Viewing Study NCT01345669

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
Ignite Creation Date: 2025-12-24 @ 11:04 PM
Ignite Modification Date: 2025-12-25 @ 8:35 PM
Study NCT ID: NCT01345669
Status: TERMINATED
Last Update Posted: 2017-12-07
First Post: 2011-04-28
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: LUX-Head&Neck 2: A Phase III Trial of Afatinib (BIBW 2992) Versus Placebo for the Treatment of Head and Neck Squamous Cell Cancer After Treatment With Chemo-radiotherapy
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Poland']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077716', 'term': 'Afatinib'}], 'ancestors': [{'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim, Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'otherDetails': "Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The trial was stopped prematurely due to futility.'}}, 'adverseEventsModule': {'timeFrame': 'From first drug administration until 4 weeks after the last drug administration, up to 84 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Afatinib (BIBW 2992)', 'description': 'Patient received Afatinib film-coated tablets with starting dose 40 mg (milligram)/day and escalation to 50 mg/day and/or reduction to 40, 30 or 20 mg/day according to absence or presence of drug-related adverse events (AEs), orally, once daily for up to 80 weeks or until recurrence / occurrence of second primary tumour, unacceptable side effects, or other reason necessitating withdrawal.', 'otherNumAtRisk': 411, 'otherNumAffected': 407, 'seriousNumAtRisk': 411, 'seriousNumAffected': 80}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Patient received placebo matching Afatinib film-coated tablets with matching Afatinib dosage regimen, orally, once daily for up to 80 weeks or until recurrence / occurrence of second primary tumour, unacceptable side effects, or other reason necessitating withdrawal.', 'otherNumAtRisk': 206, 'otherNumAffected': 169, 'seriousNumAtRisk': 206, 'seriousNumAffected': 51}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cheilitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 335}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 41}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 107}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 23}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 126}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Paronychia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 85}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 19}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 23}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 17}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 12}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 30}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 17}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dermatitis acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 112}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 76}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 16}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Palmar-plantar erythrodysaesthesia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 13}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 188}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 34}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Skin fissures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 12}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Aortic valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Deafness neurosensory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Inappropriate antidiuretic hormone secretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Retinal tear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Duodenal ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Gastric perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Glossitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Intestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Large intestine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pancreatitis relapsing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Disease recurrence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Impaired healing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Bile duct stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Sarcoidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Appendicitis perforated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Carbuncle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cellulitis of male external genital organ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Groin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hepatitis E', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Oropharyngeal candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Urethritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Osteoradionecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Patella fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Post procedural complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Radiation fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Radiation necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Vascular graft complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Electrocardiogram QT prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Groin pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Osteonecrosis of jaw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Scleroderma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Metastases to lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Metastases to lymph nodes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Neoplasm recurrence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Oesophageal carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Oropharyngeal squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Recurrent cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Squamous cell carcinoma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Carotid artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Partial seizures with secondary generalisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Spinal cord compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': "Wernicke's encephalopathy", 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Device occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Balanoposthitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Laryngeal dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Laryngeal oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Laryngeal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pneumothorax spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pulmonary alveolar haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Respiratory tract oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Tracheal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dermatitis exfoliative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Disease Free Survival (DFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '411', 'groupId': 'OG000'}, {'value': '206', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Afatinib (BIBW 2992)', 'description': 'Patient received Afatinib film-coated tablets with starting dose 40 mg (milligram)/day and escalation to 50 mg/day and/or reduction to 40, 30 or 20 mg/day according to absence or presence of drug-related adverse events (AEs), orally, once daily for up to 80 weeks or until recurrence / occurrence of second primary tumour, unacceptable side effects, or other reason necessitating withdrawal.