Comparison · NCT00472849-sae
OFAR (Phase I) vs OFAR MTD (Phase II): 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. OFAR (Phase I) vs OFAR MTD (Phase II): serious adverse events. Trial comparisons, record NCT00472849-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00472849-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 | 0.667 | 0.391 | 0.862 | wilson | |
| Risk in group 2 | 0.192 | 0.12 | 0.293 | wilson | |
| Risk difference, group 1 minus group 2 | 0.474 | 0.18 | 0.682 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3.47 | 1.89 | 6.35 | log | |
| Odds ratio, group 1 over group 2 | 8.4 | 2.23 | 31.6 | log | |
| Number needed to harm, for one more participant with a serious adverse event on OFAR (Phase I) than on OFAR MTD (Phase II) | 2.11 | 1.47 | 5.54 | 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 | OFAR (Phase I) | Oxaliplatin 30 mg/m\^2/day over 2 hours before on days 1-4 Fludarabine. Fludarabine 30 mg/m\^2 daily IV over 30 minutes on days 2-3, 2-4, or 2-5 until maximum tolerated dose reached. Cytarabine 500 mg/m\^2 daily IV, 2-hour infusion starting 4 hours after first fludarabine dose started, on days 2-3, 2-4, or 2-5, until maximum tolerated dose reached. Rituximab 375 mg/m\^2 IV on day 3, course 1 (on day 1, subsequent courses). | 8 | 12 | EG000 |
| Group 2 | OFAR MTD (Phase II) | Oxaliplatin 25 mg/m\^2 IV per day MTD on days 1-4 before Fludarabine. Fludarabine 30 mg/m\^2 daily IV over 30 minutes on days 2-4. Cytarabine 500 mg/m\^2 daily IV, 2-hour infusion starting 4 hours after fludarabine dose started, on days 2-4. Rituximab 375 mg/m\^2 IV on day 3, course 1 (on day 1, subsequent courses). Pegfilgrastim 6 mg subcutaneously once per chemotherapy cycle, approximately 24 hours after last dose of chemotherapy. | 15 | 78 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse event collection from Day 1 of first cycle of therapy through sixth cycle then follow-up (every three to six months following first year) until off study. Enrollment started May 2007 and completion including follow up was January 2011.
Source ClinicalTrials.gov
Trial
- Title
- Oxaliplatin, Fludarabine, Cytarabine, and Rituximab in Patients With Richter's Transformation and Leukemias
- NCT number
- NCT00472849
- Phases
- PHASE1, PHASE2
- Conditions
- Richter's Transformation, Leukemia
- Interventions
- Oxaliplatin, Fludarabine, Cytarabine, Rituximab, Pegfilgrastim
- Lead sponsor
- M.D. Anderson Cancer Center
- Results first posted
- 2013-11-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00472849?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/NCT00472849-sae