Comparison · NCT02043548-sae
Group A: Tocilizumab vs Group B: 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
Cite this record
ConductScience Library. Group A: Tocilizumab vs Group B: Placebo: serious adverse events. Trial comparisons, record NCT02043548-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02043548-sae
On this page
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 | 0.0556 | 0.00988 | 0.258 | wilson | |
| Risk in group 2 | 0 | 0 | 0.176 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0556 | -0.126 | 0.258 | 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 harm, for one more participant with a serious adverse event on Group A: Tocilizumab than on Group B: Placebo | 18 | 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 | Group A: Tocilizumab | Tocilizumab will be given at a dose of 8mg/kg by IV infusion every 4 weeks at 6 time points (Visits 1, 2, 3, 4, 5 and 6).~tocilizumab: given at a dose of 8mg/kg by IV infusion every 4 weeks at 6 time points (Visits 1, 2, 3, 4, 5 and 6). | 1 | 18 | EG000 |
| Group 2 | Group B: Placebo | Placebo arm - no active drug~placebo: given by IV infusion every 4 weeks at 6 time points (Visits 1, 2, 3, 4, 5 and 6). | 0 | 18 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Time frame period beginning with any amount of exposure to Tocilizumab through the protocol-defined follow-up period. Total duration 1 year.
Source ClinicalTrials.gov
Trial
- Title
- Tocilizumab in the Treatment of Refractory Polymyositis and Dermatomyositis
- NCT number
- NCT02043548
- Phases
- PHASE2
- Conditions
- Dermatomyositis, Polymyositis
- Interventions
- tocilizumab, placebo
- Lead sponsor
- Chester Oddis
- Results first posted
- 2020-10-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02043548?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT02043548-sae