Comparison · NCT02891161-sae
Arm Ib: Safety Run In Phase Ib vs Arm II: Investigational Treatment Phase II: 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. Arm Ib: Safety Run In Phase Ib vs Arm II: Investigational Treatment Phase II: serious adverse events. Trial comparisons, record NCT02891161-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02891161-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 | 0.667 | 0.3 | 0.903 | wilson | |
| Risk in group 2 | 0.4 | 0.219 | 0.613 | wilson | |
| Risk difference, group 1 minus group 2 | 0.267 | -0.158 | 0.565 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.67 | 0.764 | 3.64 | log | |
| Odds ratio, group 1 over group 2 | 3 | 0.44 | 20.4 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Arm Ib: Safety Run In Phase Ib than on Arm II: Investigational Treatment Phase II | 3.75 | 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 | Arm Ib: Safety Run In Phase Ib | Subjects will receive durvalumab 1500mg Q4 weekly with RT to gross disease over 36 fractions. Durvalumab will start on Day 1. RT to start on Day 1 or 2. Subjects will receive adjuvant durvalumab monotherapy Q4 week, up to 12 months. Durvalumab monotherapy to start 4 weeks post completion of durvalumab and RT.~durvalumab: 1500 mg Q4 weekly~Radiation Therapy: 64.8 Gy, 36 daily fractions on weekdays over about 7 weeks | 4 | 6 | EG000 |
| Group 2 | Arm II: Investigational Treatment Phase II | Subjects will receive durvalumab 1500mg Q4 weekly with RT to gross disease over 36 fractions. Durvalumab will start on Day 1. RT to start on Day 1 or 2. Subjects will receive adjuvant durvalumab monotherapy Q4 week, up to 12 months. Adjuvant durvalumab monotherapy to start 4 weeks post completion of durvalumab and RT.~durvalumab: 1500 mg Q4 weekly | 8 | 20 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
Source ClinicalTrials.gov
Trial
- Title
- Durvalumab And Radiation Therapy Followed by Adjuvant Durvalumab in Patients With Urothelial Cancer (T2-4 N0-2 M0) of the Bladder
- NCT number
- NCT02891161
- Phases
- PHASE1, PHASE2
- Conditions
- Urothelial Cancer
- Interventions
- durvalumab, Radiation Therapy
- Lead sponsor
- Monika Joshi, MD
- Results first posted
- 2024-11-27
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02891161?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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