Comparison · NCT03201445-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
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ConductScience Library. Filgotinib vs Placebo: serious adverse events. Trial comparisons, record NCT03201445-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03201445-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 | 0.0326 | 0.0112 | 0.0915 | wilson | |
| Risk in group 2 | 0.0286 | 0.00787 | 0.0983 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00404 | -0.0689 | 0.0665 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.14 | 0.196 | 6.65 | log | |
| Odds ratio, group 1 over group 2 | 1.15 | 0.186 | 7.05 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Filgotinib than on Placebo | 248 | 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 (OD) up to Week 13 in DB phase (Part A). At Week 13, IBD responders, without meeting pre-specified sperm decrease thresholds, continued DB phase treatment up to Week 26 (Part B). IBD non-responders at Week 13 (end of Part A) or had disease worsening after Week 13 and prior to Week 26 (in Part B), and whose sperm parameters did not meet prespecified decrease threshold, entered the OL Phase, and received OL filgotinib 200 mg, tablet orally OD for up to Week 13 during the OL phase. At Week 26/OL Week 13, IBD responders and who had not experienced disease worsening, and whose sperm parameters did not meet prespecified decrease threshold, continued receiving the same study drug they were responding to, as part of LTE for up to 195 weeks. Participants who met prespecified sperm decrease threshold(s) discontinued study drug and switched to SOC regimen selected by investigator and entered the MP for up to 52 weeks. | 3 | 92 | EG000 |
| Group 2 | Placebo | Participants received placebo (matched to filgotinib) tablet, orally OD up to Week 13 in DB phase (Part A). At Week 13, IBD responders, without meeting pre-specified sperm decrease thresholds, continued DB phase treatment up to Week 26 (Part B). IBD non-responders at Week 13 (end of Part A) or had disease worsening after Week 13 and prior to Week 26 (in Part B), and whose sperm parameters did not meet prespecified decrease threshold, entered the OL Phase, and received OL filgotinib 200 mg, tablet orally OD for up to Week 13 during the OL phase. At Week 26/OL Week 13, IBD responders and who had not experienced disease worsening, and whose sperm parameters did not meet prespecified decrease threshold, continued receiving the same study drug they were responding to, as part of LTE for up to 195 weeks. Participants who met prespecified sperm decrease threshold(s) discontinued study drug and switched to SOC regimen selected by investigator and entered the MP for up to 52 weeks. | 2 | 70 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From first dose up to Week 226
Source ClinicalTrials.gov
Trial
- Title
- Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely Active Inflammatory Bowel Disease
- NCT number
- NCT03201445
- Phases
- PHASE2
- Conditions
- Inflammatory Bowel Disease
- Interventions
- Filgotinib, Placebo, Standard of Care
- Lead sponsor
- Lakefront Biotherapeutics NV
- Results first posted
- 2023-12-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03201445?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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