Viewing Study NCT00598702

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Ignite Creation Date: 2025-12-25 @ 3:46 AM
Ignite Modification Date: 2026-03-02 @ 4:37 PM
Study NCT ID: NCT00598702
Status: COMPLETED
Last Update Posted: 2017-05-10
First Post: 2008-01-09
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Study of the Safety & Efficacy of Intravenous Acetaminophen in Pediatric Inpatients
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D005334', 'term': 'Fever'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001832', 'term': 'Body Temperature Changes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082', 'term': 'Acetaminophen'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lawrence.hill@mallinckrodt.com', 'phone': '908-238-6370', 'title': 'Lawrence Hill, VP Clinical Development', 'organization': 'Mallinckrodt Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The Investigator may publish 18 months after Cadence's final evaluation of all study data from all sites, whichever occurs first.Manuscripts/abstracts will be provided to Cadence for review and comment at least 30 days prior to submission.Cadence shall have 30 days to respond with comments.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The original protocol required 50 subjects that completed 5 days of treatment. With protocol amendment 2, the criteria for enrollment/completion was reduced to 1 day of treatment. Subjects were required to have a minimum of 3 IV APAP doses per day.'}}, 'adverseEventsModule': {'timeFrame': "Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period.", 'description': 'Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h', 'description': 'Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours', 'otherNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h', 'description': 'Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours', 'otherNumAtRisk': 3, 'otherNumAffected': 1, 'seriousNumAtRisk': 3, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h', 'description': 'Children 2 to \\< 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours', 'otherNumAtRisk': 7, 'otherNumAffected': 5, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h', 'description': 'Children 2 to \\< 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours', 'otherNumAtRisk': 33, 'otherNumAffected': 24, 'seriousNumAtRisk': 33, 'seriousNumAffected': 13}, {'id': 'EG004', 'title': 'Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h', 'description': 'Adolescents 12 to \\<= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours', 'otherNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'seriousNumAffected': 2}, {'id': 'EG005', 'title': 'Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h', 'description': 'Adolescents 12 to \\<= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours', 'otherNumAtRisk': 42, 'otherNumAffected': 33, 'seriousNumAtRisk': 42, 'seriousNumAffected': 3}, {'id': 'EG006', 'title': 'Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h', 'description': 'Infants 12 to \\< 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours', 'otherNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h', 'description': 'Infants 12 to \\< 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours', 'otherNumAtRisk': 4, 'otherNumAffected': 2, 'seriousNumAtRisk': 4, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Abdominal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 10}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Hypophosphatemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Laryngotracheal oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 17}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Oliguria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Polyuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Pruritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Skin disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Skin irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Sputum culture positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, 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{'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Obstructive airways disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra (10.0)'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra (10.0)'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra (10.0)'}, {'term': 'Congenital Megacolon', 'notes': "Exacerbation of Hirschsprung's Disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Catheter-Related Complication', 'notes': 'Accidental dislodgement of suprapubic cathether', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Wound Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': "Subject's (Parent/Guardian) Global Evaluation of Study Treatment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '42', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h', 'description': 'Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours'}, {'id': 'OG001', 'title': 'Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h', 'description': 'Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours'}, {'id': 'OG002', 'title': 'Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h', 'description': 'Children 2 to \\< 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours'}, {'id': 'OG003', 'title': 'Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h', 'description': 'Children 2 to \\< 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours'}, {'id': 'OG004', 'title': 'Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h', 'description': 'Adolescents 12 to \\<= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours'}, {'id': 'OG005', 'title': 'Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h', 'description': 'Adolescents 12 to \\<= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours'}, {'id': 'OG006', 'title': 'Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h', 'description': 'Infants 12 to \\< 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours'}, {'id': 'OG007', 'title': 'Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h', 'description': 'Infants 12 to \\< 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours'}], 'classes': [{'title': 