Comparison · NCT05372653-sae
0.3% OPA-15406 vs 1% OPA-15406: 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. 0.3% OPA-15406 vs 1% OPA-15406: serious adverse events. Trial comparisons, record NCT05372653-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05372653-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 | 0.0244 | 0.00432 | 0.126 | wilson | |
| Risk in group 2 | 0.0345 | 0.00611 | 0.172 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0101 | -0.149 | 0.0954 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.707 | 0.0461 | 10.9 | log | |
| Odds ratio, group 1 over group 2 | 0.7 | 0.042 | 11.7 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on 0.3% OPA-15406 than on 1% OPA-15406 | 99.1 | 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 | 0.3% OPA-15406 | The 0.3% formulation was topically administered twice daily (approximately 12 hours apart between morning and night administrations) .~In this section, we display the adverse events that occurred at the time of administration of the 0.3% formulation. | 1 | 41 | EG000 |
| Group 2 | 1% OPA-15406 | After 4 weeks of the 0.3% formulation administration, the 1% formulation was administered twice daily in accordance with the prespecified rules for dose increase.~In this section, we display the adverse events that occurred at the time of administration of the 1.0% formulation. | 1 | 29 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
Source ClinicalTrials.gov
Trial
- Title
- A Long-term Trial of OPA-15406 in Infants With Atopic Dermatitis
- NCT number
- NCT05372653
- Phases
- PHASE3
- Conditions
- Atopic Dermatitis (AD)
- Interventions
- OPA-15406
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Results first posted
- 2025-03-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05372653?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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