Viewing Study NCT00532493

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: 2025-12-25 @ 12:58 AM
Ignite Modification Date: 2026-01-06 @ 10:32 AM
Study NCT ID: NCT00532493
Status: COMPLETED
Last Update Posted: 2018-05-01
First Post: 2007-09-18
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Cooperative Studies Program #563 - Prazosin and Combat Trauma PTSD
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D020447', 'term': 'Parasomnias'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011224', 'term': 'Prazosin'}], 'ancestors': [{'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Murray.Raskind@va.gov', 'phone': '(206) 764-2702', 'title': 'Dr. Murray Rasknd', 'organization': 'VA Puget Sound Health Care System'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Prazosin Group', 'description': 'Subjects randomized to this arm will be on prazosin.\n\nprazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized "first dose" effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually.', 'otherNumAtRisk': 152, 'otherNumAffected': 142, 'seriousNumAtRisk': 152, 'seriousNumAffected': 18}, {'id': 'EG001', 'title': 'Placebo Group', 'description': 'Subjects randomized to this arm will be on placebo.\n\nplacebo: "sugar" pill', 'otherNumAtRisk': 152, 'otherNumAffected': 139, 'seriousNumAtRisk': 152, 'seriousNumAffected': 17}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Microcytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 37, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 27, 'numAffected': 24}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Arteriovenous malformation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Deafness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ear discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Motion sickness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abnormal sensation in eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Presbyopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Aphthous stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Food poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Glossodynia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Haemorrhagic erosive gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 61, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 56, 'numAffected': 41}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Peptic ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Adverse drug reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 93, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 92, 'numAffected': 64}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Drug ineffective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Drug withdrawal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Feeling abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Feeling jittery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Medical device complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 17, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 14, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Thirst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Unevaluable event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hepatic steatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Food allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Multiple allergies', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Acarodermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Campylobacter infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Enteritis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fungal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Furuncle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Lyme disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Parotitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Accident at home', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Animal bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthropod sting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac procedure complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Corneal abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Delayed recovery from anaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Endotracheal intubation complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tendon injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tooth injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Toxicity to various agents', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood thyroid stimulating hormone increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Colonoscopy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Electrocardiogram abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Endoscopy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Glycosylated haemoglobin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Helicobacter test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sputum culture positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'White blood cell count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Intervertebral disc degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Osteoporosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tenosynovitis stenosans', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Lipoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Melanocytic naevus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Neuroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Squamous cell carcinoma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Amnesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Basal ganglia infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Disturbance in attention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 107, 'numAffected': 73}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 106, 'numAffected': 63}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness postural', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 61, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 47, 'numAffected': 40}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Drooling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Head discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 71, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 78, 'numAffected': 65}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Memory impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Periodic limb movement disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Restless legs syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 64, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 61, 'numAffected': 48}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sudden onset of sleep', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'VIIth nerve paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Aggression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Alcoholic psychosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Anger', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bruxism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dependence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Depressed mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 34, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 44, 'numAffected': 38}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 17, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Flashback', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hallucination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 37, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 40, 'numAffected': 36}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Libido decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nightmare', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Panic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Somnambulism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Stress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Substance abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 27, 'numAffected': 23}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Violence-related symptom', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Micturition urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nocturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 39, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 34, 'numAffected': 30}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Stress urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Epididymitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Erection increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gynaecomastia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Priapism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 9, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 71, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 54, 'numAffected': 49}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pharyngeal oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pleuritic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sneezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dermatitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperkeratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ingrowing nail', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin odour abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Substance use', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chondroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Endodontic procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hip arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nerve block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Polypectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 14, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Arteriovenous malformation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Haemorrhagic erosive gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Drug withdrawal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Campylobacter infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthropod sting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Delayed recovery from anaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Endotracheal intubation complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Toxicity to various agents', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fracture malunion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Basal ganglia infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sudden onset of sleep', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Alcoholic psychosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Substance abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Violence-related symptom', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hip arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'CAPS Recurrent Distressing Dreams Item', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prazosin Group', 'description': 'Subjects randomized to this arm will be on prazosin.\n\nprazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized "first dose" effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects randomized to this arm will be on placebo.\n\nplacebo: "sugar" pill'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.9', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '2.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'This primary outcome measure was administered at baseline and week 10. The change of the 10-week from baseline was reported.', 'description': 'Change from baseline in frequency and/or severity of combat trauma-related nightmares will be assessed by the CAPS Recurrent Distressing Dreams item. Possible range for Recurrent Distressing Dreams is 0-8. Higher score indicates more severe PTSD symptoms.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '17 participants in the prazosin group have missing data on this item at week 10; 16 participants in the placebo group have missing data on this item at week 10'}, {'type': 'PRIMARY', 'title': 'Pittsburgh Sleep Quality Index (PSQI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prazosin', 'description': 'Subjects randomized to this arm will be on prazosin.\n\nprazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized "first dose" effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects randomized to this arm will be on placebo.\n\nplacebo: "sugar" pill'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.3', 'spread': '4.2', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'This primary outcome measure was administered at baseline and week 10. The change of the 10-week from baseline was reported.', 'description': 'Change from baseline in possible range for PSQI global score 0-21. Higher PSQI score indicates worse quality of sleep.