Comparison · NCT02339740-sae
Standard Risk vs High Risk: 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. Standard Risk vs High Risk: serious adverse events. Trial comparisons, record NCT02339740-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02339740-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 | 0.0297 | 0.0102 | 0.0837 | wilson | |
| Risk in group 2 | 0.0351 | 0.00968 | 0.119 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00538 | -0.0917 | 0.0543 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.847 | 0.146 | 4.92 | log | |
| Odds ratio, group 1 over group 2 | 0.842 | 0.136 | 5.19 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Standard Risk than on High Risk | 186 | 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 | Standard Risk | WBC \<10,000 cells/µL | 3 | 101 | EG000 |
| Group 2 | High Risk | WBC ≥10,000 cells/µL | 2 | 57 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- While patients were on protocol therapy (including up to 6 courses) or during follow-up.
Source ClinicalTrials.gov
Trial
- Title
- Tretinoin and Arsenic Trioxide in Treating Patients With Untreated Acute Promyelocytic Leukemia
- NCT number
- NCT02339740
- Phases
- PHASE3
- Conditions
- Acute Promyelocytic Leukemia With t(15;17)(q24.1;q21.2); PML-RARA
- Interventions
- Arsenic Trioxide, Cytarabine, Dexamethasone, Idarubicin, Laboratory Biomarker Analysis, Mitoxantrone Hydrochloride, Quality-of-Life Assessment, Questionnaire Administration, Tretinoin
- Lead sponsor
- Children's Oncology Group
- Results first posted
- 2021-12-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02339740?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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