Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2026-03-01 @ 3:52 PM
Study NCT ID:
NCT03384966
Status:
COMPLETED
Last Update Posted:
2025-07-09
First Post:
2017-12-20
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Medical Research Study to Evaluate the Effects of ACT-246475 in Adults With Coronary Artery Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000601315', 'term': 'selatogrel'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'viatrisinnovationclinicaltrials@viatris.com', 'phone': '+41 58 844 07 44', 'title': 'Viatris Innovation Clinical Trial Information', 'organization': 'Viatris Innovation GmbH'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Blood was collected with phenylalanine-proline-arginine-chloromethyl ketone as anticoagulant. Any direct comparison of absolute PRU values obtained in this study with those published from studies of other P2Y12 inhibitors should take this into account.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were recorded up to 35 days after the single subcutaneous selatogrel dose administration. Treatment period: Treatment emergent adverse events were those adverse events with onset and up to 48 hours after study treatment administration. The follow-up period started on Day 3 and ended with the safety follow-up telephone call 35 days after selatogrel administration. During the follow-up period the participants continued to be observed. No interventions were performed.', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment Period - Selatogrel 8 mg', 'description': 'In the treatment period 8 mg of selatogrel was administered via a single subcutaneous injection either in the abdomen or the thigh.', 'otherNumAtRisk': 114, 'deathsNumAtRisk': 114, 'otherNumAffected': 36, 'seriousNumAtRisk': 114, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Treatment Period - Selatogrel 16 mg', 'description': 'In the treatment period 16 mg of selatogrel was administered via a single subcutaneous injection either in the abdomen or the thigh.', 'otherNumAtRisk': 115, 'deathsNumAtRisk': 115, 'otherNumAffected': 26, 'seriousNumAtRisk': 115, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Treatment Period - Placebo', 'description': 'In the treatment period placebo matching selatogrel was administered via a single subcutaneous injection either in the abdomen or the thigh.', 'otherNumAtRisk': 116, 'deathsNumAtRisk': 116, 'otherNumAffected': 25, 'seriousNumAtRisk': 116, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Follow-up Period - Selatogrel 8 mg', 'description': 'Participants that had been administered a single subcutaneous injection containing 8 mg selatogrel in the treatment period were followed-up for adverse events after the treatment period. The follow-up period started on Day 3 and ended with a telephone call or visit on Day 35.', 'otherNumAtRisk': 114, 'deathsNumAtRisk': 114, 'otherNumAffected': 13, 'seriousNumAtRisk': 114, 'deathsNumAffected': 1, 'seriousNumAffected': 5}, {'id': 'EG004', 'title': 'Follow-up Period - Selatogrel 16 mg', 'description': 'Participants that had been administered a single subcutaneous injection containing 16 mg selatogrel were followed-up for adverse events after the treatment period. The follow-up period started on Day 3 and ended with a telephone call or visit on Day 35.', 'otherNumAtRisk': 115, 'deathsNumAtRisk': 115, 'otherNumAffected': 10, 'seriousNumAtRisk': 115, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Follow-up Period - Placebo', 'description': 'Participants that had been administered a single subcutaneous injection containing placebo matching selatogrel were followed-up for adverse events after the treatment period. The follow-up period started on Day 3 and ended with a telephone call or visit on Day 35.', 'otherNumAtRisk': 116, 'deathsNumAtRisk': 116, 'otherNumAffected': 13, 'seriousNumAtRisk': 116, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Injection site bruise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Medical device site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Vessel puncture site bruise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Vessel puncture site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Vessel puncture site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Vaginal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Eye contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Procedural dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Procedural nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Wound haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Blood potassium increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'White blood cell count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'ECG P wave inverted', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Dizziness postural', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 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'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Iron deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 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'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Syncope', 'notes': 'Participant was hospitalized 12 days after study treatment administration.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Non-cardiac chest pain', 'notes': 'Participant was hospitalized 30 days after study treatment administration.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Angina pectoris', 'notes': 'Participant was hospitalized 12 days after study treatment administration.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Costochondritis', 'notes': 'Participant was hospitalized 14 days after study treatment administration.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Myocardial infarctions', 'notes': 'Participant was hospitalized 18 days after study treatment administration.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Cardiac arrest', 'notes': 'Participant died 18 days after study treatment administration.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Ventricular fibrillation', 'notes': 'Participant died 18 days after study treatment administration.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Selatogrel 8 mg', 'description': 'Selatogrel 8 mg was administered as a single subcutaneous dose.'}, {'id': 'OG001', 'title': 'Selatogrel 16 mg', 'description': 'Selatogrel 16 mg was administered as a single subcutaneous dose.