Comparison · NCT01696084-sae
Arm A (CPX-351) vs Arm B (7+3): 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 A (CPX-351) vs Arm B (7+3): serious adverse events. Trial comparisons, record NCT01696084-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01696084-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 | 0.588 | 0.509 | 0.663 | wilson | |
| Risk in group 2 | 0.43 | 0.354 | 0.51 | wilson | |
| Risk difference, group 1 minus group 2 | 0.158 | 0.0454 | 0.265 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.37 | 1.09 | 1.71 | log | |
| Odds ratio, group 1 over group 2 | 1.89 | 1.2 | 2.98 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Arm A (CPX-351) than on Arm B (7+3) | 6.34 | 3.78 | 22 | 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 | Arm A (CPX-351) | Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with CPX-351. The number of inductions and consolidations a subject received depended on response. | 90 | 153 | EG000 |
| Group 2 | Arm B (7+3) | Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7 + 3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received depended on response. | 65 | 151 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Source ClinicalTrials.gov
Trial
- Title
- Phase III Study of CPX-351 Versus 7+3 in Patients 60-75 Years Old With Untreated High Risk (Secondary) Acute Myeloid Leukemia
- NCT number
- NCT01696084
- Phases
- PHASE3
- Conditions
- High Risk Acute Myeloid Leukemia
- Interventions
- CPX-351, 7+3 (cytarabine and daunorubicin)
- Lead sponsor
- Jazz Pharmaceuticals
- Results first posted
- 2017-10-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01696084?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/NCT01696084-sae