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patient received placebo matching Afatinib film-coated tablets with matching Afatinib dosage regimen, orally, once daily for up to 80 weeks or until recurrence / occurrence of second primary tumour, unacceptable side effects, or other reason necessitating withdrawal.'}], 'classes': [{'categories': [{'measurements': [{'value': '43.40', 'comment': "Non calculable because the 75th percentile hasn't been reached", 'groupId': 'OG000', 'lowerLimit': '16.82', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': "Non calculable because the median hasn't been reached", 'groupId': 'OG001', 'lowerLimit': '16.69', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.4806', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.126', 'ciLowerLimit': '0.809', 'ciUpperLimit': '1.569', 'estimateComment': 'Hazard ratio (Afatinib vs. Placebo) from Cox proportional hazards model stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).', 'groupDescription': 'DFS was analysed using a stratified log-rank test with nodal status (N0- N2a vs. N2b-N3) and Eastern Cooperative Oncology Group (ECOG) performance status (0 vs. 1) being the stratification factors.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 5 years', 'description': 'Disease Free Survival defined as the time from randomisation until documented tumour recurrence/ second primary tumour (SPT) or death from any cause, whichever occurred first.', 'unitOfMeasure': 'Months', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomised Set (RS): Included all patients who were randomised, regardless of taking investigational treatment (as randomised)'}, {'type': 'SECONDARY', 'title': 'Disease Free Survival (DFS) Rate at 2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Afatinib (BIBW 2992)', 'description': 'Patient received Afatinib film-coated tablets with starting dose 40 mg (milligram)/day and escalation to 50 mg/day and/or reduction to 40, 30 or 20 mg/day according to absence or presence of drug-related adverse events (AEs), orally, once daily for up to 80 weeks or until recurrence / occurrence of second primary tumour, unacceptable side effects, or other reason necessitating withdrawal.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patient received placebo matching Afatinib film-coated tablets with matching Afatinib dosage regimen, orally, once daily for up to 80 weeks or until recurrence / occurrence of second primary tumour, unacceptable side effects, or other reason necessitating withdrawal.'}], 'classes': [{'categories': [{'measurements': [{'value': '67.2', 'groupId': 'OG000', 'lowerLimit': '61.2', 'upperLimit': '72.5'}, {'value': '73.5', 'groupId': 'OG001', 'lowerLimit': '66.0', 'upperLimit': '79.5'}]}]}], 'analyses': [{'pValue': '0.1610', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Kaplan-Meier estimates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.27', 'ciLowerLimit': '-15.04', 'ciUpperLimit': '2.50', 'estimateComment': 'Difference in Kaplan-Meier estimates of Afatinib vs. Placebo is provided.', 'groupDescription': 'Kaplan-Meier (KM) curves were calculated for each treatment group, separately, and the estimates of DFS probabilities from the curves and 95% Confidence interval (CI) (using the Greenwood standard error estimate) were tabulated', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 2 years', 'description': 'Disease Free Survival (DFS) rate at 2 years. Probability of being disease free at 2 years in percentage is provided based on Kaplan-Meier method.', 'unitOfMeasure': 'Probability (%)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomised Set, the number of patients from the randomized set those are disease free (or DFS) at 2 years.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patient Deaths (Overall Survival (OS))', 'denoms': [{'units': 'Participants', 'counts': [{'value': '411', 'groupId': 'OG000'}, {'value': '206', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Afatinib (BIBW 2992)', 'description': 'Patient received Afatinib film-coated tablets with starting dose 40 mg (milligram)/day and escalation to 50 mg/day and/or reduction to 40, 30 or 20 mg/day according to absence or presence of drug-related adverse events (AEs), orally, once daily for up to 80 weeks or until recurrence / occurrence of second primary tumour, unacceptable side effects, or other reason necessitating withdrawal.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patient received placebo matching Afatinib film-coated tablets with matching Afatinib dosage regimen, orally, once daily for up to 80 weeks or until recurrence / occurrence of second primary tumour, unacceptable side effects, or other reason necessitating withdrawal.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.1', 'groupId': 'OG000', 'lowerLimit': '16.82', 'upperLimit': 'NA'}, {'value': '11.2', 'groupId': 'OG001', 'lowerLimit': '16.69', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.1301', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.444', 'ciLowerLimit': '0.895', 'ciUpperLimit': '2.332', 'pValueComment': 'p-value (two-sided) from log-rank test stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).', 'groupDescription': 'Hazard ratio from Cox proportional hazards model stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 years', 'description': 'Overall survival (OS), defined as the time from randomisation until death (regardless of cause). Due to the small event rate in both treatment arms caused by the early termination of the trial, the hazard estimate is not interpretable. Hence presented the total randomized and the percentage of patients died.', 'unitOfMeasure': 'Percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomised Set (RS): Included all patients who were randomised, regardless of taking investigational treatment (as randomised)'}, {'type': 'SECONDARY', 'title': 'Patients With Improved Health Related Quality of Life (HRQOL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '411', 'groupId': 'OG000'}, {'value': '206', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Afatinib (BIBW 2992)', 'description': 'Patient received Afatinib film-coated tablets with starting dose 40 mg (milligram)/day and escalation to 50 mg/day and/or reduction to 40, 30 or 20 mg/day according to absence or presence of drug-related adverse events (AEs), orally, once daily for up to 80 weeks or until recurrence / occurrence of second primary tumour, unacceptable side effects, or other reason necessitating withdrawal.