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching placebo was administered as a single subcutaneous dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '58.9', 'ciLowerLimit': '22.4', 'ciUpperLimit': '154.8', 'pValueComment': 'A p-value significance level was set to 0.025, based on an overall Type-I error rate of 0.05 adjusted for multiple comparisons using a Bonferroni approach (two comparisons).', 'groupDescription': 'The study aimed at assessing the efficacy of each selatogrel dose versus placebo. The proportion of responders for each of the two doses of selatogrel was compared to placebo.\n\nNo imputation was considered for handling missing values.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '61.2', 'ciLowerLimit': '23.1', 'ciUpperLimit': '162.3', 'pValueComment': 'A p-value significance level was set to 0.025, based on an overall Type-I error rate of 0.05 adjusted for multiple comparisons using a Bonferroni approach (two comparisons).', 'groupDescription': 'The study aimed at assessing the efficacy of each selatogrel dose versus placebo. The proportion of responders for each of the two doses of selatogrel was compared to placebo.\n\nNo imputation was considered for handling missing values in the main analysis.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From 15 minutes after administration of the subcutaneous injection up to 24 hours', 'description': 'The pharmacodynamic response was determined by measuring the inhibition of platelet aggregation, using VerifyNow®. The VerifyNow® is a point-of-care test measuring platelet reactivity. The results are expressed as P2Y12 reaction units (PRU). The target of 100 PRU corresponds to 80% inhibition of ADP-induced platelet aggregation. A participant with a PRU of less than 100 starting from 30 minutes after the administration of study treatment and lasting for at least 3 hours was considered a "responder".', 'unitOfMeasure': 'Count of participants (i.e., responders)', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - all participants that were randomized and who had study treatment administered.'}, {'type': 'SECONDARY', 'title': 'Maximum Selatogrel Plasma Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Selatogrel 8 mg', 'description': 'Selatogrel 8 mg was administered as a single subcutaneous dose.'}, {'id': 'OG001', 'title': 'Selatogrel 16 mg', 'description': 'Selatogrel 16 mg was administered as a single subcutaneous dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '298', 'groupId': 'OG000', 'lowerLimit': '146', 'upperLimit': '868'}, {'value': '484', 'groupId': 'OG001', 'lowerLimit': '161', 'upperLimit': '1030'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, and from 15 minutes after administration of the subcutaneous injection up to 24 hours', 'description': 'The Cmax is the peak concentration of selatogrel in the plasma after subcutaneous injection.\n\nThe pharmacokinetic parameters of selatogrel (ACT-246475) were derived by non-compartmental analyses of the plasma concentration-time profiles.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic analysis set - all participants that had a selatogrel concentration measurement after administration of study treatment.'}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Selatogrel Plasma Concentration (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Selatogrel 8 mg', 'description': 'Selatogrel 8 mg was administered as a single subcutaneous dose.'}, {'id': 'OG001', 'title': 'Selatogrel 16 mg', 'description': 'Selatogrel 16 mg was administered as a single subcutaneous dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.52', 'groupId': 'OG000', 'lowerLimit': '0.38', 'upperLimit': '1.05'}, {'value': '0.53', 'groupId': 'OG001', 'lowerLimit': '0.23', 'upperLimit': '2.02'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose, and from 15 minutes after administration of the subcutaneous injection up to 24 hours', 'description': 'Time after subcutaneous injection to reach the maximum observed selatogrel plasma concentration (Cmax).', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic analysis set - all participants that had a selatogrel concentration measurement after administration of study treatment.'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration-time Curve of Selatogrel From Time Zero to 24 Hour Time Point (AUC0-24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Selatogrel 8 mg', 'description': 'Selatogrel 8 mg was administered as a single subcutaneous dose.'}, {'id': 'OG001', 'title': 'Selatogrel 16 mg', 'description': 'Selatogrel 16 mg was administered as a single subcutaneous dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '716', 'groupId': 'OG000', 'lowerLimit': '347', 'upperLimit': '1425'}, {'value': '1358', 'groupId': 'OG001', 'lowerLimit': '487', 'upperLimit': '2758'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, and from 15 minutes after administration of the subcutaneous injection up to 24 hours post-dose', 'description': 'The area under the plasma concentration-time curve is the integral of the concentration-time curve after subcutaneous injection of selatogrel.\n\nThe plasma pharmacokinetic parameters of selatogrel (ACT-246475) were derived by non-compartmental analyses of the plasma concentration-time profiles.', 'unitOfMeasure': 'hours*ng/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic analysis set - all participants that had a selatogrel concentration measurement after administration of study treatment.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation by Site of Treatment Administration (Thigh or Abdomen)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}, {'value': '58', 'groupId': 'OG004'}, {'value': '58', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Selatogrel 8 mg (Thigh)', 'description': 'Selatogrel 8 mg was administered as a single subcutaneous dose.'}, {'id': 'OG001', 'title': 'Selatogrel 8 mg (Abdomen)', 'description': 'Selatogrel 8 mg was administered as a single subcutaneous dose.'}, {'id': 'OG002', 'title': 'Selatogrel 16 mg (Thigh)', 'description': 'Selatogrel 16 mg was administered as a single subcutaneous dose.'}, {'id': 'OG003', 'title': 'Selatogrel 16 mg (Abdomen)', 'description': 'Selatogrel 16 mg was administered as a single subcutaneous dose.'}, {'id': 'OG004', 'title': 'Placebo (Thigh)', 'description': 'Matching placebo was administered as a single subcutaneous dose.'