Comparison · NCT00033371-sae
Arm I: Celecoxib and Placebo vs Arm II: Celecoxib and Eflornithine: 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: Celecoxib and Placebo vs Arm II: Celecoxib and Eflornithine: serious adverse events. Trial comparisons, record NCT00033371-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00033371-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 | 0 | 0.0653 | wilson | |
| Risk in group 2 | 0.0526 | 0.0181 | 0.144 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0526 | -0.144 | 0.0212 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one fewer participant with a serious adverse event on Arm I: Celecoxib and Placebo than on Arm II: Celecoxib and Eflornithine | 19 | 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: Celecoxib and Placebo | Celecoxib 400 mg orally twice daily (PO BID) and Placebo once a day. Treatment continues for 6 months (up to 200 days). | 0 | 55 | EG000 |
| Group 2 | Arm II: Celecoxib and Eflornithine | Celecoxib 400 mg PO BID and Eflornithine PO daily 0.5 g/m\^2/day rounded down to the nearest 250 mg dose (body surface area (BSA) of \< 1.4 = 500 mg/day; BSA of 1.5 - 2.0 = 750 mg/day; BSA of 2.1 - 2.5 = 1000 mg/day; BSA of \> 2.6 = 1,250 mg/day). Treatment continues for 6 months (up to 200 days). | 3 | 57 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported.
Source ClinicalTrials.gov
Trial
- Title
- Celecoxib With or Without Eflornithine in Preventing Colorectal Cancer in Patients With Familial Adenomatous Polyposis
- NCT number
- NCT00033371
- Phases
- PHASE2
- Conditions
- Colorectal Cancer, Familial Adenomatous Polyposis
- Interventions
- Celecoxib, Placebo, eflornithine, Laboratory biomarker analysis, Questionnaire administration
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2015-02-04
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00033371?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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