Trial Outcomes & Findings for IDentification of Factors Predictive of Tofacitinib's Survival in Patient With Rheumatoid Arthritis (NCT NCT03981900)

NCT ID: NCT03981900

Last Updated: 2024-10-01

Results Overview

The duration of tofacitinib drug survival was calculated as: date of permanent drug discontinuation minus date of first taking the drug + 1. If a participant did not present with the event of interest, that is they did not have a permanent drug discontinuation record during the study, then they were censored at the time of their last visit. Kaplan-Meier method was used for estimation.

Recruitment status

COMPLETED

Target enrollment

314 participants

Primary outcome timeframe

Date of initiation of study drug treatment up to date of permanent drug discontinuation or date of censoring (up to a maximum of 48 months)

Results posted on

2024-10-01

Participant Flow

Participants diagnosed with moderate-to-severe active rheumatoid arthritis who initiated Tofacitinib in the real-world setting were observed in this study.

Participant milestones

Participant milestones
Measure	Tofacitinib Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).
Overall Study STARTED	314
Overall Study Safety Analysis Set (SAS)	309
Overall Study Full Analysis Set (FAS)	306
Overall Study COMPLETED	227
Overall Study NOT COMPLETED	87

Reasons for withdrawal

Reasons for withdrawal
Measure	Tofacitinib Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).
Overall Study Participant decision - Without withdrawal of consent	17
Overall Study Adverse Event	5
Overall Study Protocol Violation	1
Overall Study Withdrawal by Subject	7
Overall Study Lost to Follow-up	46
Overall Study Decision of the researcher	3
Overall Study Death	3
Overall Study Other	5

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tofacitinib n=309 Participants Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).
Age, Customized < 65 years	194 Participants n=309 Participants
Age, Customized >= 65 Years	112 Participants n=309 Participants
Age, Customized Missing	3 Participants n=309 Participants
Sex/Gender, Customized Female	241 Participants n=309 Participants
Sex/Gender, Customized Male	65 Participants n=309 Participants
Sex/Gender, Customized Missing	3 Participants n=309 Participants

PRIMARY outcome

Timeframe: Date of initiation of study drug treatment up to date of permanent drug discontinuation or date of censoring (up to a maximum of 48 months)

Population: Full analysis set population included participants who met the eligibility criteria, received at least one dose of Tofacitinib and had at least one set of post-baseline measurements.

Outcome measures

Outcome measures
Measure	Tofacitinib n=306 Participants Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).
Duration of Tofacitinib Drug Survival	26.4 Months Interval 24.1 to Data for the upper limit of 95% CI was not estimable due to insufficient follow-up in this study.

SECONDARY outcome

Timeframe: Baseline, Month 1, 3, 6, 12, 18 and 24

Population: Full analysis set population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. Here, "Number of participants analyzed" signifies number of participants evaluable and contributed to data for this outcome measure. Here, "Number Analyzed" signifies number of participants evaluable at specified time points. No imputation used for missing values.

PCS is a 13 item questionnaire around thoughts and emotions experienced during pain, with each question scored on a 5-point scale ranging from 0 (not at all) to 4 (all the time), where higher scores indicated worse condition. There are three subscales of PCS: rumination (thinking deeply) \[4 items\], exaggeration \[3 items\] and helplessness \[6 items\]. Total scores and domain scores are derived by summing the scores of the individual items. Overall possible Total PCS score range is 0 to 52, where higher scores signifies worse condition. A total score of greater than or equal to (\>=) 20 indicates a clinically relevant level of catastrophising. Mean change from baseline in total PCS score is reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Tofacitinib n=231 Participants Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).
Change From Baseline in Total Pain Catastrophising Scale (PCS) Score at Month 1, 3, 6, 12, 18 and 24 Baseline	20.4 Units on a scale Standard Deviation 14.0
Change From Baseline in Total Pain Catastrophising Scale (PCS) Score at Month 1, 3, 6, 12, 18 and 24 Change at Month 1	-5.2 Units on a scale Standard Deviation 10.4
Change From Baseline in Total Pain Catastrophising Scale (PCS) Score at Month 1, 3, 6, 12, 18 and 24 Change at Month 3	-6.6 Units on a scale Standard Deviation 11.1
Change From Baseline in Total Pain Catastrophising Scale (PCS) Score at Month 1, 3, 6, 12, 18 and 24 Change at Month 6	-8.4 Units on a scale Standard Deviation 11.4
Change From Baseline in Total Pain Catastrophising Scale (PCS) Score at Month 1, 3, 6, 12, 18 and 24 Change at Month 12	-8.2 Units on a scale Standard Deviation 11.6
Change From Baseline in Total Pain Catastrophising Scale (PCS) Score at Month 1, 3, 6, 12, 18 and 24 Change at Month 18	-8.8 Units on a scale Standard Deviation 11.2
Change From Baseline in Total Pain Catastrophising Scale (PCS) Score at Month 1, 3, 6, 12, 18 and 24 Change at Month 24	-8.7 Units on a scale Standard Deviation 10.8

SECONDARY outcome

Timeframe: Baseline, Month 1, 3, 6 12, 18 and 24

Population: Full analysis set population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. Here, "Number Analyzed" signifies number of participants evaluable at specified time points. No imputation used for missing values.