}, {'id': 'OG005', 'title': 'Placebo (Abdomen)', 'description': 'Matching placebo was administered as a single subcutaneous dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.1915', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Logistic regression (Type III analysis)'}], 'paramType': 'NUMBER', 'timeFrame': 'From 15 minutes after administration of the subcutaneous injection up to 24 hours', 'description': 'The inhibition of platelet aggregation based on the route of administration, i.e. whether the pharmacodynamic response was different if selatogrel was administered subcutaneously in the thigh or in the abdomen, was analyzed.\n\nThe pharmacodynamic response was determined by measuring the inhibition of platelet aggregation, using VerifyNow®. The VerifyNow® is a point-of-care test measuring platelet reactivity. The results are expressed as P2Y12 reaction units (PRU). The target of 100 PRU corresponds to 80% inhibition of ADP-induced platelet aggregation. A participant with a PRU of less than 100 starting from 30 minutes after the administration of study treatment and lasting for at least 3 hours was considered a "responder".', 'unitOfMeasure': 'Count of participants (i.e., responders)', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - all participants that were randomized and who had study treatment administered.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation - Sensitivity Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Selatogrel 8 mg', 'description': 'Selatogrel 8 mg was administered as a single subcutaneous dose.'}, {'id': 'OG001', 'title': 'Selatogrel 16 mg', 'description': 'Selatogrel 16 mg was administered as a single subcutaneous dose.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching placebo was administered as a single subcutaneous dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From 15 minutes after administration of the subcutaneous injection up to 24 hours', 'description': 'To assess the robustness of results for the pharmacodynamic response, the main analysis was repeated for the per protocol participants. The pharmacodynamic response was determined by measuring the inhibition of platelet aggregation, using VerifyNow®. The VerifyNow® is a point-of-care test measuring platelet reactivity. The results are expressed as P2Y12 reaction units (PRU). The target of 100 PRU corresponds to 80% inhibition of ADP-induced platelet aggregation. A participant with a PRU of less than 100 starting from 30 minutes after the administration of study treatment and lasting for at least 3 hours was considered a "responder".', 'unitOfMeasure': 'Count of participants (i.e., responders)', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol set'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Maximum Platelet Aggregation (MPA) as Measured by Light Transmission Aggregometry (LTA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Selatogrel 8 mg', 'description': 'Selatogrel 8 mg was administered as a single subcutaneous dose.'}, {'id': 'OG001', 'title': 'Selatogrel 16 mg', 'description': 'Selatogrel 16 mg was administered as a single subcutaneous dose.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching placebo was administered as a single subcutaneous dose.'}], 'classes': [{'title': 'Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '61.9', 'spread': '29.79', 'groupId': 'OG000'}, {'value': '62.4', 'spread': '31.5', 'groupId': 'OG001'}, {'value': '65.6', 'spread': '29.6', 'groupId': 'OG002'}]}]}, {'title': '30 minutes post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '13.1', 'spread': '12.1', 'groupId': 'OG000'}, {'value': '13.5', 'spread': '11.9', 'groupId': 'OG001'}, {'value': '65.3', 'spread': '28.0', 'groupId': 'OG002'}]}]}, {'title': '1 hour post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '114', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '14.5', 'spread': '14.1', 'groupId': 'OG000'}, {'value': '15.8', 'spread': '15.7', 'groupId': 'OG001'}, {'value': '65.6', 'spread': '28.0', 'groupId': 'OG002'}]}]}, {'title': '2 hours post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '114', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '17.0', 'spread': '12.8', 'groupId': 'OG000'}, {'value': '16.5', 'spread': '14.5', 'groupId': 'OG001'}, {'value': '63.0', 'spread': '26.8', 'groupId': 'OG002'}]}]}, {'title': '8 hours post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '35.4', 'spread': '25.5', 'groupId': 'OG000'}, {'value': '32.1', 'spread': '25.1', 'groupId': 'OG001'}, {'value': '63.7', 'spread': '27.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference with placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-27.49', 'ciLowerLimit': '-35.4', 'ciUpperLimit': '-19.6', 'groupDescription': 'Longitudinal analysis of the treatment effect, from start of treatment to 8 hours after injection.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'P-value significance level is set to 0.025, i.e. type I error (0.05) adjusted for multiplicity (2 comparisons) using a Bonferroni approach.'}, {'pValue': '<.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean difference with placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-31.06', 'ciLowerLimit': '-39.0', 'ciUpperLimit': '-23.1', 'groupDescription': 'Longitudinal analysis of the treatment effect, from start of treatment up to 8 hours after injection.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'P-value significance level is set to 0.025, i.e. type I error (0.05) adjusted for multiplicity (2 comparisons) using a Bonferroni approach'}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, and from 30 minutes after administration of the subcutaneous injection up to 8 hours', 'description': 'Light transmission aggregometry was used as complementary method to the VerifyNow® to evaluate the effect of selatogrel on platelet aggregation. Platelet aggregation was triggered by addition of Adenosine diphosphate (ADP) 20 µM (micromole per liter) and monitored over 6 minutes. Maximum Platelet Aggregation (MPA) to 20 μM ADP was assessed by light transmission aggregometry (LTA), an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing platelet-rich plasma stimulated with 20 µM ADP, relative to platelet-poor plasma (100% light transmittance). A lower MPA % reflects stronger platelet inhibition, whereas a higher MPA % reflects weaker inhibition.', 'unitOfMeasure': 'percent maximum platelet aggregation (%)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - all participants that were randomized and who had study treatment administered.