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patient received placebo matching Afatinib film-coated tablets with matching Afatinib dosage regimen, orally, once daily for up to 80 weeks or until recurrence / occurrence of second primary tumour, unacceptable side effects, or other reason necessitating withdrawal.'}], 'classes': [{'title': 'Swallowing (Q5-Q8 from QLQ-HN35)', 'categories': [{'measurements': [{'value': '34.8', 'groupId': 'OG000', 'lowerLimit': '16.82', 'upperLimit': 'NA'}, {'value': '27.2', 'groupId': 'OG001', 'lowerLimit': '16.69', 'upperLimit': 'NA'}]}]}, {'title': 'Pain HN35 (Q1-Q4 from QLQ-HN35)', 'categories': [{'measurements': [{'value': '33.8', 'groupId': 'OG000'}, {'value': '26.2', 'groupId': 'OG001'}]}]}, {'title': 'Global health status/QoL(Q29-Q30 from QLQ-C30)', 'categories': [{'measurements': [{'value': '33.6', 'groupId': 'OG000'}, {'value': '38.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0561', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.431', 'ciLowerLimit': '0.991', 'ciUpperLimit': '2.068', 'groupDescription': "Odds ratio and p-value from logistic regression analysis of 'improved vs. not improved' stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3) for Swallowing (Q5-Q8 from QLQ-HN35).", 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0523', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.446', 'ciLowerLimit': '0.996', 'ciUpperLimit': '2.098', 'groupDescription': "Odds ratio and p-value from logistic regression analysis of 'improved vs. not improved' stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3) for Pain HN35 (Q1-Q4 from QLQ-HN35).", 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.2570', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.818', 'ciLowerLimit': '0.577', 'ciUpperLimit': '1.158', 'groupDescription': "Odds ratio and p-value from logistic regression analysis of 'improved vs. not improved' stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3) for Global health status/QoL(Q29-Q30 from QLQ-C30).", 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 years', 'description': 'HRQoL questionnaires focused on 3 scales: Pain scale from H\\&N35, Swallowing scale from H\\&N35 and Global health status/QoL scale from C30. Improvement was defined as a score that improved from baseline by at least 10 points (on the 0-100 point scale) at any time during the study. If a patient had not improved, worsening was defined as a 10-point worsening at any time during the study. Patients who had neither improved nor worsened were considered as stable. Percentages of patients with improvement in HRQoL are presented.', 'unitOfMeasure': 'Percentage of Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomised Set (RS): Included all patients who were randomised, regardless of taking investigational treatment (as randomised)'}, {'type': 'SECONDARY', 'title': 'Time to Deterioration in Health Related Quality of Life (HRQOL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '411', 'groupId': 'OG000'}, {'value': '206', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Afatinib (BIBW 2992)', 'description': 'Patient received Afatinib film-coated tablets with starting dose 40 mg (milligram)/day and escalation to 50 mg/day and/or reduction to 40, 30 or 20 mg/day according to absence or presence of drug-related adverse events (AEs), orally, once daily for up to 80 weeks or until recurrence / occurrence of second primary tumour, unacceptable side effects, or other reason necessitating withdrawal.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patient received placebo matching Afatinib film-coated tablets with matching Afatinib dosage regimen, orally, once daily for up to 80 weeks or until recurrence / occurrence of second primary tumour, unacceptable side effects, or other reason necessitating withdrawal.'}], 'classes': [{'title': 'Swallowing', 'categories': [{'measurements': [{'value': '18.43', 'comment': "Non calculable because the 75th percentile hasn't been reached", 'groupId': 'OG000', 'lowerLimit': '3.68', 'upperLimit': 'NA'}, {'value': '31.44', 'comment': "Non calculable because the 75th percentile hasn't been reached", 'groupId': 'OG001', 'lowerLimit': '3.78', 'upperLimit': 'NA'}]}]}, {'title': 'Pain HN35', 'categories': [{'measurements': [{'value': '12.06', 'comment': "Non calculable because the 75th percentile hasn't been reached", 'groupId': 'OG000', 'lowerLimit': '1.91', 'upperLimit': 'NA'}, {'value': '31.08', 'comment': "Non calculable because the 75th percentile hasn't been reached", 'groupId': 'OG001', 'lowerLimit': '3.78', 'upperLimit': 'NA'}]}]}, {'title': 'Global health status/QoL', 'categories': [{'measurements': [{'value': '7.59', 'comment': "Non calculable because the 75th percentile hasn't been reached", 'groupId': 'OG000', 'lowerLimit': '1.87', 'upperLimit': 'NA'}, {'value': '25.79', 'comment': "Non calculable because the 75th percentile hasn't been reached", 'groupId': 'OG001', 'lowerLimit': '6.21', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.0591', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.295', 'ciLowerLimit': '0.986', 'ciUpperLimit': '1.700', 'pValueComment': 'P-value from log-rank test stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).', 'groupDescription': 'For swallowing scale; Hazard ratio from Cox proportional hazard model stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0049', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.456', 'ciLowerLimit': '1.113', 'ciUpperLimit': '1.905', 'pValueComment': 'P-value from log-rank test stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).', 'groupDescription': 'For pain HN35 scale; Hazard ratio from Cox proportional hazard model stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.604', 'ciLowerLimit': '1.238', 'ciUpperLimit': '2.079', 'pValueComment': 'P-value from log-rank test stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).', 'groupDescription': 'For global health status/QoL scale; Hazard ratio from Cox proportional hazard model stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 5 years', 'description': 'HRQoL questionnaires focused on 3 scales: Pain scale from H\\&N35, Swallowing scale from H\\&N35 and Global health status/QoL scale from C30. Time to deterioration was defined as the time from randomisation to the first 10-point worsening on the 0-100 point scale. Patients with no deterioration (including those with disease recurrence/SPT) were censored at the last available HRQoL assessment date. Patients with no post-baseline assessments were censored on the day of randomisation.', 'unitOfMeasure': 'Months', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomised Set (RS): Included all patients who were randomised, regardless of taking investigational treatment (as randomised)'}, {'type': 'SECONDARY', 'title': 'Health Related Quality of Life (HRQOL) Scores Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '411', 'groupId': 'OG000'}, {'value': '206', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Afatinib (BIBW 2992)', 'description': 'Patient received Afatinib film-coated tablets with starting dose 40 mg (milligram)/day and escalation to 50 mg/day and/or reduction to 40, 30 or 20 mg/day according to absence or presence of drug-related adverse events (AEs), orally, once daily for up to 80 weeks or until recurrence / occurrence of second primary tumour, unacceptable side effects, or other reason necessitating withdrawal.