Viewing Study NCT02954458

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Ignite Creation Date: 2025-12-25 @ 12:05 AM
Ignite Modification Date: 2026-02-27 @ 8:48 AM
Study NCT ID: NCT02954458
Status: COMPLETED
Last Update Posted: 2025-03-28
First Post: 2016-11-02
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Long-term Safety and Efficacy Study of Teduglutide in Pediatric Participants With Short Bowel Syndrome (SBS)
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013594', 'term': 'Syringes'}, {'id': 'D009339', 'term': 'Needles'}], 'ancestors': [{'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTransparency@takeda.com', 'phone': '+1 866 842 5335', 'title': 'Study Director', 'organization': 'Shire'}, 'certainAgreement': {'otherDetails': 'If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From start of study drug administration up to follow-up (up to 46 months)', 'eventGroups': [{'id': 'EG000', 'title': 'Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 6, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Non-teduglutide/Teduglutide Treatment (NTT/TED)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Teduglutide /Non-teduglutide Treatment (TED/NTT)', 'description': 'Participants who received teduglutide in the core study TEDC14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Teduglutide/Teduglutide Treatment (TED/TED)', 'description': 'Participants who received teduglutide in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 50, 'seriousNumAtRisk': 50, 'deathsNumAffected': 2, 'seriousNumAffected': 41}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 33, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 10, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Abnormal faeces', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Anal incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 29, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Frequent bowel movements', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 12, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 11, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 77, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Catheter site discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Catheter site extravasation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Catheter site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Complication associated with device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Medical device site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 21, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Thirst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Drug-induced liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Gastrointestinal bacterial overgrowth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Malassezia infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 15, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Otitis media acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 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'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Superior vena cava occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Vena cava thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.'}, {'id': 'OG001', 'title': 'Non-teduglutide/Teduglutide Treatment (NTT/TED)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.'}, {'id': 'OG002', 'title': 'Teduglutide /Non-teduglutide Treatment (TED/NTT)', 'description': 'Participants who received teduglutide in the core study TEDC14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.'}, {'id': 'OG003', 'title': 'Teduglutide/Teduglutide Treatment (TED/TED)', 'description': 'Participants who received teduglutide in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of study drug administration up to follow-up (up to 46 months)', 'description': 'An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs were defined as AEs that started or worsened on or after the date of first dose of teduglutide for participants in the TED/TED, TED/NTT, and NTT/TED treatment groups, or after the core study baseline visit for participants in the NTT/NTT group.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Average Total Urine Output at End of Treatment (EOT) of Last Cycle During Teduglutide Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-teduglutide/Teduglutide Treatment (NTT/TED)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.'}, {'id': 'OG001', 'title': 'Teduglutide/Teduglutide Treatment (TED/TED)', 'description': 'Participants who received teduglutide in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.26', 'spread': '1.692', 'groupId': 'OG000'}, {'value': '2.51', 'spread': '22.607', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'Average total urine output was recorded over a 48-hour period of parental support (PS) stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The Average daily urine output milliliter per kilogram per day (mL/kg/day) was calculated as: Total urine output over 48 hours / 2) / body weight (kilogram \\[kg\\]) where total urine output was calculated as the sum of the urine output in milliliter (mL) and the urine-only diaper weights in gram (g) (1g = 1mL) for the participant collected on the output diary form of electronic case report from (eCRF).', 'unitOfMeasure': 'mL/kg/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Average Total Urine Output at Last Visit During Non-Teduglutide Treatment (NT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.'}, {'id': 'OG001', 'title': 'Non-teduglutide/Teduglutide Treatment (NTT/TED)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.'}, {'id': 'OG002', 'title': 'Teduglutide /Non-teduglutide Treatment (TED/NTT)', 'description': 'Participants who received teduglutide in the core study TEDC14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.'}, {'id': 'OG003', 'title': 'Teduglutide/Teduglutide Treatment (TED/TED)', 'description': 'Participants who received teduglutide in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.89', 'spread': '7.431', 'groupId': 'OG000'}, {'value': '15.01', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG002'}, {'value': '-6.87', 'spread': '26.299', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Last visit in NT (up to Month 39)', 'description': 'Average total urine output was recorded over a 48 hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. Average daily urine output mL/kg/day was calculated as: (Total urine output over 48 hours/2) / body weight (kg) where total urine output was calculated as the sum of the urine output in mL and the urine-only diaper weights in gram (1g = 1mL) for the participant collected on the output diary form of electronic case report from (eCRF).', 'unitOfMeasure': 'mL/kg/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for all the four arms: NTT/NTT, NTT/TED, TED/NTT and TED/TED. Participants who received teduglutide treatment could enter a NT period when the teduglutide treatment criteria were not met.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Average Number of Stools Per Day at EOT of Last Cycle During Teduglutide Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-teduglutide/Teduglutide Treatment (NTT/TED)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.'}, {'id': 'OG001', 'title': 'Teduglutide/Teduglutide Treatment (TED/TED)', 'description': 'Participants who received teduglutide in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.47', 'spread': '2.272', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized by the average number of stools per day. The average number of stools per day was calculated as (sum of the daily data in a 48-hour period/2).', 'unitOfMeasure': 'Stools per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Average Number of Stools Per Day at Last Visit During Non-Teduglutide Treatment (NT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.'}, {'id': 'OG001', 'title': 'Non-teduglutide/Teduglutide Treatment (NTT/TED)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.'}, {'id': 'OG002', 'title': 'Teduglutide /Non-teduglutide Treatment (TED/NTT)', 'description': 'Participants who received teduglutide in the core study TEDC14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.'}, {'id': 'OG003', 'title': 'Teduglutide/Teduglutide Treatment (TED/TED)', 'description': 'Participants who received teduglutide in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.50', 'spread': '0.913', 'groupId': 'OG000'}, {'value': '0.38', 'spread': '1.780', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Last visit in NT (up to Month 39)', 'description': 'Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized by the average number of stools per day. The average number of stools per day was calculated as (sum of the daily data in a 48-hour period/2).', 'unitOfMeasure': 'Stools per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for all the four arms: NTT/NTT, NTT/TED, TED/NTT and TED/TED. Participants who received teduglutide treatment could enter a NT period when the teduglutide treatment criteria were not met.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Average Total Daily Stool/Mixed Stool Diaper Weight at EOT of Last Cycle During Teduglutide Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-teduglutide/Teduglutide Treatment (NTT/TED)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.'}, {'id': 'OG001', 'title': 'Teduglutide/Teduglutide Treatment (TED/TED)', 'description': 'Participants who received teduglutide in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}, {'value': '-11.35', 'spread': '25.667', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized by the average total daily stool/mixed stool diaper weight (gram per kilogram per day \\[g/kg/day\\]). The body weight was used to calculate the daily stool/mixed stool diaper weight (g/kg/day).', 'unitOfMeasure': 'g/kg/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Average Total Daily Stool/Mixed Stool Diaper Weight at Last Visit During Non-Teduglutide Treatment (NT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.'}, {'id': 'OG001', 'title': 'Non-teduglutide/Teduglutide Treatment (NTT/TED)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.'}, {'id': 'OG002', 'title': 'Teduglutide /Non-teduglutide Treatment (TED/NTT)', 'description': 'Participants who received teduglutide in the core study TEDC14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.'}, {'id': 'OG003', 'title': 'Teduglutide/Teduglutide Treatment (TED/TED)', 'description': 'Participants who received teduglutide in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.31', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}, {'value': '-4.98', 'spread': '20.892', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Last visit in NT (up to Month 39)', 'description': 'Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized by the average total daily stool/mixed stool diaper weight (gram per kilogram per day \\[g/kg/day\\]). The body weight was used to calculate the daily stool/mixed stool diaper weight (g/kg/day).', 'unitOfMeasure': 'g/kg/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for all the four arms: NTT/NTT, NTT/TED, TED/NTT and TED/TED. Participants who received teduglutide treatment could enter a NT period when the teduglutide treatment criteria were not met.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Average Total Ostomy Output at EOT of Last Cycle During Teduglutide Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-teduglutide/Teduglutide Treatment (NTT/TED)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.'}, {'id': 'OG001', 'title': 'Teduglutide/Teduglutide Treatment (TED/TED)', 'description': 'Participants who received teduglutide in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.52', 'spread': '11.675', 'groupId': 'OG000'}, {'value': '12.16', 'spread': '35.079', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized the average ostomy output per day (mL/kg/day).', 'unitOfMeasure': 'mL/kg/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Average Total Ostomy Output at Last Visit During Non-Teduglutide Treatment (NT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.'}, {'id': 'OG001', 'title': 'Non-teduglutide/Teduglutide Treatment (NTT/TED)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.'}, {'id': 'OG002', 'title': 'Teduglutide /Non-teduglutide Treatment (TED/NTT)', 'description': 'Participants who received teduglutide in the core study TEDC14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.'}, {'id': 'OG003', 'title': 'Teduglutide/Teduglutide Treatment (TED/TED)', 'description': 'Participants who received teduglutide in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.89', 'spread': '37.835', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Last visit in NT (up to Month 39)', 'description': 'Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized the average ostomy output per day.', 'unitOfMeasure': 'mL/kg/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for all the four arms: NTT/NTT, NTT/TED, TED/NTT and TED/TED. Participants who received teduglutide treatment could enter a NT period when the teduglutide treatment criteria were not met.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Average Bristol Stool Form Score at EOT of Last Cycle During Teduglutide Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-teduglutide/Teduglutide Treatment (NTT/TED)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.'}, {'id': 'OG001', 'title': 'Teduglutide/Teduglutide Treatment (TED/TED)', 'description': 'Participants who received teduglutide in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.54', 'spread': '0.977', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The Average daily fecal output was summarized the average typical stool form score using Bristol Stool Form Scale. The average typical stool form score was calculated as (sum of the daily data in a 48-hour period / 2). Typical Stool Form based on Bristol Stool Form Scale: 1 - Separate hard lumps, hard to pass, 2 - Sausage-shaped, but lumpy, 3 - Like a sausage but with cracks on the surface, 4- Like a sausage or snake, smooth and soft, 5- Soft blobs with clear-cut edges, 6- Fluffy pieces with ragged edges, a mushy stool, 7- Watery, no solid pieces. Entirely liquid.', 'unitOfMeasure': 'Scale on a Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Average Bristol Stool Form Score at Last Visit During Non-Teduglutide Treatment (NT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.'