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '17 participants in the prazosin group have missing data on this item at week 10; 16 participants in the placebo group have missing data on this item at week 10'}, {'type': 'SECONDARY', 'title': 'Pittsburgh Sleep Quality Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prazosin', 'description': 'Subjects randomized to this arm will be on prazosin.\n\nprazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized "first dose" effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects randomized to this arm will be on placebo.\n\nplacebo: "sugar" pill'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '14.4', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '14.7', 'spread': '3.5', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 6', 'categories': [{'measurements': [{'value': '-2.1', 'spread': '3.9', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '4.2', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 10', 'categories': [{'measurements': [{'value': '-2.3', 'spread': '4.2', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '4', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 14', 'categories': [{'measurements': [{'value': '-3.1', 'spread': '3.9', 'groupId': 'OG000'}, {'value': '-2.7', 'spread': '3.9', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 18', 'categories': [{'measurements': [{'value': '-2.4', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '-2.8', 'spread': '4', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 22', 'categories': [{'measurements': [{'value': '-2.9', 'spread': '4', 'groupId': 'OG000'}, {'value': '-2.7', 'spread': '4.2', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 26', 'categories': [{'measurements': [{'value': '-2.9', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '-2.7', 'spread': '4.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).', 'description': 'Change from baseline in possible range for PSQI global score 0-21. Higher PSQI score indicates worse quality of sleep.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks'}, {'type': 'SECONDARY', 'title': 'CAPS Recurrent Distressing Dreams Item', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prazosin Group', 'description': 'Subjects randomized to this arm will be on prazosin.\n\nprazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized "first dose" effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects randomized to this arm will be on placebo.\n\nplacebo: "sugar" pill'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '6.3', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '6.3', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 6', 'categories': [{'measurements': [{'value': '-1.3', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 10', 'categories': [{'measurements': [{'value': '-1.9', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '2.3', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 14', 'categories': [{'measurements': [{'value': '-2.2', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '2.5', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 18', 'categories': [{'measurements': [{'value': '-1.8', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '2.5', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 22', 'categories': [{'measurements': [{'value': '-2.4', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '2.4', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 26', 'categories': [{'measurements': [{'value': '-2.3', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '2.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination) to assess temporal course of changes in symptoms in response to prazosin or placebo.', 'description': 'Change from baseline in frequency and/or severity of combat trauma-related nightmares will be assessed by the CAPS Recurrent Distressing Dreams item. Possible range for Recurrent Distressing Dreams is 0-8. Higher score indicates more severe PTSD symptoms.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks'}, {'type': 'SECONDARY', 'title': 'Clinical Global Impression of Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prazosin', 'description': 'Subjects randomized to this arm will be on prazosin.\n\nprazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized "first dose" effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects randomized to this arm will be on placebo.\n\nplacebo: "sugar" pill'}], 'classes': [{'title': 'Week 6', 'categories': [{'measurements': [{'value': '3.2', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '3.3', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '1.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 14', 'categories': [{'measurements': [{'value': '3', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '3', 'spread': '1.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 18', 'categories': [{'measurements': [{'value': '3.2', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '3', 'spread': '1.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 22', 'categories': [{'measurements': [{'value': '2.9', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 26', 'categories': [{'measurements': [{'value': '2.9', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'This secondary outcome measure was administered at 6, 10, 14, 18, 22 and 26 weeks (or early termination).', 'description': 'Change from baseline in possible range for Clinical Global Impression of Change (CGIC) 1-7. As compared to baseline global condition, 1 is marked improvement, 2 is moderate improvement, 3 is minimal improvement, 4 is no change, 5 is minimal worsening, 6 is moderate worsening, and 7 is marked worsening.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks'}, {'type': 'SECONDARY', 'title': 'Total CAPS Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prazosin', 'description': 'Subjects randomized to this arm will be on prazosin.\n\nprazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized "first dose" effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects randomized to this arm will be on placebo.\n\nplacebo: "sugar" pill'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '80.7', 'spread': '15.5', 'groupId': 'OG000'}, {'value': '81.9', 'spread': '17.1', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 6', 'categories': [{'measurements': [{'value': '-9.9', 'spread': '16', 'groupId': 'OG000'}, {'value': '-9.1', 'spread': '16.9', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 10', 'categories': [{'measurements': [{'value': '-11.4', 'spread': '17.2', 'groupId': 'OG000'}, {'value': '-12.1', 'spread': '19.4', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 18', 'categories': [{'measurements': [{'value': '-11.6', 'spread': '18.3', 'groupId': 'OG000'}, {'value': '-17.2', 'spread': '21.7', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 26', 'categories': [{'measurements': [{'value': '-14.1', 'spread': '21.8', 'groupId': 'OG000'}, {'value': '-16.2', 'spread': '24.