Comparison · NCT01387815-sae
Topical/Traditional vs Adalimumab: 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. Topical/Traditional vs Adalimumab: serious adverse events. Trial comparisons, record NCT01387815-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01387815-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 | 0.00606 | 0.00166 | 0.0218 | wilson | |
| Risk in group 2 | 0.0701 | 0.0472 | 0.103 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0641 | -0.0973 | -0.0362 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.0864 | 0.0205 | 0.364 | log | |
| Odds ratio, group 1 over group 2 | 0.0809 | 0.0189 | 0.346 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Topical/Traditional than on Adalimumab | 15.6 | 10.3 | 27.6 | 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 | Topical/Traditional | Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents. | 2 | 330 | EG000 |
| Group 2 | Adalimumab | Participants treated with adalimumab alone or in combination with topical agents. | 23 | 328 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment.
Source ClinicalTrials.gov
Trial
- Title
- Canadian Humira Post Marketing Observational Epidemiological Study: Assessing Effectiveness in Psoriasis
- NCT number
- NCT01387815
- Phases
- Conditions
- Psoriasis
- Interventions
- Adalimumab
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Results first posted
- 2019-12-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01387815?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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