Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2026-01-29 @ 5:33 PM
Study NCT ID:
NCT03177395
Status:
COMPLETED
Last Update Posted:
2019-10-03
First Post:
2017-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
PP100-01 (Calmangafodipir) for Overdose of Paracetamol
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C060076', 'term': "N,N'-bis(pyridoxal-5-phosphate)ethylenediamine-N,N'-diacetic acid"}, {'id': 'D000111', 'term': 'Acetylcysteine'}], 'ancestors': [{'id': 'D003545', 'term': 'Cysteine'}, {'id': 'D000603', 'term': 'Amino Acids, Sulfur'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'james.dear@ed.ac.uk', 'phone': '+44(0)131 242 9214', 'title': 'Dr James Dear', 'organization': 'Pharmacology, Therapeutics and Toxicology Unit, Centre for Cardiovascular Science, University of Edinburgh, UK'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events / adverse reactions were assessed at baseline, 2, 2.5, 10, 20 and 22 hours as well as ad hoc and as part of follow up. Following discharge, patients were followed up using their electronic records. AE data were collected 7, 30 and 90 days after randomisation', 'eventGroups': [{'id': 'EG000', 'title': 'Acetylcysteine (N-acetylcysteine; NAC)', 'description': "NAC infusion 100mg/kg in 200ml 'loading dose' at timepoint '0'. 12 hour NAC regime will be continued with the second dose: 200mg/kg NAC in 1000ml i.v. over 10hr as per standard care protocol in NHS Lothian.", 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 (10 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Otitis externa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Alcohol withdrawal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiration abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'heart block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Retching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypoaethesia oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tubo-ovarian abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Soft tissue injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'ntentional product misuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'substance abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'cardiac disorders', 'notes': 'Chest tightnes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastrointestinal disorders', 'notes': 'Nausea, vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Infections and infestations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injury, poisoning and procedural complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nervous system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Psychiatric disorders', 'notes': 'depressive episode;, mental health crisis;mental health issue (11006)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vascular disorders', 'notes': 'seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Safety Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetylcysteine (N-acetylcysteine; NAC)', 'description': "NAC infusion 100mg/kg in 200ml 'loading dose' at timepoint '0'. 12 hour NAC regime will be continued with the second dose: 200mg/kg NAC in 1000ml i.v. over 10hr as per standard care protocol in NHS Lothian."}, {'id': 'OG001', 'title': 'Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}, {'id': 'OG002', 'title': 'Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\n* Group A: PP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC PP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC\n* Group C: PP100-01 (10 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}, {'id': 'OG003', 'title': 'Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (10 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}], 'classes': [{'title': 'Any Adverse event', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Any serious adverse event', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Adverse event after commencement of NAC treatment', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Serious AE after commencement of NAC treatment', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Adverse event where outcome was death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Adverse event unrelated to NAC', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Adverse event possibly related to NAC', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Adverse event probably related to NAC', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Adverse event definitely related to NAC', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Adverse event unrelated to PP100-01', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Adverse event possibly related to PP100-01', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Adverse event probably related to PP100-01', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Adverse event definitely related to PP100-01', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Any suspected unexpected serious adverse reaction', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'SUSAR to NAC', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'SUSAR to PP100-01', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'SUSAR to NAC and PP100-01', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '90 days', 'description': 'Adverse Events and Serious Adverse Events', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'In addition to paracetamol overdose, 19 out of the 24 randomised participants reported taking overdoses of other medicines in addition to the paracetamol. All treatment groups included participants with paracetamol only overdoses and mixed overdoses'}, {'type': 'SECONDARY', 'title': 'ALT(U/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetylcysteine (N-acetylcysteine; NAC)', 'description': "NAC infusion 100mg/kg in 200ml 'loading dose' at timepoint '0'. 12 hour NAC regime will be continued with the second dose: 200mg/kg NAC in 1000ml i.v. over 10hr as per standard care protocol in NHS Lothian."}, {'id': 'OG001', 'title': 'Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}, {'id': 'OG002', 'title': 'Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}, {'id': 'OG003', 'title': 'Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 (10 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}], 'classes': [{'categories': [{'measurements': [{'value': '42.5', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '24.6', 'spread': '2.1', 'groupId': 'OG001'}, {'value': '29.4', 'spread': '2.3', 'groupId': 'OG002'}, {'value': '17.7', 'spread': '1.5', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline', 'description': 'The alanine aminotransferase (ALT) test is a blood test that checks for liver damage.