CSQ evaluates cognitive coping, has 21 items and 5 domains in its French version. For each item, participants rate the frequency of their use of each coping strategy on a 4- point Likert-type scale (0= Never, 1= sometimes, 2= often and 3= very often). Domain scores are derived by summing the individual items scores that make-up the domain. Five domains with score range: distraction (5 items, score range: 0 to 15), catastrophising (4 items, score range: 0 to 12), distancing from pain (4 items, score range: 0 to 12), ignoring pain sensations (5 items, score range: 0 to 15) and praying (3 items, score range: 0 to 9). For each domain, higher scores indicated worse condition. Mean change from baseline in CSQ domain scores are reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Tofacitinib n=306 Participants Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).
Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24 Distraction at baseline	13.2 Units on a scale Standard Deviation 3.8
Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24 Catastrophising at baseline	8.4 Units on a scale Standard Deviation 3.0
Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24 Distancing from Pain at baseline	7.3 Units on a scale Standard Deviation 3.2
Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24 Ignoring Pain Sensations at baseline	11.3 Units on a scale Standard Deviation 3.6
Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24 Praying at baseline	5.6 Units on a scale Standard Deviation 2.9
Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24 Distraction, Change at month 1	-0.4 Units on a scale Standard Deviation 3.3
Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24 Catastrophising, Change at month 1	-0.6 Units on a scale Standard Deviation 2.8
Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24 Distancing from Pain, Change at month 1	-0.0 Units on a scale Standard Deviation 2.9
Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24 Ignoring Pain Sensations, Change at month 1	-0.7 Units on a scale Standard Deviation 3.7
Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24 Praying, Change at month 1	-0.1 Units on a scale Standard Deviation 2.2
Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24 Distraction, Change at month 3	-0.9 Units on a scale Standard Deviation 4.5
Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24 Catastrophising, Change at month 3	-1.0 Units on a scale Standard Deviation 3.3
Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24 Distancing from Pain, Change at month 3	-0.2 Units on a scale Standard Deviation 3.9
Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24 Ignoring Pain Sensations, Change at month 3	-0.2 Units on a scale Standard Deviation 4.1
Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24 Praying, Change at month 3	-0.5 Units on a scale Standard Deviation 2.0
Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24 Distraction, Change at month 6	-1.5 Units on a scale Standard Deviation 4.2
Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24 Catastrophising, Change at month 6	-1.5 Units on a scale Standard Deviation 2.6
Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24 Distancing from Pain, Change at month 6	-0.5 Units on a scale Standard Deviation 4.1
Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24 Ignoring Pain Sensations, Change at month 6	-0.3 Units on a scale Standard Deviation 4.4
Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24 Praying, Change at month 6	-0.7 Units on a scale Standard Deviation 2.1
Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24 Distraction, Change at month 12	-1.5 Units on a scale Standard Deviation 4.3
Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24 Catastrophising, Change at month 12	-1.8 Units on a scale Standard Deviation 2.4
Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24 Distancing from Pain, Change at month 12	-0.6 Units on a scale Standard Deviation 3.9
Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24 Ignoring Pain Sensations, Change at month 12	-0.9 Units on a scale Standard Deviation 4.5
Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24 Praying, Change at month 12	-0.7 Units on a scale Standard Deviation 2.2
Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24 Distraction, Change at month 18	-1.5 Units on a scale Standard Deviation 4.5
Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24 Catastrophising, Change at month 18	-1.6 Units on a scale Standard Deviation 2.7
Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24 Distancing from Pain, Change at month 18	-0.5 Units on a scale Standard Deviation 3.3
Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24 Ignoring Pain Sensations, Change at month 18	-0.8 Units on a scale Standard Deviation 4.4
Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24 Praying, Change at month 18	-0.6 Units on a scale Standard Deviation 2.2
Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24 Distraction, Change at month 24	-1.6 Units on a scale Standard Deviation 5.4
Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24 Catastrophising, Change at month 24	-1.6 Units on a scale Standard Deviation 2.6
Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24 Distancing from Pain, Change at month 24	-0.7 Units on a scale Standard Deviation 2.8
Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24 Ignoring Pain Sensations, Change at month 24	-0.5 Units on a scale Standard Deviation 4.4
Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24 Praying, Change at month 24	-0.7 Units on a scale Standard Deviation 2.2

SECONDARY outcome

Timeframe: Baseline, Month 1, 3, 6, 12 18, and 24

Population: Full analysis set population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. Here, "Number Analyzed" signifies number of participants evaluable at specified time points. No imputation used for missing values.

DAS28-4 ESR is a composite endpoint, calculated using 4 variables (represented by '4' in the name). Components includes: Tender Joint Count (TJC) with 28 joints assessed, Swollen Joint Count (SJC) with 28 joints assessed, ESR (millimeter per hours \[mm/h\]) and Patient Global Assessment (PtGA) recorded on 100 mm VAS (scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher scores=more disease activity). The calculation of DAS28-4 ESR is as follows: 0.56 \* square root (sqrt) (TJC) + 0.28 \* sqrt (SJC) + 0.70\* In (ESR) + 0.014\* (PtGA); where ln = natural logarithm. Total DAS28-4 score range: 0 to 9.4, higher score=more disease activity. DAS28(ESR) score of \<=3.2 indicates LDA. Percentage of participants with DAS28-4 ESR \<=3.2 is presented in this outcome measure.

Outcome measures

Outcome measures
Measure	Tofacitinib n=306 Participants Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).
Percentage of Participants With Low Disease Activity (LDA) According to Disease Activity Index 28 (DAS28)-4 Erythrocyte Sedimentation Rate (ESR) (<=3.2) Baseline	7.2 Percentage of participants
Percentage of Participants With Low Disease Activity (LDA) According to Disease Activity Index 28 (DAS28)-4 Erythrocyte Sedimentation Rate (ESR) (<=3.2) Month 1	34.9 Percentage of participants
Percentage of Participants With Low Disease Activity (LDA) According to Disease Activity Index 28 (DAS28)-4 Erythrocyte Sedimentation Rate (ESR) (<=3.2) Month 3	46.4 Percentage of participants
Percentage of Participants With Low Disease Activity (LDA) According to Disease Activity Index 28 (DAS28)-4 Erythrocyte Sedimentation Rate (ESR) (<=3.2) Month 6	52.4 Percentage of participants
Percentage of Participants With Low Disease Activity (LDA) According to Disease Activity Index 28 (DAS28)-4 Erythrocyte Sedimentation Rate (ESR) (<=3.2) Month 12	57.0 Percentage of participants
Percentage of Participants With Low Disease Activity (LDA) According to Disease Activity Index 28 (DAS28)-4 Erythrocyte Sedimentation Rate (ESR) (<=3.2) Month 18	55.2 Percentage of participants
Percentage of Participants With Low Disease Activity (LDA) According to Disease Activity Index 28 (DAS28)-4 Erythrocyte Sedimentation Rate (ESR) (<=3.2) Month 24	60.2 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Month 1, 3, 6, 12 18, and 24

Population: Full analysis set population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. Here, "Number Analyzed" signifies number of participants evaluable at specified time points. No imputation used for missing values.

DAS28-4 CRP is a composite endpoint, calculated using 4 variables (represented by '-4' in the name). Components includes: TJC with 28 joints assessed, SJC with 28 joints assessed, CRP (mg/L) and PtGA recorded on 100 mm VAS (scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher scores=more disease activity). The calculation of DAS28-4 CRP is as follows: 0.56 \* sqrt (TJC) + 0.28 \* sqrt (SJC) + 0.36 \* ln (CRP+l) + 0.014\*PtGA + 0.96; where ln = natural logarithm. Total DAS28-4 score range: 0 to 9.4, higher score=more disease activity. DAS28(CRP) score of \<=3.2 indicates LDA. Percentage of participants with DAS28-4 CRP \<=3.2 is presented in this outcome measure.

Outcome measures

Outcome measures
Measure	Tofacitinib n=306 Participants Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).
Percentage of Participants With LDA According to DAS28-4 C Reactive Protein (CRP) (<=3.2) Baseline	9.8 Percentage of participants
Percentage of Participants With LDA According to DAS28-4 C Reactive Protein (CRP) (<=3.2) Month 1	46.2 Percentage of participants
Percentage of Participants With LDA According to DAS28-4 C Reactive Protein (CRP) (<=3.2) Month 3	55.9 Percentage of participants
Percentage of Participants With LDA According to DAS28-4 C Reactive Protein (CRP) (<=3.2) Month 6	69.3 Percentage of participants
Percentage of Participants With LDA According to DAS28-4 C Reactive Protein (CRP) (<=3.2) Month 12	66.0 Percentage of participants
Percentage of Participants With LDA According to DAS28-4 C Reactive Protein (CRP) (<=3.2) Month 18	71.9 Percentage of participants
Percentage of Participants With LDA According to DAS28-4 C Reactive Protein (CRP) (<=3.2) Month 24	73.7 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Month 1, 3, 6, 12 18, and 24

Population: Full analysis set population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. Here, "Number Analyzed" signifies number of participants evaluable at specified time points. No imputation used for missing values.

