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The objective of this study is to identify any problems and questions with respect to the safety and efficacy of Xeljanz during the post-marketing period as required by the regulation of MFDS.
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs), Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs) | 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. | From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years) |
| Number of Participants With Unexpected AEs, Unexpected SAEs, Unexpected ADRs and Unexpected SADRs | 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. | From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years) |
| Duration of Adverse Events |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in DAS28 (ESR) | 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. |
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Inclusion Criteria:
To be included in the study all patients will have received at least 1 dose of Xeljanz for the treatment of the following indication as per local labelling. Moderately to severely active RA in adult patients who have had an inadequate response or intolerance to previous therapy with at least 1 biological DMARD. Or Active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to previous antirheumatic drugs (DMARDs)
Exclusion Criteria:
According to Contraindication on label, the investigator should discontinue the patient's treatment if the laboratory test results are as below Patients with an absolute neutrophil count (ANC) <500 cells/mm3 Patients with a hemoglobin level <8 g/dL
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adult rheumatoid arthritis or psoriatic arthritis taking tofacitinib within label as Ministry of Food and Drung Safety in Korea has approved
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soonchunhyang University Cheonan Hospital, Department of Rheumatology | Chunan-si | Chungcheongnam-do | 330-721 | South Korea | ||
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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This was a study conducted in Korea. The investigator enrolled participants to whom Xeljanz was prescribed for the first time according to the local product document and who agreed to participate in this study. Xeljanz was administered according to the "Dosage and Administration" of the approved labeling.
Xeljanz was medicated by the investigator's prescription under usual clinical practice.
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| ID | Title | Description |
|---|---|---|
| FG000 | Post-Marketing Surveillance: Xeljanz | Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 26, 2022 | May 19, 2023 |
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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. |
| From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years) |
| Number of Participants With Adverse Events by Their Severity | 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. | From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years) |
| Number of Participants With Adverse Events by Their Outcome | 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. | From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years) |
| Number of Participants With Adverse Events by Their Seriousness Criteria | 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. | From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years) |
| Number of Participants With Adverse Events by Their Action Taken With Regard to 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. 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. | From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years) |
| Number of Participants With Adverse Events by Their Causality to 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. 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. | From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years) |
| Number of Participants With Adverse Events According to Demographic Characteristics | 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. | From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years) |
| Number of Participants With Adverse Events According to Other Baseline Characteristics | 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. | From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years) |
| Number of Participants With Adverse Events - Multivariate Logistic Regression Analysis | 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. | From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years) |
| Number of Geriatric Participants With Adverse Events and Adverse Drug Reactions | 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. | From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years) |
| Number of Participants With Adverse Events and Adverse Drug Reactions - Renal Disorder | 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. | From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years) |
| Number of Participants With Adverse Events and Adverse Drug Reactions - Hepatic Disorder | 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. | From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years) |
| Number of Participants With Adverse Events and Adverse Drug Reactions - Other Than Safety Analysis Population | 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. | From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years) |
| From Baseline to 6 months after treatment (through study completion, up to approximately 6 years) |
