As required for new medications approved by the Ministry of Food and Drug Safety, safety and efficacy information should be provided for a minimum of 90 patients treated in the setting of routine practice during 4 years following approval (until 19 September 2022). Out of all the enrolled patients, at least 18 cases (20%) will be followed up until the 52nd week to see the long term safety of Xeljanz.
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Percentage of Participants With Adverse Events, Adverse Drug Reactions, Serious Adverse Events and Serious Adverse Drug Reactions
Timeframe: From first dose of Xeljanz until 52 weeks
Number of Participants With Adverse Events, Adverse Drug Reactions, Serious Adverse Events and Serious Adverse Drug Reactions in Long Term Users
Timeframe: From first dose of Xeljanz until 52 weeks
Percentage of Participants With Unexpected Adverse Events (AE), Unexpected Adverse Drug Reactions, Unexpected Serious Adverse Events (SAE), and Unexpected Serious Adverse Drug Reactions
Timeframe: From first dose of Xeljanz until 52 weeks
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
Timeframe: From first dose of Xeljanz until 52 weeks
Percentage of Participants With Adverse Events of Special Interest
Timeframe: From first dose of Xeljanz until 52 weeks
Number of Participants With Adverse Events of Special Interest in Long Term Users
Timeframe: From first dose of Xeljanz until 52 weeks
Number of Participants With Adverse Events by Their Severity
Timeframe: From first dose of Xeljanz until 52 weeks
Number of Participants With Adverse Events by Their Severity in Long Term Users
Timeframe: From first dose of Xeljanz until 52 weeks
Number of Participants With Adverse Events by Their Outcomes
Timeframe: From first dose of Xeljanz until 52 weeks
Number of Participants With Adverse Events by Their Outcomes in Long Term Users
Timeframe: From first dose of Xeljanz until 52 weeks
Number of Participants With Adverse Events by Their Seriousness
Timeframe: From first dose of Xeljanz until 52 weeks
Number of Participants With Adverse Events by Their Seriousness in Long Term Users
Timeframe: From first dose of Xeljanz until 52 weeks
Number of Participants With Adverse Events by Action Taken
Timeframe: From first dose of Xeljanz until 52 weeks
Number of Participants With Adverse Events by Action Taken in Long Term Users
Timeframe: From first dose of Xeljanz until 52 weeks
Number of Participants With Adverse Events by Their Causality Assessment
Timeframe: From first dose of Xeljanz until 52 weeks
Number of Participants With Adverse Events by Their Causality Assessment in Long Term Users
Timeframe: From first dose of Xeljanz until 52 weeks
Number of Participants With Adverse Events by Their Other Causality Assessment
Timeframe: From first dose of Xeljanz until 52 weeks
Number of Participants With Adverse Events by Their Other Causality Assessment in Long Term Users
Timeframe: From first dose of Xeljanz until 52 weeks