Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-27 @ 11:02 PM
Study NCT ID:
NCT00784134
Status:
COMPLETED
Last Update Posted:
2018-12-05
First Post:
2008-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III
Sponsor:
Organization:
Raw JSON
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Hanley', 'organization': 'Johns Hopkins University Division of Brain Injury Outcomes'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '180 days since symptom onset', 'eventGroups': [{'id': 'EG000', 'title': 'Alteplase', 'description': 'Administration of alteplase via the intraventricular catheter\n\nAlteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses', 'otherNumAtRisk': 249, 'otherNumAffected': 165, 'seriousNumAtRisk': 249, 'seriousNumAffected': 114}, {'id': 'EG001', 'title': 'Saline Placebo', 'description': '1 ml of normal saline administered via the intraventricular catheter\n\nNormal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses', 'otherNumAtRisk': 251, 'otherNumAffected': 178, 'seriousNumAtRisk': 251, 'seriousNumAffected': 151}], 'otherEvents': [{'term': 'Bacteremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 20, 'numAffected': 20}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Depressed level of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 76, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 74, 'numAffected': 67}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hydrocephalus, communicating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 24, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 33, 'numAffected': 33}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Intracranial hemorrhage: Catheter Tract, New', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 37, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 47, 'numAffected': 39}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Intracranial hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 53, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 50, 'numAffected': 42}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 41, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 53, 'numAffected': 53}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 20, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 38, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 23, 'numAffected': 23}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'seriousEvents': [{'term': 'Abdominal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Acute renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Adult respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Allergic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Altered mental status', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Anoxic brain damage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Anoxic brain injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Aphasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Asystole', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Bacteremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Brain and catheter related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Brainstorming/autonomic dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Bronchial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'COPD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cerebrospinal fluid leakage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cerebrovascular death (brain death)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cerebrovascular death (brain death)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Chest wall pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cognitive disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Colonic perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Congestive heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Death due to index bleeding event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Death due to index bleeding event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 21, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Depressed level of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Diabetes mellitus, Type I', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Diencephalic storming', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Duodenal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Edema cerebral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Esophageal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Extensor posturing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Gastric hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Gastrointestinal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Gastroparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 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1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Ventriculitis, bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Ventriculitis, bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Ventriculitis, non-bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Ventriculitis, non-bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Wound infection, non-neurologic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Participants With Modified Rankin Scale (mRS) <=3 - Dichotomized Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '245', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alteplase', 'description': 'Administration of alteplase via the intraventricular catheter\n\nAlteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}, {'id': 'OG001', 'title': 'Saline Placebo', 'description': '1 ml of normal saline administered via the intraventricular catheter\n\nNormal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}], 'classes': [{'categories': [{'measurements': [{'value': '47.6', 'groupId': 'OG000'}, {'value': '44.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.554', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.027', 'ciLowerLimit': '-0.062', 'ciUpperLimit': '0.115', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.465', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.18', 'ciLowerLimit': '0.75', 'ciUpperLimit': '1.87', 'pValueComment': 'Multivariable logit model adjusted for age, GCS, thalamus, stability ICH volume and stability IVH volume.', 'statisticalMethod': 'Multivariable Logit Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '180 days', 'description': 'Analysis modified on September 29, 2015 to account for adaptive randomization. The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All the non-missing mRS scores at 180 days were analyzed.'}, {'type': 'PRIMARY', 'title': 'Participant Score on the Modified Rankin Scale (mRS) - Ordinal Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '245', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alteplase', 'description': 'Administration of alteplase via the intraventricular catheter\n\nAlteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}, {'id': 'OG001', 'title': 'Saline Placebo', 'description': '1 ml of normal saline administered via the intraventricular catheter\n\nNormal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '5'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '6'}]}]}], 'analyses': [{'pValue': '0.484', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.89', 'ciLowerLimit': '0.63', 'ciUpperLimit': '1.25', 'pValueComment': 'Generalized ordered logit model adjusted for age, GCS, thalamus, stability ICH volume and stability IVH volume (categorical) compares odds ratio for mRS score \\> K v. \\<= K for K = 1 - 4; Alt v. Sal.', 'statisticalMethod': 'Generalized ordered Logit Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.44', 'ciLowerLimit': '0.28', 'ciUpperLimit': '0.71', 'pValueComment': 'The same generalized ordered logit model, adjusting for age, GCS, thalamus, stability ICH volume and stability IVH volume (categorical), compares odds ratio for mRS score greater than 5 versus mRS score equal or less than 5 (dead versus alive).', 'statisticalMethod': 'Generalized ordered Logit Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': '180 days', 'description': 'The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).', 'unitOfMeasure': 'mRS score', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All the non-missing mRS scores at 180 days were analyzed.'}, {'type': 'PRIMARY', 'title': 'Participants With Modified Rankin Scale (mRS) <=4 - Dichotomized Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '245', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alteplase', 'description': 'Administration of alteplase via the intraventricular catheter\n\nAlteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}, {'id': 'OG001', 'title': 'Saline Placebo', 'description': '1 ml of normal saline administered via the intraventricular catheter\n\nNormal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}], 'classes': [{'categories': [{'measurements': [{'value': '64.2', 'groupId': 'OG000'}, {'value': '61.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.552', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.026', 'ciLowerLimit': '-0.059', 'ciUpperLimit': '0.111', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.350', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.23', 'ciLowerLimit': '0.80', 'ciUpperLimit': '1.90', 'pValueComment': 'Multivariable logit model adjusting for age, GCS, thalamus, stability ICH volume and stability IVH volume (categorical).', 'statisticalMethod': 'Multivariable Logit Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '180 days', 'description': 'The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All the non-missing mRS scores at 180 days were analyzed.'