Comparison · NCT00397254-07487fcd
Rizatriptan 27 Tablets - Clinical Limit vs Rizatriptan 9 Tablets - Formulary Limit: Adverse Experiences
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. Rizatriptan 27 Tablets - Clinical Limit vs Rizatriptan 9 Tablets - Formulary Limit: Adverse Experiences. Trial comparisons, record NCT00397254-07487fcd. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00397254-07487fcd
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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 | 0.234 | 0.153 | 0.34 | wilson | |
| Risk in group 2 | 0.324 | 0.229 | 0.437 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0906 | -0.229 | 0.0521 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.721 | 0.428 | 1.21 | log | |
| Odds ratio, group 1 over group 2 | 0.636 | 0.31 | 1.3 | log | |
| Number needed to treat, for one fewer participant with the outcome on Rizatriptan 27 Tablets - Clinical Limit than on Rizatriptan 9 Tablets - Formulary Limit | 11 | 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 | Rizatriptan 27 Tablets - Clinical Limit | Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a clinical limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month. | 18 | 77 | OG000 |
| Group 2 | Rizatriptan 9 Tablets - Formulary Limit | Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a formulary limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month. | 24 | 74 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Adverse Experiences
- Description
Participants with one or more Adverse Experiences (AEs) in Formulary Limit Group versus Clinical Limit Group collected from time patient provided informed consent until return at Visit 7 or through 14 days post-dosing of the last dose of study medication if serious adverse experience. Defined as any unfavorable and unintended change in structure, function, or chemistry of the body temporally associated with use of provided product whether or not considered related to use of the product. Includes any worsening of a preexisting condition temporally associated with use of provided product.
- Time frame
- 6 months
- Population
197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).
Source ClinicalTrials.gov
Trial
- Title
- Two Rizatriptan Prescribing Portions for Treatment of Migraine
- NCT number
- NCT00397254
- Phases
- PHASE4
- Conditions
- Migraine
- Interventions
- rizatriptan, rizatriptan
- Lead sponsor
- Clinvest
- Results first posted
- 2009-09-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00397254?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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