SDAI is a composite end point, calculated as TJC + SJC (both using 28 joints) + PtGA (0-10 cm scale, higher score=more disease activity) + Physician Global Assessment (PhGA) (0-10 cm scale, higher score=more disease activity) + CRP (milligrams per deciliter \[mg/dL\]). The SDAI score is classified into four categories: remission (\<=3.3), low (\>3.3-11), moderate (\>11-26), and high (\>26) disease activity. The SDAI score ranges from 0 to 86 where higher scores indicates high disease activity. SDAI score of \<=11 indicates LDA. Percentage of participants with SDAI \<=11 is presented in this outcome measure.

Outcome measures

Outcome measures
Measure	Tofacitinib n=306 Participants Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).
Percentage of Participants With LDA According to Simplified Disease Activity Index (SDAI) <=11 Baseline	6.6 Percentage of participants
Percentage of Participants With LDA According to Simplified Disease Activity Index (SDAI) <=11 Month 1	39.4 Percentage of participants
Percentage of Participants With LDA According to Simplified Disease Activity Index (SDAI) <=11 Month 3	54.0 Percentage of participants
Percentage of Participants With LDA According to Simplified Disease Activity Index (SDAI) <=11 Month 6	67.2 Percentage of participants
Percentage of Participants With LDA According to Simplified Disease Activity Index (SDAI) <=11 Month 12	64.7 Percentage of participants
Percentage of Participants With LDA According to Simplified Disease Activity Index (SDAI) <=11 Month 18	68.2 Percentage of participants
Percentage of Participants With LDA According to Simplified Disease Activity Index (SDAI) <=11 Month 24	74.1 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Month 1, 3, 6, 12 18, and 24

Population: Full analysis set population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. Here, "Number Analyzed" signifies number of participants evaluable at specified time points. No imputation used for missing values.

CDAI is a composite end point, calculated as TJC + SJC (both using 28 joints) + PtGA (0-10 cm scale, higher score=more disease activity) + PhGA (0-10 cm scale, higher score=more disease activity). The CDAI score is classified into four categories: remission (\<=2.8), low (\>2.8-10), moderate (\>10-22), and high (\>22) disease activity. The CDAI score ranges from 0 to 76, where higher scores indicates high disease activity. CDAI score of \<=10 indicates LDA. Percentage of participants with CDAI \<=10 is presented in this outcome measure.

Outcome measures

Outcome measures
Measure	Tofacitinib n=306 Participants Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).
Percentage of Participants With LDA According to Clinical Disease Activity Index (CDAI) <=10 Baseline	6.1 Percentage of participants
Percentage of Participants With LDA According to Clinical Disease Activity Index (CDAI) <=10 Month 1	41.8 Percentage of participants
Percentage of Participants With LDA According to Clinical Disease Activity Index (CDAI) <=10 Month 3	56.4 Percentage of participants
Percentage of Participants With LDA According to Clinical Disease Activity Index (CDAI) <=10 Month 6	67.0 Percentage of participants
Percentage of Participants With LDA According to Clinical Disease Activity Index (CDAI) <=10 Month 12	66.3 Percentage of participants
Percentage of Participants With LDA According to Clinical Disease Activity Index (CDAI) <=10 Month 18	68.8 Percentage of participants
Percentage of Participants With LDA According to Clinical Disease Activity Index (CDAI) <=10 Month 24	70.9 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Month 1, 3, 6, 12 18, and 24

Population: Full analysis set population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. Here, "Number Analyzed" signifies number of participants evaluable at specified time points. No imputation used for missing values.

DAS28-4 ESR is a composite endpoint, calculated using 4 variables (represented by '-4' in the name). Components includes: TJC with 28 joints assessed, SJC with 28 joints assessed, ESR (mm/h) and PtGA recorded on 100 mm VAS (scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher scores=more disease activity). The calculation of DAS28-4 ESR is as follows: 0.56 \* sqrt (TJC) + 0.28 \* sqrt (SJC) + 0.70\* In(ESR) + 0.014\* (PtGA); where ln = natural logarithm. Total DAS28-4 score range: 0 to 9.4, higher score=more disease activity. DAS28(ESR) score of \<2.6 indicates LDA. Percentage of participants with DAS28-4 ESR \<2.6 is presented in this outcome measure.

Outcome measures

Outcome measures
Measure	Tofacitinib n=306 Participants Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).
Percentage of Participants With Remission According to DAS28-4 ESR<2.6 Baseline	3.6 Percentage of participants
Percentage of Participants With Remission According to DAS28-4 ESR<2.6 Month 1	17.8 Percentage of participants
Percentage of Participants With Remission According to DAS28-4 ESR<2.6 Month 3	27.6 Percentage of participants
Percentage of Participants With Remission According to DAS28-4 ESR<2.6 Month 6	34.9 Percentage of participants
Percentage of Participants With Remission According to DAS28-4 ESR<2.6 Month 12	32.6 Percentage of participants
Percentage of Participants With Remission According to DAS28-4 ESR<2.6 Month 18	33.6 Percentage of participants
Percentage of Participants With Remission According to DAS28-4 ESR<2.6 Month 24	38.8 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Month 1, 3, 6, 12 18, and 24

Population: Full analysis set population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. Here, "Number Analyzed" signifies number of participants evaluable at specified time points. No imputation used for missing values.

DAS28-4 CRP is a composite endpoint, calculated using 4 variables (represented by '-4' in the name). Components includes: TJC with 28 joints assessed, SJC with 28 joints assessed, CRP (mg/L) and PtGA recorded on 100 mm VAS (scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher scores=more disease activity). The calculation of DAS28-4 CRP is as follows: 0.56 \* sqrt (TJC) + 0.28 \* sqrt (SJC) + 0.36 \* ln (CRP+l) + 0.014\*PtGA + 0.96; where ln = natural logarithm. Total DAS28-4 score range: 0 to 9.4, higher score=more disease activity. DAS28(CRP) score of \<2.6 indicates LDA. Percentage of participants with DAS28-4 CRP \<2.6 is presented in this outcome measure.

Outcome measures

Outcome measures
Measure	Tofacitinib n=306 Participants Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).
Percentage of Participants With Remission According to DAS28-4 CRP <2.6 Baseline	4.9 Percentage of participants
Percentage of Participants With Remission According to DAS28-4 CRP <2.6 Month 1	29.3 Percentage of participants
Percentage of Participants With Remission According to DAS28-4 CRP <2.6 Month 3	37.3 Percentage of participants
Percentage of Participants With Remission According to DAS28-4 CRP <2.6 Month 6	46.4 Percentage of participants
Percentage of Participants With Remission According to DAS28-4 CRP <2.6 Month 12	48.1 Percentage of participants
Percentage of Participants With Remission According to DAS28-4 CRP <2.6 Month 18	48.9 Percentage of participants
Percentage of Participants With Remission According to DAS28-4 CRP <2.6 Month 24	59.3 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Month 1, 3, 6, 12 18, and 24

Population: Full analysis set population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. Here, "Number Analyzed" signifies number of participants evaluable at specified time points. No imputation used for missing values.

SDAI is a composite end point, calculated as TJC + SJC (both using 28 joints) + PtGA (0-10 cm scale, higher score=more disease activity) + PhGA (0-10 cm scale, higher score=more disease activity) + CRP (mg/dL). The SDAI score is classified into four categories: remission (\<=3.3), low (\>3.3-11), moderate (\>11-26), and high (\>26) disease activity. The SDAI score ranges from 0 to 86 where higher scores indicates high disease activity. SDAI score of \<=3.3 indicates LDA. Percentage of participants with SDAI \<=3.3 is presented in this outcome measure.

