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonitis/pulmonary infiltrates', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Desquamation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain - Abdomen NOS', 'notes': 'None otherwise specified (NOS)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory - other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Embolism', 'notes': 'Thrombosis/ thrombus/ embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hemoglobin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial fibrillation', 'notes': 'Supraventricular and nodal arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac General', 'notes': 'Cardiac General', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac ischemia/infarction', 'notes': 'Cardiac ischemia/infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Paroxysmal Atrial Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ventricular fibrillation', 'notes': 'Ventricular arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysphagia (difficulty swallowing)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Esophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fistula, Esophagus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastritis', 'notes': 'Gastritis (including bile reflux gastritis)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mucositis/stomatitis', 'notes': 'Mucositis/stomatitis (functional/symptomatic) Esophagus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Perforation, GIColon', 'notes': 'GI/Colon Perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constitutional Symptoms - Fatigue', 'notes': 'Fatigue (asthenia, lethargy, malaise)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constitutional Symptoms - Fever', 'notes': 'Fever (in the absence of neutropenia, where neutropenia is defined as ANC \\<1.0 x 10eFever (in the absence of neutropenia, where neutropenia is defined as ANC \\<1.0 x 10e9/L)9/L)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constitutional Symptoms- Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemorrhage - Respiratory tract NOS', 'notes': 'Hemorrhage, pulmonary/upper respiratory/ Respiratory tract None otherwise specified (NOS)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemorrhage, GI Lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemorrhage, pulmonary/upper respiratory - Bronchopulmonary', 'notes': 'Hemorrhage, pulmonary/upper respiratory Bronchopulmonary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemorrhage, pulmonary/upper respiratory- Lung', 'notes': 'Hemorrhage, pulmonary/upper respiratory- Lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemorrhage/Bleeding - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain - Abdomen NOS', 'notes': 'None otherwise specified (NOW)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain - Bone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain - Joint', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain- Chest/thorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Allergic Reaction', 'notes': 'Allergic reaction/hypersensitivity (including drug fever)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Colitis, Infectious', 'notes': 'example: Clostridium difficile', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Febrile neutropenia', 'notes': 'Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infection)(ANC \\<1.0 x 10e9/L, fever \\>=38.5 degrees C)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection - Blood', 'notes': 'Infection with normal ANC or Grade 1 or 2 neutrophils Blood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection - Foreign body', 'notes': 'Infection with normal ANC or Grade 1 or 2 neutrophils Foreign body (e.g., graft, implant, prosthesis, stent)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection - Lung', 'notes': 'Infection with normal ANC or Grade 1 or 2 neutrophils Lung (pneumonia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection - Wound', 'notes': 'Infection with normal ANC or Grade 1 or 2 neutrophils Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal / Soft Tissue - Other', 'notes': 'Musculoskeletal / Soft Tissue - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebrovascular Ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neurology - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Somnolence/depressed level of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Obstruction - Ureter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea (shortness of breath)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pleural effusion (non-malignant)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonitis/pulmonary infiltrates', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper Respiratory - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound complication, non-infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intra-operative Injury - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombosis/embolism (vascular access-related)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombosis/thrombus/embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vascular - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tarceva', 'description': 'Tarceva 150mg\n\nErlotinib (tarceva): Erlotinib 150mg orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events, death or completion of 3 years of therapy.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matched Placebo\n\nPlacebo: Matched placebo orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events death or completion of 3 years of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.4', 'comment': 'Data could not be found; The data cannot be located/provided due to the PI leaving the institution.