Comparison · NCT00835770-91449197
BG00012 240 mg BID vs BG00012 240 mg TID: Number of Participants With Treatment-Emergent 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. BG00012 240 mg BID vs BG00012 240 mg TID: Number of Participants With Treatment-Emergent Adverse Events (AEs). Trial comparisons, record NCT00835770-91449197. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00835770-91449197
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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 | 0.949 | 0.933 | 0.962 | wilson | |
| Risk in group 2 | 0.938 | 0.92 | 0.952 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0115 | -0.0104 | 0.0336 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.01 | 0.989 | 1.04 | log | |
| Odds ratio, group 1 over group 2 | 1.24 | 0.825 | 1.87 | log | |
| Number needed to treat, for one more participant with the outcome on BG00012 240 mg BID than on BG00012 240 mg TID | 86.8 | 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 | BG00012 240 mg BID | Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. | 824 | 868 | OG000 |
| Group 2 | BG00012 240 mg TID | Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. | 814 | 868 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Treatment-Emergent Adverse Events (AEs)
- Description
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
- Time frame
- Day 1 up to Week 561
- Population
Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Source ClinicalTrials.gov
Trial
- Title
- BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS)
- NCT number
- NCT00835770
- Phases
- PHASE3
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Interventions
- dimethyl fumarate, Placebo
- Lead sponsor
- Biogen
- Results first posted
- 2020-12-31
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00835770?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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