Comparison · NCT02118584-deaths
Part 1 (OLE): Etrolizumab vs Part 2 (PML SM): deaths from any cause
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): deaths from any cause. Trial comparisons, record NCT02118584-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02118584-deaths
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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 | 0.00508 | 0.00267 | 0.00962 | wilson | |
| Risk in group 2 | 0.00126 | 0.000222 | 0.00708 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00382 | -0.00248 | 0.00848 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 4.04 | 0.513 | 31.8 | log | |
| Odds ratio, group 1 over group 2 | 4.06 | 0.513 | 32.1 | log | |
| Number needed to harm, for one more death from any cause on Part 1 (OLE): Etrolizumab than on Part 2 (PML SM) | 262 | 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 | Part 1 (OLE): Etrolizumab | Participants received etrolizumab 105 mg, SC, Q4W for maximum of 369.9 weeks, followed by a 12-week safety follow-up. | 9 | 1,773 | EG000 |
| Group 2 | Part 2 (PML SM) | Participants from Part 1 (OLE) and from Phase II/III studies 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 the Part 2 (PML SM). Participants were monitored for PML for a maximum of 92-weeks, during which no etrolizumab treatment was administered. | 1 | 796 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, all-cause mortality
- Time frame
Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks
Source ClinicalTrials.gov
Trial
- Title
- Study for Participants With Ulcerative Colitis Previously Enrolled in Etrolizumab Phase II/III Studies
- NCT number
- NCT02118584
- Phases
- PHASE3
- Conditions
- Ulcerative Colitis
- Interventions
- Etrolizumab
- Lead sponsor
- Hoffmann-La Roche
- Results first posted
- 2024-10-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02118584?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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