Comparison · NCT00986440-sae
CS-7017 0.5 mg 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
Cite this record
ConductScience Library. CS-7017 0.5 mg vs Placebo: serious adverse events. Trial comparisons, record NCT00986440-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00986440-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 | 0.146 | 0.0688 | 0.284 | wilson | |
| Risk in group 2 | 0.119 | 0.0519 | 0.25 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0273 | -0.125 | 0.181 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.23 | 0.407 | 3.72 | log | |
| Odds ratio, group 1 over group 2 | 1.27 | 0.355 | 4.53 | log | |
| Number needed to harm, for one more participant with a serious adverse event on CS-7017 0.5 mg than on Placebo | 36.6 | 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 | CS-7017 0.5 mg | Participants who were randomized to receive two 0.25 mg CS-7017 tablets (i.e. a dose of 0.5 mg) administered by mouth twice daily (PO BID), for a total of four tablets per day. | 6 | 41 | EG000 |
| Group 2 | Placebo | Participants who were randomized to receive matching placebo. | 5 | 42 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 3 years 3 months in the Safety Analysis Set.
Source ClinicalTrials.gov
Trial
- Title
- Study of CS-7017 in Colorectal Cancer Patients Who Have Achieved Disease Control Following First-Line Chemotherapy
- NCT number
- NCT00986440
- Phases
- PHASE2
- Conditions
- Colorectal Cancer
- Interventions
- CS-7017, Placebo
- Lead sponsor
- Daiichi Sankyo
- Results first posted
- 2020-11-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00986440?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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