Trial Outcomes & Findings for Korea Post-marketing Surveillance for Xeljanz (Registered) in Ulcerative Colitis Patients (NCT NCT04071405)

NCT ID: NCT04071405

Last Updated: 2024-09-03

Results Overview

An adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal product which need not necessarily have causal relationship with product treatment or usage. Serious adverse event was any adverse event that resulted in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Adverse drug reaction (ADR) was any untoward medical occurrence attributed to Xeljanz. Serious ADR: any ADR resulting in any of following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. 95% confidence interval (CI) was based on Clopper-Pearson method. This outcome measure is reported for all participants including long term users (i.e. treated with Xeljanz for at least 52 weeks).

• Recruitment status: COMPLETED
• Target enrollment: 110 participants
• Primary outcome timeframe: From first dose of Xeljanz until 52 weeks
• Results posted on: 2024-09-03

Participant Flow

Adult participants with moderately to severely active ulcerative colitis (UC) who had an inadequate response or intolerance to basic treatments or biological agents and were prescribed Xeljanz (tofacitinib) for the first time as part of routine practice at Korean healthcare centers were observed in this post-marketing surveillance study.

Participant milestones

Measure	Tofacitinib Participants with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to basic treatments or biological agents and received tofacitinib as part of routine practice at Korean health care centers were observed.
Overall Study STARTED	110
Overall Study Safety Population	107
Overall Study COMPLETED	107
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Tofacitinib Participants with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to basic treatments or biological agents and received tofacitinib as part of routine practice at Korean health care centers were observed.
Overall Study Protocol Violation	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Tofacitinib n=107 Participants Participants with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to basic treatments or biological agents and received tofacitinib as part of routine practice at Korean health care centers were observed.
Age, Continuous	40.83 Years STANDARD_DEVIATION 13.37 • n=107 Participants
Sex: Female, Male Female	31 Participants n=107 Participants
Sex: Female, Male Male	76 Participants n=107 Participants

PRIMARY outcome

Timeframe: From first dose of Xeljanz until 52 weeks

Population: Safety analysis set included all participants registered for this study who were prescribed at least 1 dose of Xeljanz according to the local label and followed up for safety data.

An adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal product which need not necessarily have causal relationship with product treatment or usage. Serious adverse event was any adverse event that resulted in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Adverse drug reaction (ADR) was any untoward medical occurrence attributed to Xeljanz. Serious ADR: any ADR resulting in any of following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. 95% confidence interval (CI) was based on Clopper-Pearson method. This outcome measure is reported for all participants including long term users (i.e. treated with Xeljanz for at least 52 weeks).

Outcome measures

Measure	Tofacitinib n=107 Participants Participants with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to basic treatments or biological agents and received tofacitinib as part of routine practice at Korean health care centers were observed.
Percentage of Participants With Adverse Events, Adverse Drug Reactions, Serious Adverse Events and Serious Adverse Drug Reactions Adverse events	40.19 Percentage of participants Interval 30.82 to 50.11
Percentage of Participants With Adverse Events, Adverse Drug Reactions, Serious Adverse Events and Serious Adverse Drug Reactions Adverse drug reactions	24.30 Percentage of participants Interval 16.53 to 33.54
Percentage of Participants With Adverse Events, Adverse Drug Reactions, Serious Adverse Events and Serious Adverse Drug Reactions Serious adverse events	7.48 Percentage of participants Interval 3.28 to 14.2
Percentage of Participants With Adverse Events, Adverse Drug Reactions, Serious Adverse Events and Serious Adverse Drug Reactions Serious adverse drug reactions	0.93 Percentage of participants Interval 0.02 to 5.1

PRIMARY outcome

Timeframe: From first dose of Xeljanz until 52 weeks

Population: Safety analysis set included all participants registered for this study who were prescribed at least 1 dose of Xeljanz according to the local label and followed up for safety data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

An adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal product which need not necessarily have causal relationship with product treatment or usage. A serious adverse event was any adverse event that resulted in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. An adverse drug reaction (ADR) was any untoward medical occurrence attributed to Xeljanz. Serious ADR: any ADR resulting in any of following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. This outcome measure was analyzed only in long term users.

Outcome measures

Measure	Tofacitinib n=60 Participants Participants with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to basic treatments or biological agents and received tofacitinib as part of routine practice at Korean health care centers were observed.
Number of Participants With Adverse Events, Adverse Drug Reactions, Serious Adverse Events and Serious Adverse Drug Reactions in Long Term Users Adverse events	27 Participants
Number of Participants With Adverse Events, Adverse Drug Reactions, Serious Adverse Events and Serious Adverse Drug Reactions in Long Term Users Adverse drug reactions	18 Participants
Number of Participants With Adverse Events, Adverse Drug Reactions, Serious Adverse Events and Serious Adverse Drug Reactions in Long Term Users Serious adverse events	3 Participants
Number of Participants With Adverse Events, Adverse Drug Reactions, Serious Adverse Events and Serious Adverse Drug Reactions in Long Term Users Serious adverse drug reactions	0 Participants

PRIMARY outcome

Timeframe: From first dose of Xeljanz until 52 weeks

Population: Safety analysis set included all participants registered for this study who were prescribed at least 1 dose of Xeljanz according to the local label and followed up for safety data.

Unexpected AE: any event that may be symptomatically, pathophysiologically related to event listed in labeling, but differed from labeled event because of greater severity or specificity. ADR: any untoward medical occurrence attributed to Xeljanz. All events that were not included in "Precautions for use" section of local product document were classified as "unexpected" adverse drug reactions. Serious ADR: any ADR resulting in any of following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. SAE: any untoward medical occurrence in participant administered medicinal/nutritional product at any dose that resulted in death was life-threatening. 95% CI was based on Clopper-Pearson method. This outcome measure is reported for all participants including long term users.

Outcome measures

Measure	Tofacitinib n=107 Participants Participants with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to basic treatments or biological agents and received tofacitinib as part of routine practice at Korean health care centers were observed.
Percentage of Participants With Unexpected Adverse Events (AE), Unexpected Adverse Drug Reactions, Unexpected Serious Adverse Events (SAE), and Unexpected Serious Adverse Drug Reactions Unexpected adverse events	22.43 Percentage of participants Interval 14.93 to 31.51
Percentage of Participants With Unexpected Adverse Events (AE), Unexpected Adverse Drug Reactions, Unexpected Serious Adverse Events (SAE), and Unexpected Serious Adverse Drug Reactions Unexpected adverse drug reactions	12.15 Percentage of participants Interval 6.63 to 19.88
Percentage of Participants With Unexpected Adverse Events (AE), Unexpected Adverse Drug Reactions, Unexpected Serious Adverse Events (SAE), and Unexpected Serious Adverse Drug Reactions Unexpected serious adverse events	3.74 Percentage of participants Interval 1.03 to 9.3
Percentage of Participants With Unexpected Adverse Events (AE), Unexpected Adverse Drug Reactions, Unexpected Serious Adverse Events (SAE), and Unexpected Serious Adverse Drug Reactions Unexpected serious adverse drug reactions	0 Percentage of participants Interval 0.0 to 0.0

PRIMARY outcome

Timeframe: From first dose of Xeljanz until 52 weeks

Population: Safety analysis set included all participants registered for this study who were prescribed at least 1 dose of Xeljanz according to the local label and followed up for safety data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Unexpected AE: any event that may be symptomatically, pathophysiologically related to event listed in labeling, but differed from labeled event because of greater severity or specificity. ADR: any untoward medical occurrence attributed to Xeljanz. All events that were not included in "Precautions for use" section of local product document were classified as "unexpected" adverse drug reactions. Serious ADR: any ADR resulting in any of following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. SAE: any untoward medical occurrence in participant administered medicinal/nutritional product at any dose that resulted in death was life-threatening. This outcome measure was analyzed only in long term users.

