Comparison · NCT00103311-sae
Arm I vs Arm 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 I vs Arm II: serious adverse events. Trial comparisons, record NCT00103311-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00103311-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 | 0.424 | 0.272 | 0.592 | wilson | |
| Risk in group 2 | 0.419 | 0.264 | 0.592 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00489 | -0.225 | 0.233 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.01 | 0.57 | 1.8 | log | |
| Odds ratio, group 1 over group 2 | 1.02 | 0.378 | 2.75 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Arm I than on Arm II | 205 | 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 I | Patients receive SB-715992 IV at 7 mg/m2 over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies | 14 | 33 | EG000 |
| Group 2 | Arm II | Patients receive SB-715992 IV at 18 mg/m2 over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies | 13 | 31 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events were over a period of 4 years.
Source ClinicalTrials.gov
Trial
- Title
- SB-715992 in Treating Patients With Advanced or Metastatic Colorectal Cancer
- NCT number
- NCT00103311
- Phases
- PHASE2
- Conditions
Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage IIIA Colon Cancer, Stage IIIA Rectal Cancer, Stage IIIB Colon Cancer, Stage IIIB Rectal Cancer, Stage IIIC Colon Cancer, Stage IIIC Rectal Cancer, Stage IVA Colon Cancer, Stage IVA Rectal Cancer, Stage IVB Colon Cancer, Stage IVB Rectal Cancer
- Interventions
- ispinesib, laboratory biomarker analysis
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2015-03-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00103311?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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