Comparison · NCT00928707-sae
GIVINOSTAT + MTD Hydroxyurea_1 vs GIVINOSTAT + MTD Hydroxyurea_2: 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. GIVINOSTAT + MTD Hydroxyurea_1 vs GIVINOSTAT + MTD Hydroxyurea_2: serious adverse events. Trial comparisons, record NCT00928707-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00928707-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 | 0.0909 | 0.0253 | 0.278 | wilson | |
| Risk in group 2 | 0.0455 | 0.00807 | 0.218 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0455 | -0.139 | 0.236 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2 | 0.195 | 20.5 | log | |
| Odds ratio, group 1 over group 2 | 2.1 | 0.176 | 25 | log | |
| Number needed to harm, for one more participant with a serious adverse event on GIVINOSTAT + MTD Hydroxyurea_1 than on GIVINOSTAT + MTD Hydroxyurea_2 | 22 | 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 | GIVINOSTAT + MTD Hydroxyurea_1 | 50 mg o.d. of GIVINOSTAT + MTD of HU monotherapy~GIVINOSTAT (ITF2357) 50 mg o.d. + MTD Hydroxyurea: 50 mg o.d. of GIVINOSTAT + MTD of HU monotherapy | 2 | 22 | EG000 |
| Group 2 | GIVINOSTAT + MTD Hydroxyurea_2 | 50 mg b.i.d. of GIVINOSTAT + MTD of HU monotherapy~GIVINOSTAT (ITF2357) 50 mg b.i.d. + MTD Hydroxyurea: 50 mg b.i.d. of GIVINOSTAT + MTD HU monotherapy | 1 | 22 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events (AEs) were recorded at weeks 1 ,3, 6, 9, 12, 16, 20 or end of treatment visit (week 24 or 7 days after last drug intake)
Source ClinicalTrials.gov
Trial
- Title
- Phase II Study of GIVINOSTAT (ITF2357) in Combination With Hydroxyurea in Polycythemia Vera
- NCT number
- NCT00928707
- Phases
- PHASE2
- Conditions
- Polycythemia Vera
- Interventions
- GIVINOSTAT (ITF2357) 50 mg o.d. + MTD Hydroxyurea, GIVINOSTAT (ITF2357) 50 mg b.i.d. + MTD Hydroxyurea
- Lead sponsor
- Italfarmaco
- Results first posted
- 2019-10-31
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00928707?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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