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '8.1', 'comment': 'Data could not be found; The data cannot be located/provided due to the PI leaving the institution.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.165', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.65', 'ciUpperLimit': '1.33', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '5 years', 'description': 'Progression Free Survival is defined as time from randomization until documented disease progression or death from any cause. The Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.0) was used to determine disease progression. Irradiated target lesions were considered non-measurable disease. Symptomatic radiographic changes of irradiated non-measurable disease required pathologically confirmation or positive FDG-PET scan 6 months following completion of concurrent chemoradiation to be considered locoregional disease progression. Global deterioration of health status requiring discontinuation of treatment without objective evidence of progression was considered distant disease progression.', 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'NA = not available; The data cannot be located/provided due to the PI leaving the institution.'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tarceva', 'description': 'Tarceva 150mg\n\nErlotinib (tarceva): Erlotinib 150mg orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events, death or completion of 2 years of therapy.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matched Placebo\n\nPlacebo: Matched placebo orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events death or completion of 3 years of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.5', 'comment': 'Data could not be found; The data cannot be located/provided due to the PI leaving the institution.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '20.3', 'comment': 'Data could not be found; The data cannot be located/provided due to the PI leaving the institution.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.32', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.18', 'ciLowerLimit': '0.85', 'ciUpperLimit': '1.63', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of randomization until the date of death from any cause, assessed up to 50 months', 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'NA = not available; The data cannot be located/provided due to the PI leaving the institution.'}, {'type': 'SECONDARY', 'title': 'Percent of Participants Surviving 3 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tarceva', 'description': 'Tarceva 150mg\n\nErlotinib (tarceva): Erlotinib 150mg orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events, death or completion of 3 years of therapy.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matched Placebo\n\nPlacebo: Matched placebo orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events death or completion of 3 years of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '36 months', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Serious Adverse Event Profile Relating to Death, Disability, Life-threatening, Hospitalization, and Impairment/Damage for Concurrent Chemoradiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tarceva', 'description': 'Tarceva 150mg\n\nErlotinib (tarceva): Erlotinib 150mg orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events, death or completion of 3 years of therapy.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matched Placebo\n\nPlacebo: Matched placebo orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events death or completion of 3 years of therapy.'}], 'classes': [{'title': 'Death', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Disability', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Life-threatening', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Hospitalization', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'Impairment/damange', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '18 months', 'description': 'Number of participants with treatment-related serious adverse events (SAEs) observed in each SAE category for each arm relating to death, disability, life-threatening, hospitalization, and impairment/damage is reported. For participants with multiple SAEs, the SAE report having the strongest relationship to study drug is summarized.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Serious Adverse Event Profile Relating to Death, Disability, Life-threatening, Hospitalization, and Impairment/Damage for Erlotinib and Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tarceva', 'description': 'Tarceva 150mg\n\nErlotinib (tarceva): Erlotinib 150mg orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events, death or completion of 3 years of therapy.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matched Placebo\n\nPlacebo: Matched placebo orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events death or completion of 3 years of therapy.'}], 'classes': [{'title': 'Death', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Disability', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Life-threatening', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hospitalization (initial or prolonged)', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Impairment/damange', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '18 months', 'description': 'Number of participants with treatment-related serious adverse events (SAEs) observed in each SAE category for each arm relating to death, disability, life-threatening, hospitalization, and impairment/damage is reported. For participants with multiple SAEs, the SAE report having the strongest relationship to study drug is summarized.