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Study · Non-randomized trial · n = 89 · 2021

14 results

Safety Findings in Pediatric Patients During Long-Term Treatment With Teduglutide for Short-Bowel Syndrome-Associated Intestinal Failure: Pooled Analysis of 4 Clinical Studies.

Hill S, Carter BA, Cohran V, Horslen S, Kaufman SS, Kocoshis SA, Mercer DF, Merritt RJ, Pakarinen MP, Protheroe S, Thompson JF, Vanderpool CPB and 5 more

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Venick RS, Wales PW, Smith SE, Yoon M, Grimm AA

JPEN. Journal of parenteral and enteral nutrition2 Mar 2021Cited by 23 (Europe PMC)

PMID33305440 (opens in a new tab)PMCIDPMC8647158 (opens in a new tab)DOI10.1002/jpen.2061 (opens in a new tab)PepBankPUB-33305440
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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC. Results still quote short attributed sentences.

Results from this study14

14 results from studies that gave the peptide. 14 results from people.

  1. 01HumanNon-randomized trialSafety outcome

    All 89 children with SBS-IF receiving teduglutide had adverse events.

    In plain wordsAll 89 children receiving teduglutide had adverse events.

    Peptide
    Teduglutide
    Outcome
    Not applicableAny adverse event
    Study

    n = 89

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · median 51.7 weeks (range 5.0-94.7 weeks)As given in this study (human).

    Source sentences

    Summary
    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%).
    2 context sentences
    Summary · context
    Safety data from teduglutide-treated patients in 4 clinical trials were pooled.
    Summary · context
    Safety data are reported for 89 pediatric patients treated with teduglutide for a median (range) of 51.7 (5.0-94.7) weeks.
  2. 02HumanNon-randomized trialSafety outcome

    Vomiting occurred in 51.7% of children receiving teduglutide.

    In plain wordsVomiting occurred in 51.7% of children receiving teduglutide.

    Peptide
    Teduglutide
    Outcome
    Not applicableVomiting
    Study

    n = 89

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · median 51.7 weeks (range 5.0-94.7 weeks)As given in this study (human).

    Measurements

    Vomiting incidence
    51.7%
    pediatric patients treated with teduglutide

    Source sentences

    Summary
    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%).
    2 context sentences
    Summary · context
    Safety data from teduglutide-treated patients in 4 clinical trials were pooled.
    Summary · context
    Safety data are reported for 89 pediatric patients treated with teduglutide for a median (range) of 51.7 (5.0-94.7) weeks.
  3. 03HumanNon-randomized trialSafety outcome

    Pyrexia occurred in 43.8% of children receiving teduglutide.

    In plain wordsFever occurred in 43.8% of children receiving teduglutide.

    Peptide
    Teduglutide
    Outcome
    Not applicablePyrexia
    Study

    n = 89

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · median 51.7 weeks (range 5.0-94.7 weeks)As given in this study (human).

    Measurements

    Pyrexia incidence
    43.8%
    pediatric patients treated with teduglutide

    Source sentences

    Summary
    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%).
    2 context sentences
    Summary · context
    Safety data from teduglutide-treated patients in 4 clinical trials were pooled.
    Summary · context
    Safety data are reported for 89 pediatric patients treated with teduglutide for a median (range) of 51.7 (5.0-94.7) weeks.
  4. 04HumanNon-randomized trialSafety outcome

    Upper respiratory tract infection occurred in 41.6% of children receiving teduglutide.

    In plain wordsUpper respiratory infections occurred in 41.6% of children receiving teduglutide.

    Peptide
    Teduglutide
    Outcome
    Not applicableUpper respiratory tract infection
    Study

    n = 89

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · median 51.7 weeks (range 5.0-94.7 weeks)As given in this study (human).

    Measurements

    Upper respiratory tract infection incidence
    41.6%
    pediatric patients treated with teduglutide

    Source sentences

    Summary
    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%).
    2 context sentences
    Summary · context
    Safety data from teduglutide-treated patients in 4 clinical trials were pooled.
    Summary · context
    Safety data are reported for 89 pediatric patients treated with teduglutide for a median (range) of 51.7 (5.0-94.7) weeks.
  5. 05HumanNon-randomized trialSafety outcome

    Cough occurred in 33.7% of children receiving teduglutide.

    In plain wordsCough occurred in 33.7% of children receiving teduglutide.

