Ignite Creation Date:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2026-03-01 @ 3:22 PM
Study NCT ID:
NCT03690206
Status:
COMPLETED
Last Update Posted:
2025-07-17
First Post:
2018-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy And Safety Evaluation of Glepaglutide in Treatment of Short Bowel Syndrome (SBS)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Italy'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D012778', 'term': 'Short Bowel Syndrome'}], 'ancestors': [{'id': 'D008286', 'term': 'Malabsorption Syndromes'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info@zealandpharma.com', 'phone': '+45 8877 3600', 'title': 'Head of clinical operations', 'organization': 'Zealand Pharma A/S'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks.', 'description': "Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption.\n\nFor the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).", 'eventGroups': [{'id': 'EG000', 'title': 'Glepaglutide SC Injections Twice Weekly', 'description': 'Intervention: Glepaglutide\n\nglepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 30, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'Glepaglutide SC Injections Once Weekly and Placebo Once Weekly', 'description': 'Intervention: Glepaglutide\n\nglepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog\n\nPlacebo: Placebo for glepaglutide', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 31, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 10}, {'id': 'EG002', 'title': 'Placebo SC Injections Twice Weekly', 'description': 'Intervention: Placebo\n\nPlacebo: Placebo for glepaglutide', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 25, 'seriousNumAtRisk': 36, 'deathsNumAffected': 0, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Stoma site oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 11, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Stoma complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Stomal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Stoma site irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Stoma site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Stoma site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 7, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 135, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 116, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 60, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 31, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 29, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 44, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Injection site irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 13, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Injection site rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 22, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Complication associated with device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 8, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Osteoporosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Gastrointestinal bacterial overgrowth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}], 'seriousEvents': [{'term': 'Stoma site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Acetabulum fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Alcohol poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Procedural pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Blood loss anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Catheter site necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Device related sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Large intestine infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Vascular device infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Gastrointestinal viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Device breakage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Device malfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Metabolic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Weekly Parenteral Support (PS) Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Glepaglutide SC Injections Twice Weekly', 'description': 'Intervention: Glepaglutide\n\nglepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog'}, {'id': 'OG001', 'title': 'Glepaglutide SC Injections Once Weekly and Placebo Once Weekly', 'description': 'Intervention: Glepaglutide\n\nglepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog\n\nPlacebo: Placebo for glepaglutide'}, {'id': 'OG002', 'title': 'Placebo SC Injections Twice Weekly', 'description': 'Intervention: Placebo\n\nPlacebo: Placebo for glepaglutide'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.13', 'groupId': 'OG000', 'lowerLimit': '-6.24', 'upperLimit': '-4.02'}, {'value': '-3.76', 'groupId': 'OG001', 'lowerLimit': '-4.96', 'upperLimit': '-2.56'}, {'value': '-2.85', 'groupId': 'OG002', 'lowerLimit': '-3.93', 'upperLimit': '-1.77'}]}]}], 'analyses': [{'pValue': '0.0039', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference to Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.28', 'ciLowerLimit': '-3.83', 'ciUpperLimit': '-0.73', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2700', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference to Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.91', 'ciLowerLimit': '-2.52', 'ciUpperLimit': '0.71', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 weeks', 'description': 'Change in weekly PS volume from baseline to Week 24. Baseline actual weekly PS volume was defined as the actual PS volume derived from a valid 7-day period prior to visit 1 (Day 1), i.e. during the stabilization phase. The actual weekly PS volume at Weeks 1, 2, 4, 8, 12, 16, 20, and 24 was derived as the actual weekly PS volume received during the valid 7-day period prior to the visit. The source for the derivation was the PS volumes recorded by the patients in the eDiary.', 'unitOfMeasure': 'L/week', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of trial drug (glepaglutide or placebo). All efficacy analyses were based on the FAS. Patients were included in the analyses as randomized.'