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'The total CAPS was administered at baseline, 6, 10, 18, and 26 weeks (or early termination).', 'description': 'Change from baseline in possible range for CAPS total score is 0-136. Higher score indicates more severe PTSD symptoms.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks'}, {'type': 'PRIMARY', 'title': 'Clinical Global Impression of Change (CGIC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prazosin', 'description': 'Subjects randomized to this arm will be on prazosin.\n\nprazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized "first dose" effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects randomized to this arm will be on placebo.\n\nplacebo: "sugar" pill'}], 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'This primary outcome measure was administered at baseline and week 10. The change of the 10-week from baseline was reported.', 'description': 'Change from baseline in possible range for Clinical Global Impression of Change 1-7. As compared to baseline global condition, 1 is marked improvement, 2 is moderate improvement, 3 is minimal improvement, 4 is no change, 5 is minimal worsening, 6 is moderate worsening, and 7 is marked worsening.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '17 participants in the prazosin group have missing data on this item at week 10; 16 participants in the placebo group have missing data on this item at week 10'}, {'type': 'SECONDARY', 'title': 'PTSD Checklist-Military Version (PCL-M) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prazosin', 'description': 'Subjects randomized to this arm will be on prazosin.\n\nprazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized "first dose" effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects randomized to this arm will be on placebo.\n\nplacebo: "sugar" pill'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '62.5', 'spread': '11.1', 'groupId': 'OG000'}, {'value': '64.3', 'spread': '12.2', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 6', 'categories': [{'measurements': [{'value': '-6.3', 'spread': '10.6', 'groupId': 'OG000'}, {'value': '-6.2', 'spread': '11', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 10', 'categories': [{'measurements': [{'value': '-7', 'spread': '12.7', 'groupId': 'OG000'}, {'value': '-5.8', 'spread': '11.6', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 14', 'categories': [{'measurements': [{'value': '-8.1', 'spread': '12.5', 'groupId': 'OG000'}, {'value': '-7.6', 'spread': '11.6', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 18', 'categories': [{'measurements': [{'value': '-7.2', 'spread': '12.3', 'groupId': 'OG000'}, {'value': '-8.4', 'spread': '13.3', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 22', 'categories': [{'measurements': [{'value': '-7.1', 'spread': '12.9', 'groupId': 'OG000'}, {'value': '-9.2', 'spread': '13.5', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 26', 'categories': [{'measurements': [{'value': '-8.2', 'spread': '13.8', 'groupId': 'OG000'}, {'value': '-9.7', 'spread': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'This secondary outcome was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks to assess change in PTSD symptom severity.', 'description': 'Change from baseline in possible range for PCL-M score 17-85. Higher PCL score indicates greater propensity for chronic and delayed PTSD.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks'}, {'type': 'SECONDARY', 'title': 'Patient Health Questionnaire-9 (PHQ9)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prazosin', 'description': 'Subjects randomized to this arm will be on prazosin.\n\nprazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized "first dose" effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects randomized to this arm will be on placebo.\n\nplacebo: "sugar" pill'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '13.7', 'spread': '5.9', 'groupId': 'OG000'}, {'value': '14.6', 'spread': '5.9', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 6', 'categories': [{'measurements': [{'value': '-1.6', 'spread': '4.7', 'groupId': 'OG000'}, {'value': '-2.8', 'spread': '5.1', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 10', 'categories': [{'measurements': [{'value': '-1.9', 'spread': '5.1', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '5.1', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 14', 'categories': [{'measurements': [{'value': '-1.9', 'spread': '5.2', 'groupId': 'OG000'}, {'value': '-2.6', 'spread': '5.3', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 18', 'categories': [{'measurements': [{'value': '-1.6', 'spread': '5.3', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '5.5', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 22', 'categories': [{'measurements': [{'value': '-2.2', 'spread': '5.6', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '5.9', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 26', 'categories': [{'measurements': [{'value': '-2', 'spread': '5.5', 'groupId': 'OG000'}, {'value': '-2.8', 'spread': '5.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).', 'description': 'Change from baseline in possible range for PHQ9 score is 0-27. Higher PHQ9 score indicates more severe depression.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks'}, {'type': 'SECONDARY', 'title': 'SF-12 Physical Standardized Score (SF-12 PCS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prazosin', 'description': 'Subjects randomized to this arm will be on prazosin.\n\nprazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized "first dose" effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects randomized to this arm will be on placebo.