Comparison · NCT01780545-sae
Experimental Arm: Arm A vs Control Arm: Arm B: 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. Experimental Arm: Arm A vs Control Arm: Arm B: serious adverse events. Trial comparisons, record NCT01780545-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01780545-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 | 0.566 | 0.467 | 0.659 | wilson | |
| Risk in group 2 | 0.446 | 0.352 | 0.543 | wilson | |
| Risk difference, group 1 minus group 2 | 0.12 | -0.0181 | 0.252 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.27 | 0.962 | 1.68 | log | |
| Odds ratio, group 1 over group 2 | 1.62 | 0.927 | 2.83 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Experimental Arm: Arm A than on Control Arm: Arm B | 8.33 | 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 | Experimental Arm: Arm A | Three doses of 600 mg OGX-427 will be administered IV during the loading dose period (days -9 to -1). Following completion of the loading dose period, 600 mg OGX-427 will be given IV weekly on days 1, 8, and 15 of each 21-day cycle. OGX-427 must be administered prior to docetaxel on day 1 of each cycle.~Following completion of 10 cycles of docetaxel, 600 mg OGX-427 will continue to be administered by IV weekly as maintenance therapy in Arm A participants who do not have disease progression (i.e., stable disease or better). Maintenance with OGX-427 will continue until disease progression or unacceptable toxicity.~Docetaxel: For Arm A Only: Docetaxel should be administered immediately following the completion of the OGX-427 infusion.~For Both Arms: Docetaxel (75 mg/M2) will be administered IV on Day 1 of each 21 day cycle for a maximum of 10 cycles. | 56 | 99 | EG000 |
| Group 2 | Control Arm: Arm B | Docetaxel (75 mg/M2) will be administered IV on day 1 of each 21 day cycle for a maximum of 10 cycles.~Docetaxel: For Arm A Only: Docetaxel should be administered immediately following the completion of the OGX-427 infusion.~For Both Arms: Docetaxel (75 mg/M2) will be administered IV on Day 1 of each 21 day cycle for a maximum of 10 cycles. | 45 | 101 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Duration of study, up to 36 months
Source ClinicalTrials.gov
Trial
- Title
- Phase 2 Study of Docetaxel +/- OGX-427 in Patients With Relapsed or Refractory Metastatic Bladder Cancer
- NCT number
- NCT01780545
- Phases
- PHASE2
- Conditions
- Bladder Cancer, Urothelial Carcinoma
- Interventions
- OGX-427, Docetaxel
- Lead sponsor
- Noah Hahn, M.D.
- Results first posted
- 2017-11-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01780545?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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