}, {'type': 'SECONDARY', 'title': 'Clinical Response in PS Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Glepaglutide SC Injections Twice Weekly', 'description': 'Intervention: Glepaglutide\n\nglepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog'}, {'id': 'OG001', 'title': 'Glepaglutide SC Injections Once Weekly and Placebo Once Weekly', 'description': 'Intervention: Glepaglutide\n\nglepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog\n\nPlacebo: Placebo for glepaglutide'}, {'id': 'OG002', 'title': 'Placebo SC Injections Twice Weekly', 'description': 'Intervention: Placebo\n\nPlacebo: Placebo for glepaglutide'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0243', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference to Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '26.6', 'ciLowerLimit': '4.3', 'ciUpperLimit': '48.9', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6255', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference to Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.5', 'ciLowerLimit': '-16.2', 'ciUpperLimit': '27.1', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '20 and 24 weeks', 'description': 'Clinical response, defined as at least 20% reduction in actual weekly PS volume from baseline to both Weeks 20 and 24.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Days Off PS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Glepaglutide SC Injections Twice Weekly', 'description': 'Intervention: Glepaglutide\n\nglepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog'}, {'id': 'OG001', 'title': 'Glepaglutide SC Injections Once Weekly and Placebo Once Weekly', 'description': 'Intervention: Glepaglutide\n\nglepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog\n\nPlacebo: Placebo for glepaglutide'}, {'id': 'OG002', 'title': 'Placebo SC Injections Twice Weekly', 'description': 'Intervention: Placebo\n\nPlacebo: Placebo for glepaglutide'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0043', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference to Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '31.7', 'ciLowerLimit': '11.4', 'ciUpperLimit': '51.9', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1675', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference to Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.3', 'ciLowerLimit': '-5.4', 'ciUpperLimit': '32.0', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 weeks', 'description': 'Achieving 1 or more days per week off PS', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Response in PS Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Glepaglutide SC Injections Twice Weekly', 'description': 'Intervention: Glepaglutide\n\nglepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog'}, {'id': 'OG001', 'title': 'Glepaglutide SC Injections Once Weekly and Placebo Once Weekly', 'description': 'Intervention: Glepaglutide\n\nglepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog\n\nPlacebo: Placebo for glepaglutide'}, {'id': 'OG002', 'title': 'Placebo SC Injections Twice Weekly', 'description': 'Intervention: Placebo\n\nPlacebo: Placebo for glepaglutide'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 and 24 weeks', 'description': 'Reduction of at least 20 percent in PS volume from baseline to both 12 and 24 weeks.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Weaned Off PS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Glepaglutide SC Injections Twice Weekly', 'description': 'Intervention: Glepaglutide\n\nglepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog'}, {'id': 'OG001', 'title': 'Glepaglutide SC Injections Once Weekly and Placebo Once Weekly', 'description': 'Intervention: Glepaglutide\n\nglepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog\n\nPlacebo: Placebo for glepaglutide'}, {'id': 'OG002', 'title': 'Placebo SC Injections Twice Weekly', 'description': 'Intervention: Placebo\n\nPlacebo: Placebo for glepaglutide'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0160', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference to Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.1', 'ciLowerLimit': '2.5', 'ciUpperLimit': '25.6', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0424', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference to Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.2', 'ciLowerLimit': '0.7', 'ciUpperLimit': '21.6', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 weeks', 'description': 'Reduction in weekly PS volume of 100 percent (weaned off)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Energy Content', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Glepaglutide SC Injections Twice Weekly', 'description': 'Intervention: Glepaglutide\n\nglepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog'}, {'id': 'OG001', 'title': 'Glepaglutide SC Injections Once Weekly and Placebo Once Weekly', 'description': 'Intervention: Glepaglutide\n\nglepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog\n\nPlacebo: Placebo for glepaglutide'}, {'id': 'OG002', 'title': 'Placebo SC Injections Twice Weekly', 'description': 'Intervention: Placebo\n\nPlacebo: Placebo for glepaglutide'}], 'classes': [{'categories': [{'measurements': [{'value': '-7360.6', 