Outcome measures

Measure	Tofacitinib n=60 Participants Participants with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to basic treatments or biological agents and received tofacitinib as part of routine practice at Korean health care centers were observed.
Number of Participants With Unexpected Adverse Events, Unexpected Adverse Drug Reactions, Unexpected Serious Adverse Events, and Unexpected Serious Adverse Drug Reactions in Long Term Users Unexpected adverse events	13 Participants
Number of Participants With Unexpected Adverse Events, Unexpected Adverse Drug Reactions, Unexpected Serious Adverse Events, and Unexpected Serious Adverse Drug Reactions in Long Term Users Unexpected adverse drug reactions	9 Participants
Number of Participants With Unexpected Adverse Events, Unexpected Adverse Drug Reactions, Unexpected Serious Adverse Events, and Unexpected Serious Adverse Drug Reactions in Long Term Users Unexpected serious adverse events	1 Participants
Number of Participants With Unexpected Adverse Events, Unexpected Adverse Drug Reactions, Unexpected Serious Adverse Events, and Unexpected Serious Adverse Drug Reactions in Long Term Users Unexpected serious adverse drug reactions	0 Participants

PRIMARY outcome

Timeframe: From first dose of Xeljanz until 52 weeks

Population: Safety analysis set included all participants registered for this study who were prescribed at least 1 dose of Xeljanz according to the local label and followed up for safety data.

An adverse event was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Adverse events of special interest were defined as serious or non-serious AEs which were of scientific and medical concern specific to the investigational product. 95% CI was based on Clopper-Pearson method. This outcome measure is reported for all participants including long term users.

Outcome measures

Measure	Tofacitinib n=107 Participants Participants with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to basic treatments or biological agents and received tofacitinib as part of routine practice at Korean health care centers were observed.
Percentage of Participants With Adverse Events of Special Interest	1.87 Percentage of participants Interval 0.23 to 6.59

PRIMARY outcome

Timeframe: From first dose of Xeljanz until 52 weeks

Population: Safety analysis set included all participants registered for this study who were prescribed at least 1 dose of Xeljanz according to the local label and followed up for safety data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

An adverse event was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Adverse events of special interest were defined as serious or non-serious AEs which were of scientific and medical concern specific to the investigational product. This outcome measure was analyzed only in long term users.

Outcome measures

Measure	Tofacitinib n=60 Participants Participants with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to basic treatments or biological agents and received tofacitinib as part of routine practice at Korean health care centers were observed.
Number of Participants With Adverse Events of Special Interest in Long Term Users	2 Participants

PRIMARY outcome

Timeframe: From first dose of Xeljanz until 52 weeks

Population: Safety analysis set included all participants registered for this study who were prescribed at least 1 dose of Xeljanz according to the local label and followed up for safety data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

An adverse event was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. AEs were categorized as per the severity: mild: did not cause any significant problem to the participant, administration of medicinal product continued without dose adjustment; moderate: caused a problem that did not interfere significantly with usual activities or the clinical status, dose of the medicinal product was adjusted or other therapy was added due to the AE; severe: caused a problem that interfered significantly with usual activities, or the clinical status and the medicinal product was stopped due to AE. One participant may experience more than one event; hence, one participant may be included in more than one category specified below. This outcome measure is reported for all participants including long term users.

Outcome measures

Measure	Tofacitinib n=43 Participants Participants with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to basic treatments or biological agents and received tofacitinib as part of routine practice at Korean health care centers were observed.
Number of Participants With Adverse Events by Their Severity Mild	35 Participants
Number of Participants With Adverse Events by Their Severity Moderate	11 Participants
Number of Participants With Adverse Events by Their Severity Severe	4 Participants

PRIMARY outcome

Timeframe: From first dose of Xeljanz until 52 weeks

Population: Safety analysis set included all participants registered for this study who were prescribed at least 1 dose of Xeljanz according to the local label and followed up for safety data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

An adverse event was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. AEs were categorized as per the severity: mild: did not cause any significant problem to the participant, administration of medicinal product continued without dose adjustment; moderate: caused a problem that did not interfere significantly with usual activities or the clinical status, dose of the medicinal product was adjusted or other therapy was added due to the AE; severe: caused a problem that interfered significantly with usual activities, or the clinical status and the medicinal product was stopped due to AE. One participant may experience more than one event; hence, one participant may be included in more than one category specified below. This outcome measure was analyzed only in long term users.

Outcome measures

Measure	Tofacitinib n=27 Participants Participants with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to basic treatments or biological agents and received tofacitinib as part of routine practice at Korean health care centers were observed.
Number of Participants With Adverse Events by Their Severity in Long Term Users Mild	24 Participants
Number of Participants With Adverse Events by Their Severity in Long Term Users Moderate	4 Participants
Number of Participants With Adverse Events by Their Severity in Long Term Users Severe	1 Participants

PRIMARY outcome

Timeframe: From first dose of Xeljanz until 52 weeks

Population: Safety analysis set included all participants registered for this study who were prescribed at least 1 dose of Xeljanz according to the local label and followed up for safety data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. AE outcomes were categorized as: recovered; recovered with sequelae; recovering; not recovered; unknown. One participant may experience more than one event; hence, one participant may be included in more than one category specified below. This outcome measure is reported for all participants including long term users.

Outcome measures

Measure	Tofacitinib n=43 Participants Participants with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to basic treatments or biological agents and received tofacitinib as part of routine practice at Korean health care centers were observed.
Number of Participants With Adverse Events by Their Outcomes Recovered	33 Participants
Number of Participants With Adverse Events by Their Outcomes Recovered with sequelae	0 Participants
Number of Participants With Adverse Events by Their Outcomes Recovering	13 Participants
Number of Participants With Adverse Events by Their Outcomes Not recovered	6 Participants
Number of Participants With Adverse Events by Their Outcomes Unknown	1 Participants

PRIMARY outcome

Timeframe: From first dose of Xeljanz until 52 weeks

Population: Safety analysis set included all participants registered for this study who were prescribed at least 1 dose of Xeljanz according to the local label and followed up for safety data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. AE outcomes were categorized as: recovered; recovered with sequelae; recovering; not recovered; unknown. One participant may experience more than one event; hence, one participant may be included in more than one category specified below. This outcome measure was analyzed only in long term users.

