Comparison · NCT01125774-bb8cb59f
Telcagepant 140 mg vs Placebo: Number of Participants With Clinical Adverse Events (AEs)
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: Number of Participants With Clinical Adverse Events (AEs). Trial comparisons, record NCT01125774-bb8cb59f. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01125774-bb8cb59f
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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 | 0.595 | 0.576 | 0.613 | wilson | |
| Risk in group 2 | 0.606 | 0.58 | 0.632 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0116 | -0.0436 | 0.0208 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.981 | 0.93 | 1.03 | log | |
| Odds ratio, group 1 over group 2 | 0.953 | 0.833 | 1.09 | log | |
| Number needed to treat, for one fewer participant with the outcome on Telcagepant 140 mg than on Placebo | 86.2 | 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. | 1,582 | 2,660 | OG000 |
| 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. | 804 | 1,326 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Clinical Adverse Events (AEs)
- Description
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE. A clinical AE is an AE reported as a result of a clinical examination or reported by the participant.
- Time frame
- Up to 14 days after the last dose of study drug (Up to 6.5 months)
- Population
All Participants as Treated (APaT) population, which included all randomized participants who took at least one dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm.
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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