Comparison · NCT03715153-0e5cddd6
BUMETANIDE (S95008) vs PLACEBO: Number of Patients With Abnormalities in 12-leads Electrocardiogram (ECG) Parameters
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. BUMETANIDE (S95008) vs PLACEBO: Number of Patients With Abnormalities in 12-leads Electrocardiogram (ECG) Parameters. Trial comparisons, record NCT03715153-0e5cddd6. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03715153-0e5cddd6
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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 | 0 | 0.0469 | wilson | |
| Risk in group 2 | 0 | 0 | 0.0475 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.0475 | 0.0469 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | BUMETANIDE (S95008) | BUMETANIDE/S95008: Oral solution dosed at 0.5 mg/mL Taken twice daily. | 0 | 78 | OG000 |
| Group 2 | PLACEBO | PLACEBO: Oral solution Taken twice daily. | 0 | 77 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Patients With Abnormalities in 12-leads Electrocardiogram (ECG) Parameters
- Description
Number of patients with clinically significant ECG abnormalities~The 12-lead electrocardiogram (ECG) is a medical test that is recorded using leads, or nodes, attached to the body. Electrocardiograms (ECGs), capture the electrical activity of the heart and transfer it to graphed paper where abnormalities are reported and interpretated by the cardiologist.
- Time frame
- Week 26
- Population
- As this measure was collected through week 26, only data gathered during the double-blind period for arms Bumetanide and Placebo were collected.
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety of Bumetanide Oral Liquid Formulation in Children Aged From 2 to Less Than 7 Years Old With Autism Spectrum Disorder.
- NCT number
- NCT03715153
- Phases
- PHASE3
- Conditions
- Autism Spectrum Disorder (ASD)
- Interventions
- BUMETANIDE (S95008) for week 0 - 26, PLACEBO for week 0 - 26, Open-Label BUMETANIDE (S95008) for weeks 26 - 52
- Lead sponsor
- Institut de Recherches Internationales Servier
- Results first posted
- 2023-06-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03715153?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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