Outcome measures

Measure	Tofacitinib n=27 Participants Participants with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to basic treatments or biological agents and received tofacitinib as part of routine practice at Korean health care centers were observed.
Number of Participants With Adverse Events by Their Outcomes in Long Term Users Recovered	21 Participants
Number of Participants With Adverse Events by Their Outcomes in Long Term Users Recovered with sequelae	0 Participants
Number of Participants With Adverse Events by Their Outcomes in Long Term Users Recovering	7 Participants
Number of Participants With Adverse Events by Their Outcomes in Long Term Users Not recovered	3 Participants
Number of Participants With Adverse Events by Their Outcomes in Long Term Users Unknown	1 Participants

PRIMARY outcome

Timeframe: From first dose of Xeljanz until 52 weeks

Population: Safety analysis set included all participants registered for this study who were prescribed at least 1 dose of Xeljanz according to the local label and followed up for safety data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

An adverse event was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Adverse events were classified as per their seriousness as following: results in death, is life-threatening, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, results in congenital anomaly/birth defect, other important medical event. One participant may experience more than one event; hence, one participant may be included in more than one category specified below. This outcome measure is reported for all participants including long term users.

Outcome measures

Measure	Tofacitinib n=43 Participants Participants with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to basic treatments or biological agents and received tofacitinib as part of routine practice at Korean health care centers were observed.
Number of Participants With Adverse Events by Their Seriousness Results in death	0 Participants
Number of Participants With Adverse Events by Their Seriousness Life-threatening	0 Participants
Number of Participants With Adverse Events by Their Seriousness Requires inpatient hospitalization or prolongation of hospitalization	8 Participants
Number of Participants With Adverse Events by Their Seriousness Results in persistent or significant disability/incapacity	0 Participants
Number of Participants With Adverse Events by Their Seriousness Results in congenital anomaly/birth defect	0 Participants
Number of Participants With Adverse Events by Their Seriousness Other important medical event	0 Participants
Number of Participants With Adverse Events by Their Seriousness Non-Serious	41 Participants

PRIMARY outcome

Timeframe: From first dose of Xeljanz until 52 weeks

Population: Safety analysis set included all participants registered for this study who were prescribed at least 1 dose of Xeljanz according to the local label and followed up for safety data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

An adverse event was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Adverse events were classified as per their seriousness as following: results in death, was life-threatening, required inpatient hospitalization or prolongation of hospitalization, resulted in persistent or significant disability/incapacity, results in congenital anomaly/birth defect, other important medical event. One participant may experience more than one event; hence, one participant may be included in more than one category specified below. This outcome measure was analyzed only in long term users.

Outcome measures

Measure	Tofacitinib n=27 Participants Participants with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to basic treatments or biological agents and received tofacitinib as part of routine practice at Korean health care centers were observed.
Number of Participants With Adverse Events by Their Seriousness in Long Term Users Results in death	0 Participants
Number of Participants With Adverse Events by Their Seriousness in Long Term Users Is life-threatening	0 Participants
Number of Participants With Adverse Events by Their Seriousness in Long Term Users Requires inpatient hospitalization or prolongation of hospitalization.	3 Participants
Number of Participants With Adverse Events by Their Seriousness in Long Term Users Results in persistent or significant disability/incapacity	0 Participants
Number of Participants With Adverse Events by Their Seriousness in Long Term Users Results in congenital anomaly/birth defect	0 Participants
Number of Participants With Adverse Events by Their Seriousness in Long Term Users Other important medical event	0 Participants
Number of Participants With Adverse Events by Their Seriousness in Long Term Users Non-Serious	26 Participants

PRIMARY outcome

Timeframe: From first dose of Xeljanz until 52 weeks

Population: Safety analysis set included all participants registered for this study who were prescribed at least 1 dose of Xeljanz according to the local label and followed up for safety data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

An adverse event was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Action taken with regard to the medicinal product included: permanently discontinued; temporarily discontinued or delayed; dose reduced; dose increased; no change; and not applicable. One participant may experience more than one event; hence, one participant may be included in more than one category specified below. This outcome measure is reported for all participants including long term users.

Outcome measures

Measure	Tofacitinib n=43 Participants Participants with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to basic treatments or biological agents and received tofacitinib as part of routine practice at Korean health care centers were observed.
Number of Participants With Adverse Events by Action Taken Permanently discontinued	8 Participants
Number of Participants With Adverse Events by Action Taken Temporary discontinued or delayed	2 Participants
Number of Participants With Adverse Events by Action Taken Dose reduced	2 Participants
Number of Participants With Adverse Events by Action Taken Dose increased	3 Participants
Number of Participants With Adverse Events by Action Taken No change	35 Participants
Number of Participants With Adverse Events by Action Taken Not applicable	1 Participants

PRIMARY outcome

Timeframe: From first dose of Xeljanz until 52 weeks

Population: Safety analysis set included all participants registered for this study who were prescribed at least 1 dose of Xeljanz according to the local label and followed up for safety data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

An adverse event was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Action taken with regard to the medicinal product included: permanently discontinued; temporarily discontinued or delayed; dose reduced; dose increased; no change; and not applicable. One participant may experience more than one event; hence, one participant may be included in more than one category specified below. This outcome measure was analyzed only in long term users.

Outcome measures

Measure	Tofacitinib n=27 Participants Participants with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to basic treatments or biological agents and received tofacitinib as part of routine practice at Korean health care centers were observed.
Number of Participants With Adverse Events by Action Taken in Long Term Users No change	26 Participants
Number of Participants With Adverse Events by Action Taken in Long Term Users Permanently discontinued	0 Participants
Number of Participants With Adverse Events by Action Taken in Long Term Users Temporary discontinued or delayed	0 Participants
Number of Participants With Adverse Events by Action Taken in Long Term Users Dose reduced	1 Participants
Number of Participants With Adverse Events by Action Taken in Long Term Users Dose increased	2 Participants
Number of Participants With Adverse Events by Action Taken in Long Term Users Not applicable	0 Participants

PRIMARY outcome

Timeframe: From first dose of Xeljanz until 52 weeks

Population: Safety analysis set included all participants registered for this study who were prescribed at least 1 dose of Xeljanz according to the local label and followed up for safety data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

An AE was any untoward medical occurrence in a participant when administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Causal relationship of AEs to the medicinal product was allocated by the investigator according to the following criteria: certain, probable/likely, possible, unlikely, conditional/unclassified, unassessible/unclassifiable, not applicable. One participant may experience more than one event; hence, one participant may be included in more than one category specified below. This outcome measure is reported for all participants including long term users.