}, {'type': 'PRIMARY', 'title': 'Random Effects Assessment of Site Effect on Modified Rankin Scale (mRS) <= 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '245', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alteplase', 'description': 'Administration of alteplase via the intraventricular catheter\n\nAlteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}, {'id': 'OG001', 'title': 'Saline Placebo', 'description': '1 ml of normal saline administered via the intraventricular catheter\n\nNormal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}], 'classes': [{'categories': [{'measurements': [{'value': '47.6', 'groupId': 'OG000'}, {'value': '44.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.428', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.18', 'ciLowerLimit': '0.78', 'ciUpperLimit': '1.80', 'pValueComment': 'Random effects model with site as random effect adjusted for age, GCS, thalamus, stability ICH volume and stability IVH volume (categorical).', 'statisticalMethod': 'Random Effects Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '180 days', 'description': 'The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All the non-missing mRS scores at 180 days were analyzed.'}, {'type': 'PRIMARY', 'title': 'Longitudinal Assessment of Participants With Modified Rankin Scale (mRS) <=3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alteplase', 'description': 'Administration of alteplase via the intraventricular catheter\n\nAlteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}, {'id': 'OG001', 'title': 'Saline Placebo', 'description': '1 ml of normal saline administered via the intraventricular catheter\n\nNormal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}], 'classes': [{'title': 'Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '245', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.4', 'groupId': 'OG000'}, {'value': '16.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '245', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.0', 'groupId': 'OG000'}, {'value': '45.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.384', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.26', 'ciLowerLimit': '0.75', 'ciUpperLimit': '2.10', 'groupDescription': 'Logit mRS scores 0-3 at 30 days', 'statisticalMethod': 'Generalized Estimating Equation Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Generalized estimating equation model adjusting for age, GCS, thalamus, stability ICH volume and stability IVH volume (categorical).'}, {'pValue': '0.964', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.62', 'ciUpperLimit': '1.64', 'groupDescription': 'Logit mRS scores 0-3 at 180 days', 'statisticalMethod': 'Generalized Estimating Equation Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Generalized estimating equation model adjusting for age, GCS, thalamus, stability ICH volume and stability IVH volume (categorical).'}], 'paramType': 'NUMBER', 'timeFrame': '30 days and 180 days', 'description': 'Comparing longitudinal modified Rankin Scale (mRS) scores 0-3 at Day 30 and Day 180. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All the non-missing mRS scores at 30 days and 180 days were analyzed.'}, {'type': 'SECONDARY', 'title': 'All Cause Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '251', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alteplase', 'description': 'Administration of alteplase via the intraventricular catheter\n\nAlteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}, {'id': 'OG001', 'title': 'Saline Placebo', 'description': '1 ml of normal saline administered via the intraventricular catheter\n\nNormal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}], 'classes': [{'categories': [{'measurements': [{'value': '18.5', 'groupId': 'OG000'}, {'value': '29.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0056', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '180 days', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients that were enrolled in CLEAR III were analyzed.'}, {'type': 'SECONDARY', 'title': 'Clot Removal (Amount of Residual Blood)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '251', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alteplase', 'description': 'Administration of alteplase via the intraventricular catheter\n\nAlteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}, {'id': 'OG001', 'title': 'Saline Placebo', 'description': '1 ml of normal saline administered via the intraventricular catheter\n\nNormal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}], 'classes': [{'categories': [{'measurements': [{'value': '0.96', 'groupId': 'OG000'}, {'value': '0.97', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'AUC/ Logit Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '72 hours', 'description': 'Change in blood volume measured between stability scan and end of treatment scan', 'unitOfMeasure': 'odds ratio per time-weighted ml', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients that were enrolled in CLEAR III were analyzed.'}, {'type': 'SECONDARY', 'title': 'Intensity of Critical Care Management - Hospital Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '251', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alteplase', 'description': 'Administration of alteplase via the intraventricular catheter\n\nAlteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}, {'id': 'OG001', 'title': 'Saline Placebo', 'description': '1 ml of normal saline administered via the intraventricular catheter\n\nNormal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000', 'lowerLimit': '17', 'upperLimit': '31'}, {'value': '24', 'groupId': 'OG001', 'lowerLimit': '16', 'upperLimit': '31'}]}]}], 'analyses': [{'pValue': '0.771', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': '30 days', 'description': 'Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP \\>20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.', 'unitOfMeasure': 'Number of days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients that were enrolled in CLEAR III were analyzed.'}, {'type': 'SECONDARY', 'title': 'Intensity of Critical Care Management - ICU Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '251', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alteplase', 'description': 'Administration of alteplase via the intraventricular catheter\n\nAlteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}, {'id': 'OG001', 'title': 'Saline Placebo', 'description': '1 ml of normal saline administered via the intraventricular catheter\n\nNormal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '21'}, {'value': '15', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '22'}]}]}], 'analyses': [{'pValue': '0.098', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': '30 days', 'description': 'Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP \\>20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.', 'unitOfMeasure': 'Number of days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients that were enrolled in CLEAR III were analyzed.'}, {'type': 'SECONDARY', 'title': 'Intensity of Critical Care Management - ICP Management', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '251', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alteplase', 'description': 'Administration of alteplase via the intraventricular catheter\n\nAlteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}, {'id': 'OG001', 'title': 'Saline Placebo', 'description': '1 ml of normal saline administered via the intraventricular catheter\n\nNormal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}], 'classes': [{'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000'}, {'value': '10.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.450', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Generalized Linear Models', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP \\>20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.', 'unitOfMeasure': 'Percentage of events of ICP >20mmHg', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients that were enrolled in CLEAR III were analyzed.'}, {'type': 'SECONDARY', 'title': 'Intensity of Critical Care Management - Mechanical Ventilation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '251', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alteplase', 'description': 'Administration of alteplase via the intraventricular catheter\n\nAlteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}, {'id': 'OG001', 'title': 'Saline Placebo', 'description': '1 ml of normal saline administered via the intraventricular catheter\n\nNormal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}], 'classes': [{'categories': [{'measurements': [{'value': '73.9', 'groupId': 'OG000'}, {'value': '76.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.501', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP \\>20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.', 'unitOfMeasure': '% of participants with ventilation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients that were enrolled in CLEAR III were analyzed.'}, {'type': 'SECONDARY', 'title': 'Intensity of Critical Care Management - Pressors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '251', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alteplase', 'description': 'Administration of alteplase via the intraventricular catheter\n\nAlteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}, {'id': 'OG001', 'title': 'Saline Placebo', 'description': '1 ml of normal saline administered via the intraventricular catheter\n\nNormal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}], 'classes': [{'categories': [{'measurements': [{'value': '24.1', 'groupId': 'OG000'}, {'value': '25.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.795', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP \\>20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.', 'unitOfMeasure': '% of participants with pressors', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients that were enrolled in CLEAR III were analyzed.'