Comparison · NCT02438137-sae
Dimethyl Fumarate (Tecfidera®) Capsules 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. Dimethyl Fumarate (Tecfidera®) Capsules vs Placebo: serious adverse events. Trial comparisons, record NCT02438137-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02438137-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 | 0.0227 | 0.00402 | 0.118 | wilson | |
| Risk in group 2 | 0.0476 | 0.00846 | 0.227 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0249 | -0.205 | 0.0782 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.477 | 0.0314 | 7.26 | log | |
| Odds ratio, group 1 over group 2 | 0.465 | 0.0277 | 7.82 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Dimethyl Fumarate (Tecfidera®) Capsules than on Placebo | 40.2 | 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 | Dimethyl Fumarate (Tecfidera®) Capsules | The starting dose for dimethyl fumarate was 120 mg twice a day orally. After 7 days, the dose was increased to the maintenance dose of 240 mg twice a day. Slower dose escalations were allowed to increase tolerability, if necessary. Participants randomized to dimethyl fumarate were instructed to take this medication twice a day with breakfast and dinner for a period of 4 months.~Dimethyl fumarate: Dimethyl fumarate capsules were dispensed at routine study appointments. 120 mg tablets were dispensed to facilitate dose titrations. Drug was dispensed in 1 month supply, so that compliance could be reconciled at follow-up visits, and recorded in accountability logs. Participants were instructed to take medication with food, (morning and at dinnertime). If participants missed a dose, they were instructed to resume their normal dose at the next scheduled time, and not to take an extra dose at their next dosing interval if they previously miss a dose. | 1 | 44 | EG000 |
| Group 2 | Placebo | The placebo is an inert product that looks like a pill and is identical to dimethyl fumarate capsules, but it contains no medicine. Participants randomized to placebo were instructed to take placebo twice a day with breakfast and dinner for a period of 4 months.~Placebo: Placebo capsules were dispensed during routine study appointments. Placebo were dispensed in 1 month supply, so that compliance could be reconciled at monthly follow-up visits, and recorded in accountability logs. Participants were instructed to take the placebo with food, in the morning and at dinnertime. If participants missed a dose, they were instructed to resume their normal dose at the next scheduled time, and not to take an extra dose at their next dosing interval if they previously missed a dose. | 1 | 21 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- For each participant, adverse events were captured at each visit beginning with Month 1 visit and ending with the Month 5 follow-up visit.
Source ClinicalTrials.gov
Trial
- Title
- Dimethyl Fumarate for Obstructive Sleep Apnea
- NCT number
- NCT02438137
- Phases
- PHASE2
- Conditions
- Obstructive Sleep Apnea, OSA, Sleep Apnea
- Interventions
- Dimethyl fumarate, Placebo
- Lead sponsor
- University of Michigan
- Results first posted
- 2017-05-31
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02438137?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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