Comparison · NCT02403323-sae
Part 1 (OLE): Etrolizumab vs Part 2 (PML SM): 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. Part 1 (OLE): Etrolizumab vs Part 2 (PML SM): serious adverse events. Trial comparisons, record NCT02403323-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02403323-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 | 0.274 | 0.244 | 0.307 | wilson | |
| Risk in group 2 | 0.00279 | 0.000492 | 0.0156 | wilson | |
| Risk difference, group 1 minus group 2 | 0.272 | 0.238 | 0.305 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 98.5 | 13.9 | 700 | log | |
| Odds ratio, group 1 over group 2 | 135 | 18.9 | 970 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Part 1 (OLE): Etrolizumab than on Part 2 (PML SM) | 3.68 | 3.28 | 4.2 | from the risk difference interval |
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 | Part 1 (OLE): Etrolizumab | Participants received etrolizumab 105 mg, SC, Q4W for a maximum of 320 weeks followed by a 12-week safety follow-up. | 206 | 751 | EG000 |
| Group 2 | Part 2 (PML SM) | Participants from Part 1 (OLE) and from the study GA29144 who were not eligible/did not wish to enroll in Part 1 (OLE) and had completed the 12-week safety follow-up period were enrolled in Part 2 (PML SM). Participants were monitored for PML for a maximum of 92-weeks, during which no etrolizumab treatment was administered. | 1 | 359 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or in study GA29144 up to a maximum of 92-weeks
Source ClinicalTrials.gov
Trial
- Title
- Open-Label Extension and Safety Study for Participants With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144
- NCT number
- NCT02403323
- Phases
- PHASE3
- Conditions
- Crohn Disease
- Interventions
- Etrolizumab
- Lead sponsor
- Hoffmann-La Roche
- Results first posted
- 2024-12-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02403323?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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