}, {'type': 'SECONDARY', 'title': 'Intensity of Critical Care Management - Shunts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '251', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alteplase', 'description': 'Administration of alteplase via the intraventricular catheter\n\nAlteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}, {'id': 'OG001', 'title': 'Saline Placebo', 'description': '1 ml of normal saline administered via the intraventricular catheter\n\nNormal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}], 'classes': [{'categories': [{'measurements': [{'value': '18.5', 'groupId': 'OG000'}, {'value': '17.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.784', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP \\>20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.', 'unitOfMeasure': '% of participants with shunts', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients that were enrolled in CLEAR III were analyzed.'}, {'type': 'SECONDARY', 'title': 'Intensity of Critical Care Management - All Infections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '251', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alteplase', 'description': 'Administration of alteplase via the intraventricular catheter\n\nAlteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}, {'id': 'OG001', 'title': 'Saline Placebo', 'description': '1 ml of normal saline administered via the intraventricular catheter\n\nNormal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}], 'classes': [{'categories': [{'measurements': [{'value': '48.2', 'groupId': 'OG000'}, {'value': '50.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.592', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP \\>20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.', 'unitOfMeasure': '% of participants with infections', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients that were enrolled in CLEAR III were analyzed.'}, {'type': 'SECONDARY', 'title': 'Intensity of Critical Care Management - Pneumonia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '251', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alteplase', 'description': 'Administration of alteplase via the intraventricular catheter\n\nAlteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}, {'id': 'OG001', 'title': 'Saline Placebo', 'description': '1 ml of normal saline administered via the intraventricular catheter\n\nNormal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}], 'classes': [{'categories': [{'measurements': [{'value': '26.1', 'groupId': 'OG000'}, {'value': '32.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.105', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP \\>20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.', 'unitOfMeasure': '% of participants with pneumonia', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients that were enrolled in CLEAR III were analyzed.'}, {'type': 'SECONDARY', 'title': 'Intensity of Critical Care Management - All Infections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '251', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alteplase', 'description': 'Administration of alteplase via the intraventricular catheter\n\nAlteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}, {'id': 'OG001', 'title': 'Saline Placebo', 'description': '1 ml of normal saline administered via the intraventricular catheter\n\nNormal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}], 'classes': [{'categories': [{'measurements': [{'value': '49.8', 'groupId': 'OG000'}, {'value': '56.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.152', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '180 days', 'description': 'Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP \\>20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.', 'unitOfMeasure': '% of participants with infections', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients that were enrolled in CLEAR III were analyzed.'}, {'type': 'SECONDARY', 'title': 'Safety/Mortality - Mortality Within 30 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '251', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alteplase', 'description': 'Administration of alteplase via the intraventricular catheter\n\nAlteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}, {'id': 'OG001', 'title': 'Saline Placebo', 'description': '1 ml of normal saline administered via the intraventricular catheter\n\nNormal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}], 'classes': [{'categories': [{'measurements': [{'value': '8.8', 'groupId': 'OG000'}, {'value': '14.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.055', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.055', 'ciLowerLimit': '-0.111', 'ciUpperLimit': '0.008', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality.', 'unitOfMeasure': 'Percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients that were enrolled in CLEAR III were analyzed.'}, {'type': 'SECONDARY', 'title': 'Safety/Mortality - Bacterial Brain Infections Within 30 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '251', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alteplase', 'description': 'Administration of alteplase via the intraventricular catheter\n\nAlteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}, {'id': 'OG001', 'title': 'Saline Placebo', 'description': '1 ml of normal saline administered via the intraventricular catheter\n\nNormal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}], 'classes': [{'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000'}, {'value': '10.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.202', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.035', 'ciLowerLimit': '-0.084', 'ciUpperLimit': '0.014', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality.', 'unitOfMeasure': '% of participants with brain infection', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients that were enrolled in CLEAR III were analyzed.'}, {'type': 'SECONDARY', 'title': 'Safety/Mortality - Systematic Bleeds Within 72 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '251', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alteplase', 'description': 'Administration of alteplase via the intraventricular catheter\n\nAlteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}, {'id': 'OG001', 'title': 'Saline Placebo', 'description': '1 ml of normal saline administered via the intraventricular catheter\n\nNormal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.771', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.004', 'ciLowerLimit': '-0.022', 'ciUpperLimit': '0.030', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '72 hours', 'description': 'Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality.', 'unitOfMeasure': '% of participants with systematic bleeds', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients that were enrolled in CLEAR III were analyzed.'}, {'type': 'SECONDARY', 'title': 'Safety/Mortality - Systematic Bleeds Within 30 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '251', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alteplase', 'description': 'Administration of alteplase via the intraventricular catheter\n\nAlteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}, {'id': 'OG001', 'title': 'Saline Placebo', 'description': '1 ml of normal saline administered via the intraventricular catheter\n\nNormal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000'}, {'value': '3.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.811', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.004', 'ciLowerLimit': '-0.028', 'ciUpperLimit': '0.036', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality.', 'unitOfMeasure': '% of participants with systematic bleeds', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients that were enrolled in CLEAR III were analyzed.'}, {'type': 'SECONDARY', 'title': 'Adverse and Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '251', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alteplase', 'description': 'Administration of alteplase via the intraventricular catheter\n\nAlteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}, {'id': 'OG001', 'title': 'Saline Placebo', 'description': '1 ml of normal saline administered via the intraventricular catheter\n\nNormal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}], 'classes': [{'categories': [{'measurements': [{'value': '45.8', 'groupId': 'OG000'}, {'value': '60.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0017', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.144', 'ciLowerLimit': '-0.230', 'ciUpperLimit': '-0.057', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '180 days', 'description': 'Assessment of number of adverse and serious adverse events by treatment group.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients that were enrolled in CLEAR III were analyzed.'}, {'type': 'SECONDARY', 'title': 'Predicting Hazards of Death by Treatment Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '251', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alteplase', 'description': 'Administration of alteplase via the intraventricular catheter\n\nAlteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}, {'id': 'OG001', 'title': 'Saline Placebo', 'description': '1 ml of normal saline administered via the intraventricular catheter\n\nNormal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}], 'classes': [{'categories': [{'measurements': [{'value': '18.5', 'groupId': 'OG000'}, {'value': '29.