'Poor', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Fair', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Good', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '17', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}, {'title': 'Excellent', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 to Day 5, Day 7 or Early Termination from study', 'description': "Subject's (parent/guardian) was asked to evaluate the overall study treatment using a 4-point categorical evaluation scale (0= poor, 1= fair, 2=good, 3= excellent).", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All analysis will be carried out using the safety population, defined as all subjects who received at least one dose of study medication.', 'anticipatedPostingDate': '2009-09'}, {'type': 'PRIMARY', 'title': 'Number of Subjects Reporting at Least One Treatment Emergent Adverse Event (TEAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '42', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h', 'description': 'Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours'}, {'id': 'OG001', 'title': 'Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h', 'description': 'Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours'}, {'id': 'OG002', 'title': 'Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h', 'description': 'Children 2 to \\< 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours'}, {'id': 'OG003', 'title': 'Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h', 'description': 'Children 2 to \\< 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours'}, {'id': 'OG004', 'title': 'Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h', 'description': 'Adolescents 12 to \\<= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours'}, {'id': 'OG005', 'title': 'Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h', 'description': 'Adolescents 12 to \\<= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours'}, {'id': 'OG006', 'title': 'Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h', 'description': 'Infants 12 to \\< 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours'}, {'id': 'OG007', 'title': 'Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h', 'description': 'Infants 12 to \\< 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose to end of treatment period', 'description': 'A TEAE is defined as an adverse event that starts on or after the start of study medication.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'All analysis will be carried out using the safety population, defined as all subjects who received at least one dose of study medication.', 'anticipatedPostingDate': '2009-09'}, {'type': 'SECONDARY', 'title': "Physician's Global Assessment of Study Treatment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '42', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h', 'description': 'Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours'}, {'id': 'OG001', 'title': 'Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h', 'description': 'Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours'}, {'id': 'OG002', 'title': 'Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h', 'description': 'Children 2 to \\< 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours'}, {'id': 'OG003', 'title': 'Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h', 'description': 'Children 2 to \\< 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours'}, {'id': 'OG004', 'title': 'Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h', 'description': 'Adolescents 12 to \\<= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours'}, {'id': 'OG005', 'title': 'Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h', 'description': 'Adolescents 12 to \\<= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours'}, {'id': 'OG006', 'title': 'Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h', 'description': 'Infants 12 to \\< 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours'}, {'id': 'OG007', 'title': 'Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h', 'description': 'Infants 12 to \\< 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours'}], 'classes': [{'title': 'Poor', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Fair', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Good', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}, {'title': 'Excellent', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of study or Early Termination', 'description': 'Physicians were asked to evaluate the overall study treatment using a 4-point categorical evaluation scale (0= poor, 1= fair,2=good, 3= excellent).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All analysis will be carried out using the safety population, defined as all subjects who received at least one dose of study medication.', 'anticipatedPostingDate': '2009-09'}, {'type': 'PRIMARY', 'title': 'Number of Subjects Reporting at Least One Serious Treatment Emergent Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '42', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h', 'description': 'Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours'}, {'id': 'OG001', 'title': 'Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h', 'description': 'Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours'}, {'id': 'OG002', 'title': 'Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h', 'description': 'Children 2 to \\< 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours'}, {'id': 'OG003', 'title': 'Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h', 'description': 'Children 2 to \\< 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours'}, {'id': 'OG004', 'title': 'Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h', 'description': 'Adolescents 12 to \\<= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours'}, {'id': 'OG005', 'title': 'Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h', 'description': 'Adolescents 12 to \\<= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours'}, {'id': 'OG006', 'title': 'Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h', 'description': 'Infants 12 to \\< 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours'}, {'id': 'OG007', 'title': 'Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h', 'description': 'Infants 12 to \\< 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose to 30 days after last dose', 'description': 'A Serious