'groupId': 'OG000', 'lowerLimit': '-48521', 'upperLimit': '130351'}, {'value': '-3085.9', 'groupId': 'OG001', 'lowerLimit': '-56550', 'upperLimit': '1423'}, {'value': '-734.2', 'groupId': 'OG002', 'lowerLimit': '-46307', 'upperLimit': '1670'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24 weeks', 'description': 'Change in weekly energy content of PS from baseline', 'unitOfMeasure': 'kJ/week', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Days on PS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Glepaglutide SC Injections Twice Weekly', 'description': 'Intervention: Glepaglutide\n\nglepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog'}, {'id': 'OG001', 'title': 'Glepaglutide SC Injections Once Weekly and Placebo Once Weekly', 'description': 'Intervention: Glepaglutide\n\nglepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog\n\nPlacebo: Placebo for glepaglutide'}, {'id': 'OG002', 'title': 'Placebo SC Injections Twice Weekly', 'description': 'Intervention: Placebo\n\nPlacebo: Placebo for glepaglutide'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.00', 'groupId': 'OG000', 'lowerLimit': '-5.0', 'upperLimit': '0.0'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-7.0', 'upperLimit': '1.0'}, {'value': '0.00', 'groupId': 'OG002', 'lowerLimit': '-4.0', 'upperLimit': '0.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24 weeks', 'description': 'Change in number of days on PS per week from baseline', 'unitOfMeasure': 'days/week', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in PS Volume Per Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Glepaglutide SC Injections Twice Weekly', 'description': 'Intervention: Glepaglutide\n\nglepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog'}, {'id': 'OG001', 'title': 'Glepaglutide SC Injections Once Weekly and Placebo Once Weekly', 'description': 'Intervention: Glepaglutide\n\nglepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog\n\nPlacebo: Placebo for glepaglutide'}, {'id': 'OG002', 'title': 'Placebo SC Injections Twice Weekly', 'description': 'Intervention: Placebo\n\nPlacebo: Placebo for glepaglutide'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '20 and 24 weeks', 'description': 'Achieving reduction of at least 40 percent in PS volume from baseline to both 20 and 24 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Global Impression of Change Scale (PGIC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Glepaglutide SC Injections Twice Weekly', 'description': 'Intervention: Glepaglutide glepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog'}, {'id': 'OG001', 'title': 'Glepaglutide SC Injections Once Weekly and Placebo Once Weekly', 'description': 'Intervention: Glepaglutide glepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog Placebo: Placebo for glepaglutide'}, {'id': 'OG002', 'title': 'Placebo SC Injections Twice Weekly', 'description': 'Intervention: Placebo Placebo: Placebo for glepaglutide'}], 'classes': [{'title': 'PGIC improved', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'PGIC much/very much improved', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks', 'description': 'Patient Global Impression of Change scale (PGIC) improvement at Weeks 4, 12, 20, and 24 PGIC improvement was defined as responding "Very Much Improved" or "Much Improved" on a 7-point Likert Scale. Improvement between each glepaglutide treatment regimen compared to placebo was tested by week, using the CMH test adjusted for the stratification factor. Improvement between each glepaglutide treatment regimen versus placebo was tested using collapsed categories of Improvement, No Change, and Worsening, where Improvement is defined as a response of "Very Much Improved" or "Much Improved" or "Minimally Improved", and No Change is defined as the response of "No Change", and Worsening is defined as a response of "Minimally Worse" or "Much Worse" or "Very Much Worse". Improvement using collapsed categories between each glepaglutide treatment regimen compared to placebo was tested by week using a Mantel-Haenszel chi-squared test for ordered categories.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Safety - Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Glepaglutide SC Injections Twice Weekly', 'description': 'Intervention: Glepaglutide\n\nglepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog'}, {'id': 'OG001', 'title': 'Glepaglutide SC Injections Once Weekly and Placebo Once Weekly', 'description': 'Intervention: Glepaglutide\n\nglepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog\n\nPlacebo: Placebo for glepaglutide'}, {'id': 'OG002', 'title': 'Placebo SC Injections Twice Weekly', 'description': 'Intervention: Placebo\n\nPlacebo: Placebo for glepaglutide'}], 'classes': [{'title': 'All AEs', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}]}, {'title': 'Serious adverse events', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'AE Severity: Severe', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'AE Severity: Moderate', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}, {'title': 'AE Severity: Mild', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}]}, {'title': 'Relationship: Related', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}, {'title': 'Relationship: Unlikely related', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'Relationship: Not related', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}]}, {'title': 'AEs leading to trial withdrarwal', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'AEs with action taken drug withdrawn', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'AEs with action taken drug