Comparison · NCT01125774-sae
Telcagepant 140 mg 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. Telcagepant 140 mg vs Placebo: serious adverse events. Trial comparisons, record NCT01125774-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01125774-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 | 0.0094 | 0.00637 | 0.0138 | wilson | |
| Risk in group 2 | 0.00754 | 0.0041 | 0.0138 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00186 | -0.00512 | 0.00747 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.25 | 0.6 | 2.59 | log | |
| Odds ratio, group 1 over group 2 | 1.25 | 0.598 | 2.61 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Telcagepant 140 mg than on Placebo | 538 | 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 | Telcagepant 140 mg | Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses. | 25 | 2,660 | EG000 |
| Group 2 | Placebo | Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses. | 10 | 1,326 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 14 days after the last dose of study drug (Up to 6.5 months)
Source ClinicalTrials.gov
Trial
- Title
- Telcagepant for Prevention of Menstrually Related Migraine in Female Participants With Episodic Migraine (MK-0974-065)
- NCT number
- NCT01125774
- Phases
- PHASE2, PHASE3
- Conditions
- Migraine
- Interventions
- Telcagepant, Placebo
- Lead sponsor
- Merck Sharp & Dohme LLC
- Results first posted
- 2014-10-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01125774?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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