Outcome measures

Measure	Tofacitinib n=43 Participants Participants with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to basic treatments or biological agents and received tofacitinib as part of routine practice at Korean health care centers were observed.
Number of Participants With Adverse Events by Their Causality Assessment Certain	1 Participants
Number of Participants With Adverse Events by Their Causality Assessment Probable/likely	0 Participants
Number of Participants With Adverse Events by Their Causality Assessment Possible	9 Participants
Number of Participants With Adverse Events by Their Causality Assessment Unlikely	22 Participants
Number of Participants With Adverse Events by Their Causality Assessment Conditional/ unclassified	6 Participants
Number of Participants With Adverse Events by Their Causality Assessment Unassessible/ unclassifiable	13 Participants
Number of Participants With Adverse Events by Their Causality Assessment Not applicable	0 Participants

PRIMARY outcome

Timeframe: From first dose of Xeljanz until 52 weeks

Population: Safety analysis set included all participants registered for this study who were prescribed at least 1 dose of Xeljanz according to the local label and followed up for safety data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

An AE was any untoward medical occurrence in a participant when administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Causal relationship of AEs to the medicinal product was allocated by the investigator according to the following criteria: certain, probable/likely, possible, unlikely, conditional/unclassified, unassessible/unclassifiable, not applicable. One participant may experience more than one event; hence, one participant may be included in more than one category specified below. This outcome measure was analyzed only in long term users.

Outcome measures

Measure	Tofacitinib n=27 Participants Participants with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to basic treatments or biological agents and received tofacitinib as part of routine practice at Korean health care centers were observed.
Number of Participants With Adverse Events by Their Causality Assessment in Long Term Users Certain	0 Participants
Number of Participants With Adverse Events by Their Causality Assessment in Long Term Users Probable/likely	0 Participants
Number of Participants With Adverse Events by Their Causality Assessment in Long Term Users Possible	4 Participants
Number of Participants With Adverse Events by Their Causality Assessment in Long Term Users Unlikely	11 Participants
Number of Participants With Adverse Events by Their Causality Assessment in Long Term Users Conditional/unclassified	5 Participants
Number of Participants With Adverse Events by Their Causality Assessment in Long Term Users Unassessible/unclassifiable	11 Participants
Number of Participants With Adverse Events by Their Causality Assessment in Long Term Users Not applicable	0 Participants

PRIMARY outcome

Timeframe: From first dose of Xeljanz until 52 weeks

Population: Safety analysis set included all participants registered for this study who were prescribed at least 1 dose of Xeljanz according to the local label and followed up for safety data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

An AE was any untoward medical occurrence in a participant when administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Adverse events by their other causality assessment (in case of unlikely) were classified as: Disease under the study, Other diseases, Concomitant treatment medication or non-medication, and Other. One participant may experience more than one event; hence, one participant may be included in more than one category specified below. This outcome measure is reported for all participants including long term users.

Outcome measures

Measure	Tofacitinib n=22 Participants Participants with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to basic treatments or biological agents and received tofacitinib as part of routine practice at Korean health care centers were observed.
Number of Participants With Adverse Events by Their Other Causality Assessment Other diseases	5 Participants
Number of Participants With Adverse Events by Their Other Causality Assessment Disease under the study	13 Participants
Number of Participants With Adverse Events by Their Other Causality Assessment Concomitant treatment medication or non-medication	2 Participants
Number of Participants With Adverse Events by Their Other Causality Assessment Other	5 Participants

PRIMARY outcome

Timeframe: From first dose of Xeljanz until 52 weeks

Population: Safety analysis set included all participants registered for this study who were prescribed at least 1 dose of Xeljanz according to the local label and followed up for safety data. Here, 'Overall Number of participants Analyzed' signifies participants evaluable for this outcome measure.

An AE was any untoward medical occurrence in a participant when administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Adverse events by their other causality assessment (in case of unlikely) were classified as: Disease under the study, Other diseases, Concomitant treatment medication or non-medication, and Other. One participant may experience more than one event; hence, one participant may be included in more than one category specified below. This outcome measure included only long term users. This outcome measure was analyzed only in long term users.

Outcome measures

Measure	Tofacitinib n=11 Participants Participants with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to basic treatments or biological agents and received tofacitinib as part of routine practice at Korean health care centers were observed.
Number of Participants With Adverse Events by Their Other Causality Assessment in Long Term Users Disease under the study	6 Participants
Number of Participants With Adverse Events by Their Other Causality Assessment in Long Term Users Other diseases	3 Participants
Number of Participants With Adverse Events by Their Other Causality Assessment in Long Term Users Concomitant treatment medication or non-medication	1 Participants
Number of Participants With Adverse Events by Their Other Causality Assessment in Long Term Users Other	2 Participants

SECONDARY outcome

Timeframe: Baseline, Week 8, Week 16 and Week 24

Population: Effectiveness analysis included all participants who had participated in safety analysis, whose effectiveness data available after 24 weeks of treatment or based on the last assessment performed at the time of treatment discontinuation if participant did not complete the 24 weeks of treatment. If. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. 'Number Analyzed (n)' signifies participants evaluable for specified rows.

Mayo score (MS): measured disease activity (DA) of UC; total score range=0 to 12, higher score=severe DA. Mayo index was based on 4 clinical evaluation criteria: Stool frequency, Rectal bleeding, Endoscopy finding, Physician's global assessment(PGA).Each sub-score range=0 to 3,higher score=more severe DA.Stool frequency:0=normal number of stool, 1=1 to 2 stool/day >normal, 2=3 to 4 stool/day >normal, 3= >4 stool/day >normal; Rectal bleeding:0=None,1=Visible blood with stool less than half time, 2=Visible blood with stool>half time, 3=Mostly blood with rare stool; Endoscopic finding:0=Normal/inactive, 1=Mild with erythema, decreased vascular pattern, mild friability, 2=Moderate with marked erythema, absent vascular pattern, friability, erosion, 3=Severe with spontaneous bleeding, ulceration, pseudopolyp; PGA: 0=Normal/inactive, 1=Mild, 2=Moderate, 3=severe Partial MS=sum of all evaluation criteria, except endoscopy finding.Partial MS score range=0 to 9;higher score=more severe DA.