}, {'id': 'OG001', 'title': 'Non-teduglutide/Teduglutide Treatment (NTT/TED)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.'}, {'id': 'OG002', 'title': 'Teduglutide /Non-teduglutide Treatment (TED/NTT)', 'description': 'Participants who received teduglutide in the core study TEDC14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.'}, {'id': 'OG003', 'title': 'Teduglutide/Teduglutide Treatment (TED/TED)', 'description': 'Participants who received teduglutide in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.25', 'spread': '0.500', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG002'}, {'value': '-0.08', 'spread': '0.583', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Last visit in NT (up to Month 39)', 'description': 'Fecal output was recorded over a 48 hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized separately the average typical stool form score using Bristol Stool Form Scale. The average typical stool form score was calculated as (sum of the daily data in a 48-hour period / 2). Typical Stool Form based on Bristol Stool Form Scale: 1- Separate hard lumps, hard to pass, 2- Sausage-shaped, but lumpy, 3- Like a sausage but with cracks on the surface, 4 - Like a sausage or snake, smooth and soft, 5- Soft blobs with clear-cut edges, 6- Fluffy pieces with ragged edges, a mushy stool, 7- Watery, no solid pieces. Entirely liquid.', 'unitOfMeasure': 'Scale on a Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for all the four arms: NTT/NTT, NTT/TED, TED/NTT and TED/TED. Participants who received teduglutide treatment could enter a NT period when the teduglutide treatment criteria were not met.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Positive Specific Antibodies at End of Study (EOS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-teduglutide/Teduglutide Treatment (NTT/TED)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.'}, {'id': 'OG001', 'title': 'Teduglutide /Non-teduglutide Treatment (TED/NTT)', 'description': 'Participants who received teduglutide in the core study TEDC14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.'}, {'id': 'OG002', 'title': 'Teduglutide/Teduglutide Treatment (TED/TED)', 'description': 'Participants who received teduglutide in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At EOS (up to 46 months)', 'description': 'Number of participants with positive specific antibodies to teduglutide were used to summarize the presence of antibodies.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for the 3 arms: NTT/TED, TED/NTT and TED/TED only.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Body Weight Z-score at EOT of Last Cycle During Teduglutide Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-teduglutide/Teduglutide Treatment (NTT/TED)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.'}, {'id': 'OG001', 'title': 'Teduglutide/Teduglutide Treatment (TED/TED)', 'description': 'Participants who received teduglutide in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.087', 'spread': '0.422', 'groupId': 'OG000'}, {'value': '-0.164', 'spread': '0.951', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'Body weight was measured using Z-score. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age \\>= 2 years old) and World Health Organization (age \\< 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.', 'unitOfMeasure': 'Z-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Body Weight Z-score at Last Visit During Non-Teduglutide Treatment (NT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.'}, {'id': 'OG001', 'title': 'Non-teduglutide/Teduglutide Treatment (NTT/TED)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.'}, {'id': 'OG002', 'title': 'Teduglutide /Non-teduglutide Treatment (TED/NTT)', 'description': 'Participants who received teduglutide in the core study TEDC14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.'}, {'id': 'OG003', 'title': 'Teduglutide/Teduglutide Treatment (TED/TED)', 'description': 'Participants who received teduglutide in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.489', 'spread': '0.542', 'groupId': 'OG000'}, {'value': '-0.132', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG001'}, {'value': '0.013', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG002'}, {'value': '-0.363', 'spread': '0.657', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Last visit in NT (up to Month 39)', 'description': 'Body weight was measured using Z-score. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age \\>= 2 years old) and World Health Organization (age \\< 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.', 'unitOfMeasure': 'Z-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for all the four arms: NTT/NTT, NTT/TED, TED/NTT and TED/TED. Participants who received teduglutide treatment could enter a NT period when the teduglutide treatment criteria were not met.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Height Z-score at EOT of Last Cycle During Teduglutide Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-teduglutide/Teduglutide Treatment (NTT/TED)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.'}, {'id': 'OG001', 'title': 'Teduglutide/Teduglutide Treatment (TED/TED)', 'description': 'Participants who received teduglutide in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.118', 'spread': '0.968', 'groupId': 'OG000'}, {'value': '-0.277', 'spread': '0.797', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'Height was measured using Z-score. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age \\>= 2 years old) and World Health Organization (age \\< 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.', 'unitOfMeasure': 'Z-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Height Z-score at Last Visit During Non-Teduglutide Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.'}, {'id': 'OG001', 'title': 'Non-teduglutide/Teduglutide Treatment (NTT/TED)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.'}, {'id': 'OG002', 'title': 'Teduglutide /Non-teduglutide Treatment (TED/NTT)', 'description': 'Participants who received teduglutide in the core study TEDC14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.'}, {'id': 'OG003', 'title': 'Teduglutide/Teduglutide Treatment (TED/TED)', 'description': 'Participants who received teduglutide in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.518', 'spread': '0.451', 'groupId': 'OG000'}, {'value': '-0.770', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG001'}, {'value': '0.220', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG002'}, {'value': '-0.132', 'spread': '0.466', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Last visit in NT (up to Month 39)', 'description': 'Height was measured using Z-score. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age \\>= 2 years old) and World Health Organization (age \\< 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.', 'unitOfMeasure': 'Z-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for all the four arms: NTT/NTT, NTT/TED, TED/NTT and TED/TED. Participants who received teduglutide treatment could enter a NT period when the teduglutide treatment criteria were not met.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Head Circumference Z-score at EOT of Last Cycle During Teduglutide Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-teduglutide/Teduglutide Treatment (NTT/TED)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.'}, {'id': 'OG001', 'title': 'Teduglutide/Teduglutide Treatment (TED/TED)', 'description': 'Participants who received teduglutide in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.727', 'spread': '0.440', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'Head circumference was measured using Z-score. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age \\>= 2 years old) and World Health Organization (age \\< 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.', 'unitOfMeasure': 'Z-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Head Circumference Z-score at Last Visit During Non-Teduglutide Treatment (NT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.'}, {'id': 'OG001', 'title': 'Non-teduglutide/Teduglutide Treatment (NTT/TED)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.'}, {'id': 'OG002', 'title': 'Teduglutide /Non-teduglutide Treatment (TED/NTT)', 'description': 'Participants who received teduglutide in the core study TEDC14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.'}, {'id': 'OG003', 'title': 'Teduglutide/Teduglutide Treatment (TED/TED)', 'description': 'Participants who received teduglutide in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.309', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Last visit in NT (up to Month 39)', 'description': 'Head circumference was measured using Z-score. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age \\>= 2 years old) and World Health Organization (age \\< 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.', 'unitOfMeasure': 'Z-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for all the four arms: NTT/NTT, NTT/TED, TED/NTT and TED/TED. Participants who received teduglutide treatment could enter a NT period when the teduglutide treatment criteria were not met.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Body Mass Index (BMI) Z-score at EOT of Last Cycle During Teduglutide Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-teduglutide/Teduglutide Treatment (NTT/TED)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.'}, {'id': 'OG001', 'title': 'Teduglutide/Teduglutide Treatment (TED/TED)', 'description': 'Participants who received teduglutide in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.215', 'spread': '0.142', 'groupId': 'OG000'}, {'value': '0.035', 'spread': '0.904', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'BMI Z-score was calculated by using the height and weight data. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age \\>= 2 years old) and World Health Organization (age \\< 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.', 'unitOfMeasure': 'Z-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Body Mass Index (BMI) Z-score at Last Visit During Non-Teduglutide Treatment (NT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.'}, {'id': 'OG001', 'title': 'Non-teduglutide/Teduglutide Treatment (NTT/TED)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.'}, {'id': 'OG002', 'title': 'Teduglutide /Non-teduglutide Treatment (TED/NTT)', 'description': 'Participants who received teduglutide in the core study TEDC14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.'}, {'id': 'OG003', 'title': 'Teduglutide/Teduglutide Treatment (TED/TED)', 'description': 'Participants who received teduglutide in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.545', 'spread': '1.335', 'groupId': 'OG000'}, {'value': '0.791', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG001'}, {'value': '-0.564', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG002'}, {'value': '-0.148', 'spread': '0.555', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Last visit in NT (up to Month 39)', 'description': 'BMI Z-score was calculated by using the height and weight data. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age \\>= 2 years old) and World Health Organization (age \\< 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.', 'unitOfMeasure': 'Z-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for all the four arms: NTT/NTT, NTT/TED, TED/NTT and TED/TED. Participants who received teduglutide treatment could enter a NT period when the teduglutide treatment criteria were not met.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Diary Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-teduglutide/Teduglutide Treatment (NTT/TED)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.'}, {'id': 'OG001', 'title': 'Teduglutide/Teduglutide Treatment (TED/TED)', 'description': 'Participants who received teduglutide in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.'}], 'classes': [{'title': 'Change at EOT of Cycle 1: >= 20% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 1: >= 50% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 1: >= 75% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 2: >= 20% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 2: >= 50% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 2: >= 75% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 3: >= 20% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 3: >= 50% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 3: >= 75% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 4: >= 20% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 4: >= 50% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 4: >= 75% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 5: >= 20% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 5: >= 50% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 5: >= 75% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 6: >= 20% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 6: >= 50% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 6: >= 75% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Last Cycle: >= 20% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Last Cycle: >= 50% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Last Cycle: >= 75% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'Number of participants who achieved at least 20%, 50%, and 75% reduction from baseline in diary PS volume at EOT of last cycle during teduglutide treatment was reported.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment. Number of participants in each categories are mutually exhaustive at each time point.