Comparison · NCT01104415-b71acd5e
Telotristat Etiprate- Core Phase vs Telotristat Etiprate- Extension Period: Number of Participants With an Improvement in Global Assessment of Symptoms Associated With Carcinoid Syndrome
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Telotristat Etiprate- Core Phase vs Telotristat Etiprate- Extension Period: Number of Participants With an Improvement in Global Assessment of Symptoms Associated With Carcinoid Syndrome. Trial comparisons, record NCT01104415-b71acd5e. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01104415-b71acd5e
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.769 | 0.497 | 0.918 | wilson | |
| Risk in group 2 | 0.571 | 0.25 | 0.842 | wilson | |
| Risk difference, group 1 minus group 2 | 0.198 | -0.186 | 0.552 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.35 | 0.664 | 2.73 | log | |
| Odds ratio, group 1 over group 2 | 2.5 | 0.346 | 18 | log | |
| Number needed to treat, for one more participant with the outcome on Telotristat Etiprate- Core Phase than on Telotristat Etiprate- Extension Period | 5.06 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Telotristat Etiprate- Core Phase | Following a 2-week Run-In Period, participants received telotristat etiprate capsules at a starting dose of 150 mg, orally three times daily (TID) for 14 days in the Core Phase. Dose escalations (250 mg, 350 mg, 500 mg) occurred serially every 14 days, up to a maximum dosage of telotristat etiprate 500 mg TID, as guided by specific clinical criteria for dose escalation. Upon completion of 12 weeks of treatment, participants were eligible to receive telotristat etiprate in the optional Open-label Extension Period. | 10 | 13 | OG000 |
| Group 2 | Telotristat Etiprate- Extension Period | Participants received telotristat etiprate at their highest tolerated dose (250 mg or 500 mg), orally, TID for 124 weeks in the Open-label Extension Period. If neither dose was tolerated participants were discontinued from the study and completed the 2-week Follow-up Visit. | 4 | 7 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With an Improvement in Global Assessment of Symptoms Associated With Carcinoid Syndrome
- Description
Participants assessed their symptoms using a weekly subjective response to the following question, In the past 7 days, have you had adequate relief of your carcinoid syndrome bowel complaints such as diarrhea, urgent need to have a bowel movement, abdominal pain, or discomfort?. The values for improvement in global assessment of symptoms associated with carcinoid syndrome in the Core Phase were averaged from Weeks 9 to 12.
- Time frame
- Core Phase: Weeks 9-12; Extension Period: Week 24
- Population
EFAS in Core Phase included all participants who had at least 1 post-Baseline efficacy assessment and FAS in Extension Period included all participants in the safety set who had at least 1 post-Baseline efficacy assessment in the 124-week Extension Period. Number analyzed is the number of participants with evaluable data at the given time-point.
Source ClinicalTrials.gov
Trial
- Title
- Study of Telotristat Etiprate (LX1606) in Participants With Symptomatic Carcinoid Syndrome
- NCT number
- NCT01104415
- Phases
- PHASE2
- Conditions
- Carcinoid Syndrome
- Interventions
- Telotristat etiprate
- Lead sponsor
- Lexicon Pharmaceuticals
- Results first posted
- 2018-04-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01104415?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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