Comparison · NCT02348489-sae
SGI-110 (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
Cite this record
ConductScience Library. SGI-110 (Guadecitabine) vs Treatment Choice: serious adverse events. Trial comparisons, record NCT02348489-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02348489-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 | 0.815 | 0.775 | 0.85 | wilson | |
| Risk in group 2 | 0.758 | 0.713 | 0.797 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0578 | 0.00075 | 0.115 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.08 | 1 | 1.16 | log | |
| Odds ratio, group 1 over group 2 | 1.41 | 1 | 1.99 | log | |
| Number needed to harm, for one more participant with a serious adverse event on SGI-110 (Guadecitabine) than on Treatment Choice | 17.3 | 8.73 | 1,330 | 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 | SGI-110 (Guadecitabine) | Guadecitabine 60 mg/m\^2 was administered subcutaneously daily for 5 days (Days 1-5) in 28-day cycles. | 327 | 401 | EG000 |
| Group 2 | Treatment Choice | One of the following treatment regimens were administered: 20 mg cytarabine subcutaneously (SC) BID on Days 1-10 every 28 days; 20 mg/m\^2 decitabine given as a 1-hour intravenous (IV) infusion daily on Days 1-5 every 28 days; or 75 mg/m\^2 azacitidine given IV or SC daily on Days 1-7 every 28 days. | 297 | 392 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Source ClinicalTrials.gov
Trial
- Title
- SGI-110 in Adults With Untreated Acute Myeloid Leukemia (AML), Not Considered Candidates for Intensive Remission Induction
- NCT number
- NCT02348489
- Phases
- PHASE3
- Conditions
- Leukemia, Myeloid, Acute
- Interventions
- SGI-110 (guadecitabine), Treatment Choice
- Lead sponsor
- Astex Pharmaceuticals, Inc.
- Results first posted
- 2021-01-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02348489?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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