\n\nplacebo: "sugar" pill'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '35.4', 'spread': '14.5', 'groupId': 'OG000'}, {'value': '34.2', 'spread': '12.2', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 6', 'categories': [{'measurements': [{'value': '1.8', 'spread': '9.7', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '10.2', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 10', 'categories': [{'measurements': [{'value': '0.3', 'spread': '10', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '10.4', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 14', 'categories': [{'measurements': [{'value': '1.4', 'spread': '10.1', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '10.9', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 18', 'categories': [{'measurements': [{'value': '0.5', 'spread': '10', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '11.4', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 22', 'categories': [{'measurements': [{'value': '1.1', 'spread': '10.9', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '13.2', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 26', 'categories': [{'measurements': [{'value': '0.7', 'spread': '11.8', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '11.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).', 'description': 'Change from baseline in possible range for SF-12 PCS is 6-72. Higher SF-12 score indicates better level of health.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks'}, {'type': 'SECONDARY', 'title': 'SF-12 Mental Standardized Score (SF-12 MCS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prazosin', 'description': 'Subjects randomized to this arm will be on prazosin.\n\nprazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized "first dose" effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects randomized to this arm will be on placebo.\n\nplacebo: "sugar" pill'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '38.2', 'spread': '9.1', 'groupId': 'OG000'}, {'value': '39.4', 'spread': '8.4', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 6', 'categories': [{'measurements': [{'value': '-2', 'spread': '9.2', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '8.5', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 10', 'categories': [{'measurements': [{'value': '-1', 'spread': '9.2', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '8.7', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 14', 'categories': [{'measurements': [{'value': '-1.5', 'spread': '7.9', 'groupId': 'OG000'}, {'value': '-1', 'spread': '9.7', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 18', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '8.4', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '8.8', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 22', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '8.9', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '9.4', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 26', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '8.7', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '9.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).', 'description': 'Change from baseline in possible range for SF-12 MCS is 5-76. Higher SF-12 score indicates better level of health.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks'}, {'type': 'SECONDARY', 'title': 'Quality of Life Inventory (QOLI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prazosin', 'description': 'Subjects randomized to this arm will be on prazosin.\n\nprazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized "first dose" effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects randomized to this arm will be on placebo.\n\nplacebo: "sugar" pill'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.1', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '0', 'spread': '1.9', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 6', 'categories': [{'measurements': [{'value': '0.1', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '0', 'spread': '1.4', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 10', 'categories': [{'measurements': [{'value': '0', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 14', 'categories': [{'measurements': [{'value': '0.1', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '0', 'spread': '1.5', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 18', 'categories': [{'measurements': [{'value': '0.3', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '1.6', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 22', 'categories': [{'measurements': [{'value': '0.1', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '1.9', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 26', 'categories': [{'measurements': [{'value': '0.2', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).', 'description': 'Change from baseline in possible range for QOLI is -6 to 6. Higher QOLI indicates better satisfaction with life.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks'}, {'type': 'SECONDARY', 'title': 'Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prazosin', 'description': 'Subjects randomized to this arm will be on prazosin.\n\nprazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized "first dose" effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects randomized to this arm will be on placebo.\n\nplacebo: "sugar" pill'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '2.6', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 6', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 10', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 14', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '2.2', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 18', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '1.9', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 22', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '2.1', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 26', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '1.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).', 'description': 'Change from baseline in possible range for Audit-C score is 0-12. Higher score indicates heavier use of alcohol. A score of \\>=4 for male and a score of \\>=3 for female meets the criteria for alcohol use disorders.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Prazosin Group', 'description': 'Subjects randomized to this arm will be on prazosin.\n\nprazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized "first dose" effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually.'}, {'id': 'FG001', 'title': 'Placebo Group', 'description': 'Subjects randomized to this arm will be on placebo.