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.60', 'ciLowerLimit': '0.41', 'ciUpperLimit': '0.86', 'statisticalMethod': 'Cox Proportional Hazards Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted Cox Proportional Hazards Model adjusting for age, GCS, thalamus, stability ICH volume and stability IVH volume (categorical).'}], 'paramType': 'NUMBER', 'timeFrame': '180 days', 'description': 'Cox Proportional Hazards Model is used to predict the hazards ratio by treatment group.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients that were enrolled in CLEAR III were analyzed.'}, {'type': 'SECONDARY', 'title': 'Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Race (African-American)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alteplase', 'description': 'Administration of alteplase via the intraventricular catheter\n\nAlteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}, {'id': 'OG001', 'title': 'Saline Placebo', 'description': '1 ml of normal saline administered via the intraventricular catheter\n\nNormal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}], 'classes': [{'categories': [{'measurements': [{'value': '54.4', 'groupId': 'OG000'}, {'value': '48.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.410', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.064', 'ciLowerLimit': '-0.088', 'ciUpperLimit': '0.217', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '180 days', 'description': 'Assessment of modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients that reported they were African-American with a non-missing mRS score at 180 days were analyzed.'}, {'type': 'SECONDARY', 'title': 'Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Race (White)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alteplase', 'description': 'Administration of alteplase via the intraventricular catheter\n\nAlteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}, {'id': 'OG001', 'title': 'Saline Placebo', 'description': '1 ml of normal saline administered via the intraventricular catheter\n\nNormal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}], 'classes': [{'categories': [{'measurements': [{'value': '43.4', 'groupId': 'OG000'}, {'value': '41.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.781', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.016', 'ciLowerLimit': '-0.096', 'ciUpperLimit': '0.128', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '180 days', 'description': 'Assessment of modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients that reported they were White with a non-missing mRS score at 180 days were analyzed.'}, {'type': 'SECONDARY', 'title': 'Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Gender (Female)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alteplase', 'description': 'Administration of alteplase via the intraventricular catheter\n\nAlteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}, {'id': 'OG001', 'title': 'Saline Placebo', 'description': '1 ml of normal saline administered via the intraventricular catheter\n\nNormal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}], 'classes': [{'categories': [{'measurements': [{'value': '47.6', 'groupId': 'OG000'}, {'value': '45.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.773', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.020', 'ciLowerLimit': '-0.113', 'ciUpperLimit': '0.152', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '180 days', 'description': 'Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All female patients with a non-missing mRS score at 180 days were analyzed.'}, {'type': 'SECONDARY', 'title': 'Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Gender (Male)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alteplase', 'description': 'Administration of alteplase via the intraventricular catheter\n\nAlteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}, {'id': 'OG001', 'title': 'Saline Placebo', 'description': '1 ml of normal saline administered via the intraventricular catheter\n\nNormal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}], 'classes': [{'categories': [{'measurements': [{'value': '47.6', 'groupId': 'OG000'}, {'value': '44.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.587', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.032', 'ciLowerLimit': '-0.085', 'ciUpperLimit': '0.151', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '180 days', 'description': 'Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All male patients with a non-missing mRS score at 180 days were analyzed.'}, {'type': 'SECONDARY', 'title': 'Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Age (65 Years or Under)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alteplase', 'description': 'Administration of alteplase via the intraventricular catheter\n\nAlteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}, {'id': 'OG001', 'title': 'Saline Placebo', 'description': '1 ml of normal saline administered via the intraventricular catheter\n\nNormal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}], 'classes': [{'categories': [{'measurements': [{'value': '53.6', 'groupId': 'OG000'}, {'value': '52.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.775', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.015', 'ciLowerLimit': '-0.09', 'ciUpperLimit': '0.121', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '180 days', 'description': 'Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients 65 years of age or under with a non-missing mRS score at 180 days were analyzed.'}, {'type': 'SECONDARY', 'title': 'Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Age (Over 65 Years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alteplase', 'description': 'Administration of alteplase via the intraventricular catheter\n\nAlteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}, {'id': 'OG001', 'title': 'Saline Placebo', 'description': '1 ml of normal saline administered via the intraventricular catheter\n\nNormal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}], 'classes': [{'categories': [{'measurements': [{'value': '31.3', 'groupId': 'OG000'}, {'value': '29.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.808', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.019', 'ciLowerLimit': '-0.132', 'ciUpperLimit': '0.169', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '180 days', 'description': 'Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients over 65 years of age with a non-missing mRS score at 180 days were analyzed.'}, {'type': 'SECONDARY', 'title': 'Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (Less Than 20ml)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alteplase', 'description': 'Administration of alteplase via the intraventricular catheter\n\nAlteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}, {'id': 'OG001', 'title': 'Saline Placebo', 'description': '1 ml of normal saline administered via the intraventricular catheter\n\nNormal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}], 'classes': [{'categories': [{'measurements': [{'value': '55.1', 'groupId': 'OG000'}, {'value': '58.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.625', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.033', 'ciLowerLimit': '-0.165', 'ciUpperLimit': '0.099', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '180 days', 'description': 'Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients with an IVH size less than 20ml and a non-missing mRS score at 180 days were analyzed.'}, {'type': 'SECONDARY', 'title': 'Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (20-50ml)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alteplase', 'description': 'Administration of alteplase via the intraventricular catheter\n\nAlteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}, {'id': 'OG001', 'title': 'Saline Placebo', 'description': '1 ml of normal saline administered via the intraventricular catheter\n\nNormal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}], 'classes': [{'categories': [{'measurements': [{'value': '47.3', 'groupId': 'OG000'}, {'value': '38.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.191', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.087', 'ciLowerLimit': '-0.043', 'ciUpperLimit': '0.218', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '180 days', 'description': 'Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients with an IVH size between 20ml and 50ml and a non-missing mRS score at 180 days were analyzed.'}, {'type': 'SECONDARY', 'title': 'Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (Greater Than 50ml)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alteplase', 'description': 'Administration of alteplase via the intraventricular catheter\n\nAlteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}, {'id': 'OG001', 'title': 'Saline Placebo', 'description': '1 ml of normal saline administered via the intraventricular catheter\n\nNormal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}], 'classes': [{'categories': [{'measurements': [{'value': '18.5', 'groupId': 'OG000'}, {'value': '17.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.949', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0066', 'ciLowerLimit': '-0.197', 'ciUpperLimit': '0.211', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '180 days', 'description': 'Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients with an IVH size greater than 50ml and a non-missing mRS score at 180 days were analyzed.'}, {'type': 'SECONDARY', 'title': 'Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Location (Thalamic)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alteplase', 'description': 'Administration of alteplase via the intraventricular catheter\n\nAlteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}, {'id': 'OG001', 'title': 'Saline Placebo', 'description': '1 ml of normal saline administered via the intraventricular catheter\n\nNormal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}], 'classes': [{'categories': [{'measurements': [{'value': '38.8', 'groupId': 'OG000'}, {'value': '37.