Comparison · NCT00106184-sae
Treatment Group A vs Treatment Group B: 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. Treatment Group A vs Treatment Group B: serious adverse events. Trial comparisons, record NCT00106184-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00106184-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 | 0.25 | 0.174 | 0.345 | wilson | |
| Risk in group 2 | 0.394 | 0.306 | 0.49 | wilson | |
| Risk difference, group 1 minus group 2 | -0.144 | -0.267 | -0.0143 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.634 | 0.416 | 0.966 | log | |
| Odds ratio, group 1 over group 2 | 0.512 | 0.279 | 0.94 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Treatment Group A than on Treatment Group B | 6.93 | 3.75 | 70 | 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 | Treatment Group A | Subjects received rituximab at Weeks 0 and 1 followed by placebo at Weeks 8 and 9 (Treatment Group A)~Rituximab : Treatment Group A - intravenous rituximab 750mg/m2 BSA up to a maximum dose of 1 gram at Weeks 0 and 1 Placebo : Treatment Group A: placebo infusion at Weeks 8 and 9 | 24 | 96 | EG000 |
| Group 2 | Treatment Group B | Subjects received placebo at Weeks 0 and 1 followed by rituximab at Weeks 8 and 9 (Treatment Group B)~Group B - intravenous rituximab 750mg/m2 BSA up to a maximum does of 1 gram at Weeks 8 and 9~Treatment Group B: placebo infusion at Weeks 0 and 1 | 41 | 104 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Reported Adverse Events (AEs) include events starting on or after Week 0 and on or before Week 44 of the study.
Source ClinicalTrials.gov
Trial
- Title
- Rituximab for the Treatment of Refractory Adult and Juvenile Dermatomyositis (DM) and Adult Polymyositis (PM)
- NCT number
- NCT00106184
- Phases
- PHASE2
- Conditions
- Myositis, Dermatomyositis, Polymyositis, Juvenile Dermatomyositis
- Interventions
- Rituximab, Placebo
- Lead sponsor
- University of Pittsburgh
- Results first posted
- 2015-03-04
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00106184?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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