Comparison · NCT03426345-sae
Relamorelin 10 μg vs Placebo: serious adverse events
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. Relamorelin 10 μg vs Placebo: serious adverse events. Trial comparisons, record NCT03426345-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03426345-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 | 0.0516 | 0.0264 | 0.0985 | wilson | |
| Risk in group 2 | 0.0395 | 0.0182 | 0.0834 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0121 | -0.0385 | 0.0636 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.31 | 0.465 | 3.68 | log | |
| Odds ratio, group 1 over group 2 | 1.32 | 0.448 | 3.91 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Relamorelin 10 μg than on Placebo | 82.4 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Relamorelin 10 μg | Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks. | 8 | 155 | EG001 |
| Group 2 | Placebo | Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks. | 6 | 152 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to approximately 16 weeks
Source ClinicalTrials.gov
Trial
- Title
- Study to Evaluate the Safety and Efficacy of Relamorelin in Participants With Diabetic Gastroparesis Study 02
- NCT number
- NCT03426345
- Phases
- PHASE3
- Conditions
- Gastroparesis, Diabetes Mellitus
- Interventions
- Placebo, Relamorelin
- Lead sponsor
- Allergan
- Results first posted
- 2021-08-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03426345?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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