Comparison · NCT02698475-sae
Ustekinumab Standard Dosage (Main Study) vs Ustekinumab Standard Dosage (Long-Term Extension [LTE]): serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Ustekinumab Standard Dosage (Main Study) vs Ustekinumab Standard Dosage (Long-Term Extension [LTE]): serious adverse events. Trial comparisons, record NCT02698475-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02698475-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 | 0.0682 | 0.0235 | 0.182 | wilson | |
| Risk in group 2 | 0.0357 | 0.00633 | 0.177 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0325 | -0.116 | 0.15 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.91 | 0.209 | 17.5 | log | |
| Odds ratio, group 1 over group 2 | 1.98 | 0.195 | 20 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Ustekinumab Standard Dosage (Main Study) than on Ustekinumab Standard Dosage (Long-Term Extension [LTE]) | 30.8 | 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 | Ustekinumab Standard Dosage (Main Study) | Participants received ustekinumab standard weight-based dose at Weeks 0 and 4 followed by every 12 weeks (q12w) dosing up to Week 40. Ustekinumab was administered as subcutaneous (SC) injections of 0.75 milligrams per kilogram (mg/kg) for participants with weight less than (\<) 60 kilograms (kg), 45 mg for participants with weight greater than or equal to (\>=) 60 kg to less than or equal to (\<=) 100 kg, and 90 mg for participants with weight \> 100 kg. Participants had a safety follow-up till Week 56. | 3 | 44 | EG000 |
| Group 2 | Ustekinumab Standard Dosage (Long-Term Extension [LTE]) | Participants who had a beneficial response from ustekinumab treatment continued receiving ustekinumab weight based dose in a every 12 weeks (q12w) regimen from Week 56 onwards until commercially available or marketing authorization being denied or up to Week 264. Ustekinumab was administered as SC injections of 0.75 mg/kg for participants with weight \<60 kg, 45 mg for participants with weight \>=60 kg to \<=100 kg, and 90 mg for participants with weight \>100 kg. | 1 | 28 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to Week 264
Source ClinicalTrials.gov
Trial
- Title
An Efficacy, Safety, and Pharmacokinetics Study of Subcutaneously Administered Ustekinumab in the Treatment of Moderate to Severe Chronic Plaque Psoriasis in Pediatric Participants Greater Than or Equal to 6 to Less Than 12 Years of Age
- NCT number
- NCT02698475
- Phases
- PHASE3
- Conditions
- Psoriasis
- Interventions
- Ustekinumab 0.75 mg/kg, Ustekinumab 45 mg, Ustekinumab 90 mg
- Lead sponsor
- Janssen Research & Development, LLC
- Results first posted
- 2020-08-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02698475?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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