Treatment Emergent Adverse Event is defined as any untoward medical occurrence at any dose of IV APAP that;\n\n* results in death\n* is life-threatening\n* requires inpatient hospitalization or causes prolongation of existing hospitalization\n* results in persistent or significant disability/incapacity\n* is a congenital anomaly/birth defect\n* is an important medical event', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'All analysis will be carried out using the safety population, defined as all subjects who received at least one dose of study medication.', 'anticipatedPostingDate': '2009-09'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h', 'description': 'Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours'}, {'id': 'FG001', 'title': 'Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h', 'description': 'Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours'}, {'id': 'FG002', 'title': 'Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h', 'description': 'Children 2 to \\< 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours'}, {'id': 'FG003', 'title': 'Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h', 'description': 'Children 2 to \\< 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours'}, {'id': 'FG004', 'title': 'Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h', 'description': 'Adolescents 12 to \\<= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours'}, {'id': 'FG005', 'title': 'Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h', 'description': 'Adolescents 12 to \\<= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours'}, {'id': 'FG006', 'title': 'Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h', 'description': 'Infants 12 to \\< 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours'}, {'id': 'FG007', 'title': 'Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h', 'description': 'Infants 12 to \\< 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '33'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '42'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed treatment period per requirements of protocol version under which the subject enrolled.', 'groupId': 'FG000', 'numSubjects': '1'}, {'comment': 'Completed treatment period per requirements of protocol version under which the subject enrolled.', 'groupId': 'FG001', 'numSubjects': '1'}, {'comment': 'Completed treatment period per requirements of protocol version under which the subject enrolled.', 'groupId': 'FG002', 'numSubjects': '5'}, {'comment': 'Completed treatment period per requirements of protocol version under which the subject enrolled.', 'groupId': 'FG003', 'numSubjects': '25'}, {'comment': 'Completed treatment period per requirements of protocol version under which the subject enrolled.', 'groupId': 'FG004', 'numSubjects': '6'}, {'comment': 'Completed treatment period per requirements of protocol version under which the subject enrolled.', 'groupId': 'FG005', 'numSubjects': '30'}, {'comment': 'Completed treatment period per requirements of protocol version under which the subject enrolled.', 'groupId': 'FG006', 'numSubjects': '0'}, {'comment': 'Completed treatment period per requirements of protocol version under which the subject enrolled.', 'groupId': 'FG007', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '12'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Early discharge from hospital', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '10'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Dose limiting toxicity', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Multi-center study conducted in the United States from 19 Mar 2008 - 24Dec 2008', 'preAssignmentDetails': 'No subjects were entered into the "Infants (29 days to 1 year old): IV APAP 6.7 - 12.5 mg/kg q4h" group'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '42', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '100', 'groupId': 'BG008'}]}], 'groups': [{'id': 'BG000', 'title': 'Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h', 'description': 'Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours'}, {'id': 'BG001', 'title': 'Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h', 'description': 'Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours'}, {'id': 'BG002', 'title': 'Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h', 'description': 'Children 2 to \\< 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours'}, {'id': 'BG003', 'title': 'Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h', 'description': 'Children 2 to \\< 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours'}, {'id': 'BG004', 'title': 'Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h', 'description': 'Adolescents 12 to \\<= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours'}, {'id': 'BG005', 'title': 'Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h', 'description': 'Adolescents 12 to \\<= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours'}, {'id': 'BG006', 'title': 'Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h', 'description': 'Infants 12 to \\< 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours'}, {'id': 'BG007', 'title': 'Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h', 'description': 'Infants 12 to \\< 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours'}, {'id': 'BG008', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '42', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '100', 'groupId': 'BG008'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '29', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '62', 'groupId': 'BG008'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '13', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '38', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'dispFirstSubmitDate': '2009-04-03', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-04', 'studyFirstSubmitDate': '2008-01-09', 'dispFirstSubmitQcDate': '2010-12-09', 'resultsFirstSubmitDate': '2009-09-25', 'studyFirstSubmitQcDate': '2008-01-16', 'dispFirstPostDateStruct': {'date': '2011-01-06', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-05-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-12-09', 'studyFirstPostDateStruct': {'date': '2008-01-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects Reporting at Least One Treatment Emergent Adverse Event (TEAE)', 'timeFrame': 'First dose to end of treatment period', 'description': 'A TEAE is defined as an adverse event that starts on or after the start of study medication.'