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Comparison · NCT02698475-deaths

Ustekinumab Standard Dosage (Main Study) vs Ustekinumab Standard Dosage (Long-Term Extension [LTE]): deaths from any cause

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]): deaths from any cause. Trial comparisons, record NCT02698475-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02698475-deaths

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 1000.0803wilson
Risk in group 200.00000000000000001390.121wilson
Risk difference, group 1 minus group 20-0.1210.0803newcombe hybrid score
Risk ratio, group 1 over group 2loga group has no participants with the outcome
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to harmfrom the risk difference intervalthe two groups' risks are equal

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Ustekinumab 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.
044EG000
Group 2Ustekinumab 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.
028EG001

Harm

What it counts
Total, all-cause mortality
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

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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