Comparison · NCT04220021-sae
Enrolled Subjects vs Study Completers: 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. Enrolled Subjects vs Study Completers: serious adverse events. Trial comparisons, record NCT04220021-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04220021-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 | 0.0488 | 0.0135 | 0.161 | wilson | |
| Risk in group 2 | 0 | 0 | 0.143 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0488 | -0.0986 | 0.161 | 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 harm, for one more participant with a serious adverse event on Enrolled Subjects than on Study Completers | 20.5 | 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 | Enrolled Subjects | Subjects consented to participate in the study | 2 | 41 | EG000 |
| Group 2 | Study Completers | Study participants were defined as having Completed the study if they started the study medication and completed the ALSFRS-R evaluation at baseline and 24 weeks. | 0 | 23 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From enrollment up to 24 weeks of treatment.
Source ClinicalTrials.gov
Trial
- Title
- Safety and Therapeutic Potential of the FDA-approved Drug Metformin for C9orf72 ALS/FTD
- NCT number
- NCT04220021
- Phases
- PHASE2
- Conditions
- C9orf72 Amyotrophic Lateral Sclerosis (ALS), Frontotemporal Dementia
- Interventions
- Metformin
- Lead sponsor
- University of Florida
- Results first posted
- 2025-12-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04220021?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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GET https://conductscience.org/api/comparisons/v1/NCT04220021-sae