Comparison · NCT04003974-2913cf93
Losmapimod 15 Milligrams (mg) Twice Daily (BID) vs Placebo: Number of Participants With Adverse Events of Special Interest (AESIs)
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. Losmapimod 15 Milligrams (mg) Twice Daily (BID) vs Placebo: Number of Participants With Adverse Events of Special Interest (AESIs). Trial comparisons, record NCT04003974-2913cf93. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04003974-2913cf93
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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 | 0.0876 | wilson | |
| Risk in group 2 | 0 | 0 | 0.0876 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.0876 | 0.0876 | 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 | Losmapimod 15 Milligrams (mg) Twice Daily (BID) | Participants were randomized to receive losmapimod tablets 15 mg (2×7.5 mg tablets/dose BID) orally (PO) for 48 weeks | 0 | 40 | OG000 |
| Group 2 | Placebo | Participants were randomized to receive matching placebo tablets PO BID for 48 weeks. | 0 | 40 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Adverse Events of Special Interest (AESIs)
- Description
An AESI (serious or non-serious) is one of scientific and medical concern for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate. Adverse events of special interest for this study included liver tests that met the criteria for potential drug-induced liver injury (DILI), in accordance with the Unites States (US) Food and Drug Administration (FDA) Guidance for Industry-Drug-Induced Liver Injury: Premarketing Clinical Evaluation. Number of participants with AESIs has been presented.
- Time frame
- Up to Week 48
- Population
- Safety Analysis Set
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety of Losmapimod in Subjects With Facioscapulohumeral Muscular Dystrophy (FSHD)
- NCT number
- NCT04003974
- Phases
- PHASE2
- Conditions
- Facioscapulohumeral Muscular Dystrophy (FSHD)
- Interventions
- Losmapimod oral tablet, Placebo oral tablet
- Lead sponsor
- Fulcrum Therapeutics
- Results first posted
- 2024-07-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04003974?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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