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'ALT(U/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetylcysteine (N-acetylcysteine; NAC)', 'description': "NAC infusion 100mg/kg in 200ml 'loading dose' at timepoint '0'. 12 hour NAC regime will be continued with the second dose: 200mg/kg NAC in 1000ml i.v. over 10hr as per standard care protocol in NHS Lothian."}, {'id': 'OG001', 'title': 'Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}, {'id': 'OG002', 'title': 'Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}, {'id': 'OG003', 'title': 'Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 (10 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}], 'classes': [{'categories': [{'measurements': [{'value': '41.4', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '22.9', 'spread': '1.8', 'groupId': 'OG001'}, {'value': '25.3', 'spread': '2.1', 'groupId': 'OG002'}, {'value': '15.0', 'spread': '1.3', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '10 hours', 'description': 'The alanine aminotransferase (ALT) test is a blood test that checks for liver damage.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All 24 participants received the full dose of PP100-01 according to the allocated dosing cohort, all participants received as a minimum 12 hours of NAC treatment (loading dose, plus further 10 hours). For both PP100-01 and NAC total dose was adjusted according to participant weight'}, {'type': 'SECONDARY', 'title': 'ALT(U/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetylcysteine (N-acetylcysteine; NAC)', 'description': "NAC infusion 100mg/kg in 200ml 'loading dose' at timepoint '0'. 12 hour NAC regime will be continued with the second dose: 200mg/kg NAC in 1000ml i.v. over 10hr as per standard care protocol in NHS Lothian."}, {'id': 'OG001', 'title': 'Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}, {'id': 'OG002', 'title': 'Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}, {'id': 'OG003', 'title': 'Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 (10 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}], 'classes': [{'categories': [{'measurements': [{'value': '43.3', 'spread': '3.8', 'groupId': 'OG000'}, {'value': '20.4', 'spread': '1.9', 'groupId': 'OG001'}, {'value': '25.4', 'spread': '1.8', 'groupId': 'OG002'}, {'value': '16.4', 'spread': '1.5', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '20 hours', 'description': 'The alanine aminotransferase (ALT) test is a blood test that checks for liver damage.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All 24 participants received the full dose of PP100-01 according to the allocated dosing cohort, all participants received as a minimum 12 hours of NAC treatment (loading dose, plus further 10 hours). For both PP100-01 and NAC total dose was adjusted according to participant weight'}, {'type': 'SECONDARY', 'title': 'INR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetylcysteine (N-acetylcysteine; NAC)', 'description': "NAC infusion 100mg/kg in 200ml 'loading dose' at timepoint '0'. 12 hour NAC regime will be continued with the second dose: 200mg/kg NAC in 1000ml i.v. over 10hr as per standard care protocol in NHS Lothian."}, {'id': 'OG001', 'title': 'Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}, {'id': 'OG002', 'title': 'Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}, {'id': 'OG003', 'title': 'Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 (10 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}], 'classes': [{'categories': [{'measurements': [{'value': '1.02', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '0.12', 'groupId': 'OG001'}, {'value': '0.98', 'spread': '0.04', 'groupId': 'OG002'}, {'value': '1.05', 'spread': '0.14', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'international normalised ratio (INR) characterise acute liver injury (ALI) and failure (ALF)', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All 24 participants received the full dose of PP100-01 according to the allocated dosing cohort, all participants received as a minimum 12 hours of NAC treatment (loading dose, plus further 10 hours). For both PP100-01 and NAC total dose was adjusted according to participant weight'}, {'type': 'SECONDARY', 'title': 'INR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetylcysteine (N-acetylcysteine; NAC)', 'description': "NAC infusion 100mg/kg in 200ml 'loading dose' at timepoint '0'. 12 hour NAC regime will be continued with the second dose: 200mg/kg NAC in 1000ml i.v. over 10hr as per standard care protocol in NHS Lothian."}, {'id': 'OG001', 'title': 'Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}, {'id': 'OG002', 'title': 'Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}, {'id': 'OG003', 'title': 'Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 (10 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}], 'classes': [{'categories': [{'measurements': [{'value': '1.30', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '1.17', 'spread': '0.20', 'groupId': 'OG001'}, {'value': '1.20', 'spread': '0.00', 'groupId': 'OG002'}, {'value': '1.22', 'spread': '0.25', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 hours', 'description': 'international normalised ratio (INR) characterise acute liver injury (ALI) and failure (ALF)', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'INR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetylcysteine (N-acetylcysteine; NAC)', 'description': "NAC infusion 100mg/kg in 200ml 'loading dose' at timepoint '0'. 12 hour NAC regime will be continued with the second dose: 200mg/kg NAC in 1000ml i.v. over 10hr as per standard care protocol in NHS Lothian."