Comparison · NCT03828019-sae
Adalimumab (ADA) vs Conventional Immunosuppression (CON): 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 (ADA) vs Conventional Immunosuppression (CON): serious adverse events. Trial comparisons, record NCT03828019-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03828019-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 | 0.142 | 0.0891 | 0.218 | wilson | |
| Risk in group 2 | 0.118 | 0.0704 | 0.192 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0234 | -0.067 | 0.113 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.2 | 0.605 | 2.37 | log | |
| Odds ratio, group 1 over group 2 | 1.23 | 0.562 | 2.7 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Adalimumab (ADA) than on Conventional Immunosuppression (CON) | 42.7 | 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 | Adalimumab (ADA) | Adalimumab administered by subcutaneous injection at dosage and frequency specified below; total duration of treatment is 12 months.~Adults (≥ 18 years of age) and adolescents ≥30 kg: 80 mg as initial dose; one week later by 40 mg then 40 mg every two weeks. Adolescents \<30 kg: 40 mg as initial dose; one week later 20 mg then 20 mg every 2 weeks.~Adalimumab (ADA): Adalimumab is a fully-human monoclonal antibody to TNF-α, which is approved by the U.S. FDA for the treatment of non-infectious intermediate, posterior, and panuveitides in adults and children 2 years of age and older. | 16 | 113 | EG000 |
| Group 2 | Conventional Immunosuppression (CON) | Conventional immunosuppressive agent selected by study ophthalmologist at dose and frequency specified below;12 month treatment duration.~Azathioprine: initially 2 mg/kg/day; max dose 200 mg/day. Methotrexate initially 15mg/wk; max dose 25 mg/wk. Mycophenolate initially 1 gm BID; max dose1.5 gm BID. Cyclosporine (Sandimmune - dose 2.5 mg/kg BID and Neoral dose 2 mg/kg BID. Tacrolimus initially 1 mg BID; max dose 3 mg BID.~Conventional immunosuppression (CON): The study ophthalmologist will select amongst the permissible drugs (methotrexate, mycophenolate mofetil or azathioprine for antimetabolites; cyclosporine or tacrolimus for calcineurin inhibitors) taking into account the side effect profile of each drug with respect to subject's clinical situation. | 13 | 110 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
From enrollment through the 12 months visit (end of treatment) non-serious events were reported on the monthly or bimonthly case report form. Non serious events were analyzed by counting persons who ever reported the event over the 12 month study. Serious adverse events were reported by the clinical site as the event occurred or the site became aware of the event. Adverse event information was available only for participants (ADA N = 113, CID N= 110) who continued in the study past enrollment.
Source ClinicalTrials.gov
Trial
- Title
- Adalimumab vs. Conventional Immunosuppression for Uveitis Trial
- NCT number
- NCT03828019
- Phases
- PHASE3
- Conditions
- Uveitis
- Interventions
- Adalimumab (ADA), Conventional immunosuppression (CON)
- Lead sponsor
- JHSPH Center for Clinical Trials
- Results first posted
- 2025-05-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03828019?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/NCT03828019-sae