Comparison · NCT02384460-sae
SD-101-6.0 Cream vs Placebo (SD-101-0.0) Cream: 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. SD-101-6.0 Cream vs Placebo (SD-101-0.0) Cream: serious adverse events. Trial comparisons, record NCT02384460-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02384460-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 | 0.0191 | 0.119 | wilson | |
| Risk in group 2 | 0.092 | 0.0473 | 0.171 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0432 | -0.128 | 0.0399 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.53 | 0.166 | 1.7 | log | |
| Odds ratio, group 1 over group 2 | 0.506 | 0.146 | 1.75 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on SD-101-6.0 Cream than on Placebo (SD-101-0.0) Cream | 23.2 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | SD-101-6.0 Cream | SD-101-6.0 cream applied topically, once a day to the entire body for a period of 90 days. | 4 | 82 | EG000 |
| Group 2 | Placebo (SD-101-0.0) Cream | Placebo (SD-101-0.0) cream applied topically, once a day to the entire body for a period of 90 days. | 8 | 87 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From baseline up to 3 months.
Source ClinicalTrials.gov
Trial
- Title
- ESSENCE Study: Efficacy and Safety of SD-101 Cream in Participants With Epidermolysis Bullosa
- NCT number
- NCT02384460
- Phases
- PHASE3
- Conditions
- Epidermolysis Bullosa
- Interventions
- SD-101-6.0 cream, Placebo (SD-101-0.0) cream
- Lead sponsor
- Scioderm, Inc.
- Results first posted
- 2018-10-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02384460?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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