Outcome measures

Outcome measures
Measure	Tofacitinib n=306 Participants Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).
Percentage of Participants in Remission According to SDAI <=3.3 Baseline	1.1 Percentage of participants
Percentage of Participants in Remission According to SDAI <=3.3 Month 1	6.7 Percentage of participants
Percentage of Participants in Remission According to SDAI <=3.3 Month 3	13.7 Percentage of participants
Percentage of Participants in Remission According to SDAI <=3.3 Month 6	23.1 Percentage of participants
Percentage of Participants in Remission According to SDAI <=3.3 Month 12	29.3 Percentage of participants
Percentage of Participants in Remission According to SDAI <=3.3 Month 18	31.0 Percentage of participants
Percentage of Participants in Remission According to SDAI <=3.3 Month 24	30.2 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Month 1, 3, 6, 12 18, and 24

Population: Full analysis set population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. Here, "Number Analyzed" signifies number of participants evaluable at specified time points. No imputation used for missing values.

CDAI is a composite end point, calculated as TJC + SJC (both using 28 joints) + PtGA (0-10 cm scale) + PhGA (0-10 cm scale). The CDAI score is classified into four categories: remission (\<=2.8), low (\>2.8-10), moderate (\>10-22), and high (\>22) disease activity. The CDAI score ranges from 0 to 76, where higher scores indicates high disease activity. CDAI score of \<=2.8 indicates LDA. Percentage of participants with CDAI \<=2.8 is presented in this outcome measure.

Outcome measures

Outcome measures
Measure	Tofacitinib n=306 Participants Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).
Percentage of Participants in Remission According to CDAI<=2.8 Baseline	0.7 Percentage of participants
Percentage of Participants in Remission According to CDAI<=2.8 Month 1	6.7 Percentage of participants
Percentage of Participants in Remission According to CDAI<=2.8 Month 3	14.8 Percentage of participants
Percentage of Participants in Remission According to CDAI<=2.8 Month 6	21.5 Percentage of participants
Percentage of Participants in Remission According to CDAI<=2.8 Month 12	26.5 Percentage of participants
Percentage of Participants in Remission According to CDAI<=2.8 Month 18	26.2 Percentage of participants
Percentage of Participants in Remission According to CDAI<=2.8 Month 24	29.9 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Month 1, 3, 6, 12 18, and 24

Population: Full analysis set population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. Here, "Number Analyzed" signifies number of participants evaluable at specified time points. No imputation used for missing values.

ACREULAR 2011 Boolean criteria is derived as: ACR Remission = 1, if SJC (using 28 joints) \<=1, TJC (using 28 joints) \<=1, CRP \<=1 mg/dL, and PtGA (0 to 10 cm scale, higher score=more disease activity) \<=1 centimeter (cm) otherwise ACR remission =0. Higher scores indicated greater affection due to disease activity. Percentage of participants with remission according to ACR-EULAR 2011 Boolean criteria is reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Tofacitinib n=306 Participants Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).
Percentage of Participants With Remission According to American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) 2011 Boolean Criteria Baseline	2.7 Percentage of participants
Percentage of Participants With Remission According to American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) 2011 Boolean Criteria Month 1	8.9 Percentage of participants
Percentage of Participants With Remission According to American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) 2011 Boolean Criteria Month 3	14.9 Percentage of participants
Percentage of Participants With Remission According to American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) 2011 Boolean Criteria Month 6	22.0 Percentage of participants
Percentage of Participants With Remission According to American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) 2011 Boolean Criteria Month 12	24.6 Percentage of participants
Percentage of Participants With Remission According to American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) 2011 Boolean Criteria Month 18	26.6 Percentage of participants
Percentage of Participants With Remission According to American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) 2011 Boolean Criteria Month 24	24.4 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Month 1, 3, 6, 12, 18, and 24

DAS28-4 ESR is a composite endpoint, calculated using 4 variables (represented by '-4' in the name). Components includes: TJC with 28 joints assessed, SJC with 28 joints assessed, ESR (mm/h) and PtGA recorded on 100 mm VAS (scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher scores=more disease activity). The calculation of DAS28-4 ESR is as follows: 0.56 \* sqrt (TJC) + 0.28 \* sqrt (SJC) + 0.70\* In(ESR) + 0.014\* (PtGA); where ln = natural logarithm. Total DAS28-4 score range: 0 to 9.4, higher score=more disease activity. Mean change from baseline in DAS28-4 ESR score at months 3, 6, 12, 18 and 24 is presented in this outcome measure.

Outcome measures

Outcome measures
Measure	Tofacitinib n=249 Participants Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).
Change From Baseline in DAS28-4 ESR Score at Month 1, 3, 6, 12, 18 and 24 Baseline	4.850 Units on a scale Standard Deviation 1.180
Change From Baseline in DAS28-4 ESR Score at Month 1, 3, 6, 12, 18 and 24 Change at Month 1	-1.129 Units on a scale Standard Deviation 1.187
Change From Baseline in DAS28-4 ESR Score at Month 1, 3, 6, 12, 18 and 24 Change at Month 3	-1.419 Units on a scale Standard Deviation 1.487
Change From Baseline in DAS28-4 ESR Score at Month 1, 3, 6, 12, 18 and 24 Change at Month 6	-1.941 Units on a scale Standard Deviation 1.367
Change From Baseline in DAS28-4 ESR Score at Month 1, 3, 6, 12, 18 and 24 Change at Month 12	-1.764 Units on a scale Standard Deviation 1.347
Change From Baseline in DAS28-4 ESR Score at Month 1, 3, 6, 12, 18 and 24 Change at Month 18	-1.954 Units on a scale Standard Deviation 1.487
Change From Baseline in DAS28-4 ESR Score at Month 1, 3, 6, 12, 18 and 24 Change at Month 24	-2.008 Units on a scale Standard Deviation 1.363

SECONDARY outcome

Timeframe: Baseline, Month 1, 3, 6, 12, 18, and 24

DAS28-4 CRP is a composite endpoint, calculated using 4 variables (represented by '-4' in the name). Components includes: TJC with 28 joints assessed, SJC with 28 joints assessed, CRP (mg/L) and PtGA recorded on 100 mm VAS (scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher scores=more disease activity). The calculation of DAS28-4 CRP is as follows: 0.56 \* sqrt (TJC) + 0.28 \* sqrt (SJC) + 0.36 \* ln (CRP+l) + 0.014\*PtGA + 0.96; where ln = natural logarithm. Total DAS28-4 score range: 0 to 9.4, higher score=more disease activity. Mean change from baseline in DAS28-4 CRP score at months 3, 6, 12, 18 and 24 is presented in this outcome measure.