interrupted', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Outcome: Recovered/resolved', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}, {'title': 'Outcome: Recovering/resolving', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Outcome: Recovered/resolved with sequelae', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Outcome: Not recovered/not resolved', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'Outcome: Fatal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Outcome: Unknown', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Outcome: MIssing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 weeks', 'description': 'Incidence and type of Adverse Events over an average of 28 weeks (24 weeks treatment + 4 weeks follow up)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Clinically Significant Changes in 12-Lead Electrocardiogram (ECG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Glepaglutide SC Injections Twice Weekly', 'description': 'Intervention: Glepaglutide\n\nglepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog'}, {'id': 'OG001', 'title': 'Glepaglutide SC Injections Once Weekly and Placebo Once Weekly', 'description': 'Intervention: Glepaglutide\n\nglepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog\n\nPlacebo: Placebo for glepaglutide'}, {'id': 'OG002', 'title': 'Placebo SC Injections Twice Weekly', 'description': 'Intervention: Placebo\n\nPlacebo: Placebo for glepaglutide'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 weeks', 'description': "Number of patients with clinically significant changes in ECG will be reported. Monitored ECG parameters included heart rate (beats/min), PR interval (ms), PR interval Aggregate (ms), QRS duration aggregate (ms), QT interval aggregate (ms), QTcF interval aggregate (ms), and RR interval (ms), as well as the overall interpretation of each subject's ECG recorded as Normal, Abnormal Not Clinically Significant, or Abnormal Clinically Significant.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Safety - Changes in Blood Pressure From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Glepaglutide SC Injections Twice Weekly', 'description': 'Intervention: Glepaglutide\n\nglepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog'}, {'id': 'OG001', 'title': 'Glepaglutide SC Injections Once Weekly and Placebo Once Weekly', 'description': 'Intervention: Glepaglutide\n\nglepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog\n\nPlacebo: Placebo for glepaglutide'}, {'id': 'OG002', 'title': 'Placebo SC Injections Twice Weekly', 'description': 'Intervention: Placebo\n\nPlacebo: Placebo for glepaglutide'}], 'classes': [{'title': 'Week 1 Systolic blood pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.8', 'groupId': 'OG000', 'lowerLimit': '-7.6', 'upperLimit': '2.0'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '-4.1', 'upperLimit': '4.7'}, {'value': '-4.5', 'groupId': 'OG002', 'lowerLimit': '-8.2', 'upperLimit': '-0.7'}]}]}, {'title': 'Week 2 Systolic blood pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '-3.2', 'upperLimit': '5.1'}, {'value': '-0.1', 'groupId': 'OG001', 'lowerLimit': '-4.6', 'upperLimit': '4.4'}, {'value': '-2.7', 'groupId': 'OG002', 'lowerLimit': '-6.4', 'upperLimit': '1.0'}]}]}, {'title': 'Week 4 Systolic blood pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.7', 'groupId': 'OG000', 'lowerLimit': '-6.5', 'upperLimit': '3.1'}, {'value': '-0.2', 'groupId': 'OG001', 'lowerLimit': '-3.9', 'upperLimit': '3.4'}, {'value': '-0.3', 'groupId': 'OG002', 'lowerLimit': '-4.6', 'upperLimit': '3.9'}]}]}, {'title': 'Week 8 Systolic blood pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '-5.4', 'upperLimit': '6.0'}, {'value': '-1.5', 'groupId': 'OG001', 'lowerLimit': '-5.9', 'upperLimit': '2.9'}, {'value': '-2.5', 'groupId': 'OG002', 'lowerLimit': '-6.9', 'upperLimit': '1.8'}]}]}, {'title': 'Week 12 Systolic blood pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-4.4', 'groupId': 'OG000', 'lowerLimit': '-9.6', 'upperLimit': '0.8'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '-1.0', 'upperLimit': '7.6'}, {'value': '-0.4', 'groupId': 'OG002', 'lowerLimit': '-5.0', 'upperLimit': '4.1'}]}]}, {'title': 'Week 16 Systolic blood pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '-5.6', 'upperLimit': '5.8'}, {'value': '0.4', 'groupId': 'OG001', 'lowerLimit': '-4.7', 'upperLimit': '5.5'}, {'value': '-1.1', 'groupId': 'OG002', 'lowerLimit': '-6.3', 'upperLimit': '4.1'}]}]}, {'title': 'Week 20 Systolic blood pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '-5.8', 'upperLimit': '8.3'}, {'value': '1.2', 'groupId': 'OG001', 'lowerLimit': '-3.6', 'upperLimit': '6.0'}, {'value': '-1.0', 'groupId': 'OG002', 'lowerLimit': '-6.2', 'upperLimit': '4.3'}]}]}, {'title': 'Week 24 Systolic blood pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'groupId': 'OG000', 'lowerLimit': '-6.2', 'upperLimit': '4.1'}, {'value': '-1.1', 'groupId': 'OG001', 'lowerLimit': '-5.6', 'upperLimit': '3.4'}, {'value': '-5.9', 'groupId': 'OG002', 'lowerLimit': '-11.0', 'upperLimit': '-0.8'}]}]}, {'title': 'Week 1 Diastolic blood pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '-2.3', 'upperLimit': '3.0'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '-2.6', 'upperLimit': '3.5'}, {'value': '-2.0', 'groupId': 'OG002', 'lowerLimit': '-4.6', 'upperLimit': '0.6'}]}]}, {'title': 'Week 2 Diastolic blood pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '4.7'}, {'value': '-0.7', 'groupId': 'OG001', 'lowerLimit': '-3.1', 'upperLimit': '1.7'}, {'value': '-1.7', 'groupId': 'OG002', 'lowerLimit': '-5.0', 'upperLimit': '1.6'}]}]}, {'title': 'Week 4 Diastolic blood pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-2.8', 