}, {'id': 'OG001', 'title': 'Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}, {'id': 'OG002', 'title': 'Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}, {'id': 'OG003', 'title': 'Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 (10 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}], 'classes': [{'categories': [{'measurements': [{'value': '1.18', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '1.07', 'spread': '0.19', 'groupId': 'OG001'}, {'value': '1.08', 'spread': '0.04', 'groupId': 'OG002'}, {'value': '1.22', 'spread': '1.17', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '20 hours', 'description': 'international normalised ratio (INR) characterise acute liver injury (ALI) and failure (ALF)', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'INR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetylcysteine (N-acetylcysteine; NAC)', 'description': "NAC infusion 100mg/kg in 200ml 'loading dose' at timepoint '0'. 12 hour NAC regime will be continued with the second dose: 200mg/kg NAC in 1000ml i.v. over 10hr as per standard care protocol in NHS Lothian."}, {'id': 'OG001', 'title': 'Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}, {'id': 'OG002', 'title': 'Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}, {'id': 'OG003', 'title': 'Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 (10 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}], 'classes': [{'categories': [{'measurements': [{'value': '1.15', 'spread': '1.17', 'groupId': 'OG000'}, {'value': '1.07', 'spread': '1.12', 'groupId': 'OG001'}, {'value': '1.10', 'spread': '1.07', 'groupId': 'OG002'}, {'value': '1.10', 'spread': '1.10', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'value at 20 hours divided by baseline value for each patient', 'description': 'international normalised ratio (INR) characterise acute liver injury (ALI) and failure (ALF)', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Additional NAC Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetylcysteine (N-acetylcysteine; NAC)', 'description': "NAC infusion 100mg/kg in 200ml 'loading dose' at timepoint '0'. 12 hour NAC regime will be continued with the second dose: 200mg/kg NAC in 1000ml i.v. over 10hr as per standard care protocol in NHS Lothian."}, {'id': 'OG001', 'title': 'Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}, {'id': 'OG002', 'title': 'Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}, {'id': 'OG003', 'title': 'Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 (10 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}], 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'One', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Two', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Additional NAC at 12 hour', 'description': 'participants required additional NAC infusions after the 12-hour NAC regimen', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'K18 (U/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetylcysteine (N-acetylcysteine; NAC)', 'description': "NAC infusion 100mg/kg in 200ml 'loading dose' at timepoint '0'. 12 hour NAC regime will be continued with the second dose: 200mg/kg NAC in 1000ml i.v. over 10hr as per standard care protocol in NHS Lothian."}, {'id': 'OG001', 'title': 'Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}, {'id': 'OG002', 'title': 'Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}, {'id': 'OG003', 'title': 'Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 (10 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}], 'classes': [{'categories': [{'measurements': [{'value': '187', 'spread': '2.20', 'groupId': 'OG000'}, {'value': '177', 'spread': '1.82', 'groupId': 'OG001'}, {'value': '193', 'spread': '1.56', 'groupId': 'OG002'}, {'value': '128', 'spread': '1.25', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (2 hours)', 'description': 'In paracetamol overdose, the full-length variant of Keratin-18 (K-18) is released by necrotic hepatocyte death.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'K18(U/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetylcysteine (N-acetylcysteine; NAC)', 'description': "NAC infusion 100mg/kg in 200ml 'loading dose' at timepoint '0'. 12 hour NAC regime will be continued with the second dose: 200mg/kg NAC in 1000ml i.v. over 10hr as per standard care protocol in NHS Lothian."}, {'id': 'OG001', 'title': 'Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}, {'id': 'OG002', 'title': 'Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}, {'id': 'OG003', 'title': 'Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 (10 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}], 'classes': [{'categories': [{'measurements': [{'value': '182', 'spread': '1.95', 'groupId': 'OG000'}, {'value': '152', 'spread': '1.56', 'groupId': 'OG001'}, {'value': '170', 'spread': '1.42', 'groupId': 'OG002'}, {'value': '111', 'spread': '1.18', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '10 hours', 'description': 'In paracetamol overdose, the full-length variant of Keratin-18 (K-18) is released by necrotic hepatocyte death.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'K18 (U/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetylcysteine (N-acetylcysteine; NAC)', 'description': "NAC infusion 100mg/kg in 200ml 'loading dose' at timepoint '0'. 12 hour NAC regime will be continued with the second dose: 200mg/kg NAC in 1000ml i.v. over 10hr as per standard care protocol in NHS Lothian."}, {'id': 'OG001', 'title': 'Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}, {'id': 'OG002', 'title': 'Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}, {'id': 'OG003', 'title': 'Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 (10 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}], 'classes': [{'categories': [{'measurements': [{'value': '347', 'spread': '3.18', 'groupId': 'OG000'}, {'value': '229', 'spread': '1.94', 'groupId': 'OG001'}, {'value': '172', 'spread': '1.45', 'groupId': 'OG002'}, {'value': '181', 'spread': '1.73', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '20 hours', 'description': 'In paracetamol overdose, the full-length variant of Keratin-18 (K-18) is released by necrotic hepatocyte death.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'K18 (U/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetylcysteine (N-acetylcysteine; NAC)', 'description': "NAC infusion 100mg/kg in 200ml 'loading dose' at timepoint '0'. 12 hour NAC regime will be continued with the second dose: 200mg/kg NAC in 1000ml i.v. over 10hr as per standard care protocol in NHS Lothian."