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.812', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.014', 'ciLowerLimit': '-0.098', 'ciUpperLimit': '0.126', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '180 days', 'description': 'Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients with a thalamic blood clot location and a non-missing mRS score at 180 days were analyzed.'}, {'type': 'SECONDARY', 'title': 'Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Location (Non-Thalamic)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alteplase', 'description': 'Administration of alteplase via the intraventricular catheter\n\nAlteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}, {'id': 'OG001', 'title': 'Saline Placebo', 'description': '1 ml of normal saline administered via the intraventricular catheter\n\nNormal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}], 'classes': [{'categories': [{'measurements': [{'value': '60.6', 'groupId': 'OG000'}, {'value': '54.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.394', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.059', 'ciLowerLimit': '-0.076', 'ciUpperLimit': '0.194', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '180 days', 'description': 'Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients with a non-thalamic blood clot location and a non-missing mRS score at 180 days were analyzed.'}, {'type': 'SECONDARY', 'title': 'Functional Status - Barthel Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alteplase', 'description': 'Administration of alteplase via the intraventricular catheter\n\nAlteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}, {'id': 'OG001', 'title': 'Saline Placebo', 'description': '1 ml of normal saline administered via the intraventricular catheter\n\nNormal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}], 'classes': [{'categories': [{'measurements': [{'value': '65.2', 'spread': '37.7', 'groupId': 'OG000'}, {'value': '69.5', 'spread': '35.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.312', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '180 days', 'description': 'Assessment of NIHSS, Barthel Index, eGOS (dichotomy and ordinal) by group. The Barthel Index (BI) assesses ten functional tasks of daily living, and each task provides a measure for level of independence. Scores range from 0 and 100, with a higher score indicating greater independence.', 'unitOfMeasure': 'Barthel score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All the non-missing Barthel scores at 180 days were analyzed.'}, {'type': 'SECONDARY', 'title': 'Functional Status - Participants With Extended Glasgow Outcome (eGOS) Score >=Upper Severe Disability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '241', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alteplase', 'description': 'Administration of alteplase via the intraventricular catheter\n\nAlteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}, {'id': 'OG001', 'title': 'Saline Placebo', 'description': '1 ml of normal saline administered via the intraventricular catheter\n\nNormal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}], 'classes': [{'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.087', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.075', 'ciLowerLimit': '-0.011', 'ciUpperLimit': '0.160', 'pValueComment': 'Analysis of dichotomous eGOS, comparing Upper Severe Disability scores to Lower Severe Disability scores', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.064', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.54', 'ciLowerLimit': '0.98', 'ciUpperLimit': '2.43', 'pValueComment': 'Adjusted Multivariable Logit Model comparing eGOS scores of Upper Severe Disability or greater versus Lower Severe Disability and worse; Alteplase versus Saline', 'statisticalMethod': 'Multivariable Logit Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.336', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.42', 'ciLowerLimit': '0.70', 'ciUpperLimit': '2.89', 'pValueComment': 'Adjusted generalized ordered logit model odds ratios for eGOS scores of Moderate Disability or worse versus Good Recovery; Alteplase versus Saline', 'statisticalMethod': 'Generalized Ordered Logit Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.783', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.57', 'ciUpperLimit': '1.52', 'pValueComment': 'Adjusted generalized ordered logit model odds ratios for eGOS scores of Upper Severe Disability or worse versus Moderate Disability + Good Recovery; Alteplase versus Saline', 'statisticalMethod': 'Generalized Ordered Logit Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '180 days', 'description': 'Assessment of NIHSS, Barthel Index, eGOS (dichotomy and ordinal) by group. The extended Glasgow Outcome Scale (eGOS) is a global scale for functional outcome with eight categories: 1 - Death, 2 - Vegetative State, 3 - Lower Severe Disability, 4 - Upper Severe Disability, 5 - Lower Moderate Disability, 6 - Upper Moderate Disability, 7 - Lower Good Recovery, 8 - Upper Good Recovery.', 'unitOfMeasure': '% of participants with score>=4', 'reportingStatus': 'POSTED', 'populationDescription': 'All the non-missing eGOS scores at 180 days were analyzed.'}, {'type': 'SECONDARY', 'title': 'Functional Status - National Institutes of Health Stroke Scale (NIHSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alteplase', 'description': 'Administration of alteplase via the intraventricular catheter\n\nAlteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}, {'id': 'OG001', 'title': 'Saline Placebo', 'description': '1 ml of normal saline administered via the intraventricular catheter\n\nNormal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '7'}]}]}], 'analyses': [{'pValue': '0.14', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': '180 days', 'description': 'Assessment of NIHSS, Barthel Index, eGOS (dichotomy and ordinal) by group. The National Institutes of Health Stroke Scale (NIHSS) is a 15-item scale that assesses language, motor function, sensory loss, consciousness, visual fields, extraocular movements, coordination, neglect, and speech. It is scored from 0 (no stroke symptoms) to 42 (severe stroke).', 'unitOfMeasure': 'NIHSS score', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All the non-missing NIHSS scores at 180 days were analyzed.'}, {'type': 'SECONDARY', 'title': 'Quality of Life - Stroke Impact Scale (SIS) - Strength', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alteplase', 'description': 'Administration of alteplase via the intraventricular catheter\n\nAlteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}, {'id': 'OG001', 'title': 'Saline Placebo', 'description': '1 ml of normal saline administered via the intraventricular catheter\n\nNormal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}], 'classes': [{'categories': [{'measurements': [{'value': '54.97', 'spread': '35.37', 'groupId': 'OG000'}, {'value': '58.75', 'spread': '34.36', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.312', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '180 days', 'description': 'Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.', 'unitOfMeasure': 'SIS score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All the non-missing SIS scores at 180 days were analyzed.'}, {'type': 'SECONDARY', 'title': 'Quality of Life - Stroke Impact Scale (SIS) - Mobility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alteplase', 'description': 'Administration of alteplase via the intraventricular catheter\n\nAlteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}, {'id': 'OG001', 'title': 'Saline Placebo', 'description': '1 ml of normal saline administered via the intraventricular catheter\n\nNormal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}], 'classes': [{'categories': [{'measurements': [{'value': '58.30', 'spread': '38.16', 'groupId': 'OG000'}, {'value': '60.10', 'spread': '36.05', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.65', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '180 days', 'description': 'Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.', 'unitOfMeasure': 'SIS score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All the non-missing SIS scores at 180 days were analyzed.'}, {'type': 'SECONDARY', 'title': 'Quality of Life - Stroke Impact Scale (SIS) - Hand Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alteplase', 'description': 'Administration of alteplase via the intraventricular catheter\n\nAlteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}, {'id': 'OG001', 'title': 'Saline Placebo', 'description': '1 ml of normal saline administered via the intraventricular catheter\n\nNormal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}], 'classes': [{'categories': [{'measurements': [{'value': '53.41', 'spread': '41.86', 'groupId': 'OG000'}, {'value': '56.52', 'spread': '39.69', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.478', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '180 days', 'description': 'Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.', 'unitOfMeasure': 'SIS score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All the non-missing SIS scores at 180 days were analyzed.'