Comparison · NCT03426345-3a163156
Relamorelin 10 μg vs Placebo: Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE)
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: Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE). Trial comparisons, record NCT03426345-3a163156. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03426345-3a163156
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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 | 0.555 | 0.476 | 0.631 | wilson | |
| Risk in group 2 | 0.493 | 0.415 | 0.572 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0614 | -0.0498 | 0.171 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.12 | 0.908 | 1.39 | log | |
| Odds ratio, group 1 over group 2 | 1.28 | 0.817 | 2 | log | |
| Number needed to treat, for one more participant with the outcome on Relamorelin 10 μg than on Placebo | 16.3 | 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. | 86 | 155 | OG001 |
| Group 2 | Placebo | Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks. | 75 | 152 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE)
- Description
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE is an AE that begins or worsens after receiving study drug.
- Time frame
- Up to approximately 16 weeks
- Population
- Safety Population included all participants who received ≥1 administration of double-blind study treatment.
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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