}, {'id': 'OG001', 'title': 'Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}, {'id': 'OG002', 'title': 'Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}, {'id': 'OG003', 'title': 'Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 (10 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}], 'classes': [{'categories': [{'measurements': [{'value': '1.85', 'spread': '1.47', 'groupId': 'OG000'}, {'value': '1.29', 'spread': '1.89', 'groupId': 'OG001'}, {'value': '0.89', 'spread': '1.57', 'groupId': 'OG002'}, {'value': '1.41', 'spread': '1.83', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Ratio - value at 20 hours divided by baseline value for each patient', 'description': 'In paracetamol overdose, the full-length variant of Keratin-18 (K-18) is released by necrotic hepatocyte death.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'ccK18 (U/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetylcysteine (N-acetylcysteine; NAC)', 'description': "NAC infusion 100mg/kg in 200ml 'loading dose' at timepoint '0'. 12 hour NAC regime will be continued with the second dose: 200mg/kg NAC in 1000ml i.v. over 10hr as per standard care protocol in NHS Lothian."}, {'id': 'OG001', 'title': 'Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}, {'id': 'OG002', 'title': 'Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}, {'id': 'OG003', 'title': 'Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 (10 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}], 'classes': [{'categories': [{'measurements': [{'value': '67', 'spread': '1.99', 'groupId': 'OG000'}, {'value': '45', 'spread': '1.33', 'groupId': 'OG001'}, {'value': '84', 'spread': '1.80', 'groupId': 'OG002'}, {'value': '104', 'spread': '2.44', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (2 hours)', 'description': 'The shorter, Caspase cleaved form of K-18 is released following hepatocyte apoptosis (programmed cell death).', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'ccK18 (U/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetylcysteine (N-acetylcysteine; NAC)', 'description': "NAC infusion 100mg/kg in 200ml 'loading dose' at timepoint '0'. 12 hour NAC regime will be continued with the second dose: 200mg/kg NAC in 1000ml i.v. over 10hr as per standard care protocol in NHS Lothian."}, {'id': 'OG001', 'title': 'Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}, {'id': 'OG002', 'title': 'Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}, {'id': 'OG003', 'title': 'Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 (10 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}], 'classes': [{'categories': [{'measurements': [{'value': '72', 'spread': '2.24', 'groupId': 'OG000'}, {'value': '53', 'spread': '1.25', 'groupId': 'OG001'}, {'value': '56', 'spread': '1.57', 'groupId': 'OG002'}, {'value': '78', 'spread': '2.12', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '10 hours', 'description': 'The shorter, Caspase cleaved form of K-18 is released following hepatocyte apoptosis (programmed cell death).', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'ccK18 (U/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetylcysteine (N-acetylcysteine; NAC)', 'description': "NAC infusion 100mg/kg in 200ml 'loading dose' at timepoint '0'. 12 hour NAC regime will be continued with the second dose: 200mg/kg NAC in 1000ml i.v. over 10hr as per standard care protocol in NHS Lothian."}, {'id': 'OG001', 'title': 'Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}, {'id': 'OG002', 'title': 'Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}, {'id': 'OG003', 'title': 'Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 (10 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}], 'classes': [{'categories': [{'measurements': [{'value': '149', 'spread': '3.34', 'groupId': 'OG000'}, {'value': '66', 'spread': '1.34', 'groupId': 'OG001'}, {'value': '85', 'spread': '1.62', 'groupId': 'OG002'}, {'value': '111', 'spread': '2.56', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '20 hours', 'description': 'The shorter, Caspase cleaved form of K-18 is released following hepatocyte apoptosis (programmed cell death).', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'ccK18 (U/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetylcysteine (N-acetylcysteine; NAC)', 'description': "NAC infusion 100mg/kg in 200ml 'loading dose' at timepoint '0'. 12 hour NAC regime will be continued with the second dose: 200mg/kg NAC in 1000ml i.v. over 10hr as per standard care protocol in NHS Lothian."}, {'id': 'OG001', 'title': 'Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}, {'id': 'OG002', 'title': 'Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}, {'id': 'OG003', 'title': 'Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 (10 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}], 'classes': [{'categories': [{'measurements': [{'value': '2.22', 'spread': '1.77', 'groupId': 'OG000'}, {'value': '1.49', 'spread': '1.55', 'groupId': 'OG001'}, {'value': '1.02', 'spread': '1.79', 'groupId': 'OG002'}, {'value': '1.08', 'spread': '2.44', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Ratio - value at 20 hours divided by baseline value for each patient', 'description': 'Caspace-cleaved Keratin-18', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'miR-122 (Delta Count)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetylcysteine (N-acetylcysteine; NAC)', 'description': "NAC infusion 100mg/kg in 200ml 'loading dose' at timepoint '0'. 12 hour NAC regime will be continued with the second dose: 200mg/kg NAC in 1000ml i.v. over 10hr as per standard care protocol in NHS Lothian."}, {'id': 'OG001', 'title': 'Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}, {'id': 'OG002', 'title': 'Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}, {'id': 'OG003', 'title': 'Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 (10 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}], 'classes': [{'categories': [{'measurements': [{'value': '5.58', 'spread': '3.36', 'groupId': 'OG000'}, {'value': '5.85', 'spread': '1.50', 'groupId': 'OG001'}, {'value': '4.43', 'spread': '3.92', 'groupId': 'OG002'}, {'value': '8.73', 'spread': '2.36', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (2 hours)', 'description': 'MiR-122 is a biomarker specific for liver injury and fully conserved (translational) across in vitro models, in vivo models and humans. MiR-122 is an early marker for acute liver injury which predicts a rise in ALT activity following paracetamol overdose', 'unitOfMeasure': 'DCt', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'miR-122 (Delta Count)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetylcysteine (N-acetylcysteine; NAC)', 'description': "NAC infusion 100mg/kg in 200ml 'loading dose' at timepoint '0'. 