'upperLimit': '2.8'}, {'value': '-0.2', 'groupId': 'OG001', 'lowerLimit': '-2.5', 'upperLimit': '2.8'}, {'value': '-1.5', 'groupId': 'OG002', 'lowerLimit': '-4.6', 'upperLimit': '1.6'}]}]}, {'title': 'Week 8 Diastolic blood pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'groupId': 'OG000', 'lowerLimit': '-3.3', 'upperLimit': '2.3'}, {'value': '1.9', 'groupId': 'OG001', 'lowerLimit': '-1.3', 'upperLimit': '5.0'}, {'value': '-0.6', 'groupId': 'OG002', 'lowerLimit': '-3.3', 'upperLimit': '2.2'}]}]}, {'title': 'Week 12 Diastolic blood pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.8', 'groupId': 'OG000', 'lowerLimit': '-6.7', 'upperLimit': '1.2'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '-1.0', 'upperLimit': '5.1'}, {'value': '0.9', 'groupId': 'OG002', 'lowerLimit': '-1.8', 'upperLimit': '3.6'}]}]}, {'title': 'Week 20 Diastolic blood pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000', 'lowerLimit': '-1.5', 'upperLimit': '5.7'}, {'value': '-0.7', 'groupId': 'OG001', 'lowerLimit': '-3.9', 'upperLimit': '2.4'}, {'value': '0.4', 'groupId': 'OG002', 'lowerLimit': '-3.3', 'upperLimit': '4.1'}]}]}, {'title': 'Week 24 Diastolic blood pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '-1.6', 'upperLimit': '5.9'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-2.7', 'upperLimit': '2.7'}, {'value': '-0.9', 'groupId': 'OG002', 'lowerLimit': '-3.8', 'upperLimit': '2.1'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24', 'description': 'Changes in blood pressure are reported at Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 The data collected data are of seated diastolic and systolic blood pressure (mmHg). During treatment phase visits, vital signs were collected before investigational product injection.', 'unitOfMeasure': 'mmHg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'At certain visits those data are missing for some patients.'}, {'type': 'SECONDARY', 'title': 'Safety - Changes in Body Temperature From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Glepaglutide SC Injections Twice Weekly', 'description': 'Intervention: Glepaglutide\n\nglepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog'}, {'id': 'OG001', 'title': 'Glepaglutide SC Injections Once Weekly and Placebo Once Weekly', 'description': 'Intervention: Glepaglutide\n\nglepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog\n\nPlacebo: Placebo for glepaglutide'}, {'id': 'OG002', 'title': 'Placebo SC Injections Twice Weekly', 'description': 'Intervention: Placebo\n\nPlacebo: Placebo for glepaglutide'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-0.1', 'upperLimit': '0.2'}, {'value': '-0.0', 'groupId': 'OG001', 'lowerLimit': '-0.2', 'upperLimit': '0.1'}, {'value': '0.1', 'groupId': 'OG002', 'lowerLimit': '-0.0', 'upperLimit': '0.2'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '-0.0', 'upperLimit': '0.2'}, {'value': '-0.0', 'groupId': 'OG001', 'lowerLimit': '-0.2', 'upperLimit': '0.1'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '-0.1', 'upperLimit': '0.1'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000', 'lowerLimit': '-0.2', 'upperLimit': '0.1'}, {'value': '-0.0', 'groupId': 'OG001', 'lowerLimit': '-0.2', 'upperLimit': '0.1'}, {'value': '0.1', 'groupId': 'OG002', 'lowerLimit': '-0.1', 'upperLimit': '0.2'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-0.1', 'upperLimit': '0.2'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-0.0', 'upperLimit': '0.2'}, {'value': '-0.1', 'groupId': 'OG002', 'lowerLimit': '-0.2', 'upperLimit': '0.1'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.0', 'groupId': 'OG000', 'lowerLimit': '-0.2', 'upperLimit': '0.1'}, {'value': '-0.0', 'groupId': 'OG001', 'lowerLimit': '-0.1', 'upperLimit': '0.1'}, {'value': '0.1', 'groupId': 'OG002', 'lowerLimit': '-0.1', 'upperLimit': '0.2'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.0', 'groupId': 'OG000', 'lowerLimit': '-0.1', 'upperLimit': '0.1'}, {'value': '-0.0', 'groupId': 'OG001', 'lowerLimit': '-0.1', 'upperLimit': '0.1'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '-0.1', 'upperLimit': '0.1'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '-0.1', 'upperLimit': '0.2'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-0.1', 'upperLimit': '0.1'}, {'value': '0.1', 'groupId': 'OG002', 'lowerLimit': '-0.1', 'upperLimit': '0.2'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.0', 'groupId': 'OG000', 'lowerLimit': '-0.1', 'upperLimit': '0.1'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-0.0', 'upperLimit': '0.2'}, {'value': '0.1', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '0.2'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '28 weeks', 'description': "Changes in body temperature are reported The body temperature (ºC or ºF) was measured according to the site's usual procedure. During treatment phase visits, vital signs were collected before investigational product injection.", 'unitOfMeasure': 'degree C', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'At certain visits those data are missing for some patients.'}, {'type': 'SECONDARY', 'title': 'Immunogenicity - Occurrence of Anti-drug Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Glepaglutide SC Injections Twice Weekly', 'description': 'Intervention: Glepaglutide\n\nglepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog'}, {'id': 'OG001', 'title': 'Glepaglutide SC Injections Once Weekly and Placebo Once Weekly', 'description': 'Intervention: Glepaglutide\n\nglepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog\n\nPlacebo: Placebo for glepaglutide'}, {'id': 'OG002', 'title': 'Placebo SC Injections Twice Weekly', 'description': 'Intervention: Placebo\n\nPlacebo: Placebo for glepaglutide'}], 'classes': [{'title': 'ADA (Treatment-induced)', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'M2 BAb (Treatment-induced)', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'NAb M2 (Treatment-induced)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'GLP-2 CR (Treatment-induced)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 weeks', 'description': 'Occurrence of antibodies against glepaglutide The occurrence of glepaglutide-binding antibodies (ADA), M2 binding antibodies (M2 BAb), glepaglutide neutralizing antibodies (NAb) and GLP-2 cross-reacting antibodies (GLP-2 CR) was tested.