Comparison · NCT02450331-sae
OBSERVATION vs ATEZOLIZUMAB: 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. OBSERVATION vs ATEZOLIZUMAB: serious adverse events. Trial comparisons, record NCT02450331-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02450331-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 | 0.181 | 0.146 | 0.222 | wilson | |
| Risk in group 2 | 0.313 | 0.269 | 0.36 | wilson | |
| Risk difference, group 1 minus group 2 | -0.132 | -0.191 | -0.0719 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.578 | 0.448 | 0.747 | log | |
| Odds ratio, group 1 over group 2 | 0.485 | 0.348 | 0.677 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on OBSERVATION than on ATEZOLIZUMAB | 7.58 | 5.24 | 13.9 | 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 | OBSERVATION | Participants underwent observation starting on Day 1 for 16 cycles (up to 1 year). | 72 | 398 | EG000 |
| Group 2 | ATEZOLIZUMAB | Participants received intravenous (IV) atezolizumab on Day 1 of each 21-day cycle for 16 cycles (up to 1 year). | 122 | 390 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months)
Source ClinicalTrials.gov
Trial
- Title
- A Study of Atezolizumab Versus Observation as Adjuvant Therapy in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (UC) After Surgical Resection
- NCT number
- NCT02450331
- Phases
- PHASE3
- Conditions
- Carcinoma, Transitional Cell
- Interventions
- Atezolizumab
- Lead sponsor
- Hoffmann-La Roche
- Results first posted
- 2020-11-18
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02450331?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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