12 hour NAC regime will be continued with the second dose: 200mg/kg NAC in 1000ml i.v. over 10hr as per standard care protocol in NHS Lothian."}, {'id': 'OG001', 'title': 'Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}, {'id': 'OG002', 'title': 'Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}, {'id': 'OG003', 'title': 'Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 (10 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}], 'classes': [{'categories': [{'measurements': [{'value': '5.41', 'spread': '3.86', 'groupId': 'OG000'}, {'value': '6.14', 'spread': '1.99', 'groupId': 'OG001'}, {'value': '5.01', 'spread': '3.36', 'groupId': 'OG002'}, {'value': '9.00', 'spread': '1.45', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 hours', 'description': 'MiR-122 is a biomarker specific for liver injury and fully conserved (translational) across in vitro models, in vivo models and humans. MiR-122 is an early marker for acute liver injury which predicts a rise in ALT activity following paracetamol overdose', 'unitOfMeasure': 'DCt', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'miR-122 (Delta Count)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetylcysteine (N-acetylcysteine; NAC)', 'description': "NAC infusion 100mg/kg in 200ml 'loading dose' at timepoint '0'. 12 hour NAC regime will be continued with the second dose: 200mg/kg NAC in 1000ml i.v. over 10hr as per standard care protocol in NHS Lothian."}, {'id': 'OG001', 'title': 'Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}, {'id': 'OG002', 'title': 'Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}, {'id': 'OG003', 'title': 'Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 (10 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}], 'classes': [{'categories': [{'measurements': [{'value': '4.85', 'spread': '3.97', 'groupId': 'OG000'}, {'value': '7.12', 'spread': '2.26', 'groupId': 'OG001'}, {'value': '4.49', 'spread': '2.93', 'groupId': 'OG002'}, {'value': '8.44', 'spread': '1.50', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '20 hours', 'description': 'MiR-122 is a biomarker specific for liver injury and fully conserved (translational) across in vitro models, in vivo models and humans. MiR-122 is an early marker for acute liver injury which predicts a rise in ALT activity following paracetamol overdose', 'unitOfMeasure': 'DCt', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'miR-122 (Copies/mcL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetylcysteine (N-acetylcysteine; NAC)', 'description': "NAC infusion 100mg/kg in 200ml 'loading dose' at timepoint '0'. 12 hour NAC regime will be continued with the second dose: 200mg/kg NAC in 1000ml i.v. over 10hr as per standard care protocol in NHS Lothian."}, {'id': 'OG001', 'title': 'Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}, {'id': 'OG002', 'title': 'Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}, {'id': 'OG003', 'title': 'Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 (10 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}], 'classes': [{'categories': [{'measurements': [{'value': '146,363', 'spread': '11.7', 'groupId': 'OG000'}, {'value': '116,749', 'spread': '2.4', 'groupId': 'OG001'}, {'value': '194,075', 'spread': '13.5', 'groupId': 'OG002'}, {'value': '36,051', 'spread': '3.9', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (2 h)', 'description': 'MiR-122 is a biomarker specific for liver injury and fully conserved (translational) across in vitro models, in vivo models and humans. MiR-122 is an early marker for acute liver injury which predicts a rise in ALT activity following paracetamol overdose', 'unitOfMeasure': 'copies/mcL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'miR-122(Copies/mcL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetylcysteine (N-acetylcysteine; NAC)', 'description': "NAC infusion 100mg/kg in 200ml 'loading dose' at timepoint '0'. 12 hour NAC regime will be continued with the second dose: 200mg/kg NAC in 1000ml i.v. over 10hr as per standard care protocol in NHS Lothian."}, {'id': 'OG001', 'title': 'Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}, {'id': 'OG002', 'title': 'Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}, {'id': 'OG003', 'title': 'Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 (10 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}], 'classes': [{'categories': [{'measurements': [{'value': '206,205', 'spread': '13.0', 'groupId': 'OG000'}, {'value': '109,882', 'spread': '3.3', 'groupId': 'OG001'}, {'value': '196,732', 'spread': '9.4', 'groupId': 'OG002'}, {'value': '37,066', 'spread': '2.2', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '10 hours', 'description': 'MiR-122 is a biomarker specific for liver injury and fully conserved (translational) across in vitro models, in vivo models and humans. MiR-122 is an early marker for acute liver injury which predicts a rise in ALT activity following paracetamol overdose', 'unitOfMeasure': 'copies/mcL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'miR-122 (Copies/mcL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetylcysteine (N-acetylcysteine; NAC)', 'description': "NAC infusion 100mg/kg in 200ml 'loading dose' at timepoint '0'. 12 hour NAC regime will be continued with the second dose: 200mg/kg NAC in 1000ml i.v. over 10hr as per standard care protocol in NHS Lothian."}, {'id': 'OG001', 'title': 'Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}, {'id': 'OG002', 'title': 'Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}, {'id': 'OG003', 'title': 'Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 (10 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}], 'classes': [{'categories': [{'measurements': [{'value': '216,256', 'spread': '10.8', 'groupId': 'OG000'}, {'value': '57,664', 'spread': '3.8', 'groupId': 'OG001'}, {'value': '202,271', 'spread': '7.7', 'groupId': 'OG002'}, {'value': '40,745', 'spread': '3.2', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '20 hours', 'description': 'MiR-122 is a biomarker specific for liver injury and fully conserved (translational) across in vitro models, in vivo models and humans. MiR-122 is an early marker for acute liver injury which predicts a rise in ALT activity following paracetamol overdose', 'unitOfMeasure': 'copies/mcL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'miR-122 (Copies/mcL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetylcysteine (N-acetylcysteine; NAC)', 'description': "NAC infusion 100mg/kg in 200ml 'loading dose' at timepoint '0'. 