}, {'type': 'SECONDARY', 'title': 'Quality of Life - Stroke Impact Scale (SIS) - Activities of Daily Living', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alteplase', 'description': 'Administration of alteplase via the intraventricular catheter\n\nAlteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}, {'id': 'OG001', 'title': 'Saline Placebo', 'description': '1 ml of normal saline administered via the intraventricular catheter\n\nNormal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}], 'classes': [{'categories': [{'measurements': [{'value': '59.33', 'spread': '37.90', 'groupId': 'OG000'}, {'value': '61.19', 'spread': '34.98', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.634', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '180 days', 'description': 'Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.', 'unitOfMeasure': 'SIS score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All the non-missing SIS scores at 180 days were analyzed.'}, {'type': 'SECONDARY', 'title': 'Quality of Life - Stroke Impact Scale (SIS) - Communication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alteplase', 'description': 'Administration of alteplase via the intraventricular catheter\n\nAlteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}, {'id': 'OG001', 'title': 'Saline Placebo', 'description': '1 ml of normal saline administered via the intraventricular catheter\n\nNormal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}], 'classes': [{'categories': [{'measurements': [{'value': '76.02', 'spread': '31.47', 'groupId': 'OG000'}, {'value': '79.60', 'spread': '26.76', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.255', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '180 days', 'description': 'Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.', 'unitOfMeasure': 'SIS score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All the non-missing SIS scores at 180 days were analyzed.'}, {'type': 'SECONDARY', 'title': 'Quality of Life - Stroke Impact Scale (SIS) - Thinking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alteplase', 'description': 'Administration of alteplase via the intraventricular catheter\n\nAlteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}, {'id': 'OG001', 'title': 'Saline Placebo', 'description': '1 ml of normal saline administered via the intraventricular catheter\n\nNormal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}], 'classes': [{'categories': [{'measurements': [{'value': '58.48', 'spread': '33.11', 'groupId': 'OG000'}, {'value': '62.68', 'spread': '31.18', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.224', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '180 days', 'description': 'Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.', 'unitOfMeasure': 'SIS score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All the non-missing SIS scores at 180 days were analyzed.'}, {'type': 'SECONDARY', 'title': 'Quality of Life - Stroke Impact Scale (SIS) - Emotion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alteplase', 'description': 'Administration of alteplase via the intraventricular catheter\n\nAlteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}, {'id': 'OG001', 'title': 'Saline Placebo', 'description': '1 ml of normal saline administered via the intraventricular catheter\n\nNormal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}], 'classes': [{'categories': [{'measurements': [{'value': '73.14', 'spread': '19.62', 'groupId': 'OG000'}, {'value': '73.45', 'spread': '20.24', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.882', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '180 days', 'description': 'Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.', 'unitOfMeasure': 'SIS score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All the non-missing SIS scores at 180 days were analyzed.'}, {'type': 'SECONDARY', 'title': 'Quality of Life - Stroke Impact Scale (SIS) - Participation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alteplase', 'description': 'Administration of alteplase via the intraventricular catheter\n\nAlteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}, {'id': 'OG001', 'title': 'Saline Placebo', 'description': '1 ml of normal saline administered via the intraventricular catheter\n\nNormal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}], 'classes': [{'categories': [{'measurements': [{'value': '47.46', 'spread': '33.01', 'groupId': 'OG000'}, {'value': '49.58', 'spread': '33.03', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.551', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '180 days', 'description': 'Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.', 'unitOfMeasure': 'SIS score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All the non-missing SIS scores at 180 days were analyzed.'}, {'type': 'SECONDARY', 'title': 'Quality of Life - Stroke Impact Scale (SIS) - Recovery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alteplase', 'description': 'Administration of alteplase via the intraventricular catheter\n\nAlteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}, {'id': 'OG001', 'title': 'Saline Placebo', 'description': '1 ml of normal saline administered via the intraventricular catheter\n\nNormal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}], 'classes': [{'categories': [{'measurements': [{'value': '60.04', 'spread': '26.42', 'groupId': 'OG000'}, {'value': '63.44', 'spread': '25.44', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.224', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '180 days', 'description': 'Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.', 'unitOfMeasure': 'SIS score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All the non-missing SIS scores at 180 days were analyzed.'}, {'type': 'SECONDARY', 'title': 'Quality of Life - EuroQol Visual Analogue Scale (EQ-VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alteplase', 'description': 'Administration of alteplase via the intraventricular catheter\n\nAlteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}, {'id': 'OG001', 'title': 'Saline Placebo', 'description': '1 ml of normal saline administered via the intraventricular catheter\n\nNormal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}], 'classes': [{'categories': [{'measurements': [{'value': '62.8', 'spread': '26.0', 'groupId': 'OG000'}, {'value': '65.1', 'spread': '23.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.376', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '180 days', 'description': 'Assessment of SIS and EuroQol Visual Analog Scale by group. EuroQol Visual Analogue Scale (EQ-VAS) is a self-reported measure of health status. It is a marked scale where individuals draw a line to indicate their health, with end points of 0 (the worst health you can imagine) and 100 (the best health you can imagine).', 'unitOfMeasure': 'EuroQol score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All the non-missing EuroQol scores at 180 days were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Alteplase', 'description': 'Administration of alteplase via the intraventricular catheter\n\nAlteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}, {'id': 'FG001', 'title': 'Saline Placebo', 'description': '1 ml of normal saline administered via the intraventricular catheter\n\nNormal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '249'}, {'groupId': 'FG001', 'numSubjects': '251'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '246'}, {'groupId': 'FG001', 'numSubjects': '245'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'BG000'}, {'value': '251', 'groupId': 'BG001'}, {'value': '500', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Alteplase', 'description': 'Administration of alteplase via the intraventricular catheter\n\nAlteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}, {'id': 'BG001', 'title': 'Saline Placebo', 'description': '1 ml of normal saline administered via the intraventricular catheter\n\nNormal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '182', 'groupId': 'BG000'}, {'value': '172', 'groupId': 'BG001'}, {'value': '354', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '222', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '144', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '278', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '170', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '144', 'groupId': 'BG000'}, {'value': '161', 'groupId': 'BG001'}, {'value': '305', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '190', 'groupId': 'BG000'}, {'value': '180', 'groupId': 'BG001'}, {'value': '370', 'groupId': 'BG002'}]}]}, {'title': 'Brazil', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}, {'title': 'Switzerland', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-09', 'studyFirstSubmitDate': '2008-10-31', 'resultsFirstSubmitDate': '2017-03-30', 'studyFirstSubmitQcDate': '2008-10-31', 'lastUpdatePostDateStruct': {'date': '2018-12-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-06-01', 'studyFirstPostDateStruct': {'date': '2008-11-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participants With Modified Rankin Scale (mRS) <=3 - Dichotomized Analysis', 'timeFrame': '180 days', 'description': 'Analysis modified on September 29, 2015 to account for adaptive randomization. The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).'}, {'measure': 'Participant Score on the Modified Rankin Scale (mRS) - Ordinal Analysis', 'timeFrame': '180 days', 'description': 'The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).'}, {'measure': 'Participants With Modified Rankin Scale (mRS) <=4 - Dichotomized Analysis', 'timeFrame': '180 days', 'description': 'The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).'}, {'measure': 'Random Effects Assessment of Site Effect on Modified Rankin Scale (mRS) <= 3', 'timeFrame': '180 days', 'description': 'The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).'}, {'measure': 'Longitudinal Assessment of Participants With Modified Rankin Scale (mRS) <=3', 'timeFrame': '30 days and 180 days', 'description': 'Comparing longitudinal modified Rankin Scale (mRS) scores 0-3 at Day 30 and Day 180. