Comparison · NCT00316888-sae
Arm I (Closed to Accrual as of 11/3/2008) vs Arm II (Open to Accrual on 8/18/2009): 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 (Closed to Accrual as of 11/3/2008) vs Arm II (Open to Accrual on 8/18/2009): serious adverse events. Trial comparisons, record NCT00316888-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00316888-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 | 0.929 | 0.774 | 0.98 | wilson | |
| Risk in group 2 | 0.853 | 0.699 | 0.936 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0756 | -0.1 | 0.238 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.09 | 0.915 | 1.29 | log | |
| Odds ratio, group 1 over group 2 | 2.24 | 0.4 | 12.6 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Arm I (Closed to Accrual as of 11/3/2008) than on Arm II (Open to Accrual on 8/18/2009) | 13.2 | 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 (Closed to Accrual as of 11/3/2008) | Patients receive cisplatin IV over 60 minutes on days 1, 29, 57, and 85 and fluorouracil IV continuously over 96 hours on days 1-4, 29-32, 57-60, and 85-88. Patients also receive cetuximab IV over 120 minutes on day 50 and then IV over 60 minutes on days 57, 64, 71, 78, 85, 92, and 99 and undergo radiotherapy once daily 5 days a week for 5 weeks, beginning on day 57. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks | 26 | 28 | EG000 |
| Group 2 | Arm II (Open to Accrual on 8/18/2009) | Patients receive cetuximab IV over 120 minutes on day 1 and then IV over 60 minutes on days 8, 15, 22, 29, 36, 43, and 50. Patients also receive cisplatin IV over 60 minutes on days 1 and 36, fluorouracil IV continuously over 96 hours on days 8-11 and 36-39, and undergo radiotherapy once daily 5 days a week for 5 weeks beginning on day 8. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks | 29 | 34 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse events were assessed every cycle (1 cycle=28 days) while on treatment and for 30 days after the end of treatment. After discontinuation of treatment, severe (Grade ≥ 3) long term toxicity that had not been previously reported were collected via the Long term follow-up form using the following schedule: every 3 months within 2 years of registration, then every 6 months in years 2-5, annually afterward until year 10.
Source ClinicalTrials.gov
Trial
- Title
- Cetuximab, Cisplatin, Fluorouracil, and Radiation Therapy in Treating Patients With Anal Cancer
- NCT number
- NCT00316888
- Phases
- PHASE2
- Conditions
- Anal Cancer
- Interventions
- cetuximab, cisplatin, fluorouracil, radiotherapy
- Lead sponsor
- ECOG-ACRIN Cancer Research Group
- Results first posted
- 2016-08-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00316888?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/NCT00316888-sae