Comparison · NCT01138657-sae
Adalimumab vs 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. Adalimumab vs Placebo: serious adverse events. Trial comparisons, record NCT01138657-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01138657-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 | 0.134 | 0.0845 | 0.207 | wilson | |
| Risk in group 2 | 0.0417 | 0.0179 | 0.0938 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0928 | 0.0205 | 0.169 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3.23 | 1.22 | 8.53 | log | |
| Odds ratio, group 1 over group 2 | 3.57 | 1.26 | 10.1 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Adalimumab than on Placebo | 10.8 | 5.9 | 48.7 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Adalimumab | Participants received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15. | 16 | 119 | EG001 |
| Group 2 | Placebo | Participants received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15. | 5 | 120 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
From the first study drug administration until 70 days following the last study drug administration or until rollover into the extension study. Median duration of treatment was 91 days in the placebo arm and 129 days in the adalimumab arm.
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety of Adalimumab in Patients With Active Uveitis
- NCT number
- NCT01138657
- Phases
- PHASE3
- Conditions
- Uveitis
- Interventions
- Adalimumab, Prednisone, Placebo
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Results first posted
- 2016-08-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01138657?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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