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Bleeding Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Selatogrel 8 mg', 'description': 'Selatogrel 8 mg was administered as a single subcutaneous dose.'}, {'id': 'OG001', 'title': 'Selatogrel 16 mg', 'description': 'Selatogrel 16 mg was administered as a single subcutaneous dose.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching placebo was administered as a single subcutaneous dose.'}], 'classes': [{'title': 'All participants with at least one "bleeding event"', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Participants with Trombolysis In Myocardial Infarction (TIMI) major events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Participants with "Bleeding event of moderate intensity"', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Participants with "Bleeding event of mild intensity"', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Injection site bruising', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Contusion', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Ecchymosis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Eye contusion', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Medical device site bruise', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Mouth haemorrhage', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Vessel puncture site bruise', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Epistaxis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Vessel puncture site haematoma', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Petechiae', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Vaginal haemorrhage', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Wound haemorrhage', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From study treatment administration on Day 1 up to 48 hours', 'description': 'Treatment-emergent adverse events in the category "Haemorrhage (excluding laboratory terms)" were of special interest and their incidence listed below.\n\nThe role of the Independent Safety Event Committee was to monitor unblinded safety data obtained in the study, with a specific focus on study-drug-related clinically relevant major bleeding events, occurring within 48 hours after dosing (i.e. the treatment period).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set (SAF) included all participants who received at least one dose of study medication.'}, {'type': 'POST_HOC', 'title': 'Assessments of the Inhibition of Platelet Reactivity at Predefined Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Selatogrel 8 mg', 'description': 'Selatogrel 8 mg was administered as a single subcutaneous dose.'}, {'id': 'OG001', 'title': 'Selatogrel 16 mg', 'description': 'Selatogrel 16 mg was administered as a single subcutaneous dose.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching placebo was administered as a single subcutaneous dose.'}], 'classes': [{'title': 'Baseline (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '156.1', 'groupId': 'OG000', 'lowerLimit': '142.9', 'upperLimit': '169.3'}, {'value': '156.2', 'groupId': 'OG001', 'lowerLimit': '142', 'upperLimit': '170.5'}, {'value': '155.2', 'groupId': 'OG002', 'lowerLimit': '141.9', 'upperLimit': '168.6'}]}]}, {'title': '15 minutes post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10.1', 'groupId': 'OG000', 'lowerLimit': '5.3', 'upperLimit': '14.9'}, {'value': '4.5', 'groupId': 'OG001', 'lowerLimit': '2.6', 'upperLimit': '6.4'}, {'value': '163.3', 'groupId': 'OG002', 'lowerLimit': '149.5', 'upperLimit': '177.2'}]}]}, {'title': '30 minutes post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000', 'lowerLimit': '3.6', 'upperLimit': '12.2'}, {'value': '5.3', 'groupId': 'OG001', 'lowerLimit': '3.4', 'upperLimit': '7.2'}, {'value': '162.2', 'groupId': 'OG002', 'lowerLimit': '147.9', 'upperLimit': '176.4'}]}]}, {'title': '1 hour post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.7', 'groupId': 'OG000', 'lowerLimit': '4.5', 'upperLimit': '14.8'}, {'value': '3.5', 'groupId': 'OG001', 'lowerLimit': '2.6', 'upperLimit': '4.5'}, {'value': '161.8', 'groupId': 'OG002', 'lowerLimit': '148.6', 'upperLimit': '175.0'}]}]}, {'title': '2 hours post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12.4', 'groupId': 'OG000', 'lowerLimit': '7.0', 'upperLimit': '17.8'}, {'value': '5.7', 'groupId': 'OG001', 'lowerLimit': '3.7', 'upperLimit': '7.6'}, {'value': '162.0', 'groupId': 'OG002', 'lowerLimit': '148.5', 'upperLimit': '175.4'}]}]}, {'title': '4 hours post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '30.1', 'groupId': 'OG000', 'lowerLimit': '22.9', 'upperLimit': '37.3'}, {'value': '11.4', 'groupId': 'OG001', 'lowerLimit': '7.8', 'upperLimit': '14.9'}, {'value': '162.4', 'groupId': 'OG002', 'lowerLimit': '148.8', 'upperLimit': '176.0'}]}]}, {'title': '8 hours post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '88.1', 'groupId': 'OG000', 'lowerLimit': '76.6', 'upperLimit': '99.7'}, {'value': '47.3', 'groupId': 'OG001', 'lowerLimit': '38.9', 'upperLimit': '55.6'}, {'value': '164.1', 'groupId': 'OG002', 'lowerLimit': '150.6', 'upperLimit': '177.6'}]}]}, {'title': '24 hours post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '144.2', 'groupId': 'OG000', 'lowerLimit': '130.2', 'upperLimit': '158.1'}, {'value': '128.6', 'groupId': 'OG001', 'lowerLimit': '116.3', 'upperLimit': '140.9'}, {'value': '153.3', 'groupId': 'OG002', 'lowerLimit': '139.4', 'upperLimit': '167.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (baseline) up to 24 hours post-dose injection', 'description': 'The inhibition of platelet aggregation was determined using VerifyNow®. The VerifyNow® is a point-of-care test measuring platelet reactivity. The results are expressed as P2Y12 reaction units (PRU). After single-dose administration the inhibition of platelet aggregation was measured at pre-defined timepoints to observe the platelet reactivity and aggregation over a 24-hour timeperiod. A lower PRU reflects lower platelet reactivity, whereas a higher PRU reflects higher platelet reactivity.', 'unitOfMeasure': 'P2Y12 reaction units', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - all participants that were randomized and who had study treatment administered.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Selatogrel 8 mg', 'description': 'The study had 3 consecutive periods: the screening period, a treatment period and the follow-up period.