Comparison · NCT01757535-sae
Oral Azacitidine Plus Best Supportive Care vs Placebo Plus Best Supportive Care: 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. Oral Azacitidine Plus Best Supportive Care vs Placebo Plus Best Supportive Care: serious adverse events. Trial comparisons, record NCT01757535-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01757535-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 | 0.466 | 0.404 | 0.53 | wilson | |
| Risk in group 2 | 0.468 | 0.405 | 0.532 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00171 | -0.0913 | 0.0879 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.996 | 0.821 | 1.21 | log | |
| Odds ratio, group 1 over group 2 | 0.993 | 0.691 | 1.43 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Oral Azacitidine Plus Best Supportive Care than on Placebo Plus Best Supportive Care | 585 | 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 | Oral Azacitidine Plus Best Supportive Care | Participants received 300 mg azacitidine tablets once a day (QD) for the first 14 days of each 28-day treatment cycle until discontinuation, which includes the following reasons: disease relapse, withdrawal of consent, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, death, lost to follow-up, or protocol violation or until the end of the study. | 110 | 236 | EG000 |
| Group 2 | Placebo Plus Best Supportive Care | Participants received identically matching placebo tablets QD for the first 14 days of each 28-day treatment cycle until no longer receiving benefit, withdrawal of consent, disease relapse, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, lost to follow-up, or protocol violation or until the end of the study. | 109 | 233 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From day 1 (randomization) up to data cut off date of 06 August 2024; approximately 135.5 months
Source ClinicalTrials.gov
Trial
- Title
- Efficacy of Oral Azacitidine Plus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia (AML) in Complete Remission
- NCT number
- NCT01757535
- Phases
- PHASE3
- Conditions
- Leukemia, Myeloid, Acute
- Interventions
- Oral Azacitidine, Placebo
- Lead sponsor
- Celgene
- Results first posted
- 2020-11-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01757535?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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