Comparison · NCT03179891-sae
Interictal State (Period A) vs Ictal/Peri-ictal State (Period B): 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. Interictal State (Period A) vs Ictal/Peri-ictal State (Period B): serious adverse events. Trial comparisons, record NCT03179891-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03179891-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 | 0 | 0.104 | wilson | |
| Risk in group 2 | 0.0303 | 0.00537 | 0.153 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0303 | -0.153 | 0.0769 | 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, for one fewer participant with a serious adverse event on Interictal State (Period A) than on Ictal/Peri-ictal State (Period B) | 33 | 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 | Interictal State (Period A) | Single 12.5-mg dose of Diazepam Buccal Film administered during the interictal state.~Adult subjects with epilepsy | 0 | 33 | EG000 |
| Group 2 | Ictal/Peri-ictal State (Period B) | Single 12.5-mg dose of Diazepam Buccal Film administered during the ictal/peri-ictal state.~Adult subjects with epilepsy | 1 | 33 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse events were collected throughout the course of the study for each subject (approximately 1 month for each subject - beginning with the first DBF dose until 14 ± 2 days following the second DBF dose).
Source ClinicalTrials.gov
Trial
- Title
- Study of Diazepam Buccal Film Administered in the Interictal and in the Ictal-Periictal States to Adults With Epilepsy
- NCT number
- NCT03179891
- Phases
- PHASE2
- Conditions
- Epilepsy
- Interventions
- Diazepam Buccal Film 12.5 mg
- Lead sponsor
- Aquestive Therapeutics
- Results first posted
- 2020-09-18
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03179891?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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