\n\nplacebo: "sugar" pill'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '152'}, {'groupId': 'FG001', 'numSubjects': '152'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '122'}, {'groupId': 'FG001', 'numSubjects': '123'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '29'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Subject Moved Away', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Contraindicative Medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '304', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Prazosin Group', 'description': 'Subjects randomized to this arm will be on prazosin.\n\nprazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized "first dose" effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually.'}, {'id': 'BG001', 'title': 'Placebo Group', 'description': 'Subjects randomized to this arm will be on placebo.\n\nplacebo: "sugar" pill'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.3', 'spread': '13.8', 'groupId': 'BG000'}, {'value': '51.4', 'spread': '13.8', 'groupId': 'BG001'}, {'value': '51.8', 'spread': '13.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '146', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '297', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '192', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Highest Educational Level', 'classes': [{'title': 'Grade School or Less', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Some High School', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'High School/GED', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}, {'title': 'Some College/Ass.Degree/Tech.School', 'categories': [{'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '156', 'groupId': 'BG002'}]}]}, {'title': 'College Graduate', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}, {'title': 'Post Graduate/Professional Degree', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Did Not Answer', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Marital Status', 'classes': [{'title': 'Single', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}, {'title': 'Married', 'categories': [{'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '171', 'groupId': 'BG002'}]}]}, {'title': 'Living Together in a Relationship', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Separated', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Divorced', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}]}, {'title': 'Widowed', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Did Not Answer', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Major Depression', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '189', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Maintained on any Antidepressant', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '119', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '236', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Maintained on Selective Serotonin Re-uptake Inhibitors (SSRI)', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '113', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '226', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'PTSD clinicians ascertain interest and eligibility among their patients with nightmare. Informed consent obtained; screening assessments to determine eligibility'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 304}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2013-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-30', 'studyFirstSubmitDate': '2007-09-18', 'resultsFirstSubmitDate': '2014-04-02', 'studyFirstSubmitQcDate': '2007-09-19', 'lastUpdatePostDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-05-19', 'studyFirstPostDateStruct': {'date': '2007-09-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CAPS Recurrent Distressing Dreams Item', 'timeFrame': 'This primary outcome measure was administered at baseline and week 10. The change of the 10-week from baseline was reported.', 'description': 'Change from baseline in frequency and/or severity of combat trauma-related nightmares will be assessed by the CAPS Recurrent Distressing Dreams item. Possible range for Recurrent Distressing Dreams is 0-8. Higher score indicates more severe PTSD symptoms.'}, {'measure': 'Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': 'This primary outcome measure was administered at baseline and week 10. The change of the 10-week from baseline was reported.', 'description': 'Change from baseline in possible range for PSQI global score 0-21. Higher PSQI score indicates worse quality of sleep.'}, {'measure': 'Clinical Global Impression of Change (CGIC)', 'timeFrame': 'This primary outcome measure was administered at baseline and week 10. The change of the 10-week from baseline was reported.', 'description': 'Change from baseline in possible range for Clinical Global Impression of Change 1-7. As compared to baseline global condition, 1 is marked improvement, 2 is moderate improvement, 3 is minimal improvement, 4 is no change, 5 is minimal worsening, 6 is moderate worsening, and 7 is marked worsening.'}], 'secondaryOutcomes': [{'measure': 'Pittsburgh Sleep Quality Index', 'timeFrame': 'This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).', 'description': 'Change from baseline in possible range for PSQI global score 0-21. Higher PSQI score indicates worse quality of sleep.'}, {'measure': 'CAPS Recurrent Distressing Dreams Item', 'timeFrame': 'This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination) to assess temporal course of changes in symptoms in response to prazosin or placebo.', 'description': 'Change from baseline in frequency and/or severity of combat trauma-related nightmares will be assessed by the CAPS Recurrent Distressing Dreams item. Possible range for Recurrent Distressing Dreams is 0-8. Higher score indicates more severe PTSD symptoms.'}, {'measure': 'Clinical Global Impression of Change', 'timeFrame': 'This secondary outcome measure was administered at 6, 10, 14, 18, 22 and 26 weeks (or early termination).', 'description': 'Change from baseline in possible range for Clinical Global Impression of Change (CGIC) 1-7. As compared to baseline global condition, 1 is marked improvement, 2 is moderate improvement, 3 is minimal improvement, 4 is no change, 5 is minimal worsening, 6 is moderate worsening, and 7 is marked worsening.'}, {'measure': 'Total CAPS Score', 'timeFrame': 'The total CAPS was administered at baseline, 6, 10, 18, and 26 weeks (or early termination).', 'description': 'Change from baseline in possible range for CAPS total score is 0-136. Higher score indicates more severe PTSD symptoms.'