Outcome measures

Outcome measures
Measure	Tofacitinib n=286 Participants Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).
Change From Baseline in DAS28-4 CRP Score at Month 1, 3, 6, 12, 18 and 24 Change at Month 6	-1.902 Units on a scale Standard Deviation 1.198
Change From Baseline in DAS28-4 CRP Score at Month 1, 3, 6, 12, 18 and 24 Baseline	4.526 Units on a scale Standard Deviation 1.088
Change From Baseline in DAS28-4 CRP Score at Month 1, 3, 6, 12, 18 and 24 Change at Month 1	-1.295 Units on a scale Standard Deviation 1.135
Change From Baseline in DAS28-4 CRP Score at Month 1, 3, 6, 12, 18 and 24 Change at Month 3	-1.498 Units on a scale Standard Deviation 1.363
Change From Baseline in DAS28-4 CRP Score at Month 1, 3, 6, 12, 18 and 24 Change at Month 12	-1.909 Units on a scale Standard Deviation 1.269
Change From Baseline in DAS28-4 CRP Score at Month 1, 3, 6, 12, 18 and 24 Change at Month 18	-1.971 Units on a scale Standard Deviation 1.275
Change From Baseline in DAS28-4 CRP Score at Month 1, 3, 6, 12, 18 and 24 Change at Month 24	-2.077 Units on a scale Standard Deviation 1.215

SECONDARY outcome

Timeframe: Month 1, 3, 6, 12, 18, and 24

Population: Full analysis set population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. Here, "Number Analyzed" signifies number of participants evaluable at specified time points. No imputation used for missing values.

28 EULAR criteria to evaluate participant's response to treatment is categorised as good responder, moderate responder and non-responder based on participants DAS28-4 CRP score and decrease in DAS28-4 CRP compared to initial pre-treatment visit (Visit 0 \[V0\]). Good response: DAS28 at treatment visit \<= 3.2 and decrease in DAS 28 compared to V0 \>1.2. Moderate responder: DAS28 at treatment visit \> 3.2 to \<= 5.1 or \> 5.1 and decrease in DAS 28 compared to V0 \>1.2 DAS28 at treatment visit \<= 3.2 or \> 3.2 to \<= 5.1 and decrease in DAS 28 compared to V0 \>0.6 and \<=1.2. Non-responder: DAS28 at treatment visit \> 5.1 and decrease in DAS 28 compared to V0 \>0.6 to \<=1.2 DAS28 at treatment visit \<= 3.2 or \> 3.2 to \<= 5.1 or \> 5.1 and decrease in DAS 28 compared to V0 \<=0.6. Number of participants responding to treatment by considering DAS28 (EULAR criterion) is reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Tofacitinib n=306 Participants Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).
Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion) CRP, good responder, month 1	67 Participants
Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion) CRP, moderate responder, month 1	61 Participants
Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion) CRP, non-responder, month 1	49 Participants
Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion) CRP, good responder, month 3	97 Participants
Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion) CRP, moderate responder, month 3	63 Participants
Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion) CRP, non-responder, month 3	51 Participants
Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion) CRP, good responder, month 6	111 Participants
Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion) CRP, moderate responder, month 6	47 Participants
Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion) CRP, non-responder, month 6	27 Participants
Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion) CRP, good responder, month 12	84 Participants
Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion) CRP, moderate responder, month 12	41 Participants
Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion) CRP, non-responder, month 12	23 Participants
Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion) CRP, good responder, month 18	78 Participants
Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion) CRP, moderate responder, month 18	24 Participants
Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion) CRP, non-responder, month 18	23 Participants
Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion) CRP, good responder, month 24	70 Participants
Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion) CRP, moderate responder, month 24	28 Participants
Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion) CRP, non-responder, month 24	13 Participants
Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion) ESR, good responder, month 1	37 Participants
Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion) ESR, moderate responder, month 1	50 Participants
Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion) ESR, non-responder, month 1	48 Participants
Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion) ESR, good responder, month 3	59 Participants
Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion) ESR, moderate responder, month 3	56 Participants
Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion) ESR, non-responder, month 3	55 Participants
Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion) ESR, good responder, month 6	65 Participants
Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion) ESR, moderate responder, month 6	62 Participants
Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion) ESR, non-responder, month 6	23 Participants
Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion) ESR, good responder, month 12	55 Participants
Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion) ESR, moderate responder, month 12	40 Participants
Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion) ESR, non-responder, month 12	24 Participants
Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion) ESR, good responder, month 18	51 Participants
Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion) ESR, moderate responder, month 18	30 Participants
Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion) ESR, non-responder, month 18	18 Participants
Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion) ESR, good responder, month 24	43 Participants
Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion) ESR, moderate responder, month 24	28 Participants
Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion) ESR, non-responder, month 24	14 Participants

SECONDARY outcome

Timeframe: Baseline, Month 1, 3, 6, 12, 18, and 24

TJC (28) is the count of the total number of tender joints out of a possible 28 joints which are checked at the visit. TJC was used to measure the pain and inflammation in the joints. Mean change from baseline in TJC is reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Tofacitinib n=302 Participants Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).
Change From Baseline in TJC at Month 1, 3, 6, 12, 18 and 24 Baseline	7.4 Tender Joints Standard Deviation 6.0
Change From Baseline in TJC at Month 1, 3, 6, 12, 18 and 24 Change at Month 1	-4.2 Tender Joints Standard Deviation 5.8
Change From Baseline in TJC at Month 1, 3, 6, 12, 18 and 24 Change at Month 3	-4.3 Tender Joints Standard Deviation 6.5
Change From Baseline in TJC at Month 1, 3, 6, 12, 18 and 24 Change at Month 6	-4.9 Tender Joints Standard Deviation 6.3
Change From Baseline in TJC at Month 1, 3, 6, 12, 18 and 24 Change at Month 12	-5.0 Tender Joints Standard Deviation 7.0
Change From Baseline in TJC at Month 1, 3, 6, 12, 18 and 24 Change at Month 18	-5.1 Tender Joints Standard Deviation 5.9
Change From Baseline in TJC at Month 1, 3, 6, 12, 18 and 24 Change at Month 24	-5.1 Tender Joints Standard Deviation 6.7

SECONDARY outcome

Timeframe: Baseline, Month 1, 3, 6, 12, 18, and 24

SJC (28) is the count of the total number of swollen joints out of a possible 28 joints which are checked at the visit. SJC was used to measure the pain and inflammation in the joints. Mean change from baseline in TJC is reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Tofacitinib n=302 Participants Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).
Change From Baseline in SJC at Month 1, 3, 6, 12, 18 and 24 Change at Month 6	-3.9 Swollen Joints Standard Deviation 5.1
Change From Baseline in SJC at Month 1, 3, 6, 12, 18 and 24 Baseline	5.3 Swollen Joints Standard Deviation 5.1
Change From Baseline in SJC at Month 1, 3, 6, 12, 18 and 24 Change at Month 1	-3.0 Swollen Joints Standard Deviation 4.5
Change From Baseline in SJC at Month 1, 3, 6, 12, 18 and 24 Change at Month 3	-3.5 Swollen Joints Standard Deviation 4.9
Change From Baseline in SJC at Month 1, 3, 6, 12, 18 and 24 Change at Month 12	-4.3 Swollen Joints Standard Deviation 5.1
Change From Baseline in SJC at Month 1, 3, 6, 12, 18 and 24 Change at Month 18	-4.4 Swollen Joints Standard Deviation 5.2
Change From Baseline in SJC at Month 1, 3, 6, 12, 18 and 24 Change at Month 24	-4.3 Swollen Joints Standard Deviation 5.1

SECONDARY outcome

Timeframe: Baseline, Month 1, 3, 6, 12, 18 and 24

Population: Full analysis set population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. Here, "Number Analyzed" signifies number of participants evaluable at specified time points. No imputation used for missing values.