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patient received placebo matching Afatinib film-coated tablets with matching Afatinib dosage regimen, orally, once daily for up to 80 weeks or until recurrence / occurrence of second primary tumour, unacceptable side effects, or other reason necessitating withdrawal.'}], 'classes': [{'title': 'Swallowing', 'categories': [{'measurements': [{'value': '10.1', 'spread': '1.00', 'groupId': 'OG000', 'lowerLimit': '3.68', 'upperLimit': 'NA'}, {'value': '8.8', 'spread': '1.12', 'groupId': 'OG001', 'lowerLimit': '3.78', 'upperLimit': 'NA'}]}]}, {'title': 'Pain HN35', 'categories': [{'measurements': [{'value': '13.1', 'spread': '0.98', 'groupId': 'OG000', 'lowerLimit': '1.91', 'upperLimit': 'NA'}, {'value': '9.9', 'spread': '1.10', 'groupId': 'OG001', 'lowerLimit': '3.78', 'upperLimit': 'NA'}]}]}, {'title': 'Global health status/QoL', 'categories': [{'measurements': [{'value': '29.6', 'spread': '2.23', 'groupId': 'OG000', 'lowerLimit': '1.87', 'upperLimit': 'NA'}, {'value': '33.0', 'spread': '2.28', 'groupId': 'OG001', 'lowerLimit': '6.21', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.2232', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.3', 'ciLowerLimit': '-0.81', 'ciUpperLimit': '3.45', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.08', 'estimateComment': 'Afatinib minus Placebo mean adjusted for total with data for baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).', 'groupDescription': 'Scores (swallowing scale) over time were assessed using longitudinal mixed-effects growth curve models with the average profile over time for each endpoint described by a piecewise linear model adjusted for the fixed effects baseline ECOG performance score and nodal status.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Degrees of freedom calculated using the Kenward-Roger method.'}, {'pValue': '0.0028', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.2', 'ciLowerLimit': '1.12', 'ciUpperLimit': '5.36', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.08', 'estimateComment': 'Afatinib minus Placebo mean adjusted for total with data for baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).', 'groupDescription': 'Scores (pain scale) over time were assessed using longitudinal mixed-effects growth curve models with the average profile over time for each endpoint described by a piecewise linear model adjusted for the fixed effects baseline ECOG performance score and nodal status.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Degrees of freedom calculated using the Kenward-Roger method.'}, {'pValue': '0.0005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.4', 'ciLowerLimit': '-5.33', 'ciUpperLimit': '-1.49', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.98', 'estimateComment': 'Afatinib minus Placebo mean adjusted for total with data for baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).', 'groupDescription': 'Scores (global health/QoL) over time were assessed using longitudinal mixed-effects growth curve models with the average profile over time for each endpoint described by a piecewise linear model adjusted for the fixed effects baseline ECOG performance score and nodal status.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Degrees of freedom calculated using the Kenward-Roger method.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 5 years', 'description': 'HRQoL questionnaires focused on 3 scales: Pain scale from H\\&N35, Swallowing scale from H\\&N35 and Global health status/QoL scale from C30. Scoring of the symptom scales/items followed the European Organisation for Research and Treatment of Cancer (EORTC) scoring manual and a linear transformation of the scores to a 0-100 point scale. Higher values are better.', 'unitOfMeasure': 'Unit on Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomised Set (RS): Included all patients who were randomised, regardless of taking investigational treatment (as randomised)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Afatinib (BIBW 2992)', 'description': 'Patient received Afatinib film-coated tablets with starting dose 40 mg (milligram)/day and escalation to 50 mg/day and/or reduction to 40, 30 or 20 mg/day according to absence or presence of drug-related adverse events (AEs), orally, once daily for up to 80 weeks or until recurrence / occurrence of second primary tumour, unacceptable side effects, or other reason necessitating withdrawal.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Patient received placebo matching Afatinib film-coated tablets with matching Afatinib dosage regimen, orally, once daily for up to 80 weeks or until recurrence / occurrence of second primary tumour, unacceptable side effects, or other reason necessitating withdrawal.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '411'}, {'groupId': 'FG001', 'numSubjects': '206'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '124'}, {'groupId': 'FG001', 'numSubjects': '87'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '287'}, {'groupId': 'FG001', 'numSubjects': '119'}]}], 'dropWithdraws': [{'type': 'Primary tumour recurrence', 'reasons': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'Second primary tumour', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Other Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '111'}, {'groupId': 'FG001', 'numSubjects': '60'}]}]}], 'preAssignmentDetails': 'This was a randomised, placebo-controlled, double-blind, parallel arms, multinational phase III trial in which patients were randomised 2:1 to Afatinib or Placebo.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '411', 'groupId': 'BG000'}, {'value': '206', 'groupId': 'BG001'}, {'value': '617', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Afatinib (BIBW 2992)', 'description': 'Patient received Afatinib film-coated tablets with starting dose 40 mg (milligram)/day and escalation to 50 mg/day and/or reduction to 40, 30 or 20 mg/day according to absence or presence of drug-related adverse events (AEs), orally, once daily for up to 80 weeks or until recurrence / occurrence of second primary tumour, unacceptable side effects, or other reason necessitating withdrawal.