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Prescribed PS Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-teduglutide/Teduglutide Treatment (NTT/TED)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.'}, {'id': 'OG001', 'title': 'Teduglutide/Teduglutide Treatment (TED/TED)', 'description': 'Participants who received teduglutide in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.'}], 'classes': [{'title': 'EOT of Cycle 1: >= 20% Reduction in PS Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'EOT of Cycle 1: >= 50% Reduction in PS Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'EOT of Cycle 1: >= 75% Reduction in PS Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'EOT of Cycle 2: >= 20% Reduction in PS Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'EOT of Cycle 2: >= 50% Reduction in PS Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'EOT of Cycle 2: >= 75% Reduction in PS Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'EOT of Cycle 3: >= 20% Reduction in PS Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'EOT of Cycle 3: >= 50% Reduction in PS Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'EOT of Cycle 3: >= 75% Reduction in PS Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'EOT of Cycle 4: >= 20% Reduction in PS Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'EOT of Cycle 4: >= 50% Reduction in PS Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'EOT of Cycle 4: >= 75% Reduction in PS Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'EOT of Cycle 5: >= 20% Reduction in PS Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'EOT of Cycle 5: >= 50% Reduction in PS Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'EOT of Cycle 5: >= 75% Reduction in PS Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'EOT of Cycle 6: >= 20% Reduction in PS Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'EOT of Cycle 6: >= 50% Reduction in PS Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'EOT of Cycle 6: >= 75% Reduction in PS Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'EOT of Last Cycle: >= 20% Reduction in PS Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'EOT of Last Cycle: >= 50% Reduction in PS Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'EOT of Last Cycle: >= 75% Reduction in PS Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'Number of participants who achieved at least 20%, 50%, and 75% reduction from baseline in prescribed PS volume at EOT of east cycle during teduglutide treatment was reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-teduglutide/Teduglutide Treatment (NTT/TED)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.'}, {'id': 'OG001', 'title': 'Teduglutide/Teduglutide Treatment (TED/TED)', 'description': 'Participants who received teduglutide in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.'}], 'classes': [{'title': 'Change at EOT of Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-14.87', 'spread': '4.574', 'groupId': 'OG000'}, {'value': '-22.63', 'spread': '18.125', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.98', 'spread': '10.490', 'groupId': 'OG000'}, {'value': '-25.75', 'spread': '22.480', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-34.81', 'spread': '15.314', 'groupId': 'OG000'}, {'value': '-32.01', 'spread': '28.837', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-57.45', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}, {'value': '-32.61', 'spread': '24.639', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-56.90', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}, {'value': '-38.76', 'spread': '21.148', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-40.51', 'spread': '24.833', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Last Cycle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-33.39', 'spread': '20.503', 'groupId': 'OG000'}, {'value': '-29.36', 'spread': '25.514', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'Change from baseline in diary PS volume at EOT of each cycle during teduglutide treatment was reported.', 'unitOfMeasure': 'mL/kg/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-teduglutide/Teduglutide Treatment (NTT/TED)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.'}, {'id': 'OG001', 'title': 'Teduglutide/Teduglutide Treatment (TED/TED)', 'description': 'Participants who received teduglutide in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.'}], 'classes': [{'title': 'Percent Change at EOT of Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-23.23', 'spread': '15.103', 'groupId': 'OG000'}, {'value': '-41.88', 'spread': '34.100', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at EOT of Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-13.29', 'spread': '16.826', 'groupId': 'OG000'}, {'value': '-45.67', 'spread': '38.377', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at EOT of Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-38.66', 'spread': '2.603', 'groupId': 'OG000'}, {'value': '-46.62', 'spread': '37.756', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at EOT of Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-50.99', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}, {'value': '-51.28', 'spread': '36.364', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at EOT of Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-50.50', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}, {'value': '-58.86', 'spread': '33.522', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at EOT of Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-52.87', 'spread': '32.722', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at EOT of Last Cycle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-42.65', 'spread': '7.061', 'groupId': 'OG000'}, {'value': '-50.27', 'spread': '38.917', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'Percent change from baseline in diary PS volume at EOT of each cycle during teduglutide treatment was reported.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-teduglutide/Teduglutide Treatment (NTT/TED)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.'}, {'id': 'OG001', 'title': 'Teduglutide/Teduglutide Treatment (TED/TED)', 'description': 'Participants who received teduglutide in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.'}], 'classes': [{'title': 'Change at EOT of Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-22.57', 'spread': '13.957', 'groupId': 'OG000'}, {'value': '-20.87', 'spread': '20.957', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-65.88', 'spread': '12.621', 'groupId': 'OG000'}, {'value': '-24.24', 'spread': '24.914', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-58.82', 'spread': '4.022', 'groupId': 'OG000'}, {'value': '-30.53', 'spread': '26.449', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-68.72', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}, {'value': '-34.53', 'spread': '23.849', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-68.99', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}, {'value': '-37.78', 'spread': '22.850', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-39.10', 'spread': '24.154', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Last Cycle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-48.23', 'spread': '25.528', 'groupId': 'OG000'}, {'value': '-26.26', 'spread': '25.275', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'Change from baseline in prescribed PS volume at EOT of each cycle during teduglutide treatment was reported.', 'unitOfMeasure': 'mL/kg/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-teduglutide/Teduglutide Treatment (NTT/TED)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.'}, {'id': 'OG001', 'title': 'Teduglutide/Teduglutide Treatment (TED/TED)', 'description': 'Participants who received teduglutide in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.'}], 'classes': [{'title': 'Percent Change at EOT of Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-28.82', 'spread': '12.660', 'groupId': 'OG000'}, {'value': '-34.43', 'spread': '52.810', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at EOT of Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-73.03', 'spread': '18.304', 'groupId': 'OG000'}, {'value': '-42.38', 'spread': '42.375', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at EOT of Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-67.01', 'spread': '24.723', 'groupId': 'OG000'}, {'value': '-44.07', 'spread': '36.002', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at EOT of Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-55.20', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}, {'value': '-52.78', 'spread': '33.033', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at EOT of Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-55.42', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}, {'value': '-57.42', 'spread': '34.250', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at EOT of Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-52.62', 'spread': '33.377', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at EOT of Last Cycle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-60.20', 'spread': '22.297', 'groupId': 'OG000'}, {'value': '-40.89', 'spread': '55.305', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'Percent Change from baseline in prescribed PS volume at EOT of each cycle during teduglutide treatment was reported.', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Diary PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-teduglutide/Teduglutide Treatment (NTT/TED)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.'}, {'id': 'OG001', 'title': 'Teduglutide/Teduglutide Treatment (TED/TED)', 'description': 'Participants who received teduglutide in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.'}], 'classes': [{'title': 'Change at EOT of Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-16.95', 'spread': '15.141', 'groupId': 'OG000'}, {'value': '-17.40', 'spread': '13.401', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-10.46', 'spread': '0.023', 'groupId': 'OG000'}, {'value': '-18.71', 'spread': '16.722', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-20.77', 'spread': '0.206', 'groupId': 'OG000'}, {'value': '-22.09', 'spread': '18.009', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-34.01', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}, {'value': '-24.67', 'spread': '18.859', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-33.68', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}, {'value': '-30.20', 'spread': '13.754', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-34.46', 'spread': '20.080', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Last Cycle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-24.98', 'spread': '7.540', 'groupId': 'OG000'}, {'value': '-21.13', 'spread': '18.284', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'Change from baseline in diary PS caloric intake at EOT of each cycle during teduglutide treatment was reported. Here, kilo-calories per kilogram per day was abbreviated as (kcal/kg/day).', 'unitOfMeasure': 'kcal/kg/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Diary PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-teduglutide/Teduglutide Treatment (NTT/TED)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.'}, {'id': 'OG001', 'title': 'Teduglutide/Teduglutide Treatment (TED/TED)', 'description': 'Participants who received teduglutide in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.'}], 'classes': [{'title': 'Percent Change at EOT of Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-35.21', 'spread': '31.088', 'groupId': 'OG000'}, {'value': '-45.91', 'spread': '35.484', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at EOT of Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-14.63', 'spread': '1.162', 'groupId': 'OG000'}, {'value': '-48.66', 'spread': '38.282', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at EOT of Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-29.03', 'spread': '2.083', 'groupId': 'OG000'}, {'value': '-46.75', 'spread': '38.042', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at EOT of Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-50.31', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}, {'value': '-53.23', 'spread': '37.611', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at EOT of Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-49.81', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}, {'value': '-64.30', 'spread': '30.289', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at EOT of Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-50.89', 'spread': '25.667', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at EOT of Last Cycle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-45.98', 'spread': '16.836', 'groupId': 'OG000'}, {'value': '-52.02', 'spread': '41.386', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'Percent change from baseline in diary PS Caloric intake at EOT of each cycle during teduglutide treatment was reported.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Prescribed PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-teduglutide/Teduglutide Treatment (NTT/TED)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.'}, {'id': 'OG001', 'title': 'Teduglutide/Teduglutide Treatment (TED/TED)', 'description': 'Participants who received teduglutide in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.'