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tarceva', 'description': 'Tarceva 150mg\n\nErlotinib (tarceva): Erlotinib 150mg orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events, death or completion of 3 years of therapy.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Matched Placebo\n\nPlacebo: Matched placebo orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events death or completion of 3 years of therapy.'}], 'periods': [{'title': 'Concurrent Chemoradiation', 'milestones': [{'type': 'STARTED', 'comment': 'Patients randomized', 'achievements': [{'groupId': 'FG000', 'numSubjects': '123'}, {'groupId': 'FG001', 'numSubjects': '122'}]}, {'type': 'Received Chemoradiation', 'achievements': [{'groupId': 'FG000', 'numSubjects': '118'}, {'groupId': 'FG001', 'numSubjects': '117'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '118'}, {'groupId': 'FG001', 'numSubjects': '117'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}, {'title': 'Investigational Drug', 'milestones': [{'type': 'STARTED', 'comment': 'Patients who participated in Period 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '118'}, {'groupId': 'FG001', 'numSubjects': '117'}]}, {'type': 'Investigational Drug Dispensed', 'achievements': [{'groupId': 'FG000', 'numSubjects': '77'}, {'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': 'COMPLETED', 'comment': 'Received at least one dose', 'achievements': [{'groupId': 'FG000', 'numSubjects': '77'}, {'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '42'}]}]}], 'recruitmentDetails': 'Period 1: 245 patients were registered \\& randomized. Of those, 10 patients were ineligible due to incorrect stage, withdrawal of consent, inability to meet radiation therapy parameters, and inadequate functional status. The number of participants for each specific reason for ineligibility is unknown. They did not receive any study intervention.', 'preAssignmentDetails': 'Period 2:Study drug dispensed to only chemoradiation patients who did not experience disease progression, consent withdrawal, death, investigators discretion, or toxicity.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '245', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tarceva', 'description': 'Tarceva 150mg\n\nErlotinib (tarceva): Erlotinib 150mg orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events, death or completion of 3 years of therapy.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Matched Placebo\n\nPlacebo: Matched placebo orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events death or completion of 3 years of therapy.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68', 'groupId': 'BG000', 'lowerLimit': '39', 'upperLimit': '89'}, {'value': '67', 'groupId': 'BG001', 'lowerLimit': '38', 'upperLimit': '84'}, {'value': '67.5', 'groupId': 'BG002', 'lowerLimit': '38', 'upperLimit': '89'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '215', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 245}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-04', 'studyFirstSubmitDate': '2005-09-07', 'resultsFirstSubmitDate': '2019-03-19', 'studyFirstSubmitQcDate': '2005-09-07', 'lastUpdatePostDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-04', 'studyFirstPostDateStruct': {'date': '2005-09-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival', 'timeFrame': '5 years', 'description': 'Progression Free Survival is defined as time from randomization until documented disease progression or death from any cause. The Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.0) was used to determine disease progression. Irradiated target lesions were considered non-measurable disease. Symptomatic radiographic changes of irradiated non-measurable disease required pathologically confirmation or positive FDG-PET scan 6 months following completion of concurrent chemoradiation to be considered locoregional disease progression. Global deterioration of health status requiring discontinuation of treatment without objective evidence of progression was considered distant disease progression.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'From date of randomization until the date of death from any cause, assessed up to 50 months'}, {'measure': 'Percent of Participants Surviving 3 Years', 'timeFrame': '36 months'}, {'measure': 'Serious Adverse Event Profile Relating to Death, Disability, Life-threatening, Hospitalization, and Impairment/Damage for Concurrent Chemoradiation', 'timeFrame': '18 months', 'description': 'Number of participants with treatment-related serious adverse events (SAEs) observed in each SAE category for each arm relating to death, disability, life-threatening, hospitalization, and impairment/damage is reported. For participants with multiple SAEs, the SAE report having the strongest relationship to study drug is summarized.'}, {'measure': 'Serious Adverse Event Profile Relating to Death, Disability, Life-threatening, Hospitalization, and Impairment/Damage for Erlotinib and Placebo', 'timeFrame': '18 months', 'description': 'Number of participants with treatment-related serious adverse events (SAEs) observed in each SAE category for each arm relating to death, disability, life-threatening, hospitalization, and impairment/damage is reported. For participants with multiple SAEs, the SAE report having the strongest relationship to study drug is summarized.