}, {'measure': 'Number of Subjects Reporting at Least One Serious Treatment Emergent Adverse Event', 'timeFrame': 'First dose to 30 days after last dose', 'description': 'A Serious Treatment Emergent Adverse Event is defined as any untoward medical occurrence at any dose of IV APAP that;\n\n* results in death\n* is life-threatening\n* requires inpatient hospitalization or causes prolongation of existing hospitalization\n* results in persistent or significant disability/incapacity\n* is a congenital anomaly/birth defect\n* is an important medical event'}], 'secondaryOutcomes': [{'measure': "Subject's (Parent/Guardian) Global Evaluation of Study Treatment", 'timeFrame': 'Day 0 to Day 5, Day 7 or Early Termination from study', 'description': "Subject's (parent/guardian) was asked to evaluate the overall study treatment using a 4-point categorical evaluation scale (0= poor, 1= fair, 2=good, 3= excellent)."}, {'measure': "Physician's Global Assessment of Study Treatment", 'timeFrame': 'End of study or Early Termination', 'description': 'Physicians were asked to evaluate the overall study treatment using a 4-point categorical evaluation scale (0= poor, 1= fair,2=good, 3= excellent).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pain', 'Fever']}, 'descriptionModule': {'briefSummary': 'Intravenous acetaminophen (IVAPAP) is safe in repeated dose, multi-day clinical use when administered at a daily dose of 40 to 75 mg/kg body weight', 'detailedDescription': 'To assess the safety of intravenous acetaminophen (IV APAP) when used over one or more days for the treatment of acute pain or fever in pediatric (neonates, infants, children and adolescents) inpatients who are unable to take anything by mouth (NPO), require or would benefit from IV treatment, or are willing and able to stay on IVAPAP therapy for 1 to 7 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '37 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The Subject's Parent or Guardian must provide written informed consent, with Subject assent where appropriate, prior to the Subject's participation in the Study.\n* Be less than 17 years of age and older than 37 weeks post conception\n* Anticipated by the Investigator to require multi-day (minimum of one day) use of intravenous (IV) treatment either because of a having a status of nothing by mouth (NPO) or a medical condition that makes oral intake difficult or be willing to undergo at least 5 days of treatment with IV acetaminophen for the treatment of pain or fever\n* Have the ability to read and understand the Study procedures and have the ability to communicate meaningfully with the Study Investigator and staff (if the Subject is of preverbal age or cannot read or communicate meaningfully, then the Subject's Parent or Guardian must meet this criterion)\n* If a female of child bearing potential, have a negative pregnancy test\n\nExclusion Criteria:\n\n* Has significant medical disease(s), laboratory abnormalities or condition(s) that in the Investigator's judgment could compromise the Subject's welfare, ability to communicate with the Study staff, complete Study activities, or would otherwise contraindicate Study participation\n* Has known hypersensitivity or contraindication to receiving IV acetaminophen or the inactive ingredients (excipients) of IV acetaminophen\n* Has impaired liver function, e.g. Alanine aminotransferase (ALT) greater than or equal to 3 times the upper limit of normal (ULN), bilirubin greater than or equal to 3 times ULN, known active hepatic disease (e.g., hepatitis), evidence of clinically significant chronic liver disease or other condition affecting the liver (e.g., alcoholism as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), cirrhosis, or chronic hepatitis) that may suggest the potential for an increased susceptibility to hepatic toxicity with IV acetaminophen exposure\n* Has participated in an interventional clinical Study (investigational or marketed product) within 30 days of Study entry"}, 'identificationModule': {'nctId': 'NCT00598702', 'briefTitle': 'Study of the Safety & Efficacy of Intravenous Acetaminophen in Pediatric Inpatients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mallinckrodt'}, 'officialTitle': 'A Phase III Multi-Center, Open-Label, Prospective, Repeated Dose, Multi-Day Study of the Safety & Efficacy of Intravenous Acetaminophen in Pediatric Inpatients.', 'orgStudyIdInfo': {'id': 'CPI-APA-352'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IV Acetaminophen', 'description': '40 to 75 mg/kg/day every 4 to 6 hours', 'interventionNames': ['Drug: IV Acetaminophen']}], 'interventions': [{'name': 'IV Acetaminophen', 'type': 'DRUG', 'otherNames': ['IV APAP', 'APAP'], 'description': 'Target is 1 to 7 days of therapy with intravenous (IV) Acetaminophen (IV APAP) at a dose of 40 to 75 mg/kg body weight/day administered as an IV infusion (or by syringe pump) over 15 minutes and given every 4 to 6 hours as a scheduled dose', 'armGroupLabels': ['IV Acetaminophen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': "Lucile Salter Packard Children's Hospital at Stanford", 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '19803', 'city': 'Wilmington', 'state': 'Delaware', 'country': 'United States', 'facility': 'Alfred Dupont Hospital for Children', 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': "Children's National Medical Center", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Ann Arbor', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '65212', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'University of Missouri', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Hospital for Special Surgery', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11794', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY Stony Brook', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '77401', 'city': 'Bellaire', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Neonatal-Perinatal Physicians', 'geoPoint': {'lat': 29.70579, 'lon': -95.45883}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mallinckrodt', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}