}], 'classes': [{'title': 'Change at EOT of Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-16.94', 'spread': '15.187', 'groupId': 'OG000'}, {'value': '-15.80', 'spread': '17.337', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-37.91', 'spread': '38.003', 'groupId': 'OG000'}, {'value': '-16.00', 'spread': '18.918', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-44.01', 'spread': '27.532', 'groupId': 'OG000'}, {'value': '-20.18', 'spread': '15.633', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-34.59', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}, {'value': '-24.48', 'spread': '15.899', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-34.76', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}, {'value': '-27.83', 'spread': '15.311', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-33.30', 'spread': '19.205', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Last Cycle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-39.68', 'spread': '21.758', 'groupId': 'OG000'}, {'value': '-18.60', 'spread': '19.507', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'Change from baseline in prescribed PS caloric intake at EOT of each cycle during teduglutide treatment was reported.', 'unitOfMeasure': 'kcal/kg/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Prescribed PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-teduglutide/Teduglutide Treatment (NTT/TED)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.'}, {'id': 'OG001', 'title': 'Teduglutide/Teduglutide Treatment (TED/TED)', 'description': 'Participants who received teduglutide in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.'}], 'classes': [{'title': 'Percent Change at EOT of Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-34.79', 'spread': '31.100', 'groupId': 'OG000'}, {'value': '-40.67', 'spread': '39.607', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at EOT of Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-50.00', 'spread': '47.944', 'groupId': 'OG000'}, {'value': '-42.75', 'spread': '45.563', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at EOT of Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-59.00', 'spread': '32.825', 'groupId': 'OG000'}, {'value': '-44.74', 'spread': '35.274', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at EOT of Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-50.45', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}, {'value': '-54.32', 'spread': '32.153', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at EOT of Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-50.69', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}, {'value': '-59.49', 'spread': '30.789', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at EOT of Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-50.67', 'spread': '26.310', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at EOT of Last Cycle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-64.50', 'spread': '16.117', 'groupId': 'OG000'}, {'value': '-45.84', 'spread': '42.242', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'Percent change from baseline in prescribed PS caloric intake at EOT of each cycle during teduglutide treatment was reported.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Achieved 100% Reduction in Complete Weaning of PS Volume at EOT of Each Cycle During Teduglutide Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-teduglutide/Teduglutide Treatment (NTT/TED)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.'}, {'id': 'OG001', 'title': 'Teduglutide/Teduglutide Treatment (TED/TED)', 'description': 'Participants who received teduglutide in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.'}], 'classes': [{'title': 'EOT of Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'EOT of Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'EOT of Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'EOT of Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'EOT of Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'EOT of Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'EOT of Last Cycle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'Number of participants who achieved at least 100% reduction in complete weaning of PS volume at EOT of each cycle during teduglutide treatment was reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hours Per Day of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-teduglutide/Teduglutide Treatment (NTT/TED)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.'}, {'id': 'OG001', 'title': 'Teduglutide/Teduglutide Treatment (TED/TED)', 'description': 'Participants who received teduglutide in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.'}], 'classes': [{'title': 'Change at EOT of Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.57', 'spread': '0.990', 'groupId': 'OG000'}, {'value': '-3.58', 'spread': '3.750', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.71', 'spread': '2.424', 'groupId': 'OG000'}, {'value': '-3.55', 'spread': '4.497', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.57', 'spread': '2.222', 'groupId': 'OG000'}, {'value': '-4.19', 'spread': '5.036', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.00', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}, {'value': '-4.83', 'spread': '5.069', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.00', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}, {'value': '-5.64', 'spread': '5.392', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.14', 'spread': '4.536', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Last Cycle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.05', 'spread': '2.700', 'groupId': 'OG000'}, {'value': '-3.89', 'spread': '4.881', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'Change from baseline in hours per day of diary PS usage at EOT of each cycle during teduglutide treatment was reported. Hours per day of diary PS was calculated as: Hours per day of actual PS = (sum of hours per day for each day that PS intake data is recorded within the 7 days prior to the visit / number of days that PS hours per day data is recorded as non-zero within the 7 days prior to the visit).', 'unitOfMeasure': 'hours/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Hours Per Day of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-teduglutide/Teduglutide Treatment (NTT/TED)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.'}, {'id': 'OG001', 'title': 'Teduglutide/Teduglutide Treatment (TED/TED)', 'description': 'Participants who received teduglutide in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.'}], 'classes': [{'title': 'Percent Change at EOT of Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.76', 'spread': '8.248', 'groupId': 'OG000'}, {'value': '-33.43', 'spread': '35.645', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at EOT of Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-14.29', 'spread': '20.203', 'groupId': 'OG000'}, {'value': '-34.12', 'spread': '41.982', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at EOT of Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-26.98', 'spread': '22.448', 'groupId': 'OG000'}, {'value': '-35.11', 'spread': '41.822', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at EOT of Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-22.22', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}, {'value': '-40.68', 'spread': '42.255', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at EOT of Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-22.22', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}, {'value': '-47.07', 'spread': '44.248', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at EOT of Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-42.86', 'spread': '37.796', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at EOT of Last Cycle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-21.69', 'spread': '21.433', 'groupId': 'OG000'}, {'value': '-37.04', 'spread': '45.049', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'Percent change from baseline in hours per day of diary PS usage at EOT of each cycle during teduglutide treatment was reported. Hours per day of diary PS was calculated as: Hours per day of actual PS = (sum of hours per day for each day that PS intake data is recorded within the 7 days prior to the visit / number of days that PS hours per day data is recorded as non-zero within the 7 days prior to the visit).', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hours Per Day of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-teduglutide/Teduglutide Treatment (NTT/TED)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.'}, {'id': 'OG001', 'title': 'Teduglutide/Teduglutide Treatment (TED/TED)', 'description': 'Participants who received teduglutide in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.'}], 'classes': [{'title': 'Change at EOT of Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.000', 'groupId': 'OG000'}, {'value': '-2.60', 'spread': '4.279', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.00', 'spread': '4.243', 'groupId': 'OG000'}, {'value': '-2.78', 'spread': '5.479', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.00', 'spread': '1.414', 'groupId': 'OG000'}, {'value': '-2.79', 'spread': '5.400', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.00', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}, {'value': '-3.43', 'spread': '5.849', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.00', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}, {'value': '-3.93', 'spread': '6.070', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.000', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Last Cycle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.33', 'spread': '2.309', 'groupId': 'OG000'}, {'value': '-2.58', 'spread': '5.666', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'Change from baseline in hours per day of prescribed PS usage at EOT of each cycle during teduglutide treatment was reported. Hours per day of dairy PS was calculated as: Hours per day of actual PS = (sum of hours per day for each day that PS intake data is recorded within the 7 days prior to the visit / number of days that PS hours per day data is recorded as non-zero within the 7 days prior to the visit).', 'unitOfMeasure': 'hours/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Hours Per Day of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-teduglutide/Teduglutide Treatment (NTT/TED)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.'}, {'id': 'OG001', 'title': 'Teduglutide/Teduglutide Treatment (TED/TED)', 'description': 'Participants who received teduglutide in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.'}], 'classes': [{'title': 'Percent Change at EOT of Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.000', 'groupId': 'OG000'}, {'value': '-21.27', 'spread': '34.449', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at EOT of Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-16.67', 'spread': '23.570', 'groupId': 'OG000'}, {'value': '-22.75', 'spread': '47.101', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at EOT of Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.56', 'spread': '7.857', 'groupId': 'OG000'}, {'value': '-20.64', 'spread': '40.735', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at EOT of Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-22.22', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}, {'value': '-25.47', 'spread': '43.906', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at EOT of Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-22.22', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}, {'value': '-32.28', 'spread': '48.126', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at EOT of Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.000', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at EOT of Last Cycle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.41', 'spread': '12.830', 'groupId': 'OG000'}, {'value': '-20.91', 'spread': '47.918', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'Percent change from baseline in hours per day of prescribed PS usage at EOT of each cycle during teduglutide treatment was reported. Hours per day of dairy PS was calculated as: Hours per day of actual PS = (sum of hours per day for each day that PS intake data is recorded within the 7 days prior to the visit / number of days that PS hours per day data is recorded as non-zero within the 7 days prior to the visit).', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Days Per Week of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-teduglutide/Teduglutide Treatment (NTT/TED)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.'}, {'id': 'OG001', 'title': 'Teduglutide/Teduglutide Treatment (TED/TED)', 'description': 'Participants who received teduglutide in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.'}], 'classes': [{'title': 'Change at EOT of Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.33', 'spread': '0.577', 'groupId': 'OG000'}, {'value': '-1.41', 'spread': '2.432', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.00', 'spread': '1.414', 'groupId': 'OG000'}, {'value': '-1.76', 'spread': '2.508', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.50', 'spread': '2.121', 'groupId': 'OG000'}, {'value': '-2.13', 'spread': '2.756', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}, {'value': '-2.36', 'spread': '2.956', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}, {'value': '-2.70', 'spread': '3.107', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.00', 'spread': '2.646', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Last Cycle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.00', 'spread': '1.732', 'groupId': 'OG000'}, {'value': '-2.14', 'spread': '2.720', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'Change from baseline in days per week of diary PS usage at EOT of each cycle during teduglutide treatment was reported. Days per week of diary PS was calculated as: Days per week of actual PS = (number of days with non-zero values for PS volume within the 7 days prior to the visit / number of days for which any PS intake data was recorded within the 7 days prior to the visit) \\* 7.', 'unitOfMeasure': 'Days/week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Days Per Week of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-teduglutide/Teduglutide Treatment (NTT/TED)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.'}, {'id': 'OG001', 'title': 'Teduglutide/Teduglutide Treatment (TED/TED)', 'description': 'Participants who received teduglutide in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.'