Comparison · NCT02907359-sae
Guadecitabine vs Treatment Choice: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Guadecitabine vs Treatment Choice: serious adverse events. Trial comparisons, record NCT02907359-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02907359-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 | 0.8 | 0.748 | 0.843 | wilson | |
| Risk in group 2 | 0.533 | 0.445 | 0.619 | wilson | |
| Risk difference, group 1 minus group 2 | 0.267 | 0.167 | 0.365 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.5 | 1.26 | 1.79 | log | |
| Odds ratio, group 1 over group 2 | 3.51 | 2.21 | 5.58 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Guadecitabine than on Treatment Choice | 3.74 | 2.74 | 6 | 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 | Guadecitabine | Participants received Guadecitabine 60 mg/m\^2, SC, on Days 1-5 of each 28-day cycle for at least 6 cycles in the absence of unacceptable toxicity or disease progression requiring alternative therapy. Participants received Guadecitabine treatment beyond 6 cycles as long as the participant continued to benefit based on investigator judgment and participant response and tolerability (or up to a maximum of 36 cycles). | 216 | 270 | EG000 |
| Group 2 | Treatment Choice | Participants received one of the three treatment choice options:~1. LDAC 20 mg/m\^2 SC/IV once daily for 14 days of each 28-day cycles for at least 4 cycles in absence of disease progression or unacceptable toxicity.Participants who were responding or had stable disease were to continue treatment as per standard institutional practice.~2. Standard IC of a 7+3 regimen:Cytarabine 100-200 mg/m\^2/day given as continuous infusion for 7 days and anthracycline(daunorubicin(45-60 mg)/idarubicin(9-12 mg)/mitoxantrone(8-12 mg)/m\^2) by IV infusion for 3 days of each 28-day cycles.~3. BSC as needed during the treatment included,but was not limited to,blood transfusions(RBCs or platelets),growth factors including erythropoiesis stimulating agents,granulocyte stimulating factors,iron chelating therapy,and broad-spectrum antibiotics and/or antifungals.~Duration for treatment choice was as per locally approved prescribing information and institutional standard practice or up to a maximum 30 cycles. | 65 | 122 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From first dose through end of study (up to approximately 46.6 months)
Source ClinicalTrials.gov
Trial
- Title
- Guadecitabine (SGI-110) vs Treatment Choice in Adults With MDS or CMML Previously Treated With HMAs
- NCT number
- NCT02907359
- Phases
- PHASE3
- Conditions
- Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic
- Interventions
- Guadecitabine, Treatment Choice
- Lead sponsor
- Astex Pharmaceuticals, Inc.
- Results first posted
- 2023-05-18
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02907359?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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