Secondary data collection study: safety and effectiveness of Xeljanz in UC patients under Japanese medical practice

This investigation aims to examine the safety and effectiveness of Xeljanz in post-marketing clinical settings when it is administered chronically to patients with ulcerative colitis, based on the approval conditions.

Inclusion Criteria:

• Patients with ulcerative colitis treated with XELJANZ
• Patients naive to XELJANZ in the treatment of ulcerative colitis

Exclusion Criteria:

- None

UC patients who were confirmed to have received Xeljanz after the approval date of dosage and administration of Xeljanz for UC patients

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

A total of 2016 participants were enrolled in this study. Of the 2016 participants from whom CRFs were collected, 21 participants were excluded from the safety analysis set due to the following reasons: contract violation/deficiency (12 participants), invalid registration (3 participants), no treatment information (2 participants), and no adverse event information - no revisit (4 participants).

60 weeks

The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.