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Glepaglutide SC Injections Twice Weekly', 'description': 'Intervention: Glepaglutide\n\nglepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog'}, {'id': 'FG001', 'title': 'Glepaglutide SC Injections Once Weekly and Placebo Once Weekly', 'description': 'Intervention: Glepaglutide\n\nglepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog\n\nPlacebo: Placebo for glepaglutide'}, {'id': 'FG002', 'title': 'Placebo SC Injections Twice Weekly', 'description': 'Intervention: Placebo\n\nPlacebo: Placebo for glepaglutide'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '35'}, {'groupId': 'FG002', 'numSubjects': '36'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '35'}, {'groupId': 'FG002', 'numSubjects': '36'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'ICF withdrawal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This trial was conducted in (number of sites that randomized patients in parenthesis) Belgium (1), Denmark (2), France (2), Germany (5), the Netherlands (1), Poland (3), Canada (3), the US (7), and the UK (5).', 'preAssignmentDetails': 'Patients were diagnosed with SBS and required PS at least 3 days/week. They were willing to adhere to an individual pre-defined drinking menu during 48 h measurement periods and maintain a stable weight.\n\nThe drinking menu and the PS volume and content were adjusted during an optimization phase following by a stabilization phase.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '106', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Glepaglutide SC Injections Twice Weekly', 'description': 'Intervention: Glepaglutide\n\nglepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog'}, {'id': 'BG001', 'title': 'Glepaglutide SC Injections Once Weekly and Placebo Once Weekly', 'description': 'Intervention: Glepaglutide\n\nglepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog\n\nPlacebo: Placebo for glepaglutide'}, {'id': 'BG002', 'title': 'Placebo SC Injections Twice Weekly', 'description': 'Intervention: Placebo\n\nPlacebo: Placebo for glepaglutide'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '81', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.9', 'spread': '13.4', 'groupId': 'BG000'}, {'value': '54.0', 'spread': '12.0', 'groupId': 'BG001'}, {'value': '55.0', 'spread': '11.8', 'groupId': 'BG002'}, {'value': '55.0', 'spread': '12.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '57', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '95', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', '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': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '89', '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': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}]}, {'title': 'Denmark', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '23.57', 'spread': '3.35', 'groupId': 'BG000'}, {'value': '22.72', 'spread': '3.21', 'groupId': 'BG001'}, {'value': '23.54', 'spread': '3.57', 'groupId': 'BG002'}, {'value': '23.28', 'spread': '3.37', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-01-27', 'size': 4131506, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-08-02T10:37', 'hasProtocol': True}, {'date': '2022-08-25', 'size': 725859, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-08-02T10:43', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'dispFirstSubmitDate': '2023-05-23', 'completionDateStruct': {'date': '2022-07-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-30', 'studyFirstSubmitDate': '2018-09-17', 'resultsFirstSubmitDate': '2024-05-30', 'studyFirstSubmitQcDate': '2018-09-27', 'dispFirstPostDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-18', 'studyFirstPostDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Weekly Parenteral Support (PS) Volume', 'timeFrame': '24 weeks', 'description': 'Change in weekly PS volume from baseline to Week 24. Baseline actual weekly PS volume was defined as the actual PS volume derived from a valid 7-day period prior to visit 1 (Day 1), i.e. during the stabilization phase. The actual weekly PS volume at Weeks 1, 2, 4, 8, 12, 16, 20, and 24 was derived as the actual weekly PS volume received during the valid 7-day period prior to the visit. The source for the derivation was the PS volumes recorded by the patients in the eDiary.'}], 'secondaryOutcomes': [{'measure': 'Clinical Response in PS Volume', 'timeFrame': '20 and 24 weeks', 'description': 'Clinical response, defined as at least 20% reduction in actual weekly PS volume from baseline to both Weeks 20 and 24.'}, {'measure': 'Days Off PS', 'timeFrame': '24 weeks', 'description': 'Achieving 1 or more days per week off PS'}, {'measure': 'Clinical Response in PS Volume', 'timeFrame': '12 and 24 weeks', 'description': 'Reduction of at least 20 percent in PS volume from baseline to both 12 and 24 weeks.'