Comparison · NCT01355068-sae
Epanutin Infatabs 50 mg vs Dilantin Infatabs 50 mg: 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. Epanutin Infatabs 50 mg vs Dilantin Infatabs 50 mg: serious adverse events. Trial comparisons, record NCT01355068-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01355068-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 | 0.0000000000000000139 | 0.138 | wilson | |
| Risk in group 2 | 0 | 0 | 0.129 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.129 | 0.138 | 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 | from the risk difference interval | the two groups' risks are equal |
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 | Epanutin Infatabs 50 mg | Single oral dose of Epanutin (phenytoin) infatabs 50 mg chewable tablet (Reference) in either first intervention period or second intervention period. | 0 | 24 | EG000 |
| Group 2 | Dilantin Infatabs 50 mg | Single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet (Test) in either first intervention period or second intervention period. | 0 | 26 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- A Study to Assess if Epanutin Infatabs 50 mg From Germany Are Similar to Dilantin Infatabs 50 mg From Australia
- NCT number
- NCT01355068
- Phases
- PHASE1
- Conditions
- Healthy
- Interventions
- Epanutin Infatabs (Phenytoin), Dilantin Infatabs (Phenytoin)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Results first posted
- 2011-12-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01355068?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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