| Change From Baseline in DAS28 (CRP) | 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. | From Baseline to 6 months after treatment (through study completion, up to approximately 6 years) |
| Number of Participants With EULAR Response | 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. | From Baseline to 6 months after treatment (through study completion, up to approximately 6 years) |
| Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Month 6 | 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. | From Baseline to 6 months after treatment (through study completion, up to approximately 6 years) |
| Number of Participants With Effectiveness | 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. | From Baseline to 6 months after treatment (through study completion, up to approximately 6 years) |
| Number of Participants With Effectiveness by Demographic Characteristics | 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. | From Baseline to 6 months after treatment (through study completion, up to approximately 6 years) |
| Number of Participants With Improved Effectiveness - Multivariate Logistic Regression Analysis | 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. | From Baseline to 6 months after treatment (through study completion, up to approximately 6 years) |
| Keimyung University Dongsan Medical Center |
| Jung-Gu |
| Daegu |
| 700-712 |
| South Korea |
| Kongyang University Hospital / Rheumatology | Seogu | Daejon | 35365 | South Korea |
| Myongji Hospital / Rheumatology | Goyang-si | Deogyang-gu | 10475 | South Korea |
| Kyung Hee University Hospital at Gangdong / Rheumatology | Seoul | Gangdong-gu | 05278 | South Korea |
| VHS Medical Center / Rheumatologist | Seoul | Gangdong-gu | 05367 | South Korea |
| Hallym University Chuncheon Sacred Heart Hospital | Chuncheon | Gangwon-do | 24253 | South Korea |
| Chosun University Hospital, Rheumatism Department | Donggu | Gwang JU | 61453 | South Korea |
| Division of Rheumatology | Seongnam-si | Gyeongg-do | South Korea |
| CHA Bundang Medical Center | Seongnam-si | Gyeonggi-do | 13496 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
| Pusan National University Yangsan Hospital | Yangsan | Gyeongsangnam-do | 50612 | South Korea |
| Yangsan Hospital-Pusan National University | Yangsan | Gyeongsangnam-do | 50612 | South Korea |
| Chonbuk National University Hospital, Department of Rheumatology | Jeonju | Jeollabuk-do | 561-712 | South Korea |
| Wonkwang University Hospital / Division of Rheumatology | Iksan | Jeonlabuk-do | 570711 | South Korea |
| Ajou University Hospital, Department of Rheumatology | Suwon | Kyeongki-do | 442-712 | South Korea |
| Korea University Ansan Hospital | Ansan, Gyeonggi-do | South Korea |
| Inje University Busan Paik hospital | Busan | 47392 | South Korea |
| Kosin University Gospel Hospital | Busan | 607-702 | South Korea |
| Inje University Haeundae Paik Hospital | Busan | 612-896 | South Korea |
| Chungbuk National University Hospital | Chungcheongbuk-do | 28644 | South Korea |
| Daegu Catholic University Medical Center, Department of Rheumatology | Daegu | 705-718 | South Korea |
| Eulji University Hospital, Internal Medicine, Rheumatology | Daejeon | 302-799 | South Korea |
| Yongin Severance Hospital | Giheung-gu, Yongin-si, Gyeonggi-do | South Korea |
| Inje University IlsanPaik Hospital | Goyang-si, Gyeonggi-do | South Korea |
| Dongguk University Ilsan Medical Center | Gyeonggi-do | South Korea |
| Gachon University Gil Hospital | Incheon | 405-760 | South Korea |
| Division of Rheumatology | Incheon | South Korea |
| Jeju National University Hospital | Jeju Special Self-Goverming Province | South Korea |
| Division of Rheumatology | Metropolitan City, Daejeon | South Korea |
| Pusan National University Hospital | Pusan | 602-739 | South Korea |
| Dong-A University Hospital | Pusan | South Korea |
| Hanyang Rheuma Uhm Wan-Sik Clinic | Seoul | 04782 | South Korea |
| Division of Rheumatology, SMG-SNU Boramae Medical Center | Seoul | 07061 | South Korea |
| Seoul National University Hospital, Department of Internal Medicine | Seoul | 110-744 | South Korea |
| Seoul National University Hospital, Rheumatology, Internal Medicine | Seoul | 110-744 | South Korea |
| Kyung Hee University Hospital | Seoul | 130-872 | South Korea |
| Hanyang University Hospital, Department of Rheumatology | Seoul | 133-792 | South Korea |
| Kyunghee University East-West Neo Medical Center, 149 Sangil-dong, Gangdong-gu | Seoul | 134-890 | South Korea |
| Samsung Medical Center, Division of Rheumatology, Department of Medicine | Seoul | 135-710 | South Korea |
| The Catholic University of Korea, Kangnam St. Mary's Hospital/ Rheumatology, Internal Medicine | Seoul | 137-701 | South Korea |
| The Catholic University of Korea, Seoul St. Mary's Hospital/ Rheumatology, Internal Medicine | Seoul | 137-701 | South Korea |
| Eulji Medical Center | Seoul | 139-711 | South Korea |
| Soonchunhyang University Hospital Seoul/Department of Rheumatology | Seoul | 140-887 | South Korea |
| Konkuk University Medical Center | Seoul | 143-729 | South Korea |
| Division of Rheumatology | Seoul | South Korea |
| Ewha Womans University Mokdong Hospital | Seoul | South Korea |
| Hallym University Kangnam Sacred Heart Hospital | Seoul | South Korea |
| Kyung Hee University Medical Center | Seoul | South Korea |
| COMPLETED |
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| NOT COMPLETED |
|
|
Safety analysis set included all participants who received at least 1 dose of Xeljanz according to local product document and was assessed for safety information.
