Comparison · NCT03828539-82f3abbe
Erenumab vs Topiramate: Proportion of Patients With Treatment Discontinuation Due to an Adverse Event (AE) During the Double-blind Treatment Epoch/Period (DBTE)
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. Erenumab vs Topiramate: Proportion of Patients With Treatment Discontinuation Due to an Adverse Event (AE) During the Double-blind Treatment Epoch/Period (DBTE). Trial comparisons, record NCT03828539-82f3abbe. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03828539-82f3abbe
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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 | 0.106 | 0.0789 | 0.14 | wilson | |
| Risk in group 2 | 0.389 | 0.342 | 0.439 | wilson | |
| Risk difference, group 1 minus group 2 | -0.284 | -0.34 | -0.225 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.272 | 0.198 | 0.372 | log | |
| Odds ratio, group 1 over group 2 | 0.185 | 0.126 | 0.272 | log | |
| Number needed to treat, for one fewer participant with the outcome on Erenumab than on Topiramate | 3.53 | 2.94 | 4.44 | from the risk difference interval |
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 | Erenumab | 70 mg and 140 mg Erenumab | 41 | 388 | OG000 |
| Group 2 | Topiramate | Topiramate in the highest tolerated dose (50 - 100 mg/day) | 151 | 388 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Proportion of Patients With Treatment Discontinuation Due to an Adverse Event (AE) During the Double-blind Treatment Epoch/Period (DBTE)
- Description
The primary objective was to demonstrate the tolerability of 70 mg and 140 mg erenumab compared to topiramate in the highest tolerated dose assessed by the rate of patients discontinuing treatment due to AE during the double-blind epoch of the study.
- Time frame
- 24 Weeks
- Population
- Full Analysis Set (FAS)
Source ClinicalTrials.gov
Trial
- Title
- Head-to-head Study of Erenumab Against Topiramate in Patients With Episodic and Chronic Migraine
- NCT number
- NCT03828539
- Phases
- PHASE4
- Conditions
- Migraine
- Interventions
- Erenumab, Topiramate, Erenumab matching placebo, Topiramate matching placebo
- Lead sponsor
- Novartis Pharmaceuticals
- Results first posted
- 2021-08-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03828539?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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