Comparison · NCT01627860-sae
Topiramate Monotherapy vs Topiramate add-on Therapy: serious adverse events
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. Topiramate Monotherapy vs Topiramate add-on Therapy: serious adverse events. Trial comparisons, record NCT01627860-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01627860-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 | 0.0286 | 0.00506 | 0.145 | wilson | |
| Risk in group 2 | 0.05 | 0.00888 | 0.236 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0214 | -0.209 | 0.102 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.571 | 0.0378 | 8.65 | log | |
| Odds ratio, group 1 over group 2 | 0.559 | 0.033 | 9.45 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Topiramate Monotherapy than on Topiramate add-on Therapy | 46.7 | 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 | Topiramate Monotherapy | Participants received a starting dose of 25 mg/day during week 1 and the dosage increased to 50 mg/day in 2 doses during week 2. Consequently, the dosage increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage increased to 150 mg/day in 2 doses at week 5\~6 and 200 mg/day in 2 doses at week 7\~8. | 1 | 35 | EG000 |
| Group 2 | Topiramate add-on Therapy | Participants received topiramate in addition to previous ant-epileptic drug. Participants received a starting dose of 25 mg/day in the morning during week 1 and the dosage was increased to 50 mg/day in 2 doses (morning and evening) during week 2. Consequently, the dosage was increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage was increased to 150 mg/day in 2 doses at week 5\~6 and 200 mg/day in 2 doses at week 7\~8. | 1 | 20 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 20 weeks
Source ClinicalTrials.gov
Trial
- Title
- First Add-on vs. Mono-therapy Study of Topiramate in Neuro-Surgical Patients
- NCT number
- NCT01627860
- Phases
- PHASE4
- Conditions
- Epilepsy
- Interventions
- Topiramate add-on therapy, Topiramate monotherapy
- Lead sponsor
- Johnson & Johnson Taiwan Ltd
- Results first posted
- 2013-05-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01627860?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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