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| ID | Title | Description |
|---|---|---|
| BG000 | Post-Marketing Surveillance: Xeljanz | Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Indication, RA/PsA | RA = rheumatoid arthritis, PsA = psoriatic arthritis. | Count of Participants | Participants |
| |||||||||||||||||
| Duration of the disease, Continuous | The duration of disease since the date that the participant was initially diagnosed with RA or PsA was recorded. | Mean | Standard Deviation | Months |
| ||||||||||||||||
| Duration of the disease, Customized | The duration of disease since the date that the participant was initially diagnosed with RA or PsA was recorded. | Count of Participants | Participants |
| |||||||||||||||||
| Severity of disease activity, High/Moderate/Low/Not assessed | Disease Activity Score 18 (DAS28) >5.1 is considered to be indicative of high disease activity; DAS28 >3.2 and ≤5.1 indicates moderate disease activity; DAS28 ≤3.2 indicates low disease activity. | Count of Participants | Participants |
| |||||||||||||||||
| Radiologic progression, Yes/No/Not assessed | Radiologic progression based on clinically relevant evaluation methods, such as X-ray, ultrasonography, or magnetic resonance imaging was recorded. | Count of Participants | Participants |
| |||||||||||||||||
| Status of latent tuberculosis, Yes/No/Unknown | Count of Participants | Participants |
| ||||||||||||||||||
| Herpes zoster Vaccination, Yes/No/Unknown | Count of Participants | Participants |
| ||||||||||||||||||
| Smoking, Ex-smoking/Current smoking/Non-smoking/Unknown | Count of Participants | Participants |
| ||||||||||||||||||
| Renal disorder, Yes/No | Count of Participants | Participants |
| ||||||||||||||||||
| Hepatic disorder, Yes/No | Count of Participants | Participants |
| ||||||||||||||||||
| Allergic history, Yes/No | Count of Participants | Participants |
| ||||||||||||||||||
| Prior rheumatoid arthritis therapy, Yes/No | Count of Participants | Participants |
| ||||||||||||||||||
| Concomitant medication, Yes/No | Number of participants who received concomitant medication were recorded. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs), Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs) | 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. | The safety analysis set included all participants who had received at least 1 dose of Xeljanz according to local product document and had been assessed for safety information including AEs by investigator. | Posted | Count of Participants | Participants | From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years) |
|
|
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| Primary | Number of Participants With Unexpected AEs, Unexpected SAEs, Unexpected ADRs and Unexpected SADRs | 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. | The safety analysis set included all participants who had received at least 1 dose of Xeljanz according to local product document and had been assessed for safety information including AEs by investigator. | Posted | Count of Participants | Participants | From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years) |
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| Primary | Duration of Adverse Events | 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 safety analysis set included all participants who had received at least 1 dose of Xeljanz according to local product document and had been assessed for safety information including AEs by investigator. | Posted | Median | Full Range | Days | From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years) |
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| Primary | Number of Participants With Adverse Events by Their Severity | 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. | The safety analysis set included all participants who had received at least 1 dose of Xeljanz according to local product document and had been assessed for safety information including AEs by investigator. | Posted | Count of Participants | Participants | From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years) |
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| Primary | Number of Participants With Adverse Events by Their Outcome | 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. | The safety analysis set included all participants who had received at least 1 dose of Xeljanz according to local product document and had been assessed for safety information including AEs by investigator. | Posted | Count of Participants | Participants | From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years) |
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| Primary | Number of Participants With Adverse Events by Their Seriousness Criteria | 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. | The safety analysis set included all participants who had received at least 1 dose of Xeljanz according to local product document and had been assessed for safety information including AEs by investigator. | Posted | Count of Participants | Participants | From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years) |
|
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| Primary | Number of Participants With Adverse Events by Their Action Taken With Regard to 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. 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. | The safety analysis set included all participants who had received at least 1 dose of Xeljanz according to local product document and had been assessed for safety information including AEs by investigator. | Posted | Count of Participants | Participants | From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years) |
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| Primary | Number of Participants With Adverse Events by Their Causality to 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. 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. | The safety analysis set included all participants who had received at least 1 dose of Xeljanz according to local product document and had been assessed for safety information including AEs by investigator. | Posted | Count of Participants | Participants | From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years) |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Adverse Events According to Demographic Characteristics | 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. | The safety analysis set included all participants who had received at least 1 dose of Xeljanz according to local product document and had been assessed for safety information including AEs by investigator. | Posted | Count of Participants | Participants | From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years) |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Adverse Events According to Other Baseline Characteristics | 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. | The safety analysis set included all participants who had received at least 1 dose of Xeljanz according to local product document and had been assessed for safety information including AEs by investigator. | Posted | Count of Participants | Participants | From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years) |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Adverse Events - Multivariate Logistic Regression Analysis | 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. | The safety analysis set included all participants who had received at least 1 dose of Xeljanz according to local product document and had been assessed for safety information including AEs by investigator. | Posted | Number | Participants | From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years) |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Geriatric Participants With Adverse Events and Adverse Drug Reactions | 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. | The population included geriatric participants (aged >=65 years) in the safety population. | Posted | Count of Participants | Participants | From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years) |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Adverse Events and Adverse Drug Reactions - Renal Disorder | 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. | The population included participants with renal disorder in the safety population. | Posted | Count of Participants | Participants | From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years) |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Adverse Events and Adverse Drug Reactions - Hepatic Disorder | 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. | The