FiRST is used to detect fibromyalgia in participants with diffuse rheumatic pain. It is a questionnaire which contains 6 items: diffuse pain, painful symptoms, fatigue, sleep and cognitive disorders, nonpainful abnormal sensations and functional somatic symptoms. Each of the 6 items contain yes or no response, and a positive answer to 5 out of the 6 answers can detect fibromyalgia. At each specified time points number of participants with "Yes" or "No" to fibromyalgia is reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Tofacitinib n=306 Participants Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).
Number of Participants With Fibromyalgia Rapid Screening Tool (FiRST) Questionnaire Response Baseline, Fibromyalgia: No	156 Participants
Number of Participants With Fibromyalgia Rapid Screening Tool (FiRST) Questionnaire Response Baseline, Fibromyalgia: Yes	91 Participants
Number of Participants With Fibromyalgia Rapid Screening Tool (FiRST) Questionnaire Response Month 1, Fibromyalgia: No	124 Participants
Number of Participants With Fibromyalgia Rapid Screening Tool (FiRST) Questionnaire Response Month 1, Fibromyalgia: Yes	60 Participants
Number of Participants With Fibromyalgia Rapid Screening Tool (FiRST) Questionnaire Response Month 3, Fibromyalgia: No	149 Participants
Number of Participants With Fibromyalgia Rapid Screening Tool (FiRST) Questionnaire Response Month 3, Fibromyalgia: Yes	56 Participants
Number of Participants With Fibromyalgia Rapid Screening Tool (FiRST) Questionnaire Response Month 6, Fibromyalgia: No	135 Participants
Number of Participants With Fibromyalgia Rapid Screening Tool (FiRST) Questionnaire Response Month 6, Fibromyalgia: Yes	41 Participants
Number of Participants With Fibromyalgia Rapid Screening Tool (FiRST) Questionnaire Response Month 12, Fibromyalgia: No	111 Participants
Number of Participants With Fibromyalgia Rapid Screening Tool (FiRST) Questionnaire Response Month 12, Fibromyalgia: Yes	32 Participants
Number of Participants With Fibromyalgia Rapid Screening Tool (FiRST) Questionnaire Response Month 18, Fibromyalgia: No	89 Participants
Number of Participants With Fibromyalgia Rapid Screening Tool (FiRST) Questionnaire Response Month 18, Fibromyalgia: Yes	25 Participants
Number of Participants With Fibromyalgia Rapid Screening Tool (FiRST) Questionnaire Response Month 24, Fibromyalgia: No	80 Participants
Number of Participants With Fibromyalgia Rapid Screening Tool (FiRST) Questionnaire Response Month 24, Fibromyalgia: Yes	25 Participants

SECONDARY outcome

Timeframe: Baseline, Month 1, 3, 6, 12, 18 and 24

Morning stiffness is a common symptom of rheumatoid arthritis. The duration of morning stiffness is measured in minutes. Mean change from baseline in morning stiffness is reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Tofacitinib n=287 Participants Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).
Change From Baseline in Duration of Morning Stiffness at Month 1, 3, 6, 12, 18 and 24 Baseline	51.5 Minutes Standard Deviation 53.3
Change From Baseline in Duration of Morning Stiffness at Month 1, 3, 6, 12, 18 and 24 Change at Month 1	-24.3 Minutes Standard Deviation 43.0
Change From Baseline in Duration of Morning Stiffness at Month 1, 3, 6, 12, 18 and 24 Change at Month 3	-31.3 Minutes Standard Deviation 48.8
Change From Baseline in Duration of Morning Stiffness at Month 1, 3, 6, 12, 18 and 24 Change at Month 6	-31.5 Minutes Standard Deviation 49.1
Change From Baseline in Duration of Morning Stiffness at Month 1, 3, 6, 12, 18 and 24 Change at Month 12	-36.6 Minutes Standard Deviation 50.8
Change From Baseline in Duration of Morning Stiffness at Month 1, 3, 6, 12, 18 and 24 Change at Month 18	-32.2 Minutes Standard Deviation 47.9
Change From Baseline in Duration of Morning Stiffness at Month 1, 3, 6, 12, 18 and 24 Change at Month 24	-40.0 Minutes Standard Deviation 49.3

SECONDARY outcome

Timeframe: Month 1, 3, 6, 12, 18 and 24

Girerd questionnaire is used to evaluate participant's treatment compliance and is made up of 6 yes or no questions. lf the participant responds "no" to all questions, it is considered as participant is a good complier. lf the participant responds "yes" once or twice, it is considered as participant is a minor complier. lf the participant responds "yes" three times or more, it is considered as participant is a no-complier.

Outcome measures

Outcome measures
Measure	Tofacitinib n=306 Participants Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).
Number of Participants Based on Response to Girerd Questionnaire at Month 1, 3, 6, 12, 18 and 24 Good complier at baseline	100 Participants
Number of Participants Based on Response to Girerd Questionnaire at Month 1, 3, 6, 12, 18 and 24 Minor complier at baseline	139 Participants
Number of Participants Based on Response to Girerd Questionnaire at Month 1, 3, 6, 12, 18 and 24 No-complier at baseline	17 Participants
Number of Participants Based on Response to Girerd Questionnaire at Month 1, 3, 6, 12, 18 and 24 Good complier at month 1	89 Participants
Number of Participants Based on Response to Girerd Questionnaire at Month 1, 3, 6, 12, 18 and 24 Minor complier at month 1	91 Participants
Number of Participants Based on Response to Girerd Questionnaire at Month 1, 3, 6, 12, 18 and 24 No-complier at month 1	7 Participants
Number of Participants Based on Response to Girerd Questionnaire at Month 1, 3, 6, 12, 18 and 24 Good complier at month 3	87 Participants
Number of Participants Based on Response to Girerd Questionnaire at Month 1, 3, 6, 12, 18 and 24 Minor complier at month 3	110 Participants
Number of Participants Based on Response to Girerd Questionnaire at Month 1, 3, 6, 12, 18 and 24 No-complier at month 3	14 Participants
Number of Participants Based on Response to Girerd Questionnaire at Month 1, 3, 6, 12, 18 and 24 Good complier at month 6	58 Participants
Number of Participants Based on Response to Girerd Questionnaire at Month 1, 3, 6, 12, 18 and 24 Minor complier at month 6	106 Participants
Number of Participants Based on Response to Girerd Questionnaire at Month 1, 3, 6, 12, 18 and 24 No-complier at month 6	18 Participants
Number of Participants Based on Response to Girerd Questionnaire at Month 1, 3, 6, 12, 18 and 24 Good complier at month 12	58 Participants
Number of Participants Based on Response to Girerd Questionnaire at Month 1, 3, 6, 12, 18 and 24 Minor complier at month 12	85 Participants
Number of Participants Based on Response to Girerd Questionnaire at Month 1, 3, 6, 12, 18 and 24 No-complier at month 12	6 Participants
Number of Participants Based on Response to Girerd Questionnaire at Month 1, 3, 6, 12, 18 and 24 Good complier at month 18	49 Participants
Number of Participants Based on Response to Girerd Questionnaire at Month 1, 3, 6, 12, 18 and 24 Minor complier at month 18	63 Participants
Number of Participants Based on Response to Girerd Questionnaire at Month 1, 3, 6, 12, 18 and 24 No-complier at month 18	9 Participants
Number of Participants Based on Response to Girerd Questionnaire at Month 1, 3, 6, 12, 18 and 24 Good complier at month 24	42 Participants
Number of Participants Based on Response to Girerd Questionnaire at Month 1, 3, 6, 12, 18 and 24 Minor complier at month 24	62 Participants
Number of Participants Based on Response to Girerd Questionnaire at Month 1, 3, 6, 12, 18 and 24 No-complier at month 24	5 Participants

