Comparison · NCT04333147-sae
Otilimab 90 mg vs Otilimab 150 mg: 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. Otilimab 90 mg vs Otilimab 150 mg: serious adverse events. Trial comparisons, record NCT04333147-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04333147-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 | 0.0845 | 0.0713 | 0.0999 | wilson | |
| Risk in group 2 | 0.0781 | 0.0654 | 0.093 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00634 | -0.0136 | 0.0263 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.08 | 0.847 | 1.38 | log | |
| Odds ratio, group 1 over group 2 | 1.09 | 0.835 | 1.42 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Otilimab 90 mg than on Otilimab 150 mg | 158 | 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 | Otilimab 90 mg | Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly. | 123 | 1,456 | EG000 |
| Group 2 | Otilimab 150 mg | Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly. | 114 | 1,459 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
All AE and SAE were collected from the start of the study intervention. Initially the study was planned for 4 years approx. 208 weeks however due to early termination by sponsor; data for all Adverse event was collected up to approximately 145 Weeks only.
Source ClinicalTrials.gov
Trial
- Title
- Long-term Safety and Efficacy of GSK3196165 (Otilimab) in the Treatment of Rheumatoid Arthritis (RA)
- NCT number
- NCT04333147
- Phases
- PHASE3
- Conditions
- Arthritis, Rheumatoid
- Interventions
- Otilimab (GSK3196165), csDMARD(s)
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2024-02-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04333147?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
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GET https://conductscience.org/api/comparisons/v1/NCT04333147-sae