{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T18:43:27Z","timestamp":1790621007222,"version":"4.1.0"},"reference-count":20,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2021,3,2]],"date-time":"2021-03-02T00:00:00Z","timestamp":1614643200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["aspenjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J Parenter Enteral Nutr"],"published-print":{"date-parts":[[2021,9]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>This analysis assessed combined safety data from 4 clinical studies of teduglutide in pediatric patients with short\u2010bowel syndrome\u2013associated intestinal failure (SBS\u2013IF).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Safety data from teduglutide\u2010treated patients in 4 clinical trials were pooled. The completed 12\u2010week and 24\u2010week phase 3 core studies (NCT01952080\/EudraCT 2013\u2010004588\u201030 and NCT02682381\/EudraCT 2015\u2010002252\u201027) enrolled children aged 1\u201317 years with SBS\u2013IF. Patients could elect to enroll in ongoing open\u2010label extensions (NCT02949362\/EudraCT 2016\u2010000863\u201017 and NCT02954458\/EudraCT 2016\u2010000849\u201030). Interim data from ongoing studies were included.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Safety data are reported for 89 pediatric patients treated with teduglutide for a median (range) of 51.7 (5.0\u201394.7) weeks. Adverse events (AEs) were reported in all patients; the most common were vomiting (51.7%), pyrexia (43.8%), upper respiratory tract infection (41.6%), and cough (33.7%). Thirty\u2010five patients (39.3%) had AEs considered related to teduglutide treatment; abdominal pain and vomiting were most frequent (5.6% each). Three serious AEs in 3 patients (3.4%) were considered related to teduglutide treatment: ileus,\n                      <jats:sc>d<\/jats:sc>\n                      \u2010lactic acidosis, and gastrointestinal obstruction due to hard stools. All 3 events resolved. One cecal polyp was detected, which was not biopsied or found on repeat colonoscopy. No cases of neoplasia occurred.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Based on integrated data from 4 clinical studies, including long\u2010term follow\u2010up for \u2264161 weeks, teduglutide had a safety profile consistent with the individual core pediatric studies and as expected for pediatric patients with SBS\u2013IF who never received teduglutide. The most frequent AEs reflected treatment with teduglutide, complications of the underlying disease, and typical childhood illnesses.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/jpen.2061","type":"journal-article","created":{"date-parts":[[2020,12,11]],"date-time":"2020-12-11T01:46:12Z","timestamp":1607651172000},"page":"1456-1465","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":33,"title":["Safety Findings in Pediatric Patients During Long\u2010Term Treatment With Teduglutide for Short\u2010Bowel Syndrome\u2013Associated Intestinal Failure: Pooled Analysis of 4 Clinical Studies"],"prefix":"10.1002","volume":"45","author":[{"given":"Susan","family":"Hill","sequence":"first","affiliation":[{"name":"Great Ormond Street Hospital for Children NHS Foundation Trust  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Beth A.","family":"Carter","sequence":"additional","affiliation":[{"name":"Children's Hospital Los Angeles and Keck School of Medicine University of Southern California  Los Angeles California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Valeria","family":"Cohran","sequence":"additional","affiliation":[{"name":"Ann &amp; Robert H. Lurie Children's Hospital of Chicago  Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simon","family":"Horslen","sequence":"additional","affiliation":[{"name":"Seattle Children's Hospital and University of Washington School of Medicine  Seattle Washington USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stuart S.","family":"Kaufman","sequence":"additional","affiliation":[{"name":"MedStar Georgetown University Hospital  Washington DC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Samuel A.","family":"Kocoshis","sequence":"additional","affiliation":[{"name":"Cincinnati Children's Hospital Medical Center  Cincinnati Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David F.","family":"Mercer","sequence":"additional","affiliation":[{"name":"University of Nebraska Medical Center  Omaha Nebraska USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Russell J.","family":"Merritt","sequence":"additional","affiliation":[{"name":"Children's Hospital Los Angeles and Keck School of Medicine University of Southern California  Los Angeles California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mikko P.","family":"Pakarinen","sequence":"additional","affiliation":[{"name":"Children's Hospital University of Helsinki  Helsinki Finland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan","family":"Protheroe","sequence":"additional","affiliation":[{"name":"Birmingham Children's Hospital NHS Foundation Trust  Birmingham UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John F.","family":"Thompson","sequence":"additional","affiliation":[{"name":"Children's Hospital at Montefiore  Bronx New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charles P. B.","family":"Vanderpool","sequence":"additional","affiliation":[{"name":"Riley Hospital for Children  Indianapolis Indiana USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert S.","family":"Venick","sequence":"additional","affiliation":[{"name":"Mattel Children's Hospital UCLA California  Los Angeles California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul W.","family":"Wales","sequence":"additional","affiliation":[{"name":"The Hospital for Sick Children  Toronto Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sharon E.","family":"Smith","sequence":"additional","affiliation":[{"name":"Shire Human Genetic Therapies, Inc, a Takeda company  Cambridge Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"MinJung","family":"Yoon","sequence":"additional","affiliation":[{"name":"Shire Human Genetic Therapies, Inc, a Takeda company  Cambridge Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew A.","family":"Grimm","sequence":"additional","affiliation":[{"name":"Shire Human Genetic Therapies, Inc, a Takeda company  Cambridge Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2021,3,2]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.sempedsurg.2009.11.001"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.sempedsurg.2018.07.009"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.5223\/pghn.2019.22.4.303"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1073\/pnas.93.15.7911"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1136\/gut.50.3.428"},{"key":"e_1_2_8_7_1","unstructured":"GATTEX (teduglutide).Full prescribing information. Shire\u2010NPS Pharmaceuticals Inc;2019."},{"key":"e_1_2_8_8_1","unstructured":"Revestive (teduglutide).Full prescribing information. Shire Pharmaceuticals Ireland Limited;2019."},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpeds.2016.10.027"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/jpen.1690"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1177\/1756284820905766"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1045-1870(98)80051-4"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2017-1201"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1177\/0148607113517717"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1111\/apt.12092"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.3945\/ajcn.115.121756"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1038\/ctg.2015.69"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1152\/ajpgi.00505.2011"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clnu.2019.08.020"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10620-011-1972-8"},{"key":"e_1_2_8_21_1","doi-asserted-by":"publisher","DOI":"10.1097\/MPG.0000000000001408"}],"container-title":["Journal of Parenteral and Enteral Nutrition"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jpen.2061","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/jpen.2061","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/aspenjournals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jpen.2061","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,19]],"date-time":"2025-10-19T14:41:25Z","timestamp":1760884885000},"score":1,"resource":{"primary":{"URL":"https:\/\/aspenjournals.onlinelibrary.wiley.com\/doi\/10.1002\/jpen.2061"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,3,2]]},"references-count":20,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2021,9]]}},"alternative-id":["10.1002\/jpen.2061"],"URL":"https:\/\/doi.org\/10.1002\/jpen.2061","archive":["Portico"],"relation":{},"ISSN":["0148-6071","1941-2444"],"issn-type":[{"value":"0148-6071","type":"print"},{"value":"1941-2444","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,3,2]]},"assertion":[{"value":"2020-09-11","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-12-07","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-03-02","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}