Outcome measures

Measure	Tofacitinib n=101 Participants Participants with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to basic treatments or biological agents and received tofacitinib as part of routine practice at Korean health care centers were observed.
Mayo Index, Mayo Score and Partial Mayo Score at Baseline, Week 8, Week 16 and Week 24 Stool frequency (Baseline)	2.41 Units on a scale Standard Deviation 0.70
Mayo Index, Mayo Score and Partial Mayo Score at Baseline, Week 8, Week 16 and Week 24 Rectal bleeding (Baseline)	1.57 Units on a scale Standard Deviation 0.84
Mayo Index, Mayo Score and Partial Mayo Score at Baseline, Week 8, Week 16 and Week 24 Physician's global assessment (Baseline)	2.15 Units on a scale Standard Deviation 0.62
Mayo Index, Mayo Score and Partial Mayo Score at Baseline, Week 8, Week 16 and Week 24 Finding of endoscopy (Baseline)	2.56 Units on a scale Standard Deviation 0.56
Mayo Index, Mayo Score and Partial Mayo Score at Baseline, Week 8, Week 16 and Week 24 Mayo score (Baseline)	8.64 Units on a scale Standard Deviation 1.56
Mayo Index, Mayo Score and Partial Mayo Score at Baseline, Week 8, Week 16 and Week 24 Partial Mayo score (Baseline)	6.13 Units on a scale Standard Deviation 1.40
Mayo Index, Mayo Score and Partial Mayo Score at Baseline, Week 8, Week 16 and Week 24 Stool frequency (Week 8)	1.23 Units on a scale Standard Deviation 1.12
Mayo Index, Mayo Score and Partial Mayo Score at Baseline, Week 8, Week 16 and Week 24 Rectal bleeding (Week 8)	0.53 Units on a scale Standard Deviation 0.74
Mayo Index, Mayo Score and Partial Mayo Score at Baseline, Week 8, Week 16 and Week 24 Physician's global assessment (Week 8)	0.82 Units on a scale Standard Deviation 0.87
Mayo Index, Mayo Score and Partial Mayo Score at Baseline, Week 8, Week 16 and Week 24 Finding of endoscopy (Week 8)	1.14 Units on a scale Standard Deviation 1.07
Mayo Index, Mayo Score and Partial Mayo Score at Baseline, Week 8, Week 16 and Week 24 Mayo score (Week 8)	4.00 Units on a scale Standard Deviation 3.56
Mayo Index, Mayo Score and Partial Mayo Score at Baseline, Week 8, Week 16 and Week 24 Partial Mayo score (Week 8)	2.57 Units on a scale Standard Deviation 2.28
Mayo Index, Mayo Score and Partial Mayo Score at Baseline, Week 8, Week 16 and Week 24 Stool frequency (Week 16)	0.86 Units on a scale Standard Deviation 0.96
Mayo Index, Mayo Score and Partial Mayo Score at Baseline, Week 8, Week 16 and Week 24 Rectal bleeding (Week 16)	0.30 Units on a scale Standard Deviation 0.57
Mayo Index, Mayo Score and Partial Mayo Score at Baseline, Week 8, Week 16 and Week 24 Physician's global assessment (Week 16)	0.60 Units on a scale Standard Deviation 0.74
Mayo Index, Mayo Score and Partial Mayo Score at Baseline, Week 8, Week 16 and Week 24 Finding of endoscopy (Week 16)	1.44 Units on a scale Standard Deviation 1.08
Mayo Index, Mayo Score and Partial Mayo Score at Baseline, Week 8, Week 16 and Week 24 Mayo score (Week 16)	3.17 Units on a scale Standard Deviation 2.67
Mayo Index, Mayo Score and Partial Mayo Score at Baseline, Week 8, Week 16 and Week 24 Partial Mayo score (Week 16)	1.76 Units on a scale Standard Deviation 1.91
Mayo Index, Mayo Score and Partial Mayo Score at Baseline, Week 8, Week 16 and Week 24 Stool frequency (Week 24)	0.80 Units on a scale Standard Deviation 0.92
Mayo Index, Mayo Score and Partial Mayo Score at Baseline, Week 8, Week 16 and Week 24 Rectal bleeding (Week 24)	0.30 Units on a scale Standard Deviation 0.56
Mayo Index, Mayo Score and Partial Mayo Score at Baseline, Week 8, Week 16 and Week 24 Physician's global assessment (Week 24)	0.42 Units on a scale Standard Deviation 0.59
Mayo Index, Mayo Score and Partial Mayo Score at Baseline, Week 8, Week 16 and Week 24 Finding of endoscopy (Week 24)	0.50 Units on a scale Standard Deviation 0.71
Mayo Index, Mayo Score and Partial Mayo Score at Baseline, Week 8, Week 16 and Week 24 Mayo score (Week 24)	1.00 Units on a scale Standard Deviation 1.41
Mayo Index, Mayo Score and Partial Mayo Score at Baseline, Week 8, Week 16 and Week 24 Partial Mayo score (Week 24)	1.52 Units on a scale Standard Deviation 1.71

SECONDARY outcome

Timeframe: Baseline, Week 8, Week 16, Week 24 and Week 52

Population: Effectiveness analysis included all participants who had participated in safety analysis, whose effectiveness data available after 24 weeks of treatment. Here, 'Overall Number of participants Analyzed' signifies participants evaluable for this outcome measure. 'Number Analyzed' signifies participants evaluable for specified rows.

Mayo score (MS): measured disease activity (DA) of UC; total score range=0 to 12, higher score=severe DA. Mayo index was based on 4 clinical evaluation criteria: Stool frequency, Rectal bleeding, Endoscopy finding, Physician's global assessment (PGA). Each sub-score range=0 to 3,higher score=more severe DA. Stool frequency:0=normal number of stool, 1=1 to 2 stool/day >normal, 2=3 to 4 stool/day >normal, 3= >4 stool/day >normal; Rectal bleeding:0=None,1=Visible blood with stool less than half time, 2=Visible blood with stool>half time, 3=Mostly blood with rare stool; Endoscopic finding:0=Normal/inactive, 1=Mild with erythema, decreased vascular pattern, mild friability, 2=Moderate with marked erythema, absent vascular pattern, friability, erosion, 3=Severe with spontaneous bleeding, ulceration, pseudopolyp; PGA: 0=Normal/inactive, 1=Mild, 2=Moderate, 3=severe. Partial MS=sum of all evaluation criteria, except endoscopy finding.Partial MS score range=0 to 9; higher score=more severe DA.