12 hour NAC regime will be continued with the second dose: 200mg/kg NAC in 1000ml i.v. over 10hr as per standard care protocol in NHS Lothian."}, {'id': 'OG001', 'title': 'Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}, {'id': 'OG002', 'title': 'Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}, {'id': 'OG003', 'title': 'Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 (10 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}], 'classes': [{'categories': [{'measurements': [{'value': '1.48', 'spread': '5.71', 'groupId': 'OG000'}, {'value': '0.49', 'spread': '1.98', 'groupId': 'OG001'}, {'value': '1.04', 'spread': '8.28', 'groupId': 'OG002'}, {'value': '1.13', 'spread': '2.96', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Ratio - value at 20 hours divided by baseline value for each patient', 'description': 'MiR-122 is a biomarker specific for liver injury and fully conserved (translational) across in vitro models, in vivo models and humans. MiR-122 is an early marker for acute liver injury which predicts a rise in ALT activity following paracetamol overdose', 'unitOfMeasure': 'copies/mcL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Acetylcysteine (N-acetylcysteine; NAC)', 'description': "NAC infusion 100mg/kg in 200ml 'loading dose' at timepoint '0'. 12 hour NAC regime will be continued with the second dose: 200mg/kg NAC in 1000ml i.v. over 10hr as per standard care protocol in NHS Lothian."}, {'id': 'FG001', 'title': 'Group A: PP100-01 (Calmangafodipir 2 μmol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (2 μmol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.'}, {'id': 'FG002', 'title': 'Group B: PP100-01 (Calmangafodipir 5 μmol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (5 μmol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.'}, {'id': 'FG003', 'title': 'Group C: PP100-01 (Calmangafodipir 10 μmol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (10 μmol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Studied period: 05 June 2017 to 08 August 2018 Study centres: Edinburgh Clinical Trials Unit (ECTU) The Emergency Medicine Research Group Edinburgh (EMERGE)', 'preAssignmentDetails': 'Adults within 24 h of a paracetamol overdose that required NAC. Within each of 3 sequential cohorts, participants were randomly assigned, with concealed allocation, to NAC and a single intravenous calmangafodipir dose (n=6/dose) or NAC alone (n=2). Calmangafodipir doses were 2, 5, or 10 μmol/kg. Participants, study and clinical teams not blinded'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Acetylcysteine (N-acetylcysteine; NAC)', 'description': "NAC infusion 100mg/kg in 200ml 'loading dose' at timepoint '0'. 12 hour NAC regime will be continued with the second dose: 200mg/kg NAC in 1000ml i.v. over 10hr as per standard care protocol in NHS Lothian."}, {'id': 'BG001', 'title': 'Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}, {'id': 'BG002', 'title': 'Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\nPP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}, {'id': 'BG003', 'title': 'Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\n• Group B: PP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 (10 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.\n\nPP100-01 (calmangafodipir): PP100-01'}, {'id': 'BG004', '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'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.2', 'spread': '12.5', 'groupId': 'BG000'}, {'value': '42.5', 'spread': '13.1', 'groupId': 'BG001'}, {'value': '42.7', 'spread': '12.7', 'groupId': 'BG002'}, {'value': '22.7', 'spread': '3.3', 'groupId': 'BG003'}, {'value': '35.0', 'spread': '13.4', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Time from ingestion of paracetamol to hospital presentation', 'classes': [{'categories': [{'measurements': [{'value': '8.8', 'spread': '6.2', 'groupId': 'BG000'}, {'value': '6.0', 'spread': '6.2', 'groupId': 'BG001'}, {'value': '5.8', 'spread': '7.2', 'groupId': 'BG002'}, {'value': '4.9', 'spread': '5.2', 'groupId': 'BG003'}, {'value': '6.4', 'spread': '6.2', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'hours', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Type of overdose', 'classes': [{'title': 'Acute, ≤8 h to NAC', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}]}]}, {'title': 'Acute, >8 h to NAC', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}]}, {'title': 'Staggered intentional', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'Supra-therapeutic', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Presentation paracetamol concentration', 'classes': [{'categories': [{'measurements': [{'value': '76', 'spread': '81', 'groupId': 'BG000'}, {'value': '127', 'spread': '90', 'groupId': 'BG001'}, {'value': '74', 'spread': '44', 'groupId': 'BG002'}, {'value': '127', 'spread': '47', 'groupId': 'BG003'}, {'value': '101', 'spread': '66', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total paracetamol ingested', 'classes': [{'categories': [{'measurements': [{'value': '185', 'spread': '156', 'groupId': 'BG000'}, {'value': '235', 'spread': '77', 'groupId': 'BG001'}, {'value': '229', 'spread': '72', 'groupId': 'BG002'}, {'value': '397', 'spread': '476', 'groupId': 'BG003'}, {'value': '262', 'spread': '195', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Time from ingestion of paracetamol to start of NAC treatment', 'classes': [{'categories': [{'measurements': [{'value': '12.1', 'spread': '5.2', 'groupId': 'BG000'}, {'value': '9.8', 'spread': '6.5', 'groupId': 'BG001'}, {'value': '10.2', 'spread': '6.9', 'groupId': 'BG002'}, {'value': '8.6', 'spread': '4.1', 'groupId': 'BG003'}, {'value': '10.2', 'spread': '5.7', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'hours', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Time