SECONDARY outcome

Timeframe: Baseline, Month 1, 3, 6, 12, 18 and 24

EQ-5D-3L is a standardized, participant administered measure of self-reported instrument used to evaluate health-related quality of life. It consists of two parts: EQ-5D index score (Part I) and the EQ-VAS (Part II). For Part I, i.e. EQ-5D-3L index score, participants rated their current health state on 5 single-item dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression with each dimension having three levels of function:. 1=no problems, 2=some problems and 3=extreme problems. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score was transformed and results in a total index score range of 0 to 1.00; higher scores indicating a better health condition. Mean change from baseline in EQ-5D-3L index score is reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Tofacitinib n=257 Participants Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).
Change From Baseline in European Quality of Life (EuroQoL) 5-Dimension 3 Levels of Severity (EQ-5D-3L) Index Score at Month 1, 3, 6, 12, 18 and 24 Baseline	0.3987 Units on a scale Standard Deviation 0.3731
Change From Baseline in European Quality of Life (EuroQoL) 5-Dimension 3 Levels of Severity (EQ-5D-3L) Index Score at Month 1, 3, 6, 12, 18 and 24 Change at Month 1	0.1314 Units on a scale Standard Deviation 0.3185
Change From Baseline in European Quality of Life (EuroQoL) 5-Dimension 3 Levels of Severity (EQ-5D-3L) Index Score at Month 1, 3, 6, 12, 18 and 24 Change at Month 3	0.1767 Units on a scale Standard Deviation 0.4054
Change From Baseline in European Quality of Life (EuroQoL) 5-Dimension 3 Levels of Severity (EQ-5D-3L) Index Score at Month 1, 3, 6, 12, 18 and 24 Change at Month 6	0.1886 Units on a scale Standard Deviation 0.3638
Change From Baseline in European Quality of Life (EuroQoL) 5-Dimension 3 Levels of Severity (EQ-5D-3L) Index Score at Month 1, 3, 6, 12, 18 and 24 Change at Month 12	0.2362 Units on a scale Standard Deviation 0.4058
Change From Baseline in European Quality of Life (EuroQoL) 5-Dimension 3 Levels of Severity (EQ-5D-3L) Index Score at Month 1, 3, 6, 12, 18 and 24 Change at Month 18	0.2190 Units on a scale Standard Deviation 0.4020
Change From Baseline in European Quality of Life (EuroQoL) 5-Dimension 3 Levels of Severity (EQ-5D-3L) Index Score at Month 1, 3, 6, 12, 18 and 24 Change at Month 24	0.2123 Units on a scale Standard Deviation 0.3911

SECONDARY outcome

Timeframe: Baseline, Month 1, 3, 6, 12, 18 and 24

SF-12 was a participant reported outcome survey that represented overall health status by measuring 8 health-related aspects of an individual: Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE) and Mental Health (MH). The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. Responses on the SF-12 were also used to calculate 2 summary scores: Physical component score (PCS) and mental component score (MCS). The score range for each of these 2 summary scores was from 0 (poor health) to 100 (better health), where 100 indicated good health condition. Mean change from baseline in PCS and MCS scores are reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Tofacitinib n=306 Participants Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).
Change From Baseline in Short Form-12 Health Survey (SF-12) Score at Month 1, 3, 6, 12, 18 and 24 PCS at Baseline	35.0 Units on a scale Standard Deviation 8.7
Change From Baseline in Short Form-12 Health Survey (SF-12) Score at Month 1, 3, 6, 12, 18 and 24 PCS at Change at Month 1	3.5 Units on a scale Standard Deviation 7.6
Change From Baseline in Short Form-12 Health Survey (SF-12) Score at Month 1, 3, 6, 12, 18 and 24 PCS at Change at Month 3	5.8 Units on a scale Standard Deviation 8.9
Change From Baseline in Short Form-12 Health Survey (SF-12) Score at Month 1, 3, 6, 12, 18 and 24 PCS at Change at Month 6	5.9 Units on a scale Standard Deviation 8.7
Change From Baseline in Short Form-12 Health Survey (SF-12) Score at Month 1, 3, 6, 12, 18 and 24 PCS at Change at Month 12	6.9 Units on a scale Standard Deviation 9.2
Change From Baseline in Short Form-12 Health Survey (SF-12) Score at Month 1, 3, 6, 12, 18 and 24 PCS at Change at Month 18	6.9 Units on a scale Standard Deviation 9.1
Change From Baseline in Short Form-12 Health Survey (SF-12) Score at Month 1, 3, 6, 12, 18 and 24 PCS at Change at Month 24	7.3 Units on a scale Standard Deviation 9.8
Change From Baseline in Short Form-12 Health Survey (SF-12) Score at Month 1, 3, 6, 12, 18 and 24 MCS at Baseline	40.2 Units on a scale Standard Deviation 10.4
Change From Baseline in Short Form-12 Health Survey (SF-12) Score at Month 1, 3, 6, 12, 18 and 24 MCS at Change at Month 1	1.7 Units on a scale Standard Deviation 9.1
Change From Baseline in Short Form-12 Health Survey (SF-12) Score at Month 1, 3, 6, 12, 18 and 24 MCS at Change at Month 3	3.7 Units on a scale Standard Deviation 10.6
Change From Baseline in Short Form-12 Health Survey (SF-12) Score at Month 1, 3, 6, 12, 18 and 24 MCS at Change at Month 6	3.9 Units on a scale Standard Deviation 9.5
Change From Baseline in Short Form-12 Health Survey (SF-12) Score at Month 1, 3, 6, 12, 18 and 24 MCS at Change at Month 12	3.9 Units on a scale Standard Deviation 11.1
Change From Baseline in Short Form-12 Health Survey (SF-12) Score at Month 1, 3, 6, 12, 18 and 24 MCS at Change at Month 18	4.0 Units on a scale Standard Deviation 10.2
Change From Baseline in Short Form-12 Health Survey (SF-12) Score at Month 1, 3, 6, 12, 18 and 24 MCS at Change at Month 24	4.9 Units on a scale Standard Deviation 10.7