}, {'measure': 'PTSD Checklist-Military Version (PCL-M) Score', 'timeFrame': 'This secondary outcome was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks to assess change in PTSD symptom severity.', 'description': 'Change from baseline in possible range for PCL-M score 17-85. Higher PCL score indicates greater propensity for chronic and delayed PTSD.'}, {'measure': 'Patient Health Questionnaire-9 (PHQ9)', 'timeFrame': 'This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).', 'description': 'Change from baseline in possible range for PHQ9 score is 0-27. Higher PHQ9 score indicates more severe depression.'}, {'measure': 'SF-12 Physical Standardized Score (SF-12 PCS)', 'timeFrame': 'This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).', 'description': 'Change from baseline in possible range for SF-12 PCS is 6-72. Higher SF-12 score indicates better level of health.'}, {'measure': 'SF-12 Mental Standardized Score (SF-12 MCS)', 'timeFrame': 'This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).', 'description': 'Change from baseline in possible range for SF-12 MCS is 5-76. Higher SF-12 score indicates better level of health.'}, {'measure': 'Quality of Life Inventory (QOLI)', 'timeFrame': 'This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).', 'description': 'Change from baseline in possible range for QOLI is -6 to 6. Higher QOLI indicates better satisfaction with life.'}, {'measure': 'Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)', 'timeFrame': 'This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).', 'description': 'Change from baseline in possible range for Audit-C score is 0-12. Higher score indicates heavier use of alcohol. A score of \\>=4 for male and a score of \\>=3 for female meets the criteria for alcohol use disorders.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Combat Trauma', 'Post traumatic stress disorder', 'PTSD', 'Sleep Disturbance', 'Trauma-Related Nightmares'], 'conditions': ['PTSD', 'Sleep Disorders']}, 'referencesModule': {'references': [{'pmid': '29414272', 'type': 'RESULT', 'citation': 'Raskind MA, Peskind ER, Chow B, Harris C, Davis-Karim A, Holmes HA, Hart KL, McFall M, Mellman TA, Reist C, Romesser J, Rosenheck R, Shih MC, Stein MB, Swift R, Gleason T, Lu Y, Huang GD. Trial of Prazosin for Post-Traumatic Stress Disorder in Military Veterans. N Engl J Med. 2018 Feb 8;378(6):507-517. doi: 10.1056/NEJMoa1507598.'}]}, 'descriptionModule': {'briefSummary': 'Background: Posttraumatic stress disorder (PTSD) is a debilitating and disabling mental disorder that afflicts at least 25% of Veterans who have suffered life-threatening war zone trauma. Trauma-related nightmares and sleep disturbance are among the most treatment-resistant PTSD symptoms in Veterans. Increased responsiveness to central nervous system (CNS) norepinephrine (NE) contributes to the pathophysiology of overall PTSD and treatment-resistant nighttime symptoms. Placebo-controlled pilot studies demonstrate that the generically available CNS-active alpha-1 adrenoreceptor antagonist prazosin substantially reduces PTSD trauma nightmares and sleep disturbance and improves global clinical status (sense of well being and ability to function) in Veterans.\n\nObjective: The primary objective is to demonstrate in a large multi-site placebo-controlled trial in Veterans with war zone trauma-induced PTSD that prazosin is efficacious for PTSD trauma nightmares, sleep disturbance, and global clinical status. A secondary objective is to demonstrate prazosin effectiveness for these outcome measures during clinically meaningful long-term (26 week) maintenance treatment of PTSD. The investigators will also address prazosin efficacy and long-term effectiveness for improving total PTSD symptoms, comorbid depression, quality of life, and physical functioning.\n\nMethods: This 26 week randomized double-blind placebo-controlled study is designed to demonstrate both short term efficacy and long term effectiveness of prazosin for PTSD. The research design encompasses a shorter-term, more tightly controlled efficacy component and a longer-term, more .real world. effectiveness component. Three hundred twenty-six Veterans with war zone -related PTSD and persistent trauma nightmares will be randomized 1:1 to prazosin or placebo. Study drug will be increased using a flexible dose titration schedule based on clinical response and adverse effects to an optimum maintenance dose (1-20 mg/day). During the first 10 weeks of the study, participants will be randomized to prazosin or placebo. Previous psychotropic medications and/or psychotherapy will be maintained constant. Short term efficacy will be determined during the first 10 weeks. During the remaining 16 weeks of the 26 week trial, subjects will continue to receive stable-dose double-blind prazosin or placebo, but will have the option to receive additional psychotropic medications and/or psychotherapeutic interventions, as needed, per the judgment of the study Clinician Prescriber. It is hypothesized that prazosin will remain more clinically effective than placebo at the end of the 26-week trial, demonstrating that prazosin adds benefit over-and-above other treatments that are naturalistically administered by providers in a .real world. clinical setting.\n\nPrazosin will be judged efficacious at 10 weeks if superior to placebo on all three primary outcome measures assessing trauma nightmares, sleep disturbance, and global clinical status: the Recurrent Distressing Dreams item of the Clinician Administered PTSD Scale (CAPS), the Pittsburgh Sleep Quality Index (PSQI), and the Clinical Global Impression of Change (CGIC). Secondary outcome measures will assess prazosin effects on total PTSD symptoms, depression, physical functioning, and quality of life. Adverse effects and cardiovascular measures, including supine and standing blood pressure (BP) and heart rate (HR) will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age \\>18 years.\n* Exposure to one or more life-threatening war zone trauma events per the Combat\n* Exposure Scale \\[78\\] and documented by Department of Defense (DD) Form 214, Combat Action Ribbon (Marines), Combat Infantry Badge (Army), or other clear evidence of war zone trauma exposure.\n* Eligible for VA health care.\n* Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV diagnosis of PTSD derived from the CAPS.\n* CAPS total score \\>50.\n* CAPS Recurrent Distressing Dreams item score \\>5 (of maximum score of 8).\n* Capable of giving informed consent.\n* Stable dose of non-exclusionary (see below) medications for at least 4 weeks prior to randomization.