\n\nA participant that met all inclusion criteria and none of the exclusion criteria was randomized.\n\nIn the treatment period 8 mg of selatogrel (ACT-246475) was administered via a single subcutaneous injection either in the abdomen or the thigh.\n\nThe follow-up period started on Day 3 and ended with the safety follow-up telephone call or visit (Day 35).'}, {'id': 'FG001', 'title': 'Selatogrel 16 mg', 'description': 'The study had 3 consecutive periods: the screening period, a treatment period and the follow-up period.\n\nA participant that met all inclusion criteria and none of the exclusion criteria was randomized.\n\nIn the treatment period 16 mg of selatogrel (ACT-246475) was administered via a single subcutaneous injection either in the abdomen or the thigh.\n\nThe follow-up period started on Day 3 and ended with the safety follow-up telephone call or visit (Day 35).'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'The study had 3 consecutive periods: the screening period, a treatment period and the follow-up period.\n\nA participant that met all inclusion criteria and none of the exclusion criteria was randomized.\n\nIn the treatment period placebo matching selatogrel was administered via a single subcutaneous injection either in the abdomen or the thigh.\n\nThe follow-up period started on Day 3 and ended with the safety follow-up telephone call or visit (Day 35).'}], 'periods': [{'title': 'Randomized at End of Screening Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '115'}, {'groupId': 'FG001', 'numSubjects': '115'}, {'groupId': 'FG002', 'numSubjects': '116'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '114'}, {'groupId': 'FG001', 'numSubjects': '115'}, {'groupId': 'FG002', 'numSubjects': '116'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Physician decision due to adverse event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '114'}, {'groupId': 'FG001', 'numSubjects': '115'}, {'groupId': 'FG002', 'numSubjects': '116'}]}, {'type': 'Thigh Administration', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '57'}, {'groupId': 'FG002', 'numSubjects': '58'}]}, {'type': 'Abdomen Administration', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '58'}, {'groupId': 'FG002', 'numSubjects': '58'}]}, {'type': 'Per-protocol Analysis Set', 'comment': 'The per-protocol set includes all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).', 'achievements': [{'groupId': 'FG000', 'numSubjects': '96'}, {'groupId': 'FG001', 'numSubjects': '90'}, {'groupId': 'FG002', 'numSubjects': '93'}]}, {'type': 'Safety Analysis Set', 'comment': 'The safety analysis set (SAF) includes all participants who received at least one dose of study treatment. Participants were evaluated according to the actual treatment they received.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '114'}, {'groupId': 'FG001', 'numSubjects': '115'}, {'groupId': 'FG002', 'numSubjects': '116'}]}, {'type': 'Pharmacokinetic Analysis Set', 'comment': 'The PK analysis set includes all participants from the SAF who have at least one plasma concentration measurement after administration of study treatment. Participants in the PK set were evaluated according to the actual treatment they received.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '111'}, {'groupId': 'FG001', 'numSubjects': '115'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '114'}, {'groupId': 'FG001', 'numSubjects': '115'}, {'groupId': 'FG002', 'numSubjects': '116'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Follow-up Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '114'}, {'groupId': 'FG001', 'numSubjects': '115'}, {'groupId': 'FG002', 'numSubjects': '116'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '113'}, {'groupId': 'FG001', 'numSubjects': '115'}, {'groupId': 'FG002', 'numSubjects': '116'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study was conducted between 24 Jan and 18 Sep 2018. Twenty sites in 8 countries screened 362 participants and 17 sites randomized 346 participants.', 'preAssignmentDetails': "Of the 16 participants not randomized: 9 were ineligible; 4 withdrew consent; 1 was lost to follow-up, 1 was not randomized based on the physician's decision and 1 didn't complete screening within the protocol-defined window."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}, {'value': '345', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Selatogrel 8 mg', 'description': 'Selatogrel (ACT-246475) 8 mg was administered as a single subcutaneous dose.'}, {'id': 'BG001', 'title': 'Selatogrel 16 mg', 'description': 'Selatogrel (ACT-246475) 16 mg was administered as a single subcutaneous dose.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Matching placebo was administered as a single subcutaneous dose.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'title': 'Full analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}, {'value': '345', 'groupId': 'BG003'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '151', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '194', 'groupId': 'BG003'}]}]}, {'title': 'Per-protocol analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}, {'value': '279', 'groupId': 'BG003'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '120', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '159', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Per-protocol set - all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).'}, {'title': 'Age, Continuous', 'classes': [{'title': 'Full analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}, {'value': '345', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '64.8', 'spread': '9.4', 'groupId': 'BG000'}, {'value': '65.2', 'spread': '8.5', 'groupId': 'BG001'}, {'value': '64.9', 'spread': '9.1', 'groupId': 'BG002'}, {'value': '65.0', 'spread': '9.0', 'groupId': 'BG003'}]}]}, {'title': 'Per-protocol analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}, {'value': '279', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '64.4', 'spread': '9.7', 'groupId': 'BG000'}, {'value': '65.3', 'spread': '8.8', 'groupId': 'BG001'}, {'value': '65.1', 'spread': '9.2', 'groupId': 'BG002'}, {'value': '64.9', 'spread': '9.