}], 'classes': [{'title': 'Percent Change at EOT of Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.76', 'spread': '8.248', 'groupId': 'OG000'}, {'value': '-23.40', 'spread': '39.994', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at EOT of Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-14.29', 'spread': '20.203', 'groupId': 'OG000'}, {'value': '-29.07', 'spread': '41.805', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at EOT of Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-21.43', 'spread': '30.305', 'groupId': 'OG000'}, {'value': '-31.37', 'spread': '41.530', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at EOT of Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}, {'value': '-34.66', 'spread': '44.475', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at EOT of Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}, {'value': '-39.50', 'spread': '47.024', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at EOT of Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-42.86', 'spread': '37.796', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at EOT of Last Cycle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-14.29', 'spread': '24.744', 'groupId': 'OG000'}, {'value': '-34.46', 'spread': '43.755', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'Percent change from baseline in days per week of diary PS usage at EOT of each cycle during teduglutide treatment was reported. Days per week of diary PS was calculated as: Days per week of actual PS = (number of days with non-zero values for PS volume within the 7 days prior to the visit / number of days for which any PS intake data was recorded within the 7 days prior to the visit) \\* 7.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Days Per Week of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-teduglutide/Teduglutide Treatment (NTT/TED)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.'}, {'id': 'OG001', 'title': 'Teduglutide/Teduglutide Treatment (TED/TED)', 'description': 'Participants who received teduglutide in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.'}], 'classes': [{'title': 'Change at EOT of Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.33', 'spread': '0.577', 'groupId': 'OG000'}, {'value': '-1.42', 'spread': '2.251', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.00', 'spread': '1.414', 'groupId': 'OG000'}, {'value': '-1.65', 'spread': '2.399', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.50', 'spread': '2.121', 'groupId': 'OG000'}, {'value': '-1.85', 'spread': '2.623', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}, {'value': '-2.15', 'spread': '2.852', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}, {'value': '-2.75', 'spread': '3.041', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.00', 'spread': '2.646', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Last Cycle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.00', 'spread': '1.732', 'groupId': 'OG000'}, {'value': '-1.92', 'spread': '2.538', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'Change from baseline in days per week of prescribed PS usage at EOT of each cycle during teduglutide treatment was reported. Days per week of dairy PS was calculated as: Days per week of actual PS = (number of days with non-zero values for PS volume within the 7 days prior to the visit / number of days for which any PS intake data was recorded within the 7 days prior to the visit) \\* 7', 'unitOfMeasure': 'Days/week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Days Per Week of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-teduglutide/Teduglutide Treatment (NTT/TED)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.'}, {'id': 'OG001', 'title': 'Teduglutide/Teduglutide Treatment (TED/TED)', 'description': 'Participants who received teduglutide in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.'}], 'classes': [{'title': 'Percent Change at EOT of Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.76', 'spread': '8.248', 'groupId': 'OG000'}, {'value': '-23.18', 'spread': '36.926', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at EOT of Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-14.29', 'spread': '20.203', 'groupId': 'OG000'}, {'value': '-27.41', 'spread': '40.209', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at EOT of Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-21.43', 'spread': '30.305', 'groupId': 'OG000'}, {'value': '-27.58', 'spread': '40.258', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at EOT of Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}, {'value': '-32.12', 'spread': '43.730', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at EOT of Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}, {'value': '-40.86', 'spread': '46.839', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at EOT of Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-42.86', 'spread': '37.796', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at EOT of Last Cycle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-14.29', 'spread': '24.744', 'groupId': 'OG000'}, {'value': '-30.71', 'spread': '40.861', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'Percent change from baseline in days per week of prescribed PS usage at EOT of each cycle during teduglutide treatment was reported. Days per week of dairy PS was calculated as: Days per week of actual PS = (number of days with non-zero values for PS volume within the 7 days prior to the visit / number of days for which any PS intake data was recorded within the 7 days prior to the visit) \\* 7.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at EOT of Each Cycle During Teduglutide Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-teduglutide/Teduglutide Treatment (NTT/TED)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.'}, {'id': 'OG001', 'title': 'Teduglutide/Teduglutide Treatment (TED/TED)', 'description': 'Participants who received teduglutide in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.'}], 'classes': [{'title': 'Physical Functioning: Change at EOT of Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-21.88', 'spread': '8.839', 'groupId': 'OG000'}, {'value': '-2.44', 'spread': '22.323', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning: Change at EOT of Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-18.75', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}, {'value': '4.69', 'spread': '22.327', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning: Change at EOT of Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-18.75', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}, {'value': '-5.80', 'spread': '27.093', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning: Change at EOT of Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-9.38', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}, {'value': '4.12', 'spread': '20.872', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning: Change at EOT of Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-15.63', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}, {'value': '4.83', 'spread': '20.840', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning: Change at EOT of Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Emotional Functioning: Change at EOT of Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.50', 'spread': '10.607', 'groupId': 'OG000'}, {'value': '-2.07', 'spread': '16.807', 'groupId': 'OG001'}]}]}, {'title': 'Emotional Functioning: Change at EOT of Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.00', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}, {'value': '0.88', 'spread': '15.249', 'groupId': 'OG001'}]}]}, {'title': 'Emotional Functioning: Change at EOT of Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-15.00', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}, {'value': '-0.36', 'spread': '20.680', 'groupId': 'OG001'}]}]}, {'title': 'Emotional Functioning: Change at EOT of Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.00', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}, {'value': '1.82', 'spread': '22.811', 'groupId': 'OG001'}]}]}, {'title': 'Emotional Functioning: Change at EOT of Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}, {'value': '1.36', 'spread': '23.674', 'groupId': 'OG001'}]}]}, {'title': 'Emotional Functioning: Change at EOT of Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Social Functioning: Change at EOT of Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-12.50', 'spread': '17.678', 'groupId': 'OG000'}, {'value': '0.49', 'spread': '18.262', 'groupId': 'OG001'}]}]}, {'title': 'Social Functioning: Change at EOT of Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-25.00', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}, {'value': '5.29', 'spread': '20.484', 'groupId': 'OG001'}]}]}, {'title': 'Social Functioning: Change at EOT of Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-30.00', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}, {'value': '2.14', 'spread': '24.662', 'groupId': 'OG001'}]}]}, {'title': 'Social Functioning: Change at EOT of Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-15.00', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}, {'value': '3.86', 'spread': '23.193', 'groupId': 'OG001'}]}]}, {'title': 'Social Functioning: Change at EOT of Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-15.00', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}, {'value': '2.95', 'spread': '20.458', 'groupId': 'OG001'}]}]}, {'title': 'Social Functioning: Change at EOT of Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'School Functioning: Change at EOT of Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.33', 'spread': '25.111', 'groupId': 'OG001'}]}]}, {'title': 'School Functioning: Change at EOT of Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.93', 'spread': '27.096', 'groupId': 'OG001'}]}]}, {'title': 'School Functioning: Change at EOT of Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.17', 'spread': '33.804', 'groupId': 'OG001'}]}]}, {'title': 'School Functioning: Change at EOT of Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.89', 'spread': '25.233', 'groupId': 'OG001'}]}]}, {'title': 'School Functioning: Change at EOT of Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.33', 'spread': '23.721', 'groupId': 'OG001'}]}]}, {'title': 'School Functioning: Change at EOT of Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': "PedsQL GCS was designed to measure health-related quality of life in pediatric participants and adolescents (2 to 18 years of age). It encompasses 4 dimensions of functioning (physical \\[8 items\\], emotional \\[5 items\\], social \\[5 items\\], school \\[3 items\\]). Age groups were: Toddler (2-4 years), Young pediatric (5-7 years), Pediatric (8-12 years), and Teens (13-18 years). Depending on the participant's age, the questionnaire may be completed by parent/caregiver as appropriate. For the Toddler group, the PedsQL GCS consisted of 21 items, using a 5-point Likert scale (0 to 4); for all other groups, the PedsQL GCS consisted of 23 items, with a 3-point Likert scale (0, 2, 4) for the young pediatric, and a 5-point Likert scale for the pediatric and teens groups. Scores are transformed on a scale from 0 to 100 where 0=100, 1=75, 2=50, 3=25, and 4=0. Higher scores indicate improved quality of life.", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline In PedsQL GCS Score at Last Visit During Non-Teduglutide Treatment (NT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.'}, {'id': 'OG001', 'title': 'Non-teduglutide/Teduglutide Treatment (NTT/TED)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.'}, {'id': 'OG002', 'title': 'Teduglutide /Non-teduglutide Treatment (TED/NTT)', 'description': 'Participants who received teduglutide in the core study TEDC14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.'}, {'id': 'OG003', 'title': 'Teduglutide/Teduglutide Treatment (TED/TED)', 'description': 'Participants who received teduglutide in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.'}], 'classes': [{'title': 'Physical Functioning: Change at Last NT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.91', 'spread': '10.636', 'groupId': 'OG000'}, {'value': '-3.13', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG001'}, {'value': '31.25', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG002'}, {'value': '13.56', 'spread': '22.573', 'groupId': 'OG003'}]}]}, {'title': 'Emotional Functioning: Change at Last NT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.50', 'spread': '15.546', 'groupId': 'OG000'}, {'value': '-10.00', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG001'}, {'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG002'}, {'value': '2.50', 'spread': '23.101', 'groupId': 'OG003'}]}]}, {'title': 'Social Functioning: Change at Last NT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '4.082', 'groupId': 'OG000'}, {'value': '-10.00', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG001'}, {'value': '-10.00', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG002'}, {'value': '7.31', 'spread': '16.535', 'groupId': 'OG003'}]}]}, {'title': 'School Functioning: Change at Last NT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11.67', 'spread': '45.369', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG002'}, {'value': '3.89', 'spread': '25.954', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Last visit in NT (up to Month 39)', 'description': "PedsQL GCS was designed to measure health-related quality of life in pediatric participants and adolescents (2 to 18 years of age). It encompasses 4 dimensions of functioning (physical \\[8 items\\], emotional \\[5 items\\], social \\[5 items\\], school \\[3 items\\]). Age groups were: Toddler (2-4 years), Young pediatric (5-7 years), Pediatric (8-12 years), and Teens (13-18 years). Depending on the participant's age, the questionnaire may be completed by parent/caregiver as appropriate. For the Toddler group, the PedsQL GCS consisted of 21 items, using a 5-point Likert scale (0 to 4); for all other groups, the PedsQL GCS consisted of 23 items, with a 3-point Likert scale (0, 2, 4) for the young pediatric, and a 5-point Likert scale for the pediatric and teens groups. Scores are transformed on a scale from 0 to 100 where 0=100, 1=75, 2=50, 3=25, and 4=0. Higher scores indicate improved quality of life.", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed using safety population. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for all the four arms: NTT/NTT, NTT/TED, TED/NTT and TED/TED. Participants who received teduglutide treatment could enter a NT period when the teduglutide treatment criteria were not met.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline In PedsQL Total Family Impact Module Score at EOT of Each Cycle During Teduglutide Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-teduglutide/Teduglutide Treatment (NTT/TED)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.'}, {'id': 'OG001', 'title': 'Teduglutide/Teduglutide Treatment (TED/TED)', 'description': 'Participants who received teduglutide in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.'}], 'classes': [{'title': 'Change at EOT of Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-10.65', 'spread': '9.326', 'groupId': 'OG000'}, {'value': '1.55', 'spread': '15.071', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.78', 'spread': '3.928', 'groupId': 'OG000'}, {'value': '4.62', 'spread': '18.250', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.56', 'spread': '5.893', 'groupId': 'OG000'}, {'value': '0.20', 'spread': '20.861', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.78', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}, {'value': '5.27', 'spread': '21.637', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-13.19', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}, {'value': '5.08', 'spread': '16.152', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT of Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'PedsQL Family Impact Module was composed of 36 items comprising Physical Functioning (6 items), Emotional Functioning (5 items), Social Functioning (4 items), Cognitive Functioning (5 items), Communication (3 items), Worry (5 items), Daily Activities (3 items) and Family Relationships (5 items). Total family impact score was calculated as the sum of all the items over the number of items answered on all the scales. Scores are transformed on a scale from 0 to 100 were 0=100, 1=75, 2=50, 3=25, and 4=0. Higher scores indicate improved quality of life.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline In PedsQL Total Family Impact Module Score at Last Visit During Non-Teduglutide Treatment (NT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.'}, {'id': 'OG001', 'title': 'Non-teduglutide/Teduglutide Treatment (NTT/TED)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.'}, {'id': 'OG002', 'title': 'Teduglutide /Non-teduglutide Treatment (TED/NTT)', 'description': 'Participants who received teduglutide in the core study TEDC14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.'}, {'id': 'OG003', 'title': 'Teduglutide/Teduglutide Treatment (TED/TED)', 'description': 'Participants who received teduglutide in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.47', 'spread': '10.914', 'groupId': 'OG000'}, {'value': '-27.78', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG001'}, {'value': '-12.50', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG002'}, {'value': '6.44', 'spread': '22.648', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Last visit in NT (up to Month 39)', 'description': 'PedsQL Family Impact Module was composed of 36 items comprising Physical Functioning (6 items), Emotional Functioning (5 items), Social Functioning (4 items), Cognitive Functioning (5 items), Communication (3 items), Worry (5 items), Daily Activities (3 items) and Family Relationships (5 items). Total family impact score was calculated as the sum of all the items over the number of items answered on all the scales. Scores are transformed on a scale from 0 to 100 were 0=100, 1=75, 2=50, 3=25, and 4=0. Higher scores indicate improved quality of life', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for all the four arms: NTT/NTT, NTT/TED, TED/NTT and TED/TED. Participants who received teduglutide treatment could enter a NT period when the teduglutide treatment criteria were not met.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline In PedsQL Gastrointestinal Symptoms Module at EOT of Each Cycle During Teduglutide Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-teduglutide/Teduglutide Treatment (NTT/TED)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.'}, {'id': 'OG001', 'title': 'Teduglutide/Teduglutide Treatment (TED/TED)', 'description': 'Participants who received teduglutide in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.'}], 'classes': [{'title': 'Food and Drink Limits: Change at EOT of Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-12.50', 'spread': '17.678', 'groupId': 'OG000'}, {'value': '1.71', 'spread': '31.250', 'groupId': 'OG001'}]}]}, {'title': 'Food and Drink Limits: Change at EOT of Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.17', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}, {'value': '9.41', 'spread': '35.583', 'groupId': 'OG001'}]}]}, {'title': 'Food and Drink Limits: Change at EOT of Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.17', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}, {'value': '11.83', 'spread': '36.178', 'groupId': 'OG001'}]}]}, {'title': 'Food and Drink Limits: Change at EOT of Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.50', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}, {'value': '18.56', 'spread': '33.227', 'groupId': 'OG001'}]}]}, {'title': 'Food and Drink Limits: Change at EOT of Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}, {'value': '13.33', 'spread': '25.215', 'groupId': 'OG001'}]}]}, {'title': 'Food and Drink Limits: Change at EOT of Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea: Change at EOT of Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}, {'value': '8.56', 'spread': '21.309', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea: Change at EOT of Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}, {'value': '10.00', 'spread': '19.162', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea: Change at EOT of Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.49', 'spread': '23.665', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea: Change at EOT of Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.57', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}, {'value': '8.57', 'spread': '23.702', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea: Change at EOT of Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.56', 'spread': '27.147', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea: Change at EOT of Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'PedsQL Gastrointestinal symptoms module was composed of 58 items, comprised of 10 different symptom scales that assess gastrointestinal symptom-related quality of life: food and drink limits, trouble swallowing, heartburn and reflux, nausea and vomiting, gas and bloating, constipation, blood in poop, and diarrhea. Only the scales of food and drink limits (6 items) and diarrhea (7 items) was used in this study. Sub-scale score was calculated as the sum of the items over the number of items answered in the scale. Scores are transformed on a scale from 0 to 100 were 0=100, 1=75, 2=50, 3=25, and 4=0. Higher scores indicate improved quality of life.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline In PedsQL Gastrointestinal Symptoms Module at Last Visit During Non-Teduglutide Treatment (NT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.'}, {'id': 'OG001', 'title': 'Non-teduglutide/Teduglutide Treatment (NTT/TED)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.'}, {'id': 'OG002', 'title': 'Teduglutide /Non-teduglutide Treatment (TED/NTT)', 'description': 'Participants who received teduglutide in the core study TEDC14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.'}, {'id': 'OG003', 'title': 'Teduglutide/Teduglutide Treatment (TED/TED)', 'description': 'Participants who received teduglutide in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.'}], 'classes': [{'title': 'Food and Drink Limits: Change at Last NT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-7.29', 'spread': '32.698', 'groupId': 'OG000'}, {'value': '-29.17', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG001'}, {'value': '-8.33', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG002'}, {'value': '5.35', 'spread': '34.013', 'groupId': 'OG003'}]}]}, {'title': 'Diarrhea: Change at Last NT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-4.46', 'spread': '4.494', 'groupId': 'OG000'}, {'value': '3.57', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG002'}, {'value': '1.70', 'spread': '19.555', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Last visit in NT (up to Month 39)', 'description': 'PedsQL gastrointestinal symptoms module was composed of 58 items, comprised of 10 different symptom scales that assess gastrointestinal symptom-related quality of life: food and drink limits, trouble swallowing, heartburn and reflux, nausea and vomiting, gas and bloating, constipation, blood in poop, and diarrhea. Only the scales of food and drink limits (6 items) and diarrhea (7 items) was used in this study. Sub-scale score was calculated as the sum of the items over the number of items answered in the scale. Scores are transformed on a scale from 0 to 100 were 0=100, 1=75, 2=50, 3=25, and 4=0. Higher scores indicate improved quality of life.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed using safety population. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given categories. Data was collected and analyzed for all the four arms: NTT/NTT, NTT/TED, TED/NTT and TED/TED. Participants who received teduglutide treatment could enter a NT period when the teduglutide treatment criteria were not met.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.'}, {'id': 'FG001', 'title': 'Non-teduglutide/Teduglutide Treatment (NTT/TED)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.'}, {'id': 'FG002', 'title': 'Teduglutide /Non-teduglutide Treatment (TED/NTT)', 'description': 'Participants who received teduglutide in the core study TEDC14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.'}, {'id': 'FG003', 'title': 'Teduglutide/Teduglutide Treatment (TED/TED)', 'description': 'Participants who received teduglutide in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '7'}]}]}], 'recruitmentDetails': 'The study was conducted at 23 sites between 09 January 2017 and 05 November 2020. A total of 61 participants (children and infant) were enrolled and classified into treatment groups (NTT/NTT, NTT/TED , TED/NTT, and TED/TED) based on whether they received teduglutide in their core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] and/or during this extension study. Participants who completed their core study were eligible for this extension study.', 'preAssignmentDetails': "NTT/NTT: Participants who participated in standard of care (SOC) arm in the core study and didn't receive any TED treatment in this extension study; NTT/TED: Participants who participated in SOC arm in the core study but who subsequently received TED in this extension study; TED/NTT: Participants who received TED in the core study but didn't receive any TED treatment in this extension study; TED/TED: Participants who received TED in the core study and in this extension study."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}, {'value': '61', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.'}, {'id': 'BG001', 'title': 'Non-teduglutide/Teduglutide Treatment (NTT/TED)', 'description': 'Participants who participated in standard of care arm in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks.'}, {'id': 'BG002', 'title': 'Teduglutide /Non-teduglutide Treatment (TED/NTT)', 'description': 'Participants who received teduglutide in the core study TEDC14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study.'}, {'id': 'BG003', 'title': 'Teduglutide/Teduglutide Treatment (TED/TED)', 'description': 'Participants who received teduglutide in the core study TED-C14-006 \\[NCT02682381\\] or SHP633-301 \\[NCT03571516\\] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '5.8', 'spread': '5.43', 'groupId': 'BG000'}, {'value': '1.5', 'spread': '0.80', 'groupId': 'BG001'}, {'value': '6.0', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'BG002'}, {'value': '5.7', 'spread': '3.69', 'groupId': 'BG003'}, {'value': '5.5', 'spread': '3.86', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '41', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}, {'value': '42', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Other', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': 'Not allowed based on local regulations', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Ethnicity', 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}]}, {'title': 'Not allowed based on local regulations', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The safety population consisted of enrolled participants who provided informed consent and met all the inclusion criteria.