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Erlotinib', 'Tarceva', 'Web based', 'Stage III NSCLC'], 'conditions': ['Carcinoma, Non-Small-Cell Lung', 'Non-small Cell Lung Cancer', 'NSCLC']}, 'descriptionModule': {'briefSummary': 'This is a national, randomized, web-based, double-blind study to determine whether erlotinib (Tarceva) compared to placebo improves progression-free survival (PFS) for patients with inoperable, stage III NSCLC following concurrent docetaxel, carboplatin and thoracic radiotherapy. We hypothesize that the introduction of this orally active, well-tolerated agent following concurrent chemoradiation and prior to the emergence of drug resistance will prolong the progression-free survival by 40% (10 months → 14 months).', 'detailedDescription': 'The promising activity of erlotinib as a single agent in advanced refractory NSCLC along with its oral administration and favorable adverse event profile makes this agent an excellent candidate to incorporate into combined modality therapy in the early stages of lung cancer. Based on these data, erlotinib is an attractive novel approach to maintenance therapy in unresectable stage III NSCLC following completion of concomitant chemoradiation. Although, a subset of patients with unresectable stage III NSCLC will be long-term survivors following chemotherapy and thoracic radiation therapy, the vast majority relapse within the first year following therapy and eventually die from chemotherapy refractory disease. We hypothesize that the introduction of an potent tyrosine kinase inhibitor to the epidermal growth factor receptor following effective concomitant chemoradiotherapy with docetaxel and carboplatin will prolong the progression-free survival time for these patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unresectable, stage IIIA or IIIB NSCLC (measurable disease is not required)\n* No evidence of metastatic disease\n* No prior treatment\n* Adequate organ function\n* Adequate pulmonary function (FEV \\>= 1.0L or predicted FEV \\>0.8L)\n\nExclusion Criteria:\n\n* Metastasis\n* Prior treatment\n* Malignant pleural or pericardial effusion\n* Peripheral neuropathy \\>= grade 2'}, 'identificationModule': {'nctId': 'NCT00153803', 'briefTitle': 'Erlotinib or Placebo Following Chemoradiotherapy (Chemo/RT) in Stage III Non-Small Cell Lung Cancer (NSCLC)', 'organization': {'class': 'OTHER', 'fullName': 'Dartmouth-Hitchcock Medical Center'}, 'officialTitle': 'A National Web-Based Randomized Phase III Study of Erlotinib or Placebo Following Concurrent Docetaxel, Carboplatin, and Thoracic Radiotherapy in Patients With Inoperable Stage III Non-Small Cell Lung Cancer (D0410).', 'orgStudyIdInfo': {'id': 'D-0410'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Erlotinib (Tarceva) 150mg: Erlotinib 150mg orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events, death or completion of 3 years of therapy.', 'interventionNames': ['Drug: Erlotinib (tarceva)']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Matched Placebo: Matched placebo orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events death or completion of 3 years of therapy.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Erlotinib (tarceva)', 'type': 'DRUG', 'description': 'Erlotinib 150mg orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events, death or completion of 3 years of therapy.', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matched placebo orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events death or completion of 3 years of therapy.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35235', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Birmingham Hematology and Oncology Associates, LLC', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Oncology Specialties, P.C.', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '72913', 'city': 'Fort Smith', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Cooper Clinic', 'geoPoint': {'lat': 35.38592, 'lon': -94.39855}}, {'zip': '71913', 'city': 'Hot Springs', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Genesis Cancer Center', 'geoPoint': {'lat': 34.5037, 'lon': -93.05518}}, {'zip': '94704', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'Alta Bates Comprehensive Cancer Center', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}, {'zip': '96001', 'city': 'Redding', 'state': 'California', 'country': 'United States', 'facility': 'Northstate Cancer Speciality', 'geoPoint': {'lat': 40.58654, 'lon': -122.39168}}, {'zip': '95816', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Mercy General Hospital', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '06105', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'St. Francis Hospital Cancer Center', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '06457', 'city': 'Middletown', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Connecticut Oncology Group', 'geoPoint': {'lat': 41.56232, 'lon': -72.65065}}, {'zip': '06050', 'city': 'New Britain', 'state': 'Connecticut', 'country': 'United 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'country': 'United States', 'facility': 'Pasco Hernando Oncology Associates', 'geoPoint': {'lat': 28.55554, 'lon': -82.38991}}, {'zip': '33901', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '33919', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Lee Cancer Clinic', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '33458', 'city': 'Jupiter', 'state': 'Florida', 'country': 'United States', 'facility': 'Jupiter Medical Center', 'geoPoint': {'lat': 26.93422, 'lon': -80.09421}}, {'zip': '32055', 'city': 'Lake City', 'state': 'Florida', 'country': 'United States', 'facility': 'Cancer Care of North Florida', 'geoPoint': {'lat': 30.18968, 'lon': -82.63929}}, {'zip': '34652', 'city': 'New Port Richey', 'state': 'Florida', 'country': 'United States', 'facility': 'Pasco/Hernando Oncology', 'geoPoint': {'lat': 28.24418, 'lon': 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