Comparison · NCT04810091-sae
Placebo + SSA vs Xermelo + SSA: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Placebo + SSA vs Xermelo + SSA: serious adverse events. Trial comparisons, record NCT04810091-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04810091-sae
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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 | 0.0857 | 0.0296 | 0.224 | wilson | |
| Risk in group 2 | 0.125 | 0.0497 | 0.281 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0393 | -0.205 | 0.118 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.686 | 0.166 | 2.83 | log | |
| Odds ratio, group 1 over group 2 | 0.656 | 0.135 | 3.19 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Placebo + SSA than on Xermelo + SSA | 25.5 | 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 | Placebo + SSA | Placebo-matching telotristat ethyl tablet TID + stable-dose somatostatin analog (SSA) therapy | 3 | 35 | EG000 |
| Group 2 | Xermelo + SSA | Telotristat ethyl 500 mg po TID + stable-dose somatostatin analog (SSA) | 4 | 32 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse events were monitored from baseline throughout the follow-up period (3-month and 6-month follow-up visits) and for up to 30 days after the last dose of the study drug, with the treatment period planned for 6-months
Source ClinicalTrials.gov
Trial
- Title
- Telotristat Ethyl for the Treatment of Carcinoid Heart Disease in Patients With Metastatic Neuroendocrine Tumor
- NCT number
- NCT04810091
- Phases
- PHASE3
- Conditions
- Locally Advanced Neuroendocrine Neoplasm, Metastatic Neuroendocrine Neoplasm
- Interventions
- Placebo Administration, Questionnaire Administration, Telotristat Ethyl
- Lead sponsor
- M.D. Anderson Cancer Center
- Results first posted
- 2026-02-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04810091?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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