    Peptide
    Teduglutide
    Outcome
    Not applicableCough
    Study

    n = 89

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · median 51.7 weeks (range 5.0-94.7 weeks)As given in this study (human).

    Measurements

    Cough incidence
    33.7%
    pediatric patients treated with teduglutide

    Source sentences

    Summary
    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%).
    2 context sentences
    Summary · context
    Safety data from teduglutide-treated patients in 4 clinical trials were pooled.
    Summary · context
    Safety data are reported for 89 pediatric patients treated with teduglutide for a median (range) of 51.7 (5.0-94.7) weeks.
  6. 06HumanNon-randomized trialSafety outcome

    Thirty-five children (39.3%) had adverse events considered related to teduglutide.

    In plain wordsAdverse events considered related to teduglutide occurred in 39.3% of children.

    Peptide
    Teduglutide
    Outcome
    Not applicableTreatment-related adverse events
    Study

    n = 89

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · median 51.7 weeks (range 5.0-94.7 weeks)As given in this study (human).

    Measurements

    Patients with teduglutide-related AEs
    35 patients
    pooled safety set
    Patients with teduglutide-related AEs
    39.3%
    pooled safety set

    Source sentences

    Summary
    Thirty-five patients (39.3%) had AEs considered related to teduglutide treatment; abdominal pain and vomiting were most frequent (5.6% each).
    2 context sentences
    Summary · context
    Safety data from teduglutide-treated patients in 4 clinical trials were pooled.
    Summary · context
    Safety data are reported for 89 pediatric patients treated with teduglutide for a median (range) of 51.7 (5.0-94.7) weeks.
  7. 07HumanNon-randomized trialSafety outcome

    Abdominal pain considered related to teduglutide occurred in 5.6% of children.

    In plain wordsAbdominal pain considered related to teduglutide occurred in 5.6% of children.

    Peptide
    Teduglutide
    Outcome
    Not applicableTreatment-related abdominal pain
    Study

    n = 89

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · median 51.7 weeks (range 5.0-94.7 weeks)As given in this study (human).

    Measurements

    Treatment-related abdominal pain incidence
    5.6%
    pediatric patients treated with teduglutide

    Source sentences

    Summary
    Thirty-five patients (39.3%) had AEs considered related to teduglutide treatment; abdominal pain and vomiting were most frequent (5.6% each).
    2 context sentences
    Summary · context
    Safety data from teduglutide-treated patients in 4 clinical trials were pooled.
    Summary · context
    Safety data are reported for 89 pediatric patients treated with teduglutide for a median (range) of 51.7 (5.0-94.7) weeks.
  8. 08HumanNon-randomized trialSafety outcome

    Vomiting considered related to teduglutide occurred in 5.6% of children.

    In plain wordsVomiting considered related to teduglutide occurred in 5.6% of children.

    Peptide
    Teduglutide
    Outcome
    Not applicableTreatment-related vomiting
    Study

    n = 89

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · median 51.7 weeks (range 5.0-94.7 weeks)As given in this study (human).

    Measurements

    Treatment-related vomiting incidence
    5.6%
    pediatric patients treated with teduglutide

    Source sentences

    Summary
    Thirty-five patients (39.3%) had AEs considered related to teduglutide treatment; abdominal pain and vomiting were most frequent (5.6% each).
    2 context sentences
    Summary · context
    Safety data from teduglutide-treated patients in 4 clinical trials were pooled.
    Summary · context
    Safety data are reported for 89 pediatric patients treated with teduglutide for a median (range) of 51.7 (5.0-94.7) weeks.
  9. 09HumanNon-randomized trialSafety outcome

    Three children (3.4%) had serious adverse events considered related to teduglutide; all three events resolved.

    In plain wordsSerious events considered related to teduglutide occurred in 3.4% of children; all resolved.

    Peptide
    Teduglutide
    Outcome
    Not applicableTreatment-related serious adverse events
    Study

    n = 89

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · median 51.7 weeks (range 5.0-94.7 weeks)As given in this study (human).

    Measurements

    Treatment-related serious AEs
    3 events
    3 patients
    Patients with treatment-related serious AEs
    3.4%
    pooled safety set

    Source sentences

    Summary
    Three serious AEs in 3 patients (3.4%) were considered related to teduglutide treatment: ileus, d-lactic acidosis, and gastrointestinal obstruction due to hard stools.
    1 context sentence
    Summary · context
    All 3 events resolved.
  10. 10HumanNon-randomized trialSafety outcome

    Ileus was one of three serious events considered related to teduglutide in children; all three events resolved.