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Per-protocol set - all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Full analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}, {'value': '345', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '69', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}, {'value': '276', 'groupId': 'BG003'}]}]}, {'title': 'Per-protocol analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}, {'value': '279', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}, {'value': '230', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Per-protocol set - all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'title': 'Full analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}, {'value': '345', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '113', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}, {'value': '343', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Per-protocol analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}, {'value': '279', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}, {'value': '277', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Per-protocol set - all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).'}, {'title': 'Race (NIH/OMB)', 'classes': [{'title': 'Full analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}, {'value': '345', 'groupId': 'BG003'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}, {'value': '296', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Per-protocol analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}, {'value': '279', 'groupId': 'BG003'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}, {'value': '242', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Per-protocol set - all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}, {'value': '345', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}, {'title': 'Sweden', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}, {'value': '345', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}]}, {'title': 'Netherlands', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}, {'value': '345', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}]}]}, {'title': 'Singapore', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}, {'value': '345', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}, {'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}, {'value': '345', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '153', 'groupId': 'BG003'}]}]}, {'title': 'Denmark', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}, {'value': '345', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}, {'value': '345', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '77', 'groupId': 'BG003'}]}]}, {'title': 'Germany', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}, {'value': '345', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index', 'classes': [{'title': 'Full analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}, {'value': '345', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '29', 'spread': '5', 'groupId': 'BG000'}, {'value': '29', 'spread': '6', 'groupId': 'BG001'}, {'value': '31', 'spread': '5', 'groupId': 'BG002'}, {'value': '30', 'spread': '5', 'groupId': 'BG003'}]}]}, {'title': 'Per-protocol analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}, {'value': '279', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '29', 'spread': '5', 'groupId': 'BG000'}, {'value': '29', 'spread': '5', 'groupId': 'BG001'}, {'value': '30', 'spread': '5', 'groupId': 'BG002'}, {'value': '29', 'spread': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms per square meter (kg/m^2)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Per-protocol set - all participants who complied with the protocol sufficiently to allow adequate estimation of the treatment effect (including availability of primary pharmacodynamic endpoint assessment and absence of protocol deviations that impact on the treatment effect).'}], 'populationDescription': 'Full Analysis Set - all participants that were randomized and who had study treatment administered.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-08-31', 'size': 1163161, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-03-22T05:36', 'hasProtocol': True}, {'date': '2018-10-16', 'size': 971079, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-03-22T05:47', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double-blinding will apply to treatment (ACT-246475 vs placebo). The dose (8 mg vs 16 mg) will be single blinded (subject blinded). The site for the sub-cutaneous injection (thigh vs abdomen) will not be blinded.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 346}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'dispFirstSubmitDate': '2019-07-11', 'completionDateStruct': {'date': '2018-09-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-30', 'studyFirstSubmitDate': '2017-12-20', 'dispFirstSubmitQcDate': '2019-07-11', 'resultsFirstSubmitDate': '2021-04-23', 'studyFirstSubmitQcDate': '2017-12-20', 'dispFirstPostDateStruct': {'date': '2019-07-17', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-23', 'studyFirstPostDateStruct': {'date': '2017-12-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation by Site of Treatment Administration (Thigh or Abdomen)', 'timeFrame': 'From 15 minutes after administration of the subcutaneous injection up to 24 hours', 'description': 'The inhibition of platelet aggregation based on the route of administration, i.e. whether the pharmacodynamic response was different if selatogrel was administered subcutaneously in the thigh or in the abdomen, was analyzed.\n\nThe pharmacodynamic response was determined by measuring the inhibition of platelet aggregation, using VerifyNow®. The VerifyNow® is a point-of-care test measuring platelet reactivity. The results are expressed as P2Y12 reaction units (PRU). The target of 100 PRU corresponds to 80% inhibition of ADP-induced platelet aggregation. A participant with a PRU of less than 100 starting from 30 minutes after the administration of study treatment and lasting for at least 3 hours was considered a "responder".'}, {'measure': 'Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation - Sensitivity Analysis', 'timeFrame': 'From 15 minutes after administration of the subcutaneous injection up to 24 hours', 'description': 'To assess the robustness of results for the pharmacodynamic response, the main analysis was repeated for the per protocol participants. The pharmacodynamic response was determined by measuring the inhibition of platelet aggregation, using VerifyNow®. The VerifyNow® is a point-of-care test measuring platelet reactivity. The results are expressed as P2Y12 reaction units (PRU). The target of 100 PRU corresponds to 80% inhibition of ADP-induced platelet aggregation. A participant with a PRU of less than 100 starting from 30 minutes after the administration of study treatment and lasting for at least 3 hours was considered a "responder".'