Trial · NCT03268811
Outcomes42
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 42
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | From Baseline up to follow-up (up to 50 months) | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 \[NCT02980666\] or SHP633-305 \[NCT03268811\]). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Abnormalities in Vital Signs | From Baseline up to follow-up (up to 50 months) | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 \[NCT02980666\] or SHP633-305 \[NCT03268811\]). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | From Baseline up to follow-up (up to 50 months) | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 \[NCT02980666\] or SHP633-305 \[NCT03268811\]). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Percent Change From Baseline in Average Total Urine Output at End of Treatment (EOT) of Last Cycle During Teduglutide Treatment | Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks) | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 \[NCT02980666\] or SHP633-305 \[NCT03268811\]). Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Percent change | MEAN |
| PRIMARY | Percent Change From Baseline in Average Number of Stools Per Day at EOT of Last Cycle During Teduglutide Treatment | Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks) | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 \[NCT02980666\] or SHP633-305 \[NCT03268811\]). Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Percent change | MEAN |
| PRIMARY | Percent Change From Baseline in Average Stool/Mixed Stool Diaper Weight at EOT of Last Cycle During Teduglutide Treatment | Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks) | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 \[NCT02980666\] or SHP633-305 \[NCT03268811\]). Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Percent change | MEAN |
| PRIMARY | Percent Change From Baseline in Average Total Ostomy Output at EOT of Last Cycle During Teduglutide Treatment | Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks) | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 \[NCT02980666\] or SHP633-305 \[NCT03268811\]). Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. Here, 0 in Overall number of participants analyzed signifies that no participant was evaluable at specified time point for the specified group. | Percent change | MEAN |
| PRIMARY | Percent Change From Baseline in Average Bristol Stool Form Score at EOT of Last Cycle During Teduglutide Treatment | Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks) | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 \[NCT02980666\] or SHP633-305 \[NCT03268811\]). Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Percent change | MEAN |
| PRIMARY | Number of Participants With Anti-drug Antibodies (ADAs) (Including Neutralizing Antibodies) at EOT of Last Cycle During Teduglutide Treatment | Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks) | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 \[NCT02980666\] or SHP633-305 \[NCT03268811\]). 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. 0 in number analyzed signifies that no participant was evaluable for specified category for the specified group. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Changes in Gastrointestinal (GI) Specific Testing | Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks) | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 \[NCT02980666\] or SHP633-305 \[NCT03268811\]). Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From Baseline in Body Weight For Age Z-Score at EOT of Last Cycle During Teduglutide Treatment | Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks) | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 \[NCT02980666\] or SHP633-305 \[NCT03268811\]). Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Z-score | MEAN |
| PRIMARY | Change From Baseline in Height For Age Z-Score at EOT of Cycle 1 During Teduglutide Treatment | Baseline, EOT of Cycle 1 (up to 24 Weeks) | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 \[NCT02980666\] or SHP633-305 \[NCT03268811\]). Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Z-score | MEAN |
| PRIMARY | Change From Baseline in Height For Age Z-Score at EOT of Cycle 2 During Teduglutide Treatment | Baseline, EOT of Cycle 2 (up to 48 weeks) | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 \[NCT02980666\] or SHP633-305 \[NCT03268811\]). Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Z-score | MEAN |
| PRIMARY | Change From Baseline in Height For Age Z-Score at EOT of Cycle 3 During Teduglutide Treatment | Baseline, EOT of Cycle 3 (up to 72 weeks) | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 \[NCT02980666\] or SHP633-305 \[NCT03268811\]). Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Z-score | MEAN |
| PRIMARY | Change From Baseline in Height For Age Z-Score at EOT of Cycle 4 During Teduglutide Treatment | Baseline, EOT of Cycle 4 (up to 96 weeks) | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 \[NCT02980666\] or SHP633-305 \[NCT03268811\]). Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Z-Score | MEAN |
| PRIMARY | Change From Baseline in Height For Age Z-Score at EOT of Cycle 5 During Teduglutide Treatment | Baseline, EOT of Cycle 5 (up to 120 weeks) | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 \[NCT02980666\] or SHP633-305 \[NCT03268811\]). Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. Here,0 in Overall number of participants analyzed signifies that no participant was evaluable at specified time point for the specified group. | Z-score | MEAN |
| PRIMARY | Change From Baseline in Height For Age Z-Score at EOT of Cycle 6 During Teduglutide Treatment | Baseline, EOT of Cycle 6 (up to 144 weeks) | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 \[NCT02980666\] or SHP633-305 \[NCT03268811\]). Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. Here,0 in Overall number of participants analyzed signifies that no participant was evaluable at specified time point for the specified group. | Z-score | MEAN |
| PRIMARY | Change From Baseline in Height For Age Z-Score at EOT of Cycle 7 During Teduglutide Treatment | Baseline, EOT of Cycle 7 (up to 168 weeks) | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 \[NCT02980666\] or SHP633-305 \[NCT03268811\]). Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. Here,0 in Overall number of participants analyzed signifies that no participant was evaluable at specified time point for the specified group. | Z-score | MEAN |
| PRIMARY | Change From Baseline in Height For Age Z-Score at EOT of Cycle 8 During Teduglutide Treatment | Baseline, EOT of Cycle 8 (up to 192 weeks) | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 \[NCT02980666\] or SHP633-305 \[NCT03268811\]). Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. Here,0 in Overall number of participants analyzed signifies that no participant was evaluable at specified time point for the specified group. | Z-score | MEAN |
| PRIMARY | Change From Baseline in Height For Age Z-Score at EOT of Cycle 9 During Teduglutide Treatment | Baseline, EOT of Cycle 9 (up to 196 weeks) | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 \[NCT02980666\] or SHP633-305 \[NCT03268811\]). Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. Here,0 in Overall number of participants analyzed signifies that no participant was evaluable at specified time point for the specified group. | Z-score | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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