population included participants with hepatic disorder in the safety population. | Posted | Count of Participants | Participants | From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years) |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Adverse Events and Adverse Drug Reactions - Other Than Safety Analysis Population | 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. | The population included participants excluded from the safety population. | Posted | Count of Participants | Participants | From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in DAS28 (ESR) | 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. | The analysis set included all participants who received at least 1 dose of Xeljanz and were available for an effectiveness assessment. | Posted | Mean | Standard Deviation | Scores on a scale | From Baseline to 6 months after treatment (through study completion, up to approximately 6 years) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in DAS28 (CRP) | 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. | The analysis set included all participants who received at least 1 dose of Xeljanz and were available for an effectiveness assessment. | Posted | Mean | Standard Deviation | Scores on a scale | From Baseline to 6 months after treatment (through study completion, up to approximately 6 years) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With EULAR Response | 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. | The analysis set included all participants who received at least 1 dose of Xeljanz and were available for an effectiveness assessment. | Posted | Count of Participants | Participants | From Baseline to 6 months after treatment (through study completion, up to approximately 6 years) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Month 6 | 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 analysis set included all participants who received at least 1 dose of Xeljanz and were available for an effectiveness assessment. | Posted | Count of Participants | Participants | From Baseline to 6 months after treatment (through study completion, up to approximately 6 years) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Effectiveness | 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 analysis set included all participants who received at least 1 dose of Xeljanz and were available for an effectiveness assessment. | Posted | Count of Participants | Participants | From Baseline to 6 months after treatment (through study completion, up to approximately 6 years) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Effectiveness by Demographic Characteristics | 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 analysis set included all participants who received at least 1 dose of Xeljanz and were available for an effectiveness assessment and with improved effectiveness. | Posted | Count of Participants | Participants | From Baseline to 6 months after treatment (through study completion, up to approximately 6 years) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Improved Effectiveness - Multivariate Logistic Regression Analysis | 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. | The analysis set included all participants who received at least 1 dose of Xeljanz and were available for an effectiveness assessment and with improved effectiveness. | Posted | Count of Participants | Participants | From Baseline to 6 months after treatment (through study completion, up to approximately 6 years) |
|
|
From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Post-Marketing Surveillance: Xeljanz | Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years. | 2 | 1,009 | 40 | 1,009 | 261 | 1,009 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure congestive | Cardiac disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Peritonsillar abscess | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Sinusitis fungal | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Cartilage injury | Injury, poisoning and procedural complications | MedDRA 24.1 | Non-systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Non-systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Non-systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Non-systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Non-systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Mononeuritis | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Type IIa hyperlipidaemia | Congenital, familial and genetic disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Deafness | Ear and labyrinth disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Gastrointestinal inflammation | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Hyperchlorhydria | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Face oedema | General disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Swelling face | General disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Gallbladder polyp | Hepatobiliary disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Hepatic steatosis | Hepatobiliary disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Periodontitis | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Tinea cruris | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Tinea versicolour | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Non-systematic Assessment |
| |
| Muscle rupture | Injury, poisoning and procedural complications | MedDRA 24.1 | Non-systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase abnormal | Investigations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase abnormal | Investigations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 24.1 | Non-systematic Assessment |
| |
| High density lipoprotein increased | Investigations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Rheumatoid nodule | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Cerebral artery occlusion | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Cerebral artery stenosis | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Post herpetic neuralgia | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Tension headache | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Renal cyst | Renal and urinary disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Breast mass | Reproductive system and breast disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Heavy menstrual bleeding | Reproductive system and breast disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Scrotal pain | Reproductive system and breast disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Vocal cord thickening | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 24.1 | Non-systematic Assessment |
|
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 disclosure previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 24, 2021 | May 19, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
Not provided
Not provided
|
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| >= 50 years and < 60 years |
|
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| >= 60 years and < 70 years |
|
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| >= 70 years |
|
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| PsA |
|
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| >= 3 years and < 6 years |
|
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| >= 6 years and < 9 years |
|
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| >= 9 years and < 12 years |
|
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| >= 12 years |
|
|
| Unknown |
|
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| Moderate (DAS28 > 3.2 and <= 5.1) |
|
|
| Low (DAS28 <= 3.2) |
|
|
| Not assessed |
|
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| No |
|
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| Not assessed |
|
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|
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| Unknown |
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|
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| Unknown |
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| Non-smoking |
|
|
| Unknown |
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|
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| No |
|
|
| Title | Measurements |
|---|---|
|
| Serious Adverse Drug Reactions(SADRs) |
|
| Adverse Events of Special Interest |
|
| Adverse Drug Reactions of Special Interest |
|
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|
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| Participants |
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