}, {'measure': 'Weaned Off PS', 'timeFrame': '24 weeks', 'description': 'Reduction in weekly PS volume of 100 percent (weaned off)'}, {'measure': 'Energy Content', 'timeFrame': '24 weeks', 'description': 'Change in weekly energy content of PS from baseline'}, {'measure': 'Days on PS', 'timeFrame': '24 weeks', 'description': 'Change in number of days on PS per week from baseline'}, {'measure': 'Change in PS Volume Per Week', 'timeFrame': '20 and 24 weeks', 'description': 'Achieving reduction of at least 40 percent in PS volume from baseline to both 20 and 24 weeks'}, {'measure': 'Patient Global Impression of Change Scale (PGIC)', 'timeFrame': '24 weeks', 'description': 'Patient Global Impression of Change scale (PGIC) improvement at Weeks 4, 12, 20, and 24 PGIC improvement was defined as responding "Very Much Improved" or "Much Improved" on a 7-point Likert Scale. Improvement between each glepaglutide treatment regimen compared to placebo was tested by week, using the CMH test adjusted for the stratification factor. Improvement between each glepaglutide treatment regimen versus placebo was tested using collapsed categories of Improvement, No Change, and Worsening, where Improvement is defined as a response of "Very Much Improved" or "Much Improved" or "Minimally Improved", and No Change is defined as the response of "No Change", and Worsening is defined as a response of "Minimally Worse" or "Much Worse" or "Very Much Worse". Improvement using collapsed categories between each glepaglutide treatment regimen compared to placebo was tested by week using a Mantel-Haenszel chi-squared test for ordered categories.'}, {'measure': 'Safety - Adverse Events', 'timeFrame': '28 weeks', 'description': 'Incidence and type of Adverse Events over an average of 28 weeks (24 weeks treatment + 4 weeks follow up)'}, {'measure': 'Number of Patients With Clinically Significant Changes in 12-Lead Electrocardiogram (ECG)', 'timeFrame': '28 weeks', 'description': "Number of patients with clinically significant changes in ECG will be reported. Monitored ECG parameters included heart rate (beats/min), PR interval (ms), PR interval Aggregate (ms), QRS duration aggregate (ms), QT interval aggregate (ms), QTcF interval aggregate (ms), and RR interval (ms), as well as the overall interpretation of each subject's ECG recorded as Normal, Abnormal Not Clinically Significant, or Abnormal Clinically Significant."}, {'measure': 'Safety - Changes in Blood Pressure From Baseline', 'timeFrame': 'Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24', 'description': 'Changes in blood pressure are reported at Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 The data collected data are of seated diastolic and systolic blood pressure (mmHg). During treatment phase visits, vital signs were collected before investigational product injection.'}, {'measure': 'Safety - Changes in Body Temperature From Baseline', 'timeFrame': '28 weeks', 'description': "Changes in body temperature are reported The body temperature (ºC or ºF) was measured according to the site's usual procedure. During treatment phase visits, vital signs were collected before investigational product injection."}, {'measure': 'Immunogenicity - Occurrence of Anti-drug Antibodies', 'timeFrame': '28 weeks', 'description': 'Occurrence of antibodies against glepaglutide The occurrence of glepaglutide-binding antibodies (ADA), M2 binding antibodies (M2 BAb), glepaglutide neutralizing antibodies (NAb) and GLP-2 cross-reacting antibodies (GLP-2 CR) was tested.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Short Bowel Syndrome']}, 'referencesModule': {'references': [{'pmid': '39708985', 'type': 'DERIVED', 'citation': 'Jeppesen PB, Vanuytsel T, Subramanian S, Joly F, Wanten G, Lamprecht G, Kunecki M, Rahman F, Nielsen TSS, Berner-Hansen M, Pape UF, Mercer DF. Glepaglutide, a Long-Acting Glucagon-like Peptide-2 Analogue, Reduces Parenteral Support in Patients With Short Bowel Syndrome: A Phase 3 Randomized Controlled Trial. Gastroenterology. 2025 Apr;168(4):701-713.e6. doi: 10.1053/j.gastro.2024.11.023. Epub 2024 Dec 19.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the trial is to confirm the efficacy of glepaglutide in reducing parenteral support volume in patients with short bowel syndrome.\n\nGlepaglutide is the International Nonproprietary Name and USAN for ZP1848.', 'detailedDescription': 'A Phase 3, international, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of glepaglutide subcutaneous (SC) injections in patients with short bowel syndrome (SBS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Informed consent obtained before any trial-related activity.\n* Diagnosis of SBS defined as remaining small bowel in continuity of estimated less than 200 cm and considered stable with regard to PS need. No restorative surgery planned in the trial period.\n* Requiring PS at least 3 days per week and maintains a stable PS volume for at least 2 weeks.\n* In case of remnant colon: documented colonoscopy which does not give rise to any safety concerns.\n\nExclusion Criteria:\n\n* More than 2 SBS-related or PS-related hospitalizations within 6 months prior to Screening. No SBS-related hospitalizations within 30 days prior to randomization.\n* Poorly controlled inflammatory bowel disease that is moderately or severely active or fistula interfering with measurements or examinations required in the trial.\n* Bowel obstruction.\n* Known radiation enteritis or significant villous atrophy.\n* Cardiac disease defined as: decompensated heart failure (New York Heart Association \\[NYHA\\] Class III-IV), unstable angina pectoris, and/or myocardial infarction within the last 6 months prior to Screening.\n* Clinically significant abnormal ECG.\n* Repeated systolic blood pressure measurements \\> 180 mm Hg.\n* Human immunodeficiency virus positive, acute liver disease, or unstable chronic liver disease.\n* Any history of colon cancer. History of any other cancers unless disease-free state for at least 5 years.