\n* Psychotherapeutic treatment stable for at least 4 weeks prior to randomization.\n* Good general medical health (see Medical Exclusion Criteria below).\n* Female participants must agree to use a reliable form of birth control during the study.\n\nExclusion Criteria:\n\nMedical:\n\n* Acute or unstable chronic medical illness, including unstable angina, recent myocardial infarction (within 6 months), congestive heart failure, preexisting hypotension (systolic \\<110) or orthostatic hypotension (systolic drop \\> 20 millimeters of mercury after two minutes standing or any drop accompanied by dizziness); chronic renal or hepatic failure, pancreatitis, Meniere's disease, benign positional vertigo; narcolepsy.\n* Untreated sleep apnea, diagnosed by a sleep study, is exclusionary. Treated sleep apnea (e.g., Continuous Positive Airway Pressure, surgery) will not be exclusionary.\n* Allergy or previous adverse reaction to prazosin or other alpha-1 antagonist.\n* Wounds requiring surgery, embedded shrapnel, and recent surgical amputation do not comprise an exclusion if the individual is otherwise medically eligible.\n* Women of childbearing potential with positive pregnancy test or refusal to use effective birth control method, or who are breastfeeding will be excluded.\n\nPsychiatric/Behavioral:\n\n* Meets DSM-IV criteria for current schizophrenia, schizoaffective disorder, psychotic disorder not otherwise specified (NOS), delirium, or any DSM-IV cognitive disorder.\n* Exclusion for psychotic disorder is not to be confused with combat trauma-induced reexperiencing symptoms (transient dissociative states or flashbacks), which will not be exclusionary.\n* Substance dependence disorder within 3 months or any current substance dependence (stable methadone maintenance will not be exclusionary).\n* Current cocaine or stimulant abuse.\n* Severe psychiatric instability or severe situational life crises, including evidence of being actively suicidal or homicidal, or any behavior which poses an immediate danger to patient or others.\n* Nonsuicidal depression comorbid with PTSD will not be exclusionary (see below).\n\nMedications/Therapies:\n\n* Current use of prazosin or other alpha-1 antagonist.\n* Previous adequate trial of prazosin for PTSD.\n* Subjects on trazodone will undergo a 2-week washout period before baseline assessment. (Combining prazosin and trazodone may increase risk of priapism).\n* Sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra) will be not be permitted during the study dose titration period because of increased risk of hypotension in combination with alpha-1 blockers. Following achieving stable dose of study drug, sildenafil, tadalafil, and vardenafil will be permitted at 1/2 the usual starting dose.\n* Stimulants or alternative medications with stimulant properties (e.g., ephedra).\n* Recent exposure therapy and/or Eye Movement Desensitization and Reprogramming (EMDR). These therapies must have been completed \\> 4 weeks before randomization.\n* Other psychotropic medications and/or maintenance psychotherapy at a stable dose for at least 4 weeks will not be exclusionary."}, 'identificationModule': {'nctId': 'NCT00532493', 'acronym': 'PACT', 'briefTitle': 'Cooperative Studies Program #563 - Prazosin and Combat Trauma PTSD', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'CSP #563 - Prazosin and Combat Trauma PTSD (PACT)', 'orgStudyIdInfo': {'id': '563'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Prazosin Group', 'description': 'Subjects randomized to this arm will be on prazosin.', 'interventionNames': ['Drug: prazosin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'description': 'Subjects randomized to this arm will be on placebo.', 'interventionNames': ['Other: placebo']}], 'interventions': [{'name': 'prazosin', 'type': 'DRUG', 'description': 'Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized "first dose" effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually.', 'armGroupLabels': ['Prazosin Group']}, {'name': 'placebo', 'type': 'OTHER', 'description': '"sugar" pill', 'armGroupLabels': ['Placebo Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92357', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'VA Medical Center, Loma Linda', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '90822', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'VA Medical Center, Long Beach', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '94304-1290', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'VA Palo Alto Health Care System', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '33125', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'VA Medical Center, Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '30033', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta VA Medical and Rehab Center, Decatur', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '64128', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'VA Medical Center, Kansas City MO', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '87108-5153', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'New Mexico VA Health Care System, Albuquerque', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '10010', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Harbor HCS', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'VA Medical Center, Durham', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '28144', 'city': 'Salisbury', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Salisbury VAMC', 'geoPoint': {'lat': 35.67097, 'lon': -80.47423}}, {'zip': '02908', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'VA Medical Center, Providence', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '29209', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'WJB Dorn Veterans Hospital, Columbia', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'zip': '84148', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'VA Salt Lake City Health Care System, Salt Lake City', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '98108', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'VA Puget Sound Health Care System Seattle Division, Seattle, WA', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53705', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Wlliam S. Middleton Memorial Veterans Hospital, Madison', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Murray A. Raskind, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'VA Puget Sound Health Care System Seattle Division, Seattle, WA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}