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Comparison · NCT01163253-5ad3d302

Tofacitinib 10 mg vs Tofacitinib 5 mg or 10 mg: Number of Participants With Electrocardiogram (ECG) Abnormalities

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. Tofacitinib 10 mg vs Tofacitinib 5 mg or 10 mg: Number of Participants With Electrocardiogram (ECG) Abnormalities. Trial comparisons, record NCT01163253-5ad3d302. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01163253-5ad3d302

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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 10.003070.001490.00632wilson
Risk in group 20.003410.0009360.0124wilson
Risk difference, group 1 minus group 2-0.000344-0.009430.00374newcombe hybrid score
Risk ratio, group 1 over group 20.8990.1874.32log
Odds ratio, group 1 over group 20.8990.1864.34log
Number needed to treat, for one fewer participant with the outcome on Tofacitinib 10 mg than on Tofacitinib 5 mg or 10 mg2,910from the risk difference intervalthe interval includes no difference

Groups2

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

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Tofacitinib 10 mgParticipants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months).72,281OG000
Group 2Tofacitinib 5 mg or 10 mg
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator's discretion.
2586OG001

Outcome

Type
PRIMARY
Title
Number of Participants With Electrocardiogram (ECG) Abnormalities
Description
Criteria for ECG abnormality: PR interval \>=300 milliseconds (msec); QT interval \>=500 msec; QTcB (Bazett's Correction) and QTcF (Fridericia's Correction) 450 to \<480 msec, 480 to \<500 msec and \>=500 msec.
Time frame
Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
Population
Safety analysis set included all participants who received at least 1 dose of study drug.

Source ClinicalTrials.gov

Trial

Title
A Long Term Study To Evaluate The Safety And Tolerability Of CP-690,550 For Patients With Moderate To Severe Chronic Plaque Psoriasis
NCT number
NCT01163253
Phases
PHASE3
Conditions
Psoriasis
Interventions
CP-690,550, CP-690,550
Lead sponsor
Pfizer
Results first posted
2017-06-26

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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