Comparison · NCT01470612-sae
Tofacitinib 5 mg BID vs Tofacitinib 10 mg BID: 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. Tofacitinib 5 mg BID vs Tofacitinib 10 mg BID: serious adverse events. Trial comparisons, record NCT01470612-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01470612-sae
On this page
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 | 0.223 | 0.168 | 0.29 | wilson | |
| Risk in group 2 | 0.191 | 0.165 | 0.22 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0317 | -0.0309 | 0.104 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.17 | 0.853 | 1.59 | log | |
| Odds ratio, group 1 over group 2 | 1.21 | 0.814 | 1.81 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Tofacitinib 5 mg BID than on Tofacitinib 10 mg BID | 31.5 | 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 5 mg BID | Participants who completed Study A3921096 and were in remission at Week 52 of Study A3921096, received Tofacitinib 5 milligram (mg) tablets twice daily (BID) for maximum of 80 months in this Study A3921139. | 39 | 175 | EG000 |
| Group 2 | Tofacitinib 10 mg BID | Participants who had completed Study A3921096 and not in remission, or who had early withdrawal due to treatment failure from Study A3921096, or who were non responders after completing A3921094 or A3921095 received Tofacitinib 10 mg tablets twice daily for maximum of 84 months in this Study A3921139. | 147 | 769 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
Source ClinicalTrials.gov
Trial
- Title
- Long-Term Study Of CP-690,550 In Subjects With Ulcerative Colitis
- NCT number
- NCT01470612
- Phases
- PHASE3
- Conditions
- Ulcerative Colitis
- Interventions
- CP-690,550, CP-690,550
- Lead sponsor
- Pfizer
- Results first posted
- 2021-09-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01470612?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT01470612-sae