Comparison · NCT02655237-dd2b9220
Relugolix 40 mg vs Leuprorelin 1.88 mg or 3.75 mg: Number of Participants Who Had One or More Treatment Emergent Adverse Event (TEAE)
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. Relugolix 40 mg vs Leuprorelin 1.88 mg or 3.75 mg: Number of Participants Who Had One or More Treatment Emergent Adverse Event (TEAE). Trial comparisons, record NCT02655237-dd2b9220. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02655237-dd2b9220
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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 | 0.949 | 0.899 | 0.975 | wilson | |
| Risk in group 2 | 0.979 | 0.94 | 0.993 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0296 | -0.0818 | 0.0174 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.97 | 0.927 | 1.01 | log | |
| Odds ratio, group 1 over group 2 | 0.404 | 0.102 | 1.59 | log | |
| Number needed to treat, for one fewer participant with the outcome on Relugolix 40 mg than on Leuprorelin 1.88 mg or 3.75 mg | 33.8 | 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 | Relugolix 40 mg | Relugolix placebo matching tablets, orally, once daily along with leuprorelin acetate placebo matching injection, subcutaneously (SC), once in 4 weeks for 3 to 6 weeks in run-in period followed by relugolix 40 mg, tablets, orally, once daily and leuprorelin acetate placebo matching injection, SC, once in 4 weeks for 24 weeks in treatment period. | 131 | 138 | OG000 |
| Group 2 | Leuprorelin 1.88 mg or 3.75 mg | Relugolix placebo matching tablets, orally, once daily along with leuprorelin acetate placebo matching injection, subcutaneously (SC), once in 4 weeks for 3 to 6 weeks in run-in period followed by leuprorelin acetate 1.88 mg or 3.75 mg, injection, SC, once in 4 weeks and relugolix placebo matching tablets, orally, once daily for 24 weeks in treatment period. | 139 | 142 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants Who Had One or More Treatment Emergent Adverse Event (TEAE)
- Description
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
- Time frame
- Up to Week 28
- Population
- Safety analysis set included all participants who received at least 1 dose of the study drug for the treatment period.
Source ClinicalTrials.gov
Trial
- Title
- A Phase 3 Study to Evaluate the Efficacy and Safety of Relugolix (TAK-385) 40 mg Compared With Leuprorelin in the Treatment of Uterine Fibroids
- NCT number
- NCT02655237
- Phases
- PHASE3
- Conditions
- Uterine Fibroids
- Interventions
- Relugolix, Relugolix Placebo, Leuprorelin, Leuprorelin Placebo
- Lead sponsor
- Takeda
- Results first posted
- 2019-03-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02655237?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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