}, {'measure': 'Change From Baseline in Maximum Platelet Aggregation (MPA) as Measured by Light Transmission Aggregometry (LTA)', 'timeFrame': 'Pre-dose, and from 30 minutes after administration of the subcutaneous injection up to 8 hours', 'description': 'Light transmission aggregometry was used as complementary method to the VerifyNow® to evaluate the effect of selatogrel on platelet aggregation. Platelet aggregation was triggered by addition of Adenosine diphosphate (ADP) 20 µM (micromole per liter) and monitored over 6 minutes. Maximum Platelet Aggregation (MPA) to 20 μM ADP was assessed by light transmission aggregometry (LTA), an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing platelet-rich plasma stimulated with 20 µM ADP, relative to platelet-poor plasma (100% light transmittance). A lower MPA % reflects stronger platelet inhibition, whereas a higher MPA % reflects weaker inhibition.'}, {'measure': 'Number of Participants With Bleeding Events', 'timeFrame': 'From study treatment administration on Day 1 up to 48 hours', 'description': 'Treatment-emergent adverse events in the category "Haemorrhage (excluding laboratory terms)" were of special interest and their incidence listed below.\n\nThe role of the Independent Safety Event Committee was to monitor unblinded safety data obtained in the study, with a specific focus on study-drug-related clinically relevant major bleeding events, occurring within 48 hours after dosing (i.e. the treatment period).'}], 'primaryOutcomes': [{'measure': 'Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation', 'timeFrame': 'From 15 minutes after administration of the subcutaneous injection up to 24 hours', 'description': 'The pharmacodynamic response was determined by measuring the inhibition of platelet aggregation, using VerifyNow®. The VerifyNow® is a point-of-care test measuring platelet reactivity. The results are expressed as P2Y12 reaction units (PRU). The target of 100 PRU corresponds to 80% inhibition of ADP-induced platelet aggregation. A participant with a PRU of less than 100 starting from 30 minutes after the administration of study treatment and lasting for at least 3 hours was considered a "responder".'}], 'secondaryOutcomes': [{'measure': 'Maximum Selatogrel Plasma Concentration (Cmax)', 'timeFrame': 'Pre-dose, and from 15 minutes after administration of the subcutaneous injection up to 24 hours', 'description': 'The Cmax is the peak concentration of selatogrel in the plasma after subcutaneous injection.\n\nThe pharmacokinetic parameters of selatogrel (ACT-246475) were derived by non-compartmental analyses of the plasma concentration-time profiles.'}, {'measure': 'Time to Reach Maximum Selatogrel Plasma Concentration (Tmax)', 'timeFrame': 'Pre-dose, and from 15 minutes after administration of the subcutaneous injection up to 24 hours', 'description': 'Time after subcutaneous injection to reach the maximum observed selatogrel plasma concentration (Cmax).'}, {'measure': 'Area Under the Plasma Concentration-time Curve of Selatogrel From Time Zero to 24 Hour Time Point (AUC0-24)', 'timeFrame': 'Pre-dose, and from 15 minutes after administration of the subcutaneous injection up to 24 hours post-dose', 'description': 'The area under the plasma concentration-time curve is the integral of the concentration-time curve after subcutaneous injection of selatogrel.\n\nThe plasma pharmacokinetic parameters of selatogrel (ACT-246475) were derived by non-compartmental analyses of the plasma concentration-time profiles.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic coronary syndrome'], 'conditions': ['Stable Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '31994703', 'type': 'DERIVED', 'citation': "Storey RF, Gurbel PA, Ten Berg J, Bernaud C, Dangas GD, Frenoux JM, Gorog DA, Hmissi A, Kunadian V, James SK, Tanguay JF, Tran H, Trenk D, Ufer M, Van der Harst P, Van't Hof AWJ, Angiolillo DJ. Pharmacodynamics, pharmacokinetics, and safety of single-dose subcutaneous administration of selatogrel, a novel P2Y12 receptor antagonist, in patients with chronic coronary syndromes. Eur Heart J. 2020 Sep 1;41(33):3132-3140. doi: 10.1093/eurheartj/ehz807."}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to find out if a drug called selatogrel (ACT-246475) can prevent platelets from binding together when administered by an injection under the skin in the thigh or in the belly. Another goal is to know how fast and for how long selatogrel (ACT-246475) works and if there is a difference if the drug is injected in the thigh or in the belly. This study will also help to find out more about the safety of this new drug.', 'detailedDescription': 'To investigate the pharmacodynamic (PD) and pharmacokinetic (PK) properties of selatogrel in patients with atherosclerotic disease, the present study will be conducted in patients with chronic coronary syndromes (CCS). Assessment in a population of patients with CCS allows better control and stability of concomitant treatments, and therefore more accurate characterization of the pharmacodynamic and pharmacokinetic profiles of selatogrel in the presence of background antiplatelet therapies.\n\nThe study will have 3 periods: a screening period of up to 21 days prior to randomization, a treatment period of 2 days from randomization (Day 1) to 24 hours post dose (Day 2), and a follow-up period from Day 3 to the safety follow-up telephone call 28 to 35 days after single administration of study drug (End-of-Study).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main Inclusion Criteria:\n\n1. Signed informed consent prior to any study-mandated procedure.\n2. Male and female subjects aged from 18-85 years, inclusive.\n3. For women of childbearing potential: Negative urine pregnancy test at Visit 1 and at Visit 2 before randomization.\n4. Stable Coronary artery disease (CAD) defined by the presence of any of the following conditions:\n\n 1. History of CAD with coronary artery stenosis on coronary angiogram ≥50%.\n 2. Previously documented myocardial infarction occurring more than 3 months prior to randomization.\n5. Antiplatelet background therapy stable for at least 1 month prior to randomization.\n6. Body weight ≥ 40.0 kg (88.2 lbs).