Outcome measures

Measure	Tofacitinib n=60 Participants Participants with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to basic treatments or biological agents and received tofacitinib as part of routine practice at Korean health care centers were observed.
Mayo Index, Mayo Score and Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 for Long Term Users Stool frequency (Baseline)	2.38 Units on a scale Standard Deviation 0.72
Mayo Index, Mayo Score and Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 for Long Term Users Rectal bleeding (Baseline)	1.48 Units on a scale Standard Deviation 0.91
Mayo Index, Mayo Score and Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 for Long Term Users Physician's global assessment (Baseline)	2.08 Units on a scale Standard Deviation 0.65
Mayo Index, Mayo Score and Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 for Long Term Users Finding of endoscopy (Baseline)	2.55 Units on a scale Standard Deviation 0.57
Mayo Index, Mayo Score and Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 for Long Term Users Mayo score (Baseline)	8.5 Units on a scale Standard Deviation 1.55
Mayo Index, Mayo Score and Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 for Long Term Users Partial score (Baseline)	5.95 Units on a scale Standard Deviation 1.42
Mayo Index, Mayo Score and Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 for Long Term Users Stool frequency (Week 8)	0.96 Units on a scale Standard Deviation 1.04
Mayo Index, Mayo Score and Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 for Long Term Users Rectal bleeding (Week 8)	0.43 Units on a scale Standard Deviation 0.71
Mayo Index, Mayo Score and Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 for Long Term Users Physician's global assessment (Week 8)	0.65 Units on a scale Standard Deviation 0.75
Mayo Index, Mayo Score and Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 for Long Term Users Finding of endoscopy (Week 8)	1.00 Units on a scale Standard Deviation 0.00
Mayo Index, Mayo Score and Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 for Long Term Users Mayo score (Week 8)	3.50 Units on a scale Standard Deviation 0.71
Mayo Index, Mayo Score and Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 for Long Term Users Partial Mayo score (Week 8)	2.04 Units on a scale Standard Deviation 2.02
Mayo Index, Mayo Score and Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 for Long Term Users Stool frequency (Week 16)	0.59 Units on a scale Standard Deviation 0.72
Mayo Index, Mayo Score and Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 for Long Term Users Rectal bleeding (Week 16)	0.22 Units on a scale Standard Deviation 0.46
Mayo Index, Mayo Score and Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 for Long Term Users Physician's global assessment (Week 16)	0.47 Units on a scale Standard Deviation 0.60
Mayo Index, Mayo Score and Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 for Long Term Users Finding of endoscopy (Week 16)	1.29 Units on a scale Standard Deviation 1.05
Mayo Index, Mayo Score and Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 for Long Term Users Mayo score (Week 16)	2.37 Units on a scale Standard Deviation 1.88
Mayo Index, Mayo Score and Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 for Long Term Users Partial Mayo score (Week 16)	1.29 Units on a scale Standard Deviation 1.44
Mayo Index, Mayo Score and Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 for Long Term Users Stool frequency (Week 24)	0.70 Units on a scale Standard Deviation 0.81
Mayo Index, Mayo Score and Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 for Long Term Users Rectal bleeding (Week 24)	0.23 Units on a scale Standard Deviation 0.48
Mayo Index, Mayo Score and Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 for Long Term Users Physician's global assessment (Week 24)	0.38 Units on a scale Standard Deviation 0.57
Mayo Index, Mayo Score and Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 for Long Term Users Finding of endoscopy (Week 24)	1.00 Units on a scale Standard Deviation NA Standard deviation could not be calculated for a single participant.
Mayo Index, Mayo Score and Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 for Long Term Users Mayo score (Week 24)	2.00 Units on a scale Standard Deviation NA Standard deviation could not be calculated for a single participant.
Mayo Index, Mayo Score and Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 for Long Term Users Partial Mayo score (Week 24)	1.32 Units on a scale Standard Deviation 1.52
Mayo Index, Mayo Score and Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 for Long Term Users Stool frequency (Week 52)	0.74 Units on a scale Standard Deviation 0.85
Mayo Index, Mayo Score and Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 for Long Term Users Rectal bleeding (Week 52)	0.18 Units on a scale Standard Deviation 0.44
Mayo Index, Mayo Score and Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 for Long Term Users Physician's global assessment (Week 52)	0.56 Units on a scale Standard Deviation 0.67
Mayo Index, Mayo Score and Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 for Long Term Users Finding of endoscopy (Week 52)	1.46 Units on a scale Standard Deviation 1.33
Mayo Index, Mayo Score and Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 for Long Term Users Mayo score (Week 52)	3.54 Units on a scale Standard Deviation 3.48
Mayo Index, Mayo Score and Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 for Long Term Users Partial Mayo score (Week 52)	1.48 Units on a scale Standard Deviation 1.57

SECONDARY outcome

Timeframe: Week 8, Week 16 and Week 24

Population: Effectiveness analysis:all participants who participated in safety analysis, effectiveness data was available after 24 week(W) of treatment/based on last assessment at time of discontinuation if participant did not complete 24 W of treatment. "Overall Number of Participants Analyzed":participant evaluable for outcome measure. Participant in 'Overall Number of Participants Analyzed' contributed data to table, may not have evaluable data for each row. 'n': participant evaluable for specified row.

Mucosal healing was defined by Mayo or partial Mayo endoscopic score of 0 or 1 where 0=Normal/inactive disease,1=Mild disease with erythema, decreased vascular pattern, mild friability.

Outcome measures

Measure	Tofacitinib n=73 Participants Participants with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to basic treatments or biological agents and received tofacitinib as part of routine practice at Korean health care centers were observed.
Number of Participants With Mucosal Healing at Week 8, Week 16 and Week 24 Week 8 · Achieved	5 Participants
Number of Participants With Mucosal Healing at Week 8, Week 16 and Week 24 Week 8 · Not achieved	2 Participants
Number of Participants With Mucosal Healing at Week 8, Week 16 and Week 24 Week 16 · Achieved	37 Participants
Number of Participants With Mucosal Healing at Week 8, Week 16 and Week 24 Week 16 · Not achieved	27 Participants
Number of Participants With Mucosal Healing at Week 8, Week 16 and Week 24 Week 24 · Achieved	2 Participants
Number of Participants With Mucosal Healing at Week 8, Week 16 and Week 24 Week 24 · Not achieved	0 Participants

SECONDARY outcome

Timeframe: Week 8, Week 16, Week 24 and Week 52

Population: Effectiveness analysis set: all participants who had participated in safety analysis, whose effectiveness data available after 24 weeks of treatment. "Overall Number of Participants Analyzed": participants evaluable for this outcome measure. All participants reported under 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. 'Number Analyzed' signifies participants evaluable for specified rows.

Mucosal healing was defined by Mayo or partial Mayo endoscopic score of 0 or 1 where 0=Normal/inactive disease,1=Mild disease with erythema, decreased vascular pattern, mild friability.

Outcome measures

Measure	Tofacitinib n=57 Participants Participants with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to basic treatments or biological agents and received tofacitinib as part of routine practice at Korean health care centers were observed.
Number of Participants With Mucosal Healing at Week 8, Week 16, Week 24 and Week 52 for Long Term Users Week 8 · Achieved	2 Participants
Number of Participants With Mucosal Healing at Week 8, Week 16, Week 24 and Week 52 for Long Term Users Week 8 · Not achieved	0 Participants
Number of Participants With Mucosal Healing at Week 8, Week 16, Week 24 and Week 52 for Long Term Users Week 16 · Achieved	25 Participants
Number of Participants With Mucosal Healing at Week 8, Week 16, Week 24 and Week 52 for Long Term Users Week 16 · Not achieved	16 Participants
Number of Participants With Mucosal Healing at Week 8, Week 16, Week 24 and Week 52 for Long Term Users Week 24 · Achieved	1 Participants
Number of Participants With Mucosal Healing at Week 8, Week 16, Week 24 and Week 52 for Long Term Users Week 24 · Not achieved	0 Participants
Number of Participants With Mucosal Healing at Week 8, Week 16, Week 24 and Week 52 for Long Term Users Week 52 · Achieved	6 Participants
Number of Participants With Mucosal Healing at Week 8, Week 16, Week 24 and Week 52 for Long Term Users Week 52 · Not achieved	7 Participants

SECONDARY outcome

Timeframe: Week 8, Week 16, and Week 24

Population: Effectiveness analysis: all participants who participated in safety analysis, effectiveness data was available after 24 week(W) of treatment/based on last assessment at time of discontinuation if participant did not complete 24 W of treatment. "Overall Number of Participants Analyzed": participant evaluable for outcome measure. Participant in 'Overall Number of Participants Analyzed' contributed data to table, may not had evaluable data for each row. 'n': participant evaluable for specified row.

