Comparison · NCT01543503-sae
Tocilizumab vs TNF Inhibitor: 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. Tocilizumab vs TNF Inhibitor: serious adverse events. Trial comparisons, record NCT01543503-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01543503-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 | 0.052 | 0.0346 | 0.0775 | wilson | |
| Risk in group 2 | 0.0807 | 0.0637 | 0.102 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0287 | -0.056 | 0.00193 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.644 | 0.403 | 1.03 | log | |
| Odds ratio, group 1 over group 2 | 0.625 | 0.379 | 1.03 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Tocilizumab than on TNF Inhibitor | 34.8 | 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 | Tocilizumab | Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks. | 22 | 423 | EG000 |
| Group 2 | TNF Inhibitor | Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks. | 64 | 793 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to Week 52
Source ClinicalTrials.gov
Trial
- Title
- An Global Comparative Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis
- NCT number
- NCT01543503
- Phases
- Conditions
- Rheumatoid Arthritis
- Interventions
- Lead sponsor
- Hoffmann-La Roche
- Results first posted
- 2016-02-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01543503?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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