from ingestion of paracetamol to start of calmangafodipir', 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No IMP given', 'groupId': 'BG000'}, {'value': '12.6', 'spread': '6.8', 'groupId': 'BG001'}, {'value': '10.8', 'spread': '4.1', 'groupId': 'BG002'}, {'value': '11.8', 'spread': '5.4', 'groupId': 'BG003'}, {'value': '11.7', 'spread': '5.4', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'hours', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Any other drug ingested', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Serum creatinine', 'classes': [{'categories': [{'measurements': [{'value': '74.7', 'spread': '11.0', 'groupId': 'BG000'}, {'value': '67.5', 'spread': '13.3', 'groupId': 'BG001'}, {'value': '67.3', 'spread': '17.2', 'groupId': 'BG002'}, {'value': '69.5', 'spread': '13.1', 'groupId': 'BG003'}, {'value': '69.8', 'spread': '13.6', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'μmol/L', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All 24 participants randomised to the study. All participants received the full dose of PP100-01 according to the allocated dosing cohort where randomised to PP100-01 treatment and all participants received as a minimum 12 hours of NAC treatment (loading dose, plus further 10 hours). Total dose was adjusted according to participant weight'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-06-28', 'size': 860140, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-09-10T03:07', 'hasProtocol': True}, {'date': '2018-08-29', 'size': 458702, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-09-10T03:09', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2018-11-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-10', 'studyFirstSubmitDate': '2017-05-23', 'resultsFirstSubmitDate': '2019-07-30', 'studyFirstSubmitQcDate': '2017-06-02', 'lastUpdatePostDateStruct': {'date': '2019-10-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-10', 'studyFirstPostDateStruct': {'date': '2017-06-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety Events', 'timeFrame': '90 days', 'description': 'Adverse Events and Serious Adverse Events'}], 'secondaryOutcomes': [{'measure': 'ALT(U/L)', 'timeFrame': 'Baseline', 'description': 'The alanine aminotransferase (ALT) test is a blood test that checks for liver damage.'}, {'measure': 'ALT(U/L)', 'timeFrame': '10 hours', 'description': 'The alanine aminotransferase (ALT) test is a blood test that checks for liver damage.'}, {'measure': 'ALT(U/L)', 'timeFrame': '20 hours', 'description': 'The alanine aminotransferase (ALT) test is a blood test that checks for liver damage.'}, {'measure': 'INR', 'timeFrame': 'Baseline', 'description': 'international normalised ratio (INR) characterise acute liver injury (ALI) and failure (ALF)'}, {'measure': 'INR', 'timeFrame': '10 hours', 'description': 'international normalised ratio (INR) characterise acute liver injury (ALI) and failure (ALF)'}, {'measure': 'INR', 'timeFrame': '20 hours', 'description': 'international normalised ratio (INR) characterise acute liver injury (ALI) and failure (ALF)'}, {'measure': 'INR', 'timeFrame': 'value at 20 hours divided by baseline value for each patient', 'description': 'international normalised ratio (INR) characterise acute liver injury (ALI) and failure (ALF)'}, {'measure': 'Additional NAC Infusion', 'timeFrame': 'Additional NAC at 12 hour', 'description': 'participants required additional NAC infusions after the 12-hour NAC regimen'}, {'measure': 'K18 (U/L)', 'timeFrame': 'Baseline (2 hours)', 'description': 'In paracetamol overdose, the full-length variant of Keratin-18 (K-18) is released by necrotic hepatocyte death.'}, {'measure': 'K18(U/L)', 'timeFrame': '10 hours', 'description': 'In paracetamol overdose, the full-length variant of Keratin-18 (K-18) is released by necrotic hepatocyte death.'}, {'measure': 'K18 (U/L)', 'timeFrame': '20 hours', 'description': 'In paracetamol overdose, the full-length variant of Keratin-18 (K-18) is released by necrotic hepatocyte death.'}, {'measure': 'K18 (U/L)', 'timeFrame': 'Ratio - value at 20 hours divided by baseline value for each patient', 'description': 'In paracetamol overdose, the full-length variant of Keratin-18 (K-18) is released by necrotic hepatocyte death.'}, {'measure': 'ccK18 (U/L)', 'timeFrame': 'Baseline (2 hours)', 'description': 'The shorter, Caspase cleaved form of K-18 is released following hepatocyte apoptosis (programmed cell death).'}, {'measure': 'ccK18 (U/L)', 'timeFrame': '10 hours', 'description': 'The shorter, Caspase cleaved form of K-18 is released following hepatocyte apoptosis (programmed cell death).'}, {'measure': 'ccK18 (U/L)', 'timeFrame': '20 hours', 'description': 'The shorter, Caspase cleaved form of K-18 is released following hepatocyte apoptosis (programmed cell death).'}, {'measure': 'ccK18 (U/L)', 'timeFrame': 'Ratio - value at 20 hours divided by baseline value for each patient', 'description': 'Caspace-cleaved Keratin-18'}, {'measure': 'miR-122 (Delta Count)', 'timeFrame': 'Baseline (2 hours)', 'description': 'MiR-122 is a biomarker specific for liver injury and fully conserved (translational) across in vitro models, in vivo models and humans. MiR-122 is an early marker for acute liver injury which predicts a rise in ALT activity following paracetamol overdose'}, {'measure': 'miR-122 (Delta Count)', 'timeFrame': '10 hours', 'description': 'MiR-122 is a biomarker specific for liver injury and fully conserved (translational) across in vitro models, in vivo models and humans. MiR-122 is an early marker for acute liver injury which predicts a rise in ALT activity following paracetamol overdose'}, {'measure': 'miR-122 (Delta Count)', 'timeFrame': '20 hours', 'description': 'MiR-122 is a biomarker specific for liver injury and fully conserved (translational) across in vitro models, in vivo models and humans. MiR-122 is an early marker for acute liver injury which predicts a rise in ALT activity following paracetamol overdose'}, {'measure': 'miR-122 (Copies/mcL)', 'timeFrame': 'Baseline (2 h)', 'description': 'MiR-122 is a biomarker specific for liver injury and fully conserved (translational) across in vitro models, in vivo models and humans. MiR-122 is an early marker for acute liver injury which predicts a rise in ALT activity following paracetamol overdose'}, {'measure': 'miR-122(Copies/mcL)', 'timeFrame': '10 