Clinical remission was defined as Mayo score being less than or equal to 2 or partial MS <=1 and other sub-scores not more than 1. Total MS score range=0-12, where higher score=severe DA. MS based on 4 clinical evaluation criteria: Stool frequency, Rectal bleeding (RB), Finding of endoscopy, PGA. Each sub score range=0 to 3,higher score=more severe DA. Partial MS= sum of all evaluation criteria, except endoscopy finding. Partial MS total score=0 to 9 where, higher score=more severe disease activity.

Outcome measures

Measure	Tofacitinib n=101 Participants Participants with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to basic treatments or biological agents and received tofacitinib as part of routine practice at Korean health care centers were observed.
Number of Participants With Remission at Week 8, Week 16 and Week 24 Week 8 · Achieved	34 Participants
Number of Participants With Remission at Week 8, Week 16 and Week 24 Week 8 · Not achieved	52 Participants
Number of Participants With Remission at Week 8, Week 16 and Week 24 Week 16 · Achieved	42 Participants
Number of Participants With Remission at Week 8, Week 16 and Week 24 Week 16 · Not achieved	49 Participants
Number of Participants With Remission at Week 8, Week 16 and Week 24 Week 24 · Achieved	34 Participants
Number of Participants With Remission at Week 8, Week 16 and Week 24 Week 24 · Not achieved	26 Participants

SECONDARY outcome

Timeframe: Week 8, Week 16, Week 24 and Week 52

Population: Effectiveness analysis set: all participants who had participated in safety analysis, whose effectiveness data available after 24 weeks of treatment. Overall Number of Participants Analyzed": participants evaluable for this outcome measure. All participants reported under 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. 'Number Analyzed' signifies participants evaluable for specified rows.

Clinical remission was defined as Mayo score being less than or equal to 2 or partial MS <=1 and other sub-scores not more than 1. Total MS score range=0-12, where higher score=severe DA. MS based on 4 clinical evaluation criteria: Stool frequency, Rectal bleeding (RB), Finding of endoscopy, PGA. Each sub score range=0 to 3,higher score=more severe DA. Partial MS= sum of all evaluation criteria, except endoscopy finding. Partial MS total score=0 to 9 where, higher score=more severe disease activity.

Outcome measures

Measure	Tofacitinib n=60 Participants Participants with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to basic treatments or biological agents and received tofacitinib as part of routine practice at Korean health care centers were observed.
Number of Participants With Remission at Week 8, Week 16, Week 24 and Week 52 for Long Term Users Week 8 · Achieved	23 Participants
Number of Participants With Remission at Week 8, Week 16, Week 24 and Week 52 for Long Term Users Week 8 · Not achieved	25 Participants
Number of Participants With Remission at Week 8, Week 16, Week 24 and Week 52 for Long Term Users Week 16 · Achieved	31 Participants
Number of Participants With Remission at Week 8, Week 16, Week 24 and Week 52 for Long Term Users Week 16 · Not achieved	28 Participants
Number of Participants With Remission at Week 8, Week 16, Week 24 and Week 52 for Long Term Users Week 24 · Achieved	29 Participants
Number of Participants With Remission at Week 8, Week 16, Week 24 and Week 52 for Long Term Users Week 24 · Not achieved	18 Participants
Number of Participants With Remission at Week 8, Week 16, Week 24 and Week 52 for Long Term Users Week 52 · Achieved	27 Participants
Number of Participants With Remission at Week 8, Week 16, Week 24 and Week 52 for Long Term Users Week 52 · Not achieved	23 Participants

SECONDARY outcome

Timeframe: Week 8, Week 16 and Week 24

Population: Effectiveness analysis: all participants who participated in safety analysis, effectiveness data was available after 24 week(W) of treatment/based on last assessment at time of discontinuation if participant did not complete 24 W of treatment."Overall Number of Participants Analyzed": participant evaluable for outcome measure.Participant under 'Overall Number of Participants Analyzed' contributed data to table,may not had evaluable data for each row.'n': participants evaluable for specified row.

Clinical response was defined as Mayo score being greater than or equal to 3 point, 30% from baseline, decrease of 1 or more in Rectal bleeding score or rectal bleeding score of 0 or 1. Total MS score range=0-12, where higher score=severe DA. MS based on 4 clinical evaluation criteria: Stool frequency, Rectal bleeding (RB), Finding of endoscopy, PGA. Each sub score range=0 to 3,higher score=more severe DA. Partial MS= sum of all evaluation criteria, except endoscopy finding. Partial MS total score=0 to 9 where, higher score=more severe disease activity.

Outcome measures

Measure	Tofacitinib n=101 Participants Participants with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to basic treatments or biological agents and received tofacitinib as part of routine practice at Korean health care centers were observed.
Number of Participants With Clinical Response at Week 8, Week 16 and Week 24 Week 16 · Not achieved	12 Participants
Number of Participants With Clinical Response at Week 8, Week 16 and Week 24 Week 24 · Achieved	57 Participants
Number of Participants With Clinical Response at Week 8, Week 16 and Week 24 Week 24 · Not achieved	43 Participants
Number of Participants With Clinical Response at Week 8, Week 16 and Week 24 Week 8 · Achieved	78 Participants
Number of Participants With Clinical Response at Week 8, Week 16 and Week 24 Week 8 · Not achieved	22 Participants
Number of Participants With Clinical Response at Week 8, Week 16 and Week 24 Week 16 · Achieved	88 Participants

SECONDARY outcome

Timeframe: Week 8, Week 16, Week 24 and Week 52

Population: Effectiveness analysis set: all participants who had participated in safety analysis, whose effectiveness data available after 24 weeks of treatment. Here, 'Overall Number of participants Analyzed' signifies participants evaluable for this outcome measure.

Clinical response was defined as Mayo score being greater than or equal to 3 point, 30% from baseline, decrease of 1 or more in Rectal bleeding score or rectal bleeding score of 0 or 1. Total MS score range=0-12, where higher score=severe DA. MS based on 4 clinical evaluation criteria: Stool frequency, Rectal bleeding (RB), Finding of endoscopy, PGA. Each sub score range=0 to 3,higher score=more severe DA. Partial MS= sum of all evaluation criteria, except endoscopy finding. Partial MS total score=0 to 9 where, higher score=more severe disease activity.