SECONDARY outcome

Timeframe: Baseline, Month 1, 3, 6, 12, 18 and 24

FACIT-Fatigue questionnaire consists of 13 self-evaluated questions. Each question has a response of values 0 (not at all) to 4 (very much). Score for each question is calculated by first reversing negatively stated-items (subtracting the response from '4' except for the 2 positively stated-items) and then summing the raw (0-4) scores. The FACIT-Fatigue total score is derived by summing the response to each question which gives a value between 0 (worse score) and 52 (best score). Higher scores represent better participant's status (less fatigue). Mean change from baseline in FACIT-Fatigue total score is reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Tofacitinib n=259 Participants Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score at Month 1, 3, 6, 12, 18 and 24 Baseline	26.9 Units on a scale Standard Error 11.7
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score at Month 1, 3, 6, 12, 18 and 24 Change at Month 1	3.9 Units on a scale Standard Error 9.3
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score at Month 1, 3, 6, 12, 18 and 24 Change at Month 3	6.2 Units on a scale Standard Error 10.9
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score at Month 1, 3, 6, 12, 18 and 24 Change at Month 6	6.2 Units on a scale Standard Error 10.1
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score at Month 1, 3, 6, 12, 18 and 24 Change at Month 12	6.9 Units on a scale Standard Error 12.1
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score at Month 1, 3, 6, 12, 18 and 24 Change at Month 18	6.8 Units on a scale Standard Error 11.6
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score at Month 1, 3, 6, 12, 18 and 24 Change at Month 24	8.4 Units on a scale Standard Error 11.4

SECONDARY outcome

Timeframe: Month 24

Population: Full analysis set population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements.

Number of participants who discontinued tofacitinib due to tolerance issue.

Outcome measures

Outcome measures
Measure	Tofacitinib n=309 Participants Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).
Number of Participants With Tofacitinib Tolerance Issue	39 Participants

Adverse Events

Tofacitinib

Serious events: 64 serious events

Other events: 197 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Tofacitinib n=309 participants at risk Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).
Blood and lymphatic system disorders ANAEMIA	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Blood and lymphatic system disorders LYMPHOPROLIFERATIVE DISORDER	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Blood and lymphatic system disorders NEUTROPENIA	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Cardiac disorders ACUTE CORONARY SYNDROME	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Cardiac disorders CARDIAC FAILURE	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Cardiac disorders CARDIAC TAMPONADE	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Cardiac disorders MYOCARDIAL INFARCTION	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Cardiac disorders PERICARDITIS	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Gastrointestinal disorders OESOPHAGITIS	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Gastrointestinal disorders VOMITING	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
General disorders CHEST PAIN	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
General disorders DEATH	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
General disorders DRUG INEFFECTIVE	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
General disorders DRUG THERAPEUTIC INCOMPATIBILITY	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
General disorders INFLAMMATION	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
General disorders MALAISE	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
General disorders TREATMENT FAILURE	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Hepatobiliary disorders TUMOUR OF AMPULLA OF VATER	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations COVID-19	0.97% 3/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations APPENDICITIS	0.65% 2/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations ABSCESS	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations ABSCESS LIMB	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations ARTHRITIS BACTERIAL	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations CAMPYLOBACTER SEPSIS	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations ENDOCARDITIS	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations HELICOBACTER INFECTION	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations HEPATITIS E	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations HERPES ZOSTER	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations LATENT TUBERCULOSIS	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations PAROTITIS	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations SEPSIS	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations TUBERCULOSIS	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Injury, poisoning and procedural complications SHOULDER FRACTURE	0.65% 2/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Injury, poisoning and procedural complications ANKLE FRACTURE	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Injury, poisoning and procedural complications FIBULA FRACTURE	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Injury, poisoning and procedural complications HUMERUS FRACTURE	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Injury, poisoning and procedural complications MEDICATION ERROR	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Injury, poisoning and procedural complications OVERDOSE	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Injury, poisoning and procedural complications PELVIC FRACTURE	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Injury, poisoning and procedural complications RIB FRACTURE	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Investigations NEUTROPHIL COUNT DECREASED	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Investigations PLATELET COUNT DECREASED	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Musculoskeletal and connective tissue disorders RHEUMATOID ARTHRITIS	2.9% 9/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Musculoskeletal and connective tissue disorders BACK PAIN	0.97% 3/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.65% 2/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL CHEST PAIN	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Musculoskeletal and connective tissue disorders OSTEOARTHRITIS	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Musculoskeletal and connective tissue disorders OSTEOPOROTIC FRACTURE	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Musculoskeletal and connective tissue disorders POLYARTHRITIS	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BENIGN NEOPLASM OF THYROID GLAND	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BREAST CANCER	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) KAPOSI'S SARCOMA	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LYMPHOMA	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SMALL CELL CARCINOMA	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) TRANSITIONAL CELL CARCINOMA	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Nervous system disorders TRANSIENT ISCHAEMIC ATTACK	0.65% 2/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Nervous system disorders INTRACRANIAL MASS	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Nervous system disorders ISCHAEMIC STROKE	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Pregnancy, puerperium and perinatal conditions PREGNANCY, PUERPERIUM AND PERINATAL CONDITIONS	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Psychiatric disorders COMPLETED SUICIDE	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Renal and urinary disorders NEPHROPATHY TOXIC	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Respiratory, thoracic and mediastinal disorders LUNG DISORDER	0.65% 2/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Respiratory, thoracic and mediastinal disorders ACUTE PULMONARY OEDEMA	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Respiratory, thoracic and mediastinal disorders EPISTAXIS	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Respiratory, thoracic and mediastinal disorders PLEURISY	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Respiratory, thoracic and mediastinal disorders PNEUMONIA	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Respiratory, thoracic and mediastinal disorders PULMONARY MASS	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Respiratory, thoracic and mediastinal disorders PULMONARY OEDEMA	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Surgical and medical procedures MITRAL VALVE REPLACEMENT	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Surgical and medical procedures SPINAL FUSION SURGERY	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Vascular disorders PERIPHERAL ARTERY THROMBOSIS	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.

Other adverse events

Other adverse events
Measure	Tofacitinib n=309 participants at risk Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).
Blood and lymphatic system disorders LYMPHOPENIA	1.3% 4/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Blood and lymphatic system disorders ANAEMIA	0.97% 3/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Blood and lymphatic system disorders NEUTROPENIA	0.97% 3/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Cardiac disorders PALPITATIONS	1.3% 4/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Cardiac disorders TACHYCARDIA	0.65% 2/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Ear and labyrinth disorders VERTIGO	1.3% 4/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Ear and labyrinth disorders TINNITUS	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Endocrine disorders THYROID MASS	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Eye disorders GLARE	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Gastrointestinal disorders NAUSEA	3.6% 11/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Gastrointestinal disorders VOMITING	2.3% 7/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Gastrointestinal disorders GASTROINTESTINAL DISORDER	1.9% 6/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Gastrointestinal disorders ABDOMINAL PAIN	0.65% 2/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Gastrointestinal disorders DYSPEPSIA	0.65% 2/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Gastrointestinal disorders ABDOMINAL DISCOMFORT	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Gastrointestinal disorders ABDOMINAL DISTENSION	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Gastrointestinal disorders APHTHOUS ULCER	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Gastrointestinal disorders CONSTIPATION	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Gastrointestinal disorders EPIPLOIC APPENDAGITIS	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Gastrointestinal disorders HIATUS HERNIA	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
General disorders TREATMENT FAILURE	14.