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-10-01', 'size': 7092427, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-08-03T04:48', 'hasProtocol': True}, {'date': '2020-12-17', 'size': 1339682, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-08-03T04:48', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2020-11-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-10', 'studyFirstSubmitDate': '2016-11-02', 'resultsFirstSubmitDate': '2021-08-03', 'studyFirstSubmitQcDate': '2016-11-02', 'lastUpdatePostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-09-16', 'studyFirstPostDateStruct': {'date': '2016-11-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-10-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at EOT of Each Cycle During Teduglutide Treatment', 'timeFrame': 'Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': "PedsQL GCS was designed to measure health-related quality of life in pediatric participants and adolescents (2 to 18 years of age). It encompasses 4 dimensions of functioning (physical \\[8 items\\], emotional \\[5 items\\], social \\[5 items\\], school \\[3 items\\]). Age groups were: Toddler (2-4 years), Young pediatric (5-7 years), Pediatric (8-12 years), and Teens (13-18 years). Depending on the participant's age, the questionnaire may be completed by parent/caregiver as appropriate. For the Toddler group, the PedsQL GCS consisted of 21 items, using a 5-point Likert scale (0 to 4); for all other groups, the PedsQL GCS consisted of 23 items, with a 3-point Likert scale (0, 2, 4) for the young pediatric, and a 5-point Likert scale for the pediatric and teens groups. Scores are transformed on a scale from 0 to 100 where 0=100, 1=75, 2=50, 3=25, and 4=0. Higher scores indicate improved quality of life."}, {'measure': 'Change From Baseline In PedsQL GCS Score at Last Visit During Non-Teduglutide Treatment (NT)', 'timeFrame': 'Baseline, Last visit in NT (up to Month 39)', 'description': "PedsQL GCS was designed to measure health-related quality of life in pediatric participants and adolescents (2 to 18 years of age). It encompasses 4 dimensions of functioning (physical \\[8 items\\], emotional \\[5 items\\], social \\[5 items\\], school \\[3 items\\]). Age groups were: Toddler (2-4 years), Young pediatric (5-7 years), Pediatric (8-12 years), and Teens (13-18 years). Depending on the participant's age, the questionnaire may be completed by parent/caregiver as appropriate. For the Toddler group, the PedsQL GCS consisted of 21 items, using a 5-point Likert scale (0 to 4); for all other groups, the PedsQL GCS consisted of 23 items, with a 3-point Likert scale (0, 2, 4) for the young pediatric, and a 5-point Likert scale for the pediatric and teens groups. Scores are transformed on a scale from 0 to 100 where 0=100, 1=75, 2=50, 3=25, and 4=0. Higher scores indicate improved quality of life."}, {'measure': 'Change From Baseline In PedsQL Total Family Impact Module Score at EOT of Each Cycle During Teduglutide Treatment', 'timeFrame': 'Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'PedsQL Family Impact Module was composed of 36 items comprising Physical Functioning (6 items), Emotional Functioning (5 items), Social Functioning (4 items), Cognitive Functioning (5 items), Communication (3 items), Worry (5 items), Daily Activities (3 items) and Family Relationships (5 items). Total family impact score was calculated as the sum of all the items over the number of items answered on all the scales. Scores are transformed on a scale from 0 to 100 were 0=100, 1=75, 2=50, 3=25, and 4=0. Higher scores indicate improved quality of life.'}, {'measure': 'Change From Baseline In PedsQL Total Family Impact Module Score at Last Visit During Non-Teduglutide Treatment (NT)', 'timeFrame': 'Baseline, Last visit in NT (up to Month 39)', 'description': 'PedsQL Family Impact Module was composed of 36 items comprising Physical Functioning (6 items), Emotional Functioning (5 items), Social Functioning (4 items), Cognitive Functioning (5 items), Communication (3 items), Worry (5 items), Daily Activities (3 items) and Family Relationships (5 items). Total family impact score was calculated as the sum of all the items over the number of items answered on all the scales. Scores are transformed on a scale from 0 to 100 were 0=100, 1=75, 2=50, 3=25, and 4=0. Higher scores indicate improved quality of life'}, {'measure': 'Change From Baseline In PedsQL Gastrointestinal Symptoms Module at EOT of Each Cycle During Teduglutide Treatment', 'timeFrame': 'Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'PedsQL Gastrointestinal symptoms module was composed of 58 items, comprised of 10 different symptom scales that assess gastrointestinal symptom-related quality of life: food and drink limits, trouble swallowing, heartburn and reflux, nausea and vomiting, gas and bloating, constipation, blood in poop, and diarrhea. Only the scales of food and drink limits (6 items) and diarrhea (7 items) was used in this study. Sub-scale score was calculated as the sum of the items over the number of items answered in the scale. Scores are transformed on a scale from 0 to 100 were 0=100, 1=75, 2=50, 3=25, and 4=0. Higher scores indicate improved quality of life.'}, {'measure': 'Change From Baseline In PedsQL Gastrointestinal Symptoms Module at Last Visit During Non-Teduglutide Treatment (NT)', 'timeFrame': 'Baseline, Last visit in NT (up to Month 39)', 'description': 'PedsQL gastrointestinal symptoms module was composed of 58 items, comprised of 10 different symptom scales that assess gastrointestinal symptom-related quality of life: food and drink limits, trouble swallowing, heartburn and reflux, nausea and vomiting, gas and bloating, constipation, blood in poop, and diarrhea. Only the scales of food and drink limits (6 items) and diarrhea (7 items) was used in this study. Sub-scale score was calculated as the sum of the items over the number of items answered in the scale. Scores are transformed on a scale from 0 to 100 were 0=100, 1=75, 2=50, 3=25, and 4=0. Higher scores indicate improved quality of life.'}], 'primaryOutcomes': [{'measure': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'From start of study drug administration up to follow-up (up to 46 months)', 'description': 'An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs were defined as AEs that started or worsened on or after the date of first dose of teduglutide for participants in the TED/TED, TED/NTT, and NTT/TED treatment groups, or after the core study baseline visit for participants in the NTT/NTT group.'}, {'measure': 'Change From Baseline in Average Total Urine Output at End of Treatment (EOT) of Last Cycle During Teduglutide Treatment', 'timeFrame': 'Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'Average total urine output was recorded over a 48-hour period of parental support (PS) stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The Average daily urine output milliliter per kilogram per day (mL/kg/day) was calculated as: Total urine output over 48 hours / 2) / body weight (kilogram \\[kg\\]) where total urine output was calculated as the sum of the urine output in milliliter (mL) and the urine-only diaper weights in gram (g) (1g = 1mL) for the participant collected on the output diary form of electronic case report from (eCRF).'}, {'measure': 'Change From Baseline in Average Total Urine Output at Last Visit During Non-Teduglutide Treatment (NT)', 'timeFrame': 'Baseline, Last visit in NT (up to Month 39)', 'description': 'Average total urine output was recorded over a 48 hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. Average daily urine output mL/kg/day was calculated as: (Total urine output over 48 hours/2) / body weight (kg) where total urine output was calculated as the sum of the urine output in mL and the urine-only diaper weights in gram (1g = 1mL) for the participant collected on the output diary form of electronic case report from (eCRF).'}, {'measure': 'Change From Baseline in Average Number of Stools Per Day at EOT of Last Cycle During Teduglutide Treatment', 'timeFrame': 'Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized by the average number of stools per day. The average number of stools per day was calculated as (sum of the daily data in a 48-hour period/2).'}, {'measure': 'Change From Baseline in Average Number of Stools Per Day at Last Visit During Non-Teduglutide Treatment (NT)', 'timeFrame': 'Baseline, Last visit in NT (up to Month 39)', 'description': 'Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized by the average number of stools per day. The average number of stools per day was calculated as (sum of the daily data in a 48-hour period/2).'}, {'measure': 'Change From Baseline in Average Total Daily Stool/Mixed Stool Diaper Weight at EOT of Last Cycle During Teduglutide Treatment', 'timeFrame': 'Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized by the average total daily stool/mixed stool diaper weight (gram per kilogram per day \\[g/kg/day\\]). The body weight was used to calculate the daily stool/mixed stool diaper weight (g/kg/day).'}, {'measure': 'Change From Baseline in Average Total Daily Stool/Mixed Stool Diaper Weight at Last Visit During Non-Teduglutide Treatment (NT)', 'timeFrame': 'Baseline, Last visit in NT (up to Month 39)', 'description': 'Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized by the average total daily stool/mixed stool diaper weight (gram per kilogram per day \\[g/kg/day\\]). The body weight was used to calculate the daily stool/mixed stool diaper weight (g/kg/day).'}, {'measure': 'Change From Baseline in Average Total Ostomy Output at EOT of Last Cycle During Teduglutide Treatment', 'timeFrame': 'Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized the average ostomy output per day (mL/kg/day).'}, {'measure': 'Change From Baseline in Average Total Ostomy Output at Last Visit During Non-Teduglutide Treatment (NT)', 'timeFrame': 'Baseline, Last visit in NT (up to Month 39)', 'description': 'Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized the average ostomy output per day.'}, {'measure': 'Change From Baseline in Average Bristol Stool Form Score at EOT of Last Cycle During Teduglutide Treatment', 'timeFrame': 'Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The Average daily fecal output was summarized the average typical stool form score using Bristol Stool Form Scale. The average typical stool form score was calculated as (sum of the daily data in a 48-hour period / 2). Typical Stool Form based on Bristol Stool Form Scale: 1 - Separate hard lumps, hard to pass, 2 - Sausage-shaped, but lumpy, 3 - Like a sausage but with cracks on the surface, 4- Like a sausage or snake, smooth and soft, 5- Soft blobs with clear-cut edges, 6- Fluffy pieces with ragged edges, a mushy stool, 7- Watery, no solid pieces. Entirely liquid.'}, {'measure': 'Change From Baseline in Average Bristol Stool Form Score at Last Visit During Non-Teduglutide Treatment (NT)', 'timeFrame': 'Baseline, Last visit in NT (up to Month 39)', 'description': 'Fecal output was recorded over a 48 hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized separately the average typical stool form score using Bristol Stool Form Scale. The average typical stool form score was calculated as (sum of the daily data in a 48-hour period / 2). Typical Stool Form based on Bristol Stool Form Scale: 1- Separate hard lumps, hard to pass, 2- Sausage-shaped, but lumpy, 3- Like a sausage but with cracks on the surface, 4 - Like a sausage or snake, smooth and soft, 5- Soft blobs with clear-cut edges, 6- Fluffy pieces with ragged edges, a mushy stool, 7- Watery, no solid pieces. Entirely liquid.'}, {'measure': 'Number of Participants With Positive Specific Antibodies at End of Study (EOS)', 'timeFrame': 'At EOS (up to 46 months)', 'description': 'Number of participants with positive specific antibodies to teduglutide were used to summarize the presence of antibodies.'}, {'measure': 'Change From Baseline in Body Weight Z-score at EOT of Last Cycle During Teduglutide Treatment', 'timeFrame': 'Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'Body weight was measured using Z-score. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age \\>= 2 years old) and World Health Organization (age \\< 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.'}, {'measure': 'Change From Baseline in Body Weight Z-score at Last Visit During Non-Teduglutide Treatment (NT)', 'timeFrame': 'Baseline, Last visit in NT (up to Month 39)', 'description': 'Body weight was measured using Z-score. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age \\>= 2 years old) and World Health Organization (age \\< 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.'}, {'measure': 'Change From Baseline in Height Z-score at EOT of Last Cycle During Teduglutide Treatment', 'timeFrame': 'Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'Height was measured using Z-score. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age \\>= 2 years old) and World Health Organization (age \\< 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.'}, {'measure': 'Change From Baseline in Height Z-score at Last Visit During Non-Teduglutide Treatment', 'timeFrame': 'Baseline, Last visit in NT (up to Month 39)', 'description': 'Height was measured using Z-score. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age \\>= 2 years old) and World Health Organization (age \\< 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.'}, {'measure': 'Change From Baseline in Head Circumference Z-score at EOT of Last Cycle During Teduglutide Treatment', 'timeFrame': 'Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'Head circumference was measured using Z-score. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age \\>= 2 years old) and World Health Organization (age \\< 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.'}, {'measure': 'Change From Baseline in Head Circumference Z-score at Last Visit During Non-Teduglutide Treatment (NT)', 'timeFrame': 'Baseline, Last visit in NT (up to Month 39)', 'description': 'Head circumference was measured using Z-score. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age \\>= 2 years old) and World Health Organization (age \\< 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.'}, {'measure': 'Change From Baseline in Body Mass Index (BMI) Z-score at EOT of Last Cycle During Teduglutide Treatment', 'timeFrame': 'Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'BMI Z-score was calculated by using the height and weight data. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age \\>= 2 years old) and World Health Organization (age \\< 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.'}, {'measure': 'Change From Baseline in Body Mass Index (BMI) Z-score at Last Visit During Non-Teduglutide Treatment (NT)', 'timeFrame': 'Baseline, Last visit in NT (up to Month 39)', 'description': 'BMI Z-score was calculated by using the height and weight data. