Comparison · NCT01163253-b55aef2d
Tofacitinib 10 mg vs Tofacitinib 5 mg or 10 mg: Number of Participants With Laboratory Abnormalities
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. Tofacitinib 10 mg vs Tofacitinib 5 mg or 10 mg: Number of Participants With Laboratory Abnormalities. Trial comparisons, record NCT01163253-b55aef2d. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01163253-b55aef2d
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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 | 0.97 | 0.962 | 0.976 | wilson | |
| Risk in group 2 | 0.978 | 0.962 | 0.987 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00745 | -0.0196 | 0.00936 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.992 | 0.978 | 1.01 | log | |
| Odds ratio, group 1 over group 2 | 0.745 | 0.409 | 1.36 | log | |
| Number needed to treat, for one fewer participant with the outcome on Tofacitinib 10 mg than on Tofacitinib 5 mg or 10 mg | 134 | 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 | Tofacitinib 10 mg | Participants 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). | 2,203 | 2,271 | OG000 |
| Group 2 | Tofacitinib 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. | 565 | 578 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Laboratory Abnormalities
- Description
Abnormality criteria: hematology (hemoglobin, hematocrit, red blood cell \<0.8\*lower limit of normal \[LLN\]; reticulocyte\<0.5\*LLN,\>1.5\*ULN; platelets\<0.5\*LLN,\>1.75\* upper limit of normal \[ULN\]; WBC\<0.6\*LLN, \>1.5\*ULN; lymphocytes, neutrophils, basophils, eosinophils, monocytes\<0.8\*LLN; \>1.2\*ULN; coagulation (prothrombin \[PT\], PT ratio\>1.1\*ULN) liver function (bilirubin\>1.5\*ULN, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma GT\>0.3\*ULN, protein, albumin\<0.8\*LLN; \>1.2\*ULN, globulin\<0.5\*LLN; \>1.5\*ULN); renal function (blood urea nitrogen, creatinine\>1.3\*ULN); electrolytes(sodium\<0.95\* LLN; \>1.05\* ULN, potassium, chloride, calcium, bicarbonate\<0.9\*LLN; \>1.1\*ULN), chemistry (glucose\<0.6\*LLN; \>1.5\* ULN), urinalysis (pH \<4.5;\>8, glucose, ketones, protein, blood, urobilinogen, nitrite, bilirubin, leukocyte esterase\>=1; RBC, WBC\>=20); lipids (cholesterol \[C\], LDL-C \>1.3\*ULN, HDL-C\<0.8\*LLN, triglycerides\>1.3\* ULN), hormones(T4, T3, T4, TSH\<0.8\* LLN; \>1.2\* ULN).
- 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. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
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
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01163253?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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