Comparison · NCT05361668-sae
40 mg Paltusotine vs 80 mg Paltusotine: 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. 40 mg Paltusotine vs 80 mg Paltusotine: serious adverse events. Trial comparisons, record NCT05361668-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05361668-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 | 0.111 | 0.031 | 0.328 | wilson | |
| Risk in group 2 | 0.111 | 0.031 | 0.328 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.231 | 0.231 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 0.158 | 6.35 | log | |
| Odds ratio, group 1 over group 2 | 1 | 0.125 | 8 | log | |
| Number needed to harm | from the risk difference interval | the two groups' risks are equal |
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 | 40 mg Paltusotine | Randomized: 40 mg paltusotine: Two 20 mg tablets QD (Potential post-randomization dose escalation based on efficacy and acceptable tolerability: up to 80 mg) | 2 | 18 | EG000 |
| Group 2 | 80 mg Paltusotine | Randomized: 80 mg paltusotine: Four 20 mg tablets QD (Potential post-randomization dose escalation based on efficacy and acceptable tolerability: up to 120 mg) | 2 | 18 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse event data were collected over the 8 weeks of the RTP phase, and an EOS Visit was to occur to collect the safety data and other assessments, 28 days after last dose of study drug and was required for subjects who completed the study or early terminated. TEAE data were summarized from first dose date until last dose date (end of RTP or early term) plus 28 days (Safety follow up).
Source ClinicalTrials.gov
Trial
- Title
- Study to Evaluate the Safety, PK, and Dose Response of Paltusotine in Subjects With Carcinoid Syndrome
- NCT number
- NCT05361668
- Phases
- PHASE2
- Conditions
Carcinoid Syndrome, Carcinoid, Carcinoid Tumor, Carcinoid Tumor of Ileum, Carcinoid Tumor of Cecum, Carcinoid Syndrome Diarrhea, Carcinoid Intestine Tumor, Carcinoid Tumor of Liver, Carcinoid Tumor of Pancreas
- Interventions
- Randomized: 40 mg Paltusotine, Randomized: 80 mg Paltusotine
- Lead sponsor
- Crinetics Pharmaceuticals Inc.
- Results first posted
- 2025-10-31
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05361668?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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