Comparison · NCT02851797-sae
Givinostat vs Placebo: 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 vs Placebo: serious adverse events. Trial comparisons, record NCT02851797-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02851797-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 | 0.0678 | 0.0348 | 0.128 | wilson | |
| Risk in group 2 | 0.0328 | 0.00904 | 0.112 | wilson | |
| Risk difference, group 1 minus group 2 | 0.035 | -0.0507 | 0.0998 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.07 | 0.453 | 9.44 | log | |
| Odds ratio, group 1 over group 2 | 2.15 | 0.441 | 10.4 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Givinostat than on Placebo | 28.6 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Givinostat | Givinostat oral suspension (10 mg/mL) twice daily~givinostat: The oral suspension of givinostat (10 mg/mL) was to be dosed in fed condition as described below: Givinostat or placebo starting dose~* \> or =10 and \< 12.5 kg of weight: 13.3 mg bid = 1.3 ml oral suspension bid~* \> or =12.5 and \< 20 kg: 16.7 mg bid =1.7 ml oral suspension bid~* \> or = 20 and \< 25 kg: 20 mg bid = 2.0 ml oral suspension bid~* \> or = 25 and \< 30 kg: 23.3 mg bid = 2.3 ml oral suspension bid~* \> or = 30 and \< 40 kg: 26.7 mg bid = 2.7 ml oral suspension bid~* \> or = 40 and \< 50 kg: 33.3 mg bid = 3.3 ml oral suspension bid~* \> or = 50 and \< 60 kg: 36.7 mg bid = 3.7 ml oral suspension bid~* \> or = 60 and \< 70 kg: 40 mg bid = 4 ml oral suspension bid~* \> or = 70 kg: 46.7 mg bid = 4.7 ml oral suspension bid | 8 | 118 | EG000 |
| Group 2 | Placebo | Placebo oral suspension (10 mg/mL) twice daily~placebo: the oral suspension of placebo, manufactured to mimic givinostat, was to be dosed in fed condition as described for givinostat. | 2 | 61 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Throughout the study till the end of study (month 18, visit 15). More precisely at Visits 4 and 7 (month 1), at Visit 9 (month 2), at Visit 10 (month 3), at Visit 11 (month 6), at Visit 12 (month 9), at Visit 13 (month 12), at Visit 14 (month 15), at Visit 15 (EOS, month 18) and at the FUV (Follow-Up Visit to be performed after 4 weeks from the last dose of study drug (ie, 4 weeks ± 7 days)).
Source ClinicalTrials.gov
Trial
- Title
- Clinical Study to Evaluate the Efficacy and Safety of Givinostat in Ambulant Patients With Duchenne Muscular Dystrophy
- NCT number
- NCT02851797
- Phases
- PHASE3
- Conditions
- Duchenne Muscular Dystrophy
- Interventions
- givinostat, placebo
- Lead sponsor
- Italfarmaco
- Results first posted
- 2023-02-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02851797?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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