Comparison · NCT00120523-sae
Pimecrolimus vs Topical Corticosteroids: 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. Pimecrolimus vs Topical Corticosteroids: serious adverse events. Trial comparisons, record NCT00120523-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00120523-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 | 0.205 | 0.183 | 0.229 | wilson | |
| Risk in group 2 | 0.173 | 0.153 | 0.195 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0319 | 0.000632 | 0.063 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.18 | 1 | 1.4 | log | |
| Odds ratio, group 1 over group 2 | 1.23 | 1 | 1.51 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Pimecrolimus than on Topical Corticosteroids | 31.4 | 15.9 | 1,580 | from the risk difference interval |
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 | Pimecrolimus | 1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver | 247 | 1,205 | EG000 |
| Group 2 | Topical Corticosteroids | Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g.~Fluticasone propionate)TCS supplied locally were to be used according to the country's label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently. | 210 | 1,213 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse event data were collected throughout the study period of 5 years.
Source ClinicalTrials.gov
Trial
- Title
- 5-Year Safety Study of Pimecrolimus Cream 1% in Infants 3 - 12 Months of Age With Mild to Moderate Atopic Dermatitis
- NCT number
- NCT00120523
- Phases
- PHASE3
- Conditions
- Atopic Dermatitis
- Interventions
- Pimecrolimus, Topical corticosteroids
- Lead sponsor
- MEDA Pharma GmbH & Co. KG
- Results first posted
- 2013-01-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00120523?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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