Korean Post-marketing Surveillance for Xeljanz

An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. SAE was any untoward medical occurrence that at any dose resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity; congenital anomaly/birth defect. An ADR was any untoward medical occurrence attributed to Xeljanz in a participant who received Xeljanz. SADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Relatedness to Xeljanz was assessed by the physician.

An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. SAE was any untoward medical occurrence that at any dose resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity; congenital anomaly/birth defect. An ADR was any untoward medical occurrence attributed to Xeljanz in a participant who received Xeljanz. SADR was any SAE that is attributed to Xeljanz. Relatedness to Xeljanz was assessed by the physician. An unexpected AE was an AE with a difference in nature, severity, specificity, or outcome, compared to the product licensure/safety notification of the drug. Unexpected ADRs were unexpected AEs that were, in the investigator's opinion, of causal relationship to the study treatment.

An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. Only participants with available data are reported.

The evaluation of AE severity was done according to the following categories: mild: not causing any significant problem to the participant. Administration of medicinal product continues without dose adjustment. Moderate: causes a problem that dose not interfere significantly with usual activities or the clinical status. Dose of the medical product is adjusted or other therapy is added due to the AE. Severe: causes a problem that interferes significantly with usual activities or the clinical status. The medicinal product is stopped due to the AE. Only participants with available severity assessment data are reported.

An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. The outcomes of AE included recovered, recovered with sequelae, recovering, not recovered and unknown. One participant may experience more than one event hence one participant may be included in more than one category specified below. Only participants with available outcome assessment are reported.

An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. The seriousness criteria for AEs included 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. Only participants with available seriousness assessment data are reported.

An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship. The action taken with regard to the medicinal product included: permanently discontinued, temporarily discontinued or delayed, dose reduced, dose increased, no change, not applicable. Only participants with available action taken assessment data are reported.

An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship. The causality of AEs to Xeljanz were assessed by physician according to the following criteria: certain, probable/likely, possible, unlikely, conditional/unclassified and unassessible/unclassifiable. One participant may experience more than one event hence, one participant may be included in more than one category specified below. Only participants with available causality assessment data are reported.

An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. Number of participants with AEs classified according to the following demographic characteristics: sex: male and female; age: less than (<) 40 years, greater than or equal to (>=) 40 and < 50 years and >= 50 years and <60 years; >= 60 and <70 years; geriatric (>=65 years). Only participants with available demographic and AE assessment data are reported.

Other baseline characteristics included: indication; duration of the disease; severity of disease; radiologic progression; status of latent tuberculosis; herpes zoster vaccination; smoking; prior rheumatoid arthritis therapy; medical history; renal disorder; hepatic disorder; allergic history; concomitant medication; duration of administration. Only participants with available other baseline characteristics and AE assessment data are reported.

An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. Logistic regression analysis of multivariate analysis was performed and presented an odds ratio with 95% confidence interval to identify the factors that affect occurrence of AEs in demography and baseline characteristics, or concomitant treatment status, etc.

An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. An ADR was any untoward medical occurrence attributed to Xeljanz in a participant who received Xeljanz.

An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. An ADR was any untoward medical occurrence attributed to Xeljanz in a participant who received Xeljanz. Renal disorder was judged by the investigator.

An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. An ADR was any untoward medical occurrence attributed to Xeljanz in a participant who received Xeljanz. Hepatic disorder was judged by the investigator.

An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. An ADR was any untoward medical occurrence attributed to Xeljanz in a participant who received Xeljanz. AEs and ADRs for participants excluded from the safety analysis population were reported. The reason for exclusion included: not met the inclusion criteria/met exclusion criteria; off-label use; other significant protocol violation.

DAS28 is a modified version of the original Disease Activity Score (DAS). It is a quantitative measure of disease activity used to monitor the treatment or RA. DAS28 (erythrocyte sedimentation rate [ESR]) was calculated from: DAS28 (ESR) = 0.56*√(tender joint counter [TJC] 28) + 0.28*√(swollen joint count [SJC] 28) + 0.014*VAS+ 0.70*ln(ESR), where VAS = visual analogue scale. Total score range: 0-9.4, higher score=more disease activity.

DAS28 is a modified version of the original Disease Activity Score (DAS). It is a quantitative measure of disease activity used to monitor the treatment or RA. DAS28-3 ( C-reactive protein [CRP]) was calculated from the swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity.

European League Against Rheumatism (EULAR) response is a DAS-based response criteria that classifies individual participants as none, moderate, or good responders, depending on the extent of change and the level of disease activity reached. Participants with improvement in DAS28 from baseline >1.2 and DAS28 based EULAR <=3.2 were good responders; participants with improvement in DAS28 from baseline >0.6 and <=1.2 and DAS28 based EULAR >3.2 and <=5.1 were moderate responders; participants with improvement in DAS28 from baseline <=0.6 and DAS28-based EULAR >5.1 were none responders.

ACR20 response: ≥20% improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and CRP.

The variables included DAS28, EULAR response, and ACR20 response. The investigator made the assessment of the overall effectiveness as improved, no change, or aggravated, based on each test results and clinical judgment. No change and aggravated were classified as ineffective.

The variables included DAS28, EULAR response, and ACR20 response. The investigator made the assessment of the overall effectiveness as improved, no change, or aggravated, based on each test results and clinical judgment.

The variables included DAS28, EULAR response, and ACR20 response. The investigator made the assessment of the overall effectiveness as improved, no change, or aggravated, based on each test results and clinical judgment. Logistic regression analysis of multivariate analysis was performed and presented as odds ratios with 95% confidence interval to identify the factors that affected classified overall assessment (effective/ineffective) in demography and baseline characteristics of the participants.