Comparison · NCT01941095-sae
Tocilizumab Monotherapy vs Tocilizumab + Methotrexate or Other Non-Biologic DMARDs: 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 Monotherapy vs Tocilizumab + Methotrexate or Other Non-Biologic DMARDs: serious adverse events. Trial comparisons, record NCT01941095-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01941095-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 | 0.0645 | 0.0179 | 0.207 | wilson | |
| Risk in group 2 | 0.0758 | 0.0328 | 0.165 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0112 | -0.112 | 0.138 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.852 | 0.175 | 4.15 | log | |
| Odds ratio, group 1 over group 2 | 0.841 | 0.154 | 4.6 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Tocilizumab Monotherapy than on Tocilizumab + Methotrexate or Other Non-Biologic DMARDs | 89 | 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 Monotherapy | Participants received tocilizumab 162 mg SC injection QW as monotherapy during the treatment period of 52 weeks. | 2 | 31 | EG000 |
| Group 2 | Tocilizumab + Methotrexate or Other Non-Biologic DMARDs | Participants received tocilizumab 162 mg SC injection QW in combination with methotrexate or other non-biologic DMARDs during the treatment period of 52 weeks. | 5 | 66 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From Baseline up to end of study (Week 60)
Source ClinicalTrials.gov
Trial
- Title
- A Study of Subcutaneous Tocilizumab as Monotherapy and/or in Combination With Non-Biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Participants With Rheumatoid Arthritis
- NCT number
- NCT01941095
- Phases
- PHASE3
- Conditions
- Rheumatoid Arthritis
- Interventions
- Azathioprine, Chloroquine, Hydroxychloroquine, Leflunomide, Methotrexate, Sulfasalazine, Tocilizumab
- Lead sponsor
- Hoffmann-La Roche
- Results first posted
- 2018-11-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01941095?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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