Comparison · NCT00682786-sae
Good Risk (Thymidylate Synthase (TYMS)*2/*2, *2/*3, *2/*4) vs Poor Risk (Thymidylate Synthase (TYMS)*3/*3, *3/*4): 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. Good Risk (Thymidylate Synthase (TYMS)*2/*2, *2/*3, *2/*4) vs Poor Risk (Thymidylate Synthase (TYMS)*3/*3, *3/*4): serious adverse events. Trial comparisons, record NCT00682786-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00682786-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 | 0.167 | 0.105 | 0.254 | wilson | |
| Risk in group 2 | 0.343 | 0.208 | 0.508 | wilson | |
| Risk difference, group 1 minus group 2 | -0.176 | -0.353 | -0.0159 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.486 | 0.256 | 0.923 | log | |
| Odds ratio, group 1 over group 2 | 0.383 | 0.159 | 0.925 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Good Risk (Thymidylate Synthase (TYMS)*2/*2, *2/*3, *2/*4) than on Poor Risk (Thymidylate Synthase (TYMS)*3/*3, *3/*4) | 5.68 | 2.83 | 62.7 | from the risk difference interval |
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 | Good Risk (Thymidylate Synthase (TYMS)*2/*2, *2/*3, *2/*4) | Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable. | 16 | 96 | EG000 |
| Group 2 | Poor Risk (Thymidylate Synthase (TYMS)*3/*3, *3/*4) | Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable. | 12 | 35 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Beginning of treatment through 30 days after the end of surgery.
Source ClinicalTrials.gov
Trial
- Title
- Genotype-directed Neoadjuvant Chemoradiation for Rectal Carcinoma
- NCT number
- NCT00682786
- Phases
- PHASE2
- Conditions
- Rectal Carcinoma
- Interventions
- 5FU, Radiation, Surgery of resectable lesions, Irinotecan
- Lead sponsor
- Washington University School of Medicine
- Results first posted
- 2014-09-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00682786?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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