\n\nMain Exclusion Criteria:\n\n1. Acute coronary syndrome, percutaneous coronary intervention or any intervention for peripheral artery disease within 3 months prior to randomization.\n2. Acute ischemic stroke or transient ischemic attack (TIA) within 3 months prior to randomization.\n3. Active internal bleeding, or medical history of recent (\\< 1 month) bleeding disorders or conditions associated with high risk of bleeding (e.g., clotting disturbances, gastrointestinal bleed, hemoptysis).\n4. Hemoglobin ≤ 10 g/dL at screening.\n5. Loss of at least 250 mL of blood within 3 months of screening.\n6. Use of anticoagulants (oral, parenteral) or fibrinolytic therapy within 24 h prior to screening (Visit 1).\n7. Known platelet disorders (e.g., thrombasthenia, thrombocytopenia, von Willebrand disease).\n8. Pregnant or breastfeeding women.'}, 'identificationModule': {'nctId': 'NCT03384966', 'briefTitle': 'A Medical Research Study to Evaluate the Effects of ACT-246475 in Adults With Coronary Artery Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Viatris Inc.'}, 'officialTitle': 'A Multi-center, Double-blind, Randomized, Placebo-controlled Study to Assess the Pharmacodynamics, Pharmacokinetics, Tolerability, and Safety of a Single Subcutaneous Injection of ACT-246475 in Adults With Stable Coronary Artery Disease', 'orgStudyIdInfo': {'id': 'ID-076A201'}, 'secondaryIdInfos': [{'id': '2017-003332-36', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Selatogrel 8 mg', 'description': 'Selatogrel (ACT-246475) is given as a single subcutaneous dose of 8 mg administered in a volume of 0.8 mL. Administration will be performed at the investigational site by qualified personnel.', 'interventionNames': ['Drug: Selatogrel']}, {'type': 'EXPERIMENTAL', 'label': 'Selatogrel 16 mg', 'description': 'Selatogrel (ACT-246475) is given as a single subcutaneous dose of 16 mg administered in a volume of 0.8 mL. Administration will be performed at the investigational site by qualified personnel.', 'interventionNames': ['Drug: Selatogrel']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo matching ACT-246475 is supplied in sealed glass vials for reconstitution with water for injection. Placebo will be given as a single subcutaneous dose matching selatogrel to be administered in a volume of 0.8 mL. Administration will performed at the investigational site by qualified personnel.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Selatogrel', 'type': 'DRUG', 'otherNames': ['ACT-246475'], 'description': 'Selatogrel is a reversible P2Y12 receptor antagonist for subcutaneous administration. It is supplied in sealed glass vials at a strength of 20 mg. The vials with ACT-246475A (hydrochloride salt of ACT-246475) or matching placebo will be reconstituted with 1 mL of water for injection. Further dilution with 1 mL sodium chloride (NaCl) 0.9% will be performed for preparation of the dose of 8 mg selatogrel.', 'armGroupLabels': ['Selatogrel 8 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo for subcutaneous administration.', 'armGroupLabels': ['Placebo']}, {'name': 'Selatogrel', 'type': 'DRUG', 'otherNames': ['ACT-246575'], 'description': 'Selatogrel is a reversible P2Y12 receptor antagonist for subcutaneous administration. It is supplied in sealed glass vials at a strength of 20 mg. The vials with ACT-246475A (hydrochloride salt of ACT-246475) will be reconstituted with 1 mL of water for injection.', 'armGroupLabels': ['Selatogrel 16 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32209', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida (UF) Jacksonville', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Hospital Tampa - Pepin Heart Institute', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '73104', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'NorthShore University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University School of Medicine - Krannert Institute of Cardiology', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '21093', 'city': 'Lutherville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Inova Cardiology', 'geoPoint': {'lat': 39.42122, 'lon': -76.62608}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai Hospital (New York)', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '22042', 'city': 'Falls Church', 'state': 'Virginia', 'country': 'United States', 'facility': 'Inova Center for Thrombosis Research and Translational Medicine', 'geoPoint': {'lat': 38.88233, 'lon': -77.17109}}, {'zip': 'H1T 1C8', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Institut de Cardiologie de Montréal', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '8200', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '79189', 'city': 'Bad Krozingen', 'country': 'Germany', 'facility': 'Universitats-Herzzentrum', 'geoPoint': {'lat': 47.91667, 'lon': 7.7}}, {'zip': '9713 GZ', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'University Medical Center Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'zip': '6229 HX', 'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Maastricht UMC', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'zip': '3435 CM', 'city': 'Nieuwegein', 'country': 'Netherlands', 'facility': 'St. Antonius Ziekenhuis', 'geoPoint': {'lat': 52.02917, 'lon': 5.08056}}, {'zip': '169609', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'National Heart Centre Singapore', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '40530', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Sahlgrenska University Hospital', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'zip': '18288', 'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Uppsala University Hospital', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}, {'zip': 'NE7 7DN', 'city': 'Newcastle upon Tyne', 'country': 'United Kingdom', 'facility': 'Freeman Hospital - Cardiothoracic Department', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}, {'zip': 'S5 7AU', 'city': 'Sheffield', 'country': 'United Kingdom', 'facility': 'Sheffield Teaching Hospitals', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'zip': 'SG14AB', 'city': 'Stevenage', 'country': 'United Kingdom', 'facility': 'East & North Hertfordshire NHS Trust - Lister Hospital', 'geoPoint': {'lat': 51.90224, 'lon': -0.20256}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Viatris Innovation GmbH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Viatris Innovation GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}