Comparison · NCT01515787-sae
Group 1 vs Group 2: 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. Group 1 vs Group 2: serious adverse events. Trial comparisons, record NCT01515787-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01515787-sae
On this page
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 | 0.0171 | 0.00931 | 0.0312 | wilson | |
| Risk in group 2 | 0.0129 | 0.00626 | 0.0264 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0042 | -0.0114 | 0.0198 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.33 | 0.508 | 3.46 | log | |
| Odds ratio, group 1 over group 2 | 1.33 | 0.503 | 3.52 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Group 1 than on Group 2 | 238 | 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 | Group 1 | 5 FUCMT (chemoradiation): 5-fluorouracil 225 mg/m\^2 per day continuous IV infusion administered concurrently with radiation therapy for 5 or 7 days per week OR capecitabine 825 mg/m\^2 twice daily administered orally and concurrently with radiation therapy for 5 days per week. | 10 | 585 | EG000 |
| Group 2 | Group 2 | surgery: low anterior resection with total mesorectal excision | 7 | 543 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 5 years
Source ClinicalTrials.gov
Trial
- Title
- PROSPECT: Chemotherapy Alone or Chemotherapy Plus Radiation Therapy in Treating Patients With Locally Advanced Rectal Cancer Undergoing Surgery
- NCT number
- NCT01515787
- Phases
- PHASE2, PHASE3
- Conditions
- Colorectal Cancer
- Interventions
- FOLFOX (chemotherapy), 5 FUCMT (chemoradiation), surgery, magnetic resonance imaging or endorectal ultrasound
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Results first posted
- 2024-02-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01515787?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT01515787-sae