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age \\>= 2 years old) and World Health Organization (age \\< 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Diary Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment', 'timeFrame': 'Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'Number of participants who achieved at least 20%, 50%, and 75% reduction from baseline in diary PS volume at EOT of last cycle during teduglutide treatment was reported.'}, {'measure': 'Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Prescribed PS Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment', 'timeFrame': 'Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'Number of participants who achieved at least 20%, 50%, and 75% reduction from baseline in prescribed PS volume at EOT of east cycle during teduglutide treatment was reported.'}, {'measure': 'Change From Baseline in Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment', 'timeFrame': 'Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'Change from baseline in diary PS volume at EOT of each cycle during teduglutide treatment was reported.'}, {'measure': 'Percent Change From Baseline in Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment', 'timeFrame': 'Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'Percent change from baseline in diary PS volume at EOT of each cycle during teduglutide treatment was reported.'}, {'measure': 'Change From Baseline in Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment', 'timeFrame': 'Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'Change from baseline in prescribed PS volume at EOT of each cycle during teduglutide treatment was reported.'}, {'measure': 'Percent Change From Baseline in Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment', 'timeFrame': 'Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'Percent Change from baseline in prescribed PS volume at EOT of each cycle during teduglutide treatment was reported.'}, {'measure': 'Change From Baseline in Diary PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment', 'timeFrame': 'Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'Change from baseline in diary PS caloric intake at EOT of each cycle during teduglutide treatment was reported. Here, kilo-calories per kilogram per day was abbreviated as (kcal/kg/day).'}, {'measure': 'Percent Change From Baseline in Diary PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment', 'timeFrame': 'Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'Percent change from baseline in diary PS Caloric intake at EOT of each cycle during teduglutide treatment was reported.'}, {'measure': 'Change From Baseline in Prescribed PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment', 'timeFrame': 'Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'Change from baseline in prescribed PS caloric intake at EOT of each cycle during teduglutide treatment was reported.'}, {'measure': 'Percent Change From Baseline in Prescribed PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment', 'timeFrame': 'Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'Percent change from baseline in prescribed PS caloric intake at EOT of each cycle during teduglutide treatment was reported.'}, {'measure': 'Number of Participants Who Achieved 100% Reduction in Complete Weaning of PS Volume at EOT of Each Cycle During Teduglutide Treatment', 'timeFrame': 'Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'Number of participants who achieved at least 100% reduction in complete weaning of PS volume at EOT of each cycle during teduglutide treatment was reported.'}, {'measure': 'Change From Baseline in Hours Per Day of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment', 'timeFrame': 'Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'Change from baseline in hours per day of diary PS usage at EOT of each cycle during teduglutide treatment was reported. Hours per day of diary PS was calculated as: Hours per day of actual PS = (sum of hours per day for each day that PS intake data is recorded within the 7 days prior to the visit / number of days that PS hours per day data is recorded as non-zero within the 7 days prior to the visit).'}, {'measure': 'Percent Change From Baseline in Hours Per Day of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment', 'timeFrame': 'Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'Percent change from baseline in hours per day of diary PS usage at EOT of each cycle during teduglutide treatment was reported. Hours per day of diary PS was calculated as: Hours per day of actual PS = (sum of hours per day for each day that PS intake data is recorded within the 7 days prior to the visit / number of days that PS hours per day data is recorded as non-zero within the 7 days prior to the visit).'}, {'measure': 'Change From Baseline in Hours Per Day of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment', 'timeFrame': 'Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'Change from baseline in hours per day of prescribed PS usage at EOT of each cycle during teduglutide treatment was reported. Hours per day of dairy PS was calculated as: Hours per day of actual PS = (sum of hours per day for each day that PS intake data is recorded within the 7 days prior to the visit / number of days that PS hours per day data is recorded as non-zero within the 7 days prior to the visit).'}, {'measure': 'Percent Change From Baseline in Hours Per Day of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment', 'timeFrame': 'Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'Percent change from baseline in hours per day of prescribed PS usage at EOT of each cycle during teduglutide treatment was reported. Hours per day of dairy PS was calculated as: Hours per day of actual PS = (sum of hours per day for each day that PS intake data is recorded within the 7 days prior to the visit / number of days that PS hours per day data is recorded as non-zero within the 7 days prior to the visit).'}, {'measure': 'Change From Baseline in Days Per Week of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment', 'timeFrame': 'Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'Change from baseline in days per week of diary PS usage at EOT of each cycle during teduglutide treatment was reported. Days per week of diary PS was calculated as: Days per week of actual PS = (number of days with non-zero values for PS volume within the 7 days prior to the visit / number of days for which any PS intake data was recorded within the 7 days prior to the visit) \\* 7.'}, {'measure': 'Percent Change From Baseline in Days Per Week of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment', 'timeFrame': 'Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'Percent change from baseline in days per week of diary PS usage at EOT of each cycle during teduglutide treatment was reported. Days per week of diary PS was calculated as: Days per week of actual PS = (number of days with non-zero values for PS volume within the 7 days prior to the visit / number of days for which any PS intake data was recorded within the 7 days prior to the visit) \\* 7.'}, {'measure': 'Change From Baseline in Days Per Week of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment', 'timeFrame': 'Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'Change from baseline in days per week of prescribed PS usage at EOT of each cycle during teduglutide treatment was reported. Days per week of dairy PS was calculated as: Days per week of actual PS = (number of days with non-zero values for PS volume within the 7 days prior to the visit / number of days for which any PS intake data was recorded within the 7 days prior to the visit) \\* 7'}, {'measure': 'Percent Change From Baseline in Days Per Week of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment', 'timeFrame': 'Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)', 'description': 'Percent change from baseline in days per week of prescribed PS usage at EOT of each cycle during teduglutide treatment was reported. Days per week of dairy PS was calculated as: Days per week of actual PS = (number of days with non-zero values for PS volume within the 7 days prior to the visit / number of days for which any PS intake data was recorded within the 7 days prior to the visit) \\* 7.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Short Bowel Syndrome']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicaltrials.takeda.com/study-detail/5f6b5fd94db2bf003ab470c2', 'label': 'To obtain more information on the study, click here/on this link'}]}, 'descriptionModule': {'briefSummary': 'This study will follow participants who completed the TED-C14-006 study. The purpose of this study is to evaluate the long-term safety and efficacy of teduglutide in pediatric participants with Short Bowel Syndrome (SBS). This study will also offer teduglutide treatment to eligible participants, regardless of treatment received in TED-C14-006 or SHP633-301.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participant provides written informed consent (participant, parent or legal guardian and, as appropriate, informed assent) to participate in the study before completing any study-related procedures.\n2. Participant completed the TED-C14-006 or SHP633-301 studies (including participants in the standard of care treatment arms). Participants are considered to have completed SHP633-301 if they completed study assessments through week 24.\n3. Participant understands and is willing and able to fully adhere to study requirements as defined in this protocol.\n\nExclusion Criteria:\n\n1\\. There are no exclusion criteria for this study.'}, 'identificationModule': {'nctId': 'NCT02954458', 'briefTitle': 'Long-term Safety and Efficacy Study of Teduglutide in Pediatric Participants With Short Bowel Syndrome (SBS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Prospective, Open-label, Long-term Safety and Efficacy Study of Teduglutide in Pediatric Patients With Short Bowel Syndrome Who Completed TED-C14-006 or SHP633-301', 'orgStudyIdInfo': {'id': 'SHP633-304'}, 'secondaryIdInfos': [{'id': '2016-000849-30', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Standard of care (SOC) treatment +/- teduglutide (TED)', 'description': 'Participants will receive 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily into 1 of the 4 quadrants of the abdomen or into either the thigh or arm as needed in addition to SOC treatment.', 'interventionNames': ['Drug: TED', 'Other: SOC', 'Device: Syringe', 'Device: Needle']}], 'interventions': [{'name': 'TED', 'type': 'DRUG', 'description': '0.05 mg/kg SC injection once daily.', 'armGroupLabels': ['Standard of care (SOC) treatment +/- teduglutide (TED)']}, {'name': 'SOC', 'type': 'OTHER', 'description': 'Standard safety assessments and adjustments in nutritional support.', 'armGroupLabels': ['Standard of care (SOC) treatment +/- teduglutide (TED)']}, {'name': 'Syringe', 'type': 'DEVICE', 'description': 'Teduglutide will be administered using syringe.', 'armGroupLabels': ['Standard of care (SOC) treatment +/- teduglutide (TED)']}, {'name': 'Needle', 'type': 'DEVICE', 'description': 'Teduglutide will be administered using needle.', 'armGroupLabels': ['Standard of care (SOC) treatment +/- teduglutide (TED)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027-6062', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Childrens Hospital Los Angeles - RHU', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Mattel Children's Hospital UCLA", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94158-2531', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': "UCSF Benioff Children's Hospital", 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': "Georgetown Children's Research Network", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Riley Hospital for Children', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Boston Children's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'The Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '07024', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia Unversity Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10467-2403', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': "Children's Hosp. at Montefiore", 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Texas Children's Hospital", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Seattle Children's Hospital", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin School of Medicine and Public Health', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '1200', 'city': 'Brussels', 'state': 'Woluwe-Saint-Lambert', 'country': 'Belgium', 'facility': 'Cliniques Universitaires Saint-Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': 'T6G 1C9', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Walter C. Mackenzie Health Science Centre', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'M5G 1X8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '00290', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'Helsingin yliopistollinen keskussairaala', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '00165', 'city': 'Roma', 'country': 'Italy', 'facility': 'Ospedale Pediatrico Bambino Gesu', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': 'WC1N 3JH', 'city': 'London', 'state': 'Greater London', 'country': 'United Kingdom', 'facility': "Great Ormond Children's Hosp", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'B4 6NH', 'city': 'Birmingham', 'state': 'West Midlands', 'country': 'United Kingdom', 'facility': "Birmingham Children's Hospital", 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Shire'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'De-identified individual participant data from this particular study will not be shared as the data are subject to contractual (or consent) provisions that prohibit transfer to third parties.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shire', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}