Outcome measures

Measure	Tofacitinib n=60 Participants Participants with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to basic treatments or biological agents and received tofacitinib as part of routine practice at Korean health care centers were observed.
Number of Participants With Clinical Response at Week 8, Week 16, Week 24 and Week 52 for Long Term Users Week 8 · Achieved	45 Participants
Number of Participants With Clinical Response at Week 8, Week 16, Week 24 and Week 52 for Long Term Users Week 8 · Not achieved	15 Participants
Number of Participants With Clinical Response at Week 8, Week 16, Week 24 and Week 52 for Long Term Users Week 16 · Achieved	58 Participants
Number of Participants With Clinical Response at Week 8, Week 16, Week 24 and Week 52 for Long Term Users Week 16 · Not achieved	2 Participants
Number of Participants With Clinical Response at Week 8, Week 16, Week 24 and Week 52 for Long Term Users Week 24 · Achieved	46 Participants
Number of Participants With Clinical Response at Week 8, Week 16, Week 24 and Week 52 for Long Term Users Week 24 · Not achieved	14 Participants
Number of Participants With Clinical Response at Week 8, Week 16, Week 24 and Week 52 for Long Term Users Week 52 · Achieved	49 Participants
Number of Participants With Clinical Response at Week 8, Week 16, Week 24 and Week 52 for Long Term Users Week 52 · Not achieved	11 Participants

SECONDARY outcome

Timeframe: From first dose of Xeljanz until 24 weeks

Population: Effectiveness analysis set: all participants who had participated in safety analysis, whose effectiveness data available after 24 weeks of treatment or based on last assessment performed at time of treatment discontinuation if participant did not complete 24 weeks of treatment. Here, 'Overall Number of participants Analyzed' signifies participants evaluable for this outcome measure.

The final effectiveness evaluation was determined by the investigator into 4 categories ('Improved', 'Unchanged', 'Aggravated', 'Not assessible'). Improved: Symptoms of ulcerative colitis have improved or showed adequate maintenance effect after taking Xeljanz; Unchanged: Symptoms have not changed much since taking Xeljanz; Aggravated: Symptoms have worsened after taking Xeljanz; Not assessible.

Outcome measures

Measure	Tofacitinib n=101 Participants Participants with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to basic treatments or biological agents and received tofacitinib as part of routine practice at Korean health care centers were observed.
Number of Participants According to Final Effectiveness Evaluation by Investigator Effective, Improved	90 Participants
Number of Participants According to Final Effectiveness Evaluation by Investigator Not-effective, Unchanged	9 Participants
Number of Participants According to Final Effectiveness Evaluation by Investigator Not-effective, Aggravated	2 Participants
Number of Participants According to Final Effectiveness Evaluation by Investigator Not assessible	0 Participants

Adverse Events

Tofacitinib

Serious events: 8 serious events

Other events: 41 other events

Deaths: 0 deaths

Serious adverse events

Measure	Tofacitinib n=107 participants at risk Participants with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to basic treatments or biological agents and received tofacitinib as part of routine practice at Korean health care centers were observed.
Gastrointestinal disorders Abdominal pain	0.93% 1/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
Gastrointestinal disorders Colitis ulcerative	1.9% 2/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
Gastrointestinal disorders Pouchitis	0.93% 1/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
General disorders Drug ineffective	0.93% 1/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
Infections and infestations Anal abscess	0.93% 1/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
Infections and infestations COVID-19	0.93% 1/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
Infections and infestations Cytomegalovirus colitis	0.93% 1/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.

Other adverse events

Measure	Tofacitinib n=107 participants at risk Participants with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to basic treatments or biological agents and received tofacitinib as part of routine practice at Korean health care centers were observed.
Investigations Transaminases increased	0.93% 1/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
Investigations Vitamin D decreased	0.93% 1/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
Investigations Weight increased	0.93% 1/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
Metabolism and nutrition disorders Hypercholesterolaemia	0.93% 1/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
Metabolism and nutrition disorders Hyperlipidaemia	3.7% 4/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
Metabolism and nutrition disorders Hypoalbuminaemia	0.93% 1/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
Metabolism and nutrition disorders Increased appetite	0.93% 1/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
Musculoskeletal and connective tissue disorders Arthralgia	0.93% 1/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
Musculoskeletal and connective tissue disorders Myalgia	2.8% 3/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Essential thrombocythaemia	0.93% 1/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.93% 1/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
Nervous system disorders Dizziness	0.93% 1/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
Nervous system disorders Headache	2.8% 3/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
Nervous system disorders Hypoaesthesia	0.93% 1/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
Nervous system disorders Migraine	0.93% 1/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
Reproductive system and breast disorders Amenorrhoea	0.93% 1/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
Reproductive system and breast disorders Atrophic vulvovaginitis	0.93% 1/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
Reproductive system and breast disorders Cervical polyp	0.93% 1/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
Reproductive system and breast disorders Cervix inflammation	0.93% 1/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
Reproductive system and breast disorders Endometriosis	0.93% 1/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
Reproductive system and breast disorders Menstruation irregular	0.93% 1/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
Skin and subcutaneous tissue disorders Dermatitis	0.93% 1/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.93% 1/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
Skin and subcutaneous tissue disorders Onycholysis	0.93% 1/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
Skin and subcutaneous tissue disorders Rash	1.9% 2/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
Skin and subcutaneous tissue disorders Skin exfoliation	0.93% 1/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.93% 1/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
Blood and lymphatic system disorders Anaemia	6.5% 7/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
Gastrointestinal disorders Abdominal pain	0.93% 1/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
Gastrointestinal disorders Colitis ulcerative	4.7% 5/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
Gastrointestinal disorders Constipation	0.93% 1/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
Gastrointestinal disorders Dyspepsia	0.93% 1/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
Gastrointestinal disorders Gastritis erosive	0.93% 1/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.93% 1/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
Gastrointestinal disorders Oral pain	0.93% 1/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
Gastrointestinal disorders Pancreatitis acute	0.93% 1/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
Gastrointestinal disorders Proctalgia	0.93% 1/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
General disorders Chest discomfort	0.93% 1/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
General disorders Drug ineffective	0.93% 1/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
General disorders Loss of therapeutic response	0.93% 1/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
General disorders Pain	0.93% 1/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
General disorders Pyrexia	2.8% 3/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
Infections and infestations Anal abscess	0.93% 1/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
Infections and infestations COVID-19	0.93% 1/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
Infections and infestations Clostridium difficile infection	0.93% 1/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
Infections and infestations Cytomegalovirus colitis	0.93% 1/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
Infections and infestations Gastroenteritis	0.93% 1/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
Infections and infestations Periodontitis	0.93% 1/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
Injury, poisoning and procedural complications Spinal column injury	0.93% 1/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
Investigations Alanine aminotransferase increased	0.93% 1/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
Investigations Aspartate aminotransferase increased	1.9% 2/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
Investigations Blood cholesterol increased	1.9% 2/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
Investigations Blood creatinine increased	0.93% 1/107 • From first dose of Xeljanz until 52 weeks An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
• Publication restrictions are in place

Restriction type: OTHER