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Patient received placebo matching Afatinib film-coated tablets with matching Afatinib dosage regimen, orally, once daily for up to 80 weeks or until recurrence / occurrence of second primary tumour, unacceptable side effects, or other reason necessitating withdrawal.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.3', 'spread': '8.23', 'groupId': 'BG000'}, {'value': '57.3', 'spread': '8.64', 'groupId': 'BG001'}, {'value': '58.0', 'spread': '8.38', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '350', 'groupId': 'BG000'}, {'value': '178', 'groupId': 'BG001'}, {'value': '528', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Randomised Set (RS): Included all patients who were randomised, regardless of taking investigational treatment (as randomised)'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 617}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-10-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2016-09-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-03', 'studyFirstSubmitDate': '2011-04-28', 'resultsFirstSubmitDate': '2017-08-17', 'studyFirstSubmitQcDate': '2011-04-29', 'lastUpdatePostDateStruct': {'date': '2017-12-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-09-21', 'studyFirstPostDateStruct': {'date': '2011-05-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease Free Survival (DFS)', 'timeFrame': 'Up to 5 years', 'description': 'Disease Free Survival defined as the time from randomisation until documented tumour recurrence/ second primary tumour (SPT) or death from any cause, whichever occurred first.'}], 'secondaryOutcomes': [{'measure': 'Disease Free Survival (DFS) Rate at 2 Years', 'timeFrame': 'Up to 2 years', 'description': 'Disease Free Survival (DFS) rate at 2 years. Probability of being disease free at 2 years in percentage is provided based on Kaplan-Meier method.'}, {'measure': 'Percentage of Patient Deaths (Overall Survival (OS))', 'timeFrame': 'Up to 5 years', 'description': 'Overall survival (OS), defined as the time from randomisation until death (regardless of cause). Due to the small event rate in both treatment arms caused by the early termination of the trial, the hazard estimate is not interpretable. Hence presented the total randomized and the percentage of patients died.'}, {'measure': 'Patients With Improved Health Related Quality of Life (HRQOL)', 'timeFrame': 'Up to 5 years', 'description': 'HRQoL questionnaires focused on 3 scales: Pain scale from H\\&N35, Swallowing scale from H\\&N35 and Global health status/QoL scale from C30. Improvement was defined as a score that improved from baseline by at least 10 points (on the 0-100 point scale) at any time during the study. If a patient had not improved, worsening was defined as a 10-point worsening at any time during the study. Patients who had neither improved nor worsened were considered as stable. Percentages of patients with improvement in HRQoL are presented.'}, {'measure': 'Time to Deterioration in Health Related Quality of Life (HRQOL)', 'timeFrame': 'Up to 5 years', 'description': 'HRQoL questionnaires focused on 3 scales: Pain scale from H\\&N35, Swallowing scale from H\\&N35 and Global health status/QoL scale from C30. Time to deterioration was defined as the time from randomisation to the first 10-point worsening on the 0-100 point scale. Patients with no deterioration (including those with disease recurrence/SPT) were censored at the last available HRQoL assessment date. Patients with no post-baseline assessments were censored on the day of randomisation.'}, {'measure': 'Health Related Quality of Life (HRQOL) Scores Over Time', 'timeFrame': 'Baseline and 5 years', 'description': 'HRQoL questionnaires focused on 3 scales: Pain scale from H\\&N35, Swallowing scale from H\\&N35 and Global health status/QoL scale from C30. Scoring of the symptom scales/items followed the European Organisation for Research and Treatment of Cancer (EORTC) scoring manual and a linear transformation of the scores to a 0-100 point scale. Higher values are better.'}]}, 'conditionsModule': {'conditions': ['Head and Neck Neoplasms']}, 'referencesModule': {'references': [{'pmid': '31194247', 'type': 'DERIVED', 'citation': 'Burtness B, Haddad R, Dinis J, Trigo J, Yokota T, de Souza Viana L, Romanov I, Vermorken J, Bourhis J, Tahara M, Martins Segalla JG, Psyrri A, Vasilevskaya I, Nangia CS, Chaves-Conde M, Kiyota N, Homma A, Holeckova P, Del Campo JM, Asarawala N, Nicolau UR, Rauch D, Even C, Wang B, Gibson N, Ehrnrooth E, Harrington K, Cohen EEW; LUX-Head & Neck 2 investigators. Afatinib vs Placebo as Adjuvant Therapy After Chemoradiotherapy in Squamous Cell Carcinoma of the Head and Neck: A Randomized Clinical Trial. JAMA Oncol. 2019 Aug 1;5(8):1170-1180. doi: 10.1001/jamaoncol.2019.1146.'}, {'pmid': '25432788', 'type': 'DERIVED', 'citation': 'Burtness B, Bourhis JP, Vermorken JB, Harrington KJ, Cohen EE. Afatinib versus placebo as adjuvant therapy after chemoradiation in a double-blind, phase III study (LUX-Head & Neck 2) in patients with primary unresected, clinically intermediate-to-high-risk head and neck cancer: study protocol for a randomized controlled trial. Trials. 2014 Nov 29;15:469. doi: 10.1186/1745-6215-15-469.'}]}, 'descriptionModule': {'briefSummary': 'This randomised, double-blind phase III trial will be performed in patients with head and neck squamous cell carcinoma (HNSCC). The objectives of the trial are to compare the efficacy and safety of afatinib (BIBW 2992) with placebo as adjuvant therapy to patients who have received definitive chemo-radiotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Histologically or cytologically confirmed loco-regionally advanced head and neck squamous cell carcinoma (HNSCC), stage III to IVb\n2. Unresected tumour prior to chemo-radiotherapy (CRT)\n3. Concomitant CRT completed prior to randomisation\n4. After concomitant platinum-based CRT, no evidence of disease (NED) on clinical and radiographic examinations\n5. Eastern cooperative oncology group (ECOG) performance status 0 or 1\n\nExclusion criteria:\n\n1. Prior treatment with epidermal growth factor receptor (EGFR)-targeted small molecules, EGFR-targeted antibodies, and/or any investigational agents for HNSCC\n2. Patients with smoking history of less than or equal to 10 pack years and with primary tumour site of base of tongue and/or tonsil\n3. Any other malignancy (except for simultaneous HNSCC primaries, appropriately treated superficial basal cell skin cancer and surgically cured cervical cancer in situ) unless free of disease for at least five years\n4. Known pre-existing Interstitial Lung Disease (ILD)\n5. Pregnancy or breast feeding'}, 'identificationModule': {'nctId': 'NCT01345669', 'briefTitle': 'LUX-Head&Neck 2: A Phase III Trial of Afatinib (BIBW 2992) Versus Placebo for the Treatment of Head and Neck Squamous Cell Cancer After Treatment With Chemo-radiotherapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Randomised, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of