hours', 'description': 'MiR-122 is a biomarker specific for liver injury and fully conserved (translational) across in vitro models, in vivo models and humans. MiR-122 is an early marker for acute liver injury which predicts a rise in ALT activity following paracetamol overdose'}, {'measure': 'miR-122 (Copies/mcL)', 'timeFrame': '20 hours', 'description': 'MiR-122 is a biomarker specific for liver injury and fully conserved (translational) across in vitro models, in vivo models and humans. MiR-122 is an early marker for acute liver injury which predicts a rise in ALT activity following paracetamol overdose'}, {'measure': 'miR-122 (Copies/mcL)', 'timeFrame': 'Ratio - value at 20 hours divided by baseline value for each patient', 'description': 'MiR-122 is a biomarker specific for liver injury and fully conserved (translational) across in vitro models, in vivo models and humans. MiR-122 is an early marker for acute liver injury which predicts a rise in ALT activity following paracetamol overdose'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Paracetamol Overdose']}, 'referencesModule': {'references': [{'pmid': '31311721', 'type': 'DERIVED', 'citation': "Morrison EE, Oatey K, Gallagher B, Grahamslaw J, O'Brien R, Black P, Oosthuyzen W, Lee RJ, Weir CJ, Henriksen D, Dear JW; POP Trial Investigators. Principal results of a randomised open label exploratory, safety and tolerability study with calmangafodipir in patients treated with a 12 h regimen of N-acetylcysteine for paracetamol overdose (POP trial). EBioMedicine. 2019 Aug;46:423-430. doi: 10.1016/j.ebiom.2019.07.013. Epub 2019 Jul 13."}, {'pmid': '30621764', 'type': 'DERIVED', 'citation': 'POP Trial Investigators; Dear J. Randomised open label exploratory, safety and tolerability study with calmangafodipir in patients treated with the 12-h regimen of N-acetylcysteine for paracetamol overdose-the PP100-01 for Overdose of Paracetamol (POP) trial: study protocol for a randomised controlled trial. Trials. 2019 Jan 8;20(1):27. doi: 10.1186/s13063-018-3134-1.'}]}, 'descriptionModule': {'briefSummary': 'Investigate the safety and tolerability of PP100-01 add-on treatment to the 12hr NAC treatment regime in patients treated for paracetamol/acetaminophen overdose (POD) when NAC treatment is initiated before 24hours post POD.', 'detailedDescription': "The study will be an open label, randomised, exploratory, rising dose design, NAC controlled, phase 1 safety and tolerability study in patients treated with NAC for paracetamol/acetaminophen overdose.\n\nEntry into the study will depend on the patient's blood results confirming the need for NAC. A total of 24 patients will be assigned into one of 3 dosing cohorts of 8 patients (N=6 for PP100-01 and NAC; N=2 for NAC alone).\n\nThe study will primarily evaluate safety and tolerability for treatment with PP100-01 in combination with NAC as compared to NAC alone."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Any patient with capacity admitted to hospital within 24 hrs either a single acute POD or more than one dose of paracetamol (staggered) and deemed to require treatment with NAC.\n2. Provision of written informed consent\n3. Males and females of at least 16 years of age\n\nExclusion Criteria:\n\n1. Patients that do not have the capacity to consent to participate in the study\n2. Patients detained under the Mental Health Act or deemed unfit by the Investigator to participate due to mental health.\n3. Patients with known permanent cognitive impairment\n4. Patients who are pregnant or nursing\n5. Patients who have previously participated in the study\n6. Unreliable history of POD\n7. Patients presenting after 24hrs of POD\n8. Patients who take anticoagulants (e.g. warfarin) therapeutically or have taken an overdose of anticoagulants\n9. Patients who, in the opinion of the responsible clinician/nurse, are unlikely to complete the full course of NAC e.g. expressing wish to self-discharge\n10. Prisoners\n11. Non-English speaking patients. (Study information material will only be produced in English in view of the known and stable demographic of the Edinburgh self-harm population).'}, 'identificationModule': {'nctId': 'NCT03177395', 'acronym': 'POP', 'briefTitle': 'PP100-01 (Calmangafodipir) for Overdose of Paracetamol', 'organization': {'class': 'INDUSTRY', 'fullName': 'Egetis Therapeutics'}, 'officialTitle': 'A Randomised Open Label Exploratory, Safety and Tolerability Study With PP100-01 in Patients Treated With the 12-hour Regimen of N-Acetylcysteine for Paracetamol/Acetaminophen Overdose (The POP Trial)', 'orgStudyIdInfo': {'id': 'PP100-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Acetylcysteine (N-acetylcysteine; NAC)', 'description': "NAC infusion 100mg/kg in 200ml 'loading dose' at timepoint '0'. 12 hour NAC regime will be continued with the second dose: 200mg/kg NAC in 1000ml i.v. over 10hr as per standard care protocol in NHS Lothian."}, {'type': 'EXPERIMENTAL', 'label': 'PP100-01 (Calmangafodipir)+ NAC', 'description': 'In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:\n\n* Group A: PP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC\n* Group B: PP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC\n* Group C: PP100-01 (10 umol/kg calmangafodipir) after the "loading" dose of NAC\n\nPP100-01 treatment is administered intravenously over 5 minutes.', 'interventionNames': ['Drug: PP100-01 (calmangafodipir)', 'Drug: Acetylcysteine']}], 'interventions': [{'name': 'PP100-01 (calmangafodipir)', 'type': 'DRUG', 'otherNames': ['PP100-01'], 'description': 'PP100-01', 'armGroupLabels': ['PP100-01 (Calmangafodipir)+ NAC']}, {'name': 'Acetylcysteine', 'type': 'DRUG', 'otherNames': ['N-acetylcysteine'], 'description': 'NAC', 'armGroupLabels': ['PP100-01 (Calmangafodipir)+ NAC']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'EH16 4SA', 'city': 'Edinburgh', 'state': 'City Of Edinburgh', 'country': 'United Kingdom', 'facility': 'Royal Infirmary of Edinburgh', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}], 'overallOfficials': [{'name': 'James Dear', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Edinburgh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Egetis Therapeutics', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Edinburgh', 'class': 'OTHER'}, {'name': 'NHS Lothian', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}