Comparison · NCT00461591-sae
Apaziquone vs Placebo: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Apaziquone vs Placebo: serious adverse events. Trial comparisons, record NCT00461591-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00461591-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 | 0.229 | 0.191 | 0.272 | wilson | |
| Risk in group 2 | 0.247 | 0.208 | 0.292 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0184 | -0.0773 | 0.0405 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.926 | 0.723 | 1.19 | log | |
| Odds ratio, group 1 over group 2 | 0.904 | 0.653 | 1.25 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Apaziquone than on Placebo | 54.3 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Apaziquone | Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT | 93 | 406 | EG000 |
| Group 2 | Placebo | Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT | 98 | 396 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Treatment-emergent Adverse Events (ie, AEs that occurred or worsened following the TURBT procedure) were recorded from the time of randomization to Month 6; after Month 6 until Month 24 (end of study), only genitourinary AEs and Serious AEs (SAEs) were recorded.
Source ClinicalTrials.gov
Trial
- Title
- Single Dose Intravesical Apaziquone Postoperative in Patients Undergoing TURBT for Noninvasive Bladder Cancer (SPI-611)
- NCT number
- NCT00461591
- Phases
- PHASE3
- Conditions
- Bladder Cancer
- Interventions
- Apaziquone, Placebo, TURBT
- Lead sponsor
- Spectrum Pharmaceuticals, Inc
- Results first posted
- 2017-08-15
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00461591?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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