    In plain wordsA child receiving teduglutide had treatment-related serious ileus, which resolved.

    Peptide
    Teduglutide
    Outcome
    Not applicableIleus
    Study

    n = 89

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · median 51.7 weeks (range 5.0-94.7 weeks)As given in this study (human).

    Source sentences

    Summary
    Three serious AEs in 3 patients (3.4%) were considered related to teduglutide treatment: ileus, d-lactic acidosis, and gastrointestinal obstruction due to hard stools.
    1 context sentence
    Summary · context
    All 3 events resolved.
  11. 11HumanNon-randomized trialSafety outcome

    D-lactic acidosis was one of three serious events considered related to teduglutide in children; all three events resolved.

    In plain wordsIn children with SBS-IF, serious d-lactic acidosis was considered related to teduglutide, and it resolved.

    Peptide
    Teduglutide
    Outcome
    Not applicableD-lactic acidosis
    Study

    n = 89

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · median 51.7 weeks (range 5.0-94.7 weeks)As given in this study (human).

    Source sentences

    Summary
    Three serious AEs in 3 patients (3.4%) were considered related to teduglutide treatment: ileus, d-lactic acidosis, and gastrointestinal obstruction due to hard stools.
    3 context sentences
    Summary · context
    All 3 events resolved.
    Summary · context
    Safety data from teduglutide-treated patients in 4 clinical trials were pooled.
    Summary · context
    Safety data are reported for 89 pediatric patients treated with teduglutide for a median (range) of 51.7 (5.0-94.7) weeks.
  12. 12HumanNon-randomized trialSafety outcome

    Gastrointestinal obstruction due to hard stools was considered related to teduglutide in a child; the event resolved.

    In plain wordsIn children with SBS-IF, a serious bowel obstruction from hard stools was considered related to teduglutide, and it resolved.

    Peptide
    Teduglutide
    Outcome
    Not applicableGastrointestinal obstruction due to hard stools
    Study

    n = 89

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated · median 51.7 weeks (range 5.0-94.7 weeks)As given in this study (human).

    Source sentences

    Summary
    Three serious AEs in 3 patients (3.4%) were considered related to teduglutide treatment: ileus, d-lactic acidosis, and gastrointestinal obstruction due to hard stools.
    3 context sentences
    Summary · context
    All 3 events resolved.
    Summary · context
    Safety data from teduglutide-treated patients in 4 clinical trials were pooled.
    Summary · context
    Safety data are reported for 89 pediatric patients treated with teduglutide for a median (range) of 51.7 (5.0-94.7) weeks.
  13. 13HumanNon-randomized trialSafety outcome

    One cecal polyp was detected in teduglutide-treated children, without biopsy or detection on repeat colonoscopy.

    In plain wordsOne bowel polyp was detected in children receiving teduglutide, but was not biopsied or found on repeat examination.

    Peptide
    Teduglutide
    Outcome
    Not applicableCecal polyp
    Study

    n = 89

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated · median 51.7 weeks (range 5.0-94.7 weeks)As given in this study (human).

    Measurements

    Cecal polyps detected
    1 polyp
    pediatric patients, pooled 4 studies

    Source sentences

    Summary
    One cecal polyp was detected, which was not biopsied or found on repeat colonoscopy.
    2 context sentences
    Summary · context
    Safety data from teduglutide-treated patients in 4 clinical trials were pooled.
    Summary · context
    Safety data are reported for 89 pediatric patients treated with teduglutide for a median (range) of 51.7 (5.0-94.7) weeks.
  14. 14HumanNon-randomized trialSafety outcome

    No neoplasia occurred in children receiving teduglutide.

    In plain wordsNo neoplasia was reported in children receiving teduglutide.

    Peptide
    Teduglutide
    Outcome
    Not applicableNeoplasia
    Study

    n = 89

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · median 51.7 weeks (range 5.0-94.7 weeks)As given in this study (human).

    Source sentences

    Summary
    No cases of neoplasia occurred.
    2 context sentences
    Summary · context
    Safety data from teduglutide-treated patients in 4 clinical trials were pooled.
    Summary · context
    Safety data are reported for 89 pediatric patients treated with teduglutide for a median (range) of 51.7 (5.0-94.7) weeks.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:37 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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