Afatinib (BIBW 2992) as Adjuvant Therapy After Chemo-radiotherapy in Primary Unresected Patients With Stage III, IVa, or IVb Loco-regionally Advanced Head and Neck Squamous Cell Carcinoma', 'orgStudyIdInfo': {'id': '1200.131'}, 'secondaryIdInfos': [{'id': '2011-000392-14', 'type': 'EUDRACT_NUMBER', 'domain': 'EudraCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Afatinib (BIBW 2992)', 'description': 'Once daily', 'interventionNames': ['Drug: Afatinib']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Once daily', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Once daily', 'armGroupLabels': ['Placebo']}, {'name': 'Afatinib', 'type': 'DRUG', 'description': 'Once daily', 'armGroupLabels': ['Afatinib (BIBW 2992)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': '1200.131.00171 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': '1200.131.00181 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': '1200.131.00177 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': '1200.131.00185 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': '1200.131.00173 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': '1200.131.00176 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': '1200.131.00182 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': '1200.131.00175 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': '1200.131.00179 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': '1200.131.00188 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': '1200.131.10200 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': '1200.131.00172 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': '1200.131.00184 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'Spokane Valley', 'state': 'Washington', 'country': 'United States', 'facility': '1200.131.00198 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 47.67323, 'lon': -117.23937}}, {'city': 'Wenatchee', 'state': 'Washington', 'country': 'United States', 'facility': '1200.131.00183 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 47.42346, 'lon': -120.31035}}, {'city': 'Ciudad Autonoma de Bs As', 'country': 'Argentina', 'facility': '1200.131.05451 Boehringer Ingelheim Investigational Site'}, {'city': 'Córdoba', 'country': 'Argentina', 'facility': '1200.131.05457 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'city': 'San Miguel de Tucumán', 'country': 'Argentina', 'facility': '1200.131.05458 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': -26.81601, 'lon': -65.21051}}, {'city': 'Santa Fe', 'country': 'Argentina', 'facility': '1200.131.05452 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': -31.64881, 'lon': -60.70868}}, {'city': 'Villa Domínico', 'country': 'Argentina', 'facility': '1200.131.05453 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': -34.69421, 'lon': -58.33035}}, {'city': 'Wooloongabba', 'state': 'Queensland', 'country': 'Australia', 'facility': '1200.131.06151 Boehringer Ingelheim Investigational Site'}, {'city': 'Leoben', 'country': 'Austria', 'facility': '1200.131.04353 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 47.3765, 'lon': 15.09144}}, {'city': 'Linz', 'country': 'Austria', 'facility': '1200.131.04357 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'city': 'Salzburg', 'country': 'Austria', 'facility': '1200.131.04355 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'city': 'Vienna', 'country': 'Austria', 'facility': '1200.131.04351 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Vienna', 'country': 'Austria', 'facility': '1200.131.04359 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Brussels', 'country': 'Belgium', 'facility': '1200.131.03259 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Charleroi', 'country': 'Belgium', 'facility': '1200.131.03256 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 50.41136, 'lon': 4.44448}}, {'city': 'Hasselt', 'country': 'Belgium', 'facility': '1200.131.03255 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}, {'city': 'Kortrijk', 'country': 'Belgium', 'facility': '1200.131.03253 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 50.82803, 'lon': 3.26487}}, {'city': 'Liège', 'country': 'Belgium', 'facility': '1200.131.03252 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'city': 'Liège', 'country': 'Belgium', 'facility': '1200.131.03254 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'city': 'Namur', 'country': 'Belgium', 'facility': '1200.131.03258 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 50.4669, 'lon': 4.86746}}, {'city': 'Barretos', 'country': 'Brazil', 'facility': '1200.131.05554 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': -20.55722, 'lon': -48.56778}}, {'city': 'Jaú', 'country': 'Brazil', 'facility': '1200.131.05555 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': -22.29639, 'lon': -48.55778}}, {'city': 'Passo Fundo', 'country': 'Brazil', 'facility': '1200.131.05557 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': -28.26278, 'lon': -52.40667}}, {'city': 'Porto Alegre', 'country': 'Brazil', 'facility': '1200.131.05553 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': '1200.131.05551 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': '1200.131.05556 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': '1200.131.00152 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': '1200.131.00157 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Windsor', 'state': 'Ontario', 'country': 'Canada', 'facility': '1200.131.00151 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 42.30008, 'lon': -83.01654}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': '1200.131.00153 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': '1200.131.00154 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': '1200.131.00155 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Vina de Mar', 'country': 'Chile', 'facility': '1200.131.05652 Boehringer Ingelheim Investigational Site'}, {'city': 'Viña del Mar', 'country': 'Chile', 'facility': '1200.131.05651 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': -33.02457, 'lon': -71.55183}}, {'city': 'Brno', 'country': 'Czechia', 'facility': '1200.131.04254 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'city': 'Prague', 'country': 'Czechia', 'facility': '1200.131.04251 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Prague', 'country': 'Czechia', 'facility': '1200.131.04253 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'København Ø', 'country': 'Denmark', 'facility': '1200.131.04551 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 55.70968, 'lon': 12.56862}}, {'city': 'Alexandria', 'country': 'Egypt', 'facility': '1200.131.2052 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}, {'city': 'Turku', 'country': 'Finland', 'facility': '1200.131.35851 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}, {'city': 'Le Havre', 'country': 'France', 'facility': '1200.131.03353 