\n* Estimated creatinine clearance \\< 30 mL/min.\n* Severe hepatic impairment.\n* Use of GLP-1, GLP-2, human growth hormone, somatostatin, or analogs thereof, within 3 months prior to Screening.\n* Use of dipeptidyl peptidase (DPP)-4 inhibitors within 3 months prior to Screening.\n* Unstable systemic immunosuppressive therapy within 3 months prior to Screening.\n* Unstable biological therapy within 6 months prior to Screening.\n* Females of childbearing potential, who are pregnant, breast-feeding, intend to become pregnant or are not using highly effective contraceptive methods.\n* Previous exposure to glepaglutide.\n* Current, or within 30 days prior to Screening, participation in another interventional clinical trial that includes administration of an active compound.\n* Any condition or disease or circumstance that in the Investigator's opinion would put the patient at any undue risk, prevent completion of the trial, or interfere with the analysis of the trial results."}, 'identificationModule': {'nctId': 'NCT03690206', 'acronym': 'EASE SBS 1', 'briefTitle': 'Efficacy And Safety Evaluation of Glepaglutide in Treatment of Short Bowel Syndrome (SBS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zealand Pharma'}, 'officialTitle': 'A Phase 3, International, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Glepaglutide in Patients With Short Bowel Syndrome (SBS)', 'orgStudyIdInfo': {'id': 'ZP1848-17111'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Glepaglutide SC injections twice weekly', 'description': 'Intervention: Glepaglutide', 'interventionNames': ['Drug: glepaglutide']}, {'type': 'EXPERIMENTAL', 'label': 'Glepaglutide SC injections once weekly and placebo once weekly', 'description': 'Intervention: Glepaglutide', 'interventionNames': ['Drug: glepaglutide', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo SC injections twice weekly', 'description': 'Intervention: Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'glepaglutide', 'type': 'DRUG', 'otherNames': ['ZP1848'], 'description': 'Glucagon-Like Peptide-2 (GLP-2) analog', 'armGroupLabels': ['Glepaglutide SC injections once weekly and placebo once weekly', 'Glepaglutide SC injections twice weekly']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo for glepaglutide', 'armGroupLabels': ['Glepaglutide SC injections once weekly and placebo once weekly', 'Placebo SC injections twice weekly']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University Medical Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "University of Chicago Children's Hospital", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic College of Medicine', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '68198-3285', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '68198-3285', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center, Nashville', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'city': 'Leuven', 'country': 'Belgium', 'facility': 'UZ Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Edmonton', 'country': 'Canada', 'facility': 'The Royal Alexandra Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'N6A 4V2', 'city': 'London', 'country': 'Canada', 'facility': 'Western University', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'city': 'Toronto', 'country': 'Canada', 'facility': 'University Health Network - Toronto General Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '9000', 'city': 'Aalborg', 'country': 'Denmark', 'facility': 'Aalborg University Hospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Clichy', 'country': 'France', 'facility': 'Hôpital Beaujon', 'geoPoint': {'lat': 48.90018, 'lon': 2.30952}}, {'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'Centre Hospitalier Lyon-Sud', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité - Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Bonn', 'country': 'Germany', 'facility': 'Universitätsklinikum Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Universitätsklinikum Frankfurt - Med. Klinik I', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'city': 'Hamburg', 'country': 'Germany', 'facility': 'Asklepios Kliniken Hamburg GmbH', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Rostock', 'country': 'Germany', 'facility': 'Universitätsmedizin Rostock', 'geoPoint': {'lat': 54.0887, 'lon': 12.14049}}, {'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'UMC Radboud Nijmegen', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'city': 'Lodz', 'country': 'Poland', 'facility': 'Wojewodzki Specjalistyczny Szpital im. M. Pirogowa w Lodzi', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'city': 'Poznan', 'country': 'Poland', 'facility': 'Solumed', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'city': 'Skawina', 'country': 'Poland', 'facility': 'Szpital Skawina sp. z o.o. im. Stanley Dudricka', 'geoPoint': {'lat': 49.97524, 'lon': 19.82869}}, {'city': 'Harrow', 'country': 'United Kingdom', 'facility': "St Mark's Hospital", 'geoPoint': {'lat': 51.57835, 'lon': -0.33208}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'UCLH Foundation NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Salford Royal NHS Foundation Trust', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'city': 'Norwich', 'country': 'United Kingdom', 'facility': 'University of East Anglia', 'geoPoint': {'lat': 52.62783, 'lon': 1.29834}}, {'city': 'Southampton', 'country': 'United Kingdom', 'facility': 'University Hospital Southampton NHS Foundation Trust', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Zealand Pharma'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zealand Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}