Comparison · NCT03207815-sae
Filgotinib 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. Filgotinib vs Placebo: serious adverse events. Trial comparisons, record NCT03207815-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03207815-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 | 0.135 | 0.0591 | 0.28 | wilson | |
| Risk in group 2 | 0.0571 | 0.0158 | 0.186 | wilson | |
| Risk difference, group 1 minus group 2 | 0.078 | -0.0717 | 0.228 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.36 | 0.49 | 11.4 | log | |
| Odds ratio, group 1 over group 2 | 2.58 | 0.466 | 14.3 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Filgotinib than on Placebo | 12.8 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Filgotinib | Participants received filgotinib 200 mg tablet orally, once daily for up to 52 weeks along with a standardized prednisone burst of 60 mg/day at Day 1/Baseline followed by a protocol-defined mandatory taper schedule up to Week 15. | 5 | 37 | EG000 |
| Group 2 | Placebo | Participants received placebo to match filgotinib tablet orally, once daily for up to 52 weeks along with a standardized prednisone burst of 60 mg/day at Day 1/Baseline followed by a protocol-defined mandatory taper schedule up to Week 15. | 2 | 35 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse Events: First dose date up to 30 days after the last dose of study drug (maximum exposure up to 57 weeks); All-Cause Mortality: From randomization up to 57 weeks
Source ClinicalTrials.gov
Trial
- Title
- Study to Evaluate the Efficacy and Safety of Filgotinib in Adults With Active Noninfectious Uveitis
- NCT number
- NCT03207815
- Phases
- PHASE2
- Conditions
- Noninfectious Uveitis
- Interventions
- Filgotinib, Placebo to match filgotinib, Prednisone
- Lead sponsor
- Gilead Sciences
- Results first posted
- 2022-01-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03207815?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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