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 49.49346, 'lon': 0.10785}}, {'city': 'Marseille', 'country': 'France', 'facility': '1200.131.03362 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Nice', 'country': 'France', 'facility': '1200.131.03359 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'city': 'Orléans', 'country': 'France', 'facility': '1200.131.03365 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 47.90248, 'lon': 1.90407}}, {'city': 'Pierre-Bénite', 'country': 'France', 'facility': '1200.131.03355 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'city': 'Rouen', 'country': 'France', 'facility': '1200.131.03367 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'city': 'Saint-Cloud', 'country': 'France', 'facility': '1200.131.03370 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 48.84598, 'lon': 2.20289}}, {'city': 'Saint-Herblain', 'country': 'France', 'facility': '1200.131.03354 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}, {'city': 'Saint-Priest-en-Jarez', 'country': 'France', 'facility': '1200.131.03369 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 45.4739, 'lon': 4.37678}}, {'city': 'Salouël', 'country': 'France', 'facility': '1200.131.03366 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 49.86988, 'lon': 2.2434}}, {'city': 'Tours', 'country': 'France', 'facility': '1200.131.03356 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'city': 'Villejuif', 'country': 'France', 'facility': '1200.131.03357 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'city': 'Essen', 'country': 'Germany', 'facility': '1200.131.04954 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': '1200.131.04961 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'city': 'Hanover', 'country': 'Germany', 'facility': '1200.131.04953 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'city': 'Jena', 'country': 'Germany', 'facility': '1200.131.04956 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'city': 'Kaiserslautern', 'country': 'Germany', 'facility': '1200.131.04959 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 49.443, 'lon': 7.77161}}, {'city': 'Leipzig', 'country': 'Germany', 'facility': '1200.131.04951 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'city': 'Rostock', 'country': 'Germany', 'facility': '1200.131.04957 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 54.0887, 'lon': 12.14049}}, {'city': 'Trier', 'country': 'Germany', 'facility': '1200.131.04964 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 49.75565, 'lon': 6.63935}}, {'city': 'Ulm', 'country': 'Germany', 'facility': '1200.131.04963 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}, {'city': 'Villingen-Schwenningen', 'country': 'Germany', 'facility': '1200.131.04962 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 48.06226, 'lon': 8.49358}}, {'city': 'Chaïdári', 'country': 'Greece', 'facility': '1200.131.03054 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 38.01135, 'lon': 23.66597}}, {'city': 'Thessaloniki', 'country': 'Greece', 'facility': '1200.131.03052 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'city': 'Budapest', 'country': 'Hungary', 'facility': '1200.131.03651 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Budapest', 'country': 'Hungary', 'facility': '1200.131.03652 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Budpest', 'country': 'Hungary', 'facility': '1200.131.03656 Boehringer Ingelheim Investigational Site'}, {'city': 'Debrecen', 'country': 'Hungary', 'facility': '1200.131.03654 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'city': 'Kecskemét', 'country': 'Hungary', 'facility': '1200.131.03655 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 46.90618, 'lon': 19.69128}}, {'city': 'Ahmadābād', 'country': 'India', 'facility': '1200.131.09178 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 18.02475, 'lon': 77.31026}}, {'city': 'Bangalore', 'country': 'India', 'facility': '1200.131.09165 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'city': 'Bikaner', 'country': 'India', 'facility': '1200.131.09152 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 28.01762, 'lon': 73.31495}}, {'city': 'Chennai', 'country': 'India', 'facility': '1200.131.09163 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'city': 'Chennai', 'country': 'India', 'facility': '1200.131.09173 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'city': 'Delhi', 'country': 'India', 'facility': '1200.131.09179 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 28.65195, 'lon': 77.23149}}, {'city': 'Gurgaon', 'country': 'India', 'facility': '1200.131.09170 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 25.49781, 'lon': 82.15916}}, {'city': 'Hyderabad', 'country': 'India', 'facility': '1200.131.09180 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}, {'city': 'Jaipur', 'country': 'India', 'facility': '1200.131.09172 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 26.91962, 'lon': 75.78781}}, {'city': 'Karamsad,Anand, Gujarat', 'country': 'India', 'facility': '1200.131.09176 Boehringer Ingelheim Investigational Site'}, {'city': 'Madurai, Tamil Nadu', 'country': 'India', 'facility': '1200.131.09162 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 9.919, 'lon': 78.11953}}, {'city': 'Mazagaon, Mumbai', 'country': 'India', 'facility': '1200.131.09175 Boehringer Ingelheim Investigational Site'}, {'city': 'New Delhi', 'country': 'India', 'facility': '1200.131.09151 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}, {'city': 'Pune', 'country': 'India', 'facility': '1200.131.09164 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'city': 'Visakhapatnam', 'country': 'India', 'facility': '1200.131.09159 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 17.68009, 'lon': 83.20161}}, {'city': 'Haifa', 'country': 'Israel', 'facility': '1200.131.97251 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'city': 'Petah Tikva', 'country': 'Israel', 'facility': '1200.131.97253 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'city': 'Confreria (CN)', 'country': 'Italy', 'facility': '1200.131.03957 Boehringer Ingelheim Investigational Site'}, {'city': 'Milan', 'country': 'Italy', 'facility': '1200.131.03951 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Milan', 'country': 'Italy', 'facility': '1200.131.03955 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Milan', 'country': 'Italy', 'facility': '1200.131.03960 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Aichi, Nagoya', 'country': 'Japan', 'facility': '1200.131.08156 Boehringer Ingelheim Investigational Site'}, {'city': 'Chiba, Kashiwa', 'country': 'Japan', 'facility': '1200.131.08153 Boehringer Ingelheim Investigational Site'}, {'city': 'Hokkaido, Sapporo', 'country': 'Japan', 'facility': '1200.131.08151 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Hyogo, Akashi', 'country': 'Japan', 'facility': '1200.131.08161 Boehringer Ingelheim Investigational Site'}, {'city': 'Hyogo, Kobe', 