Comparison · NCT03238235-ef5cc6e4
Givinostat vs Placebo: Percentage of Patients With < 10% Worsening in 6MWT After 12 Months of Treatment.
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. Givinostat vs Placebo: Percentage of Patients With < 10% Worsening in 6MWT After 12 Months of Treatment. Trial comparisons, record NCT03238235-ef5cc6e4. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03238235-ef5cc6e4
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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 | 0.206 | 0.103 | 0.368 | wilson | |
| Risk in group 2 | 0.0588 | 0.0105 | 0.27 | wilson | |
| Risk difference, group 1 minus group 2 | 0.147 | -0.0875 | 0.316 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3.5 | 0.468 | 26.2 | log | |
| Odds ratio, group 1 over group 2 | 4.15 | 0.467 | 36.9 | log | |
| Number needed to treat, for one more participant with the outcome on Givinostat than on Placebo | 6.8 | 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 in a fed state~Givinostat: suspension of Givinostat (10 mg/mL) | 7 | 34 | OG000 |
| Group 2 | Placebo | Placebo oral suspension (10 mg/mL) twice daily in a fed state~Placebo: suspension manufactured to mimic Givinostat | 1 | 17 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Percentage of Patients With < 10% Worsening in 6MWT After 12 Months of Treatment.
- Description
- Percentage of patients with \< 10% worsening in 6-Minute Walking Test after 12 months of treatment with Givinostat comparing to placebo patients.
- Time frame
- after 12 months of treatment (Visit 11)
- Population
Intent-To-Treat Analysis (ITT) Set: all patients assigned treatment by randomization who received at least one dose of study medication. According to the intent to treat principle, patients were analyzed according to the treatment assigned. Patients with missing data such that \<10% worsening cannot be determined are included in the analysis as having worsened
Source ClinicalTrials.gov
Trial
- Title
- Clinical Study to Evaluate the Efficacy and Safety of Givinostat in Ambulant Patients With Becker Muscular Dystrophy
- NCT number
- NCT03238235
- Phases
- PHASE2
- Conditions
- Becker Muscular Dystrophy
- Interventions
- Givinostat, Placebo
- Lead sponsor
- Italfarmaco
- Results first posted
- 2024-11-18
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03238235?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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