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).'}], 'secondaryOutcomes': [{'measure': 'All Cause Mortality', 'timeFrame': '180 days'}, {'measure': 'Clot Removal (Amount of Residual Blood)', 'timeFrame': '72 hours', 'description': 'Change in blood volume measured between stability scan and end of treatment scan'}, {'measure': 'Intensity of Critical Care Management - Hospital Days', 'timeFrame': '30 days', 'description': 'Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP \\>20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.'}, {'measure': 'Intensity of Critical Care Management - ICU Days', 'timeFrame': '30 days', 'description': 'Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP \\>20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.'}, {'measure': 'Intensity of Critical Care Management - ICP Management', 'timeFrame': '30 days', 'description': 'Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP \\>20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.'}, {'measure': 'Intensity of Critical Care Management - Mechanical Ventilation', 'timeFrame': '30 days', 'description': 'Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP \\>20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.'}, {'measure': 'Intensity of Critical Care Management - Pressors', 'timeFrame': '30 days', 'description': 'Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP \\>20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.'}, {'measure': 'Intensity of Critical Care Management - Shunts', 'timeFrame': '30 days', 'description': 'Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP \\>20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.'}, {'measure': 'Intensity of Critical Care Management - All Infections', 'timeFrame': '30 days', 'description': 'Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP \\>20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.'}, {'measure': 'Intensity of Critical Care Management - Pneumonia', 'timeFrame': '30 days', 'description': 'Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP \\>20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.'}, {'measure': 'Intensity of Critical Care Management - All Infections', 'timeFrame': '180 days', 'description': 'Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP \\>20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.'}, {'measure': 'Safety/Mortality - Mortality Within 30 Days', 'timeFrame': '30 days', 'description': 'Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality.'}, {'measure': 'Safety/Mortality - Bacterial Brain Infections Within 30 Days', 'timeFrame': '30 days', 'description': 'Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality.'}, {'measure': 'Safety/Mortality - Systematic Bleeds Within 72 Hours', 'timeFrame': '72 hours', 'description': 'Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality.'}, {'measure': 'Safety/Mortality - Systematic Bleeds Within 30 Days', 'timeFrame': '30 days', 'description': 'Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality.'}, {'measure': 'Adverse and Serious Adverse Events', 'timeFrame': '180 days', 'description': 'Assessment of number of adverse and serious adverse events by treatment group.'}, {'measure': 'Predicting Hazards of Death by Treatment Group', 'timeFrame': '180 days', 'description': 'Cox Proportional Hazards Model is used to predict the hazards ratio by treatment group.'}, {'measure': 'Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Race (African-American)', 'timeFrame': '180 days', 'description': 'Assessment of modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).'}, {'measure': 'Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Race (White)', 'timeFrame': '180 days', 'description': 'Assessment of modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).'}, {'measure': 'Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Gender (Female)', 'timeFrame': '180 days', 'description': 'Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).'}, {'measure': 'Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Gender (Male)', 'timeFrame': '180 days', 'description': 'Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).'}, {'measure': 'Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Age (65 Years or Under)', 'timeFrame': '180 days', 'description': 'Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).'}, {'measure': 'Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Age (Over 65 Years)', 'timeFrame': '180 days', 'description': 'Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).'}, {'measure': 'Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (Less Than 20ml)', 'timeFrame': '180 days', 'description': 'Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).'}, {'measure': 'Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (20-50ml)', 'timeFrame': '180 days', 'description': 'Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).'}, {'measure': 'Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (Greater Than 50ml)', 'timeFrame': '180 days', 'description': 'Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).'}, {'measure': 'Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Location (Thalamic)', 'timeFrame': '180 days', 'description': 'Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).'}, {'measure': 'Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Location (Non-Thalamic)', 'timeFrame': '180 days', 'description': 'Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).'}, {'measure': 'Functional Status - Barthel Index', 'timeFrame': '180 days', 'description': 'Assessment of NIHSS, Barthel Index, eGOS (dichotomy and ordinal) by group. The Barthel Index (BI) assesses ten functional tasks of daily living, and each task provides a measure for level of independence. Scores range from 0 and 100, with a higher score indicating greater independence.'}, {'measure': 'Functional Status - Participants With Extended Glasgow Outcome (eGOS) Score >=Upper Severe Disability', 'timeFrame': '180 days', 'description': 'Assessment of NIHSS, Barthel Index, eGOS (dichotomy and ordinal) by group. The extended Glasgow Outcome Scale (eGOS) is a global scale for functional outcome with eight categories: 1 - Death, 2 - Vegetative State, 3 - Lower Severe Disability, 4 - Upper Severe Disability, 5 - Lower Moderate Disability, 6 - Upper Moderate Disability, 7 - Lower Good Recovery, 8 - Upper Good Recovery.'}, {'measure': 'Functional Status - National Institutes of Health Stroke Scale (NIHSS)', 'timeFrame': '180 days', 'description': 'Assessment of NIHSS, Barthel Index, eGOS (dichotomy and ordinal) by group. The National Institutes of Health Stroke Scale (NIHSS) is a 15-item scale that assesses language, motor function, sensory loss, consciousness, visual fields, extraocular movements, coordination, neglect, and speech. It is scored from 0 (no stroke symptoms) to 42 (severe stroke).'}, {'measure': 'Quality of Life - Stroke Impact Scale (SIS) - Strength', 'timeFrame': '180 days', 'description': 'Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.'}, {'measure': 'Quality of Life - Stroke Impact Scale (SIS) - Mobility', 'timeFrame': '180 days', 'description': 'Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.'}, {'measure': 'Quality of Life - Stroke Impact Scale (SIS) - Hand Function', 'timeFrame': '180 days', 'description': 'Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.'}, {'measure': 'Quality of Life - Stroke Impact Scale (SIS) - Activities of Daily Living', 'timeFrame': '180 days', 'description': 'Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.'}, {'measure': 'Quality of Life - Stroke Impact Scale (SIS) - Communication', 'timeFrame': '180 days', 'description': 'Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.'}, {'measure': 'Quality of Life - Stroke Impact Scale (SIS) - Thinking', 'timeFrame': '180 days', 'description': 'Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.'}, {'measure': 'Quality of Life - Stroke Impact Scale (SIS) - Emotion', 'timeFrame': '180 days', 'description': 'Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.'}, {'measure': 'Quality of Life - Stroke Impact Scale (SIS) - Participation', 'timeFrame': '180 days', 'description': 'Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.'}, {'measure': 'Quality of Life - Stroke Impact Scale (SIS) - Recovery', 'timeFrame': '180 days', 'description': 'Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.'}, {'measure': 'Quality of Life - EuroQol Visual Analogue Scale (EQ-VAS)', 'timeFrame': '180 days', 'description': 'Assessment of SIS and EuroQol Visual Analog Scale by group. EuroQol Visual Analogue Scale (EQ-VAS) is a self-reported measure of health status. It is a marked scale where individuals draw a line to indicate their health, with end points of 0 (the worst health you can imagine) and 100 (the best health you can imagine).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['intraventricular hemorrhage thrombolysis'], 'conditions': ['Intraventricular Hemorrhage']}, 'referencesModule': {'availIpds': [{'id': 'Data repository-VISTA', 'url': 'http://vista.gla.ac.uk', 'type': 'Data repository-VISTA', 'comment': 'when available'}, {'url': 'http://vista.gla.ac.uk', 'type': 'Study Protocol', 'comment': 'when available'}, {'url': 'http://vista.gla.ac.uk', 'type': 'Statistical Analysis Plan', 'comment': 'when available'}], 'references': [{'pmid': '35086362', 'type': 'DERIVED', 'citation': 'Roh DJ, Asonye IS, Carvalho Poyraz F, Magid-Bernstein JR, Joiner EF, Avadhani R, Awad I, Hanley DF, Ziai WC, Murthy SB. Intraventricular Hemorrhage Expansion in the CLEAR III Trial: A Post Hoc Exploratory Analysis. Stroke. 2022 Jun;53(6):1847-1853. doi: 10.1161/STROKEAHA.121.037438. Epub 2022 Jan 28.'