'country': 'Japan', 'facility': '1200.131.08157 Boehringer Ingelheim Investigational Site'}, {'city': 'Kanagawa, Isehara', 'country': 'Japan', 'facility': '1200.131.08159 Boehringer Ingelheim Investigational Site'}, {'city': 'Miyagi, Natori', 'country': 'Japan', 'facility': '1200.131.08164 Boehringer Ingelheim Investigational Site'}, {'city': 'Osaka, Osaka', 'country': 'Japan', 'facility': '1200.131.08160 Boehringer Ingelheim Investigational Site'}, {'city': 'Shizuoka, Sunto-gun', 'country': 'Japan', 'facility': '1200.131.08155 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'city': 'Tochigi, Shimotsuke', 'country': 'Japan', 'facility': '1200.131.08152 Boehringer Ingelheim Investigational Site'}, {'city': 'Tokyo, Koto-ku', 'country': 'Japan', 'facility': '1200.131.08163 Boehringer Ingelheim Investigational Site'}, {'city': 'Tokyo, Meguro-ku', 'country': 'Japan', 'facility': '1200.131.08154 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'México', 'country': 'Mexico', 'facility': '1200.131.05252 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 31.00435, 'lon': -108.15213}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': '1200.131.03152 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Leiden', 'country': 'Netherlands', 'facility': '1200.131.03153 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'city': 'Rotterdam', 'country': 'Netherlands', 'facility': '1200.131.03151 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Almada', 'country': 'Portugal', 'facility': '1200.131.35155 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 38.67902, 'lon': -9.1569}}, {'city': 'Coimbra', 'country': 'Portugal', 'facility': '1200.131.35154 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 40.20686, 'lon': -8.41996}}, {'city': 'Evora', 'country': 'Portugal', 'facility': '1200.131.35152 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 38.56587, 'lon': -7.90405}}, {'city': 'Lisbon', 'country': 'Portugal', 'facility': '1200.131.35153 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'city': 'Porto', 'country': 'Portugal', 'facility': '1200.131.35151 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'city': 'Moscow', 'country': 'Russia', 'facility': '1200.131.00759 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Omsk', 'country': 'Russia', 'facility': '1200.131.00753 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 54.99244, 'lon': 73.36859}}, {'city': 'Pyatigorsk', 'country': 'Russia', 'facility': '1200.131.00760 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 44.05, 'lon': 43.05036}}, {'city': 'Pyatigorsk', 'country': 'Russia', 'facility': '1200.131.00761 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 44.05, 'lon': 43.05036}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': '1200.131.00763 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Ufa', 'country': 'Russia', 'facility': '1200.131.00755 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 54.74306, 'lon': 55.96779}}, {'city': 'Ufa', 'country': 'Russia', 'facility': '1200.131.00762 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 54.74306, 'lon': 55.96779}}, {'city': 'Ávila', 'country': 'Spain', 'facility': '1200.131.03461 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 40.65724, 'lon': -4.69951}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': '1200.131.03451 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': '1200.131.03454 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Girona', 'country': 'Spain', 'facility': '1200.131.03463 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 41.98311, 'lon': 2.82493}}, {'city': "L'Hospitalet de Llobregat", 'country': 'Spain', 'facility': '1200.131.03452 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}, {'city': 'Lugo', 'country': 'Spain', 'facility': '1200.131.03459 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 43.00992, 'lon': -7.55602}}, {'city': 'Madrid', 'country': 'Spain', 'facility': '1200.131.03457 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': '1200.131.03464 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': '1200.131.03465 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Málaga', 'country': 'Spain', 'facility': '1200.131.03456 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'city': 'Málaga', 'country': 'Spain', 'facility': '1200.131.03462 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'city': 'Pamplona', 'country': 'Spain', 'facility': '1200.131.03455 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'city': 'Pozuelo de Alarcón, Madrid', 'country': 'Spain', 'facility': '1200.131.03460 Boehringer Ingelheim Investigational Site'}, {'city': 'Seville', 'country': 'Spain', 'facility': '1200.131.03466 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'city': 'Zaragoza', 'country': 'Spain', 'facility': '1200.131.03458 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}, {'city': 'Gothenburg', 'country': 'Sweden', 'facility': '1200.131.04652 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': '1200.131.04651 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Basel', 'country': 'Switzerland', 'facility': '1200.131.04151 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'city': 'Bern', 'country': 'Switzerland', 'facility': '1200.131.04152 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'city': 'Kharkiv', 'country': 'Ukraine', 'facility': '1200.131.03854 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 49.98177, 'lon': 36.25475}}, {'city': 'Kiev', 'country': 'Ukraine', 'facility': '1200.131.03851 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'city': 'Denbighshire', 'country': 'United Kingdom', 'facility': '1200.131.04456 Boehringer Ingelheim Investigational Site'}, {'city': 'Edinburgh', 'country': 'United Kingdom', 'facility': '1200.131.04455 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'city': 'Exeter', 'country': 'United Kingdom', 'facility': '1200.131.04459 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 50.7236, 'lon': -3.52751}}, {'city': 'Glasgow', 'country': 'United Kingdom', 'facility': '1200.131.04460 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'city': 'Leicester', 'country': 'United Kingdom', 'facility': '1200.131.04453 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'city': 'London', 'country': 'United Kingdom', 'facility': '1200.131.04451 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Manchester', 'country': 'United Kingdom', 'facility': '1200.131.04452 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'city': 'Sheffield', 'country': 'United Kingdom', 'facility': '1200.131.04454 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'city': 'Sutton', 'country': 'United Kingdom', 'facility': '1200.131.04458 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 51.35, 'lon': -0.2}}, {'city': 'Whitchurch, Cardiff', 'country': 'United Kingdom', 'facility': '1200.131.04457 Boehringer Ingelheim Investigational Site'}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}