Comparison · NCT01148810-sae
BAF312/BAF312 vs Placebo/BAF312: 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. BAF312/BAF312 vs Placebo/BAF312: serious adverse events. Trial comparisons, record NCT01148810-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01148810-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 | 0 | 0.194 | wilson | |
| Risk in group 2 | 0.3 | 0.108 | 0.603 | wilson | |
| Risk difference, group 1 minus group 2 | -0.3 | -0.603 | -0.0272 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one fewer participant with a serious adverse event on BAF312/BAF312 than on Placebo/BAF312 | 3.33 | 1.66 | 36.8 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | BAF312/BAF312 | 2 tablets each of BAF312 5mg for oral administration in period 1 and 2 tablets each of BAF312 5mg in period 2 | 0 | 16 | EG000 |
| Group 2 | Placebo/BAF312 | 2 tablets of Placebo for oral administration in period 1 and 2 tablets each of BAF312 5mg in period 2 | 3 | 10 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years.
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Tolerability of BAF312 in Patients With Polymyositis and Dermatomyositis
- NCT number
- NCT01148810
- Phases
- PHASE2
- Conditions
- Polymyositis, Dermatomyositis
- Interventions
- BAF312, Placebo
- Lead sponsor
- Novartis Pharmaceuticals
- Results first posted
- 2019-04-25
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01148810?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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