}, {'pmid': '32026447', 'type': 'DERIVED', 'citation': 'Hansen BM, Ullman N, Muschelli J, Norrving B, Dlugash R, Avadhani R, Awad I, Zuccarello M, Ziai WC, Hanley DF, Thompson RE, Lindgren A; MISTIE and CLEAR Investigators. Relationship of White Matter Lesions with Intracerebral Hemorrhage Expansion and Functional Outcome: MISTIE II and CLEAR III. Neurocrit Care. 2020 Oct;33(2):516-524. doi: 10.1007/s12028-020-00916-4.'}, {'pmid': '31571176', 'type': 'DERIVED', 'citation': 'Porter AL, Ebot J, Lane K, Mooney LH, Lannen AM, Richie EM, Dlugash R, Mayo S, Brott TG, Ziai W, Freeman WD, Hanley DF. Enhancing the Informed Consent Process Using Shared Decision Making and Consent Refusal Data from the CLEAR III Trial. Neurocrit Care. 2020 Feb;32(1):340-347. doi: 10.1007/s12028-019-00860-y.'}, {'pmid': '31177984', 'type': 'DERIVED', 'citation': 'Eslami V, Tahsili-Fahadan P, Rivera-Lara L, Gandhi D, Ali H, Parry-Jones A, Nelson LS, Thompson RE, Nekoobakht-Tak S, Dlugash R, McBee N, Awad I, Hanley DF, Ziai WC. Influence of Intracerebral Hemorrhage Location on Outcomes in Patients With Severe Intraventricular Hemorrhage. Stroke. 2019 Jul;50(7):1688-1695. doi: 10.1161/STROKEAHA.118.024187. Epub 2019 Jun 10.'}, {'pmid': '28887375', 'type': 'DERIVED', 'citation': 'Fam MD, Zeineddine HA, Eliyas JK, Stadnik A, Jesselson M, McBee N, Lane K, Cao Y, Wu M, Zhang L, Thompson RE, John S, Ziai W, Hanley DF, Awad IA; CLEAR III Trial Investigators. CSF inflammatory response after intraventricular hemorrhage. Neurology. 2017 Oct 10;89(15):1553-1560. doi: 10.1212/WNL.0000000000004493. Epub 2017 Sep 8.'}, {'pmid': '28081952', 'type': 'DERIVED', 'citation': 'Hanley DF, Lane K, McBee N, Ziai W, Tuhrim S, Lees KR, Dawson J, Gandhi D, Ullman N, Mould WA, Mayo SW, Mendelow AD, Gregson B, Butcher K, Vespa P, Wright DW, Kase CS, Carhuapoma JR, Keyl PM, Diener-West M, Muschelli J, Betz JF, Thompson CB, Sugar EA, Yenokyan G, Janis S, John S, Harnof S, Lopez GA, Aldrich EF, Harrigan MR, Ansari S, Jallo J, Caron JL, LeDoux D, Adeoye O, Zuccarello M, Adams HP Jr, Rosenblum M, Thompson RE, Awad IA; CLEAR III Investigators. Thrombolytic removal of intraventricular haemorrhage in treatment of severe stroke: results of the randomised, multicentre, multiregion, placebo-controlled CLEAR III trial. Lancet. 2017 Feb 11;389(10069):603-611. doi: 10.1016/S0140-6736(16)32410-2. Epub 2017 Jan 10.'}, {'pmid': '26243227', 'type': 'DERIVED', 'citation': 'Webb AJ, Ullman NL, Morgan TC, Muschelli J, Kornbluth J, Awad IA, Mayo S, Rosenblum M, Ziai W, Zuccarrello M, Aldrich F, John S, Harnof S, Lopez G, Broaddus WC, Wijman C, Vespa P, Bullock R, Haines SJ, Cruz-Flores S, Tuhrim S, Hill MD, Narayan R, Hanley DF; MISTIE and CLEAR Investigators. Accuracy of the ABC/2 Score for Intracerebral Hemorrhage: Systematic Review and Analysis of MISTIE, CLEAR-IVH, and CLEAR III. Stroke. 2015 Sep;46(9):2470-6. doi: 10.1161/STROKEAHA.114.007343. Epub 2015 Aug 4.'}], 'seeAlsoLinks': [{'url': 'http://braininjuryoutcomes.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The overall objective of this Phase III clinical trial is to obtain information from a population of 500 ICH subjects with intraventricular hemorrhage (IVH), representative of current clinical practice and national demographics of ICH regarding the benefit (or lack thereof) of IVH clot removal on subject function as measured by modified Rankin Scale (mRS). This application requests funding for five years to initiate a Phase III randomized clinical trial (RCT) testing the benefit of clot removal for intraventricular hemorrhage. The investigators propose to compare extraventricular drainage (EVD) use plus recombinant tissue plasminogen activator (rt-PA; Alteplase; Genentech, Inc., San Francisco, CA) with EVD+ placebo in the management and treatment of subjects with small intracerebral hemorrhage (ICH) and large intraventricular hemorrhage (IVH defined as ICH \\< 30 cc and obstruction of the 3rd or 4th ventricles by intraventricular blood clot).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-80\n* Symptom onset less than 24 hrs prior to diagnostic CT scan\n* Spontaneous ICH less than or equal to 30 cc or primary IVH\n* IVH obstructing 3rd and/or 4th ventricles\n* ICH clot stability at 6 hours or more post IVC placement\n* IVH clot stability at 6 hours or more post IVC placement\n* Catheter tract bleeding stability 6 hours or more post IVC placement\n* EVD placed per standard medical care\n* SBP less than 200 mmHg sustained for 6 hours prior to drug administration\n* Able to randomize within 72 hours of diagnostic CT scan\n* Historical Rankin of 0 or 1\n\nExclusion Criteria:\n\n* Suspected or untreated ruptured cerebral aneurysm, AVM, or tumor\n* Presence of a choroid plexus vascular malformation or Moyamoya\n* Clotting disorders\n* Platelet count less than 100,000, INR greater than 1.4\n* Pregnancy\n* Infratentorial hemorrhage\n* SAH at clinical presentation\n* ICH/IVH enlargement that cannot be stabilized in the treatment time window\n* Ongoing internal bleeding\n* Superficial or surface bleeding\n* Prior enrollment in the study\n* Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated\n* Planned or simultaneous participation (between screening and Day-30) in another interventional medical investigation or clinical trial.\n* No subject or legal representative to give written informed consent'}, 'identificationModule': {'nctId': 'NCT00784134', 'acronym': 'CLEAR III', 'briefTitle': 'Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III', 'orgStudyIdInfo': {'id': 'IVH06'}, 'secondaryIdInfos': [{'id': '5U01NS062851-05', 'link': 'https://reporter.nih.gov/quickSearch/5U01NS062851-05', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Alteplase', 'description': 'administration of alteplase via the intraventricular catheter', 'interventionNames': ['Drug: Alteplase']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline Placebo', 'description': '1 ml of normal saline administered via the intraventricular catheter', 'interventionNames': ['Other: Normal saline']}], 'interventions': [{'name': 'Alteplase', 'type': 'DRUG', 'otherNames': ['Cathflo Activase', 'rt-PA'], 'description': '1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses', 'armGroupLabels': ['Alteplase']}, {'name': 'Normal saline', 'type': 'OTHER', 'description': '1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses', 'armGroupLabels': ['Saline Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic, Arizona', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90089', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California - Keck School of Medicine', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94034', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '06106', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Hartford Hospital', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '06520-8018', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic, Jacksonville', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '34232', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Intercoastal Medical Center', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois at Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '50314', 'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Ruan Neurology Clinical and Research Center', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'Kansas University Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21230', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health System', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "St. Luke's Brain and Stroke Institute", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '65804', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Springfield Neurological and Spine Institute', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '63104', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'St. Louis University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '08103', 'city': 'Camden', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Cooper University Hospital', 'geoPoint': {'lat': 39.92595, 'lon': -75.11962}}, {'zip': '08818', 'city': 'Edison', 'state': 'New Jersey', 'country': 'United States', 'facility': 'New Jersey Neuroscience Institute at JFK', 'geoPoint': {'lat': 40.51872, 'lon': -74.4121}}, {'zip': '14203', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'University of Buffalo', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'Northshore University Hospital Long Island', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY Upstate Medical Center', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Case-Western Reserve University Hospital', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '04102', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Maine Medical Center', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '97225', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Providence Stroke Center', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19001', 'city': 'Abington', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Abington Memorial Hospital', 'geoPoint': {'lat': 40.12067, 'lon': -75.11795}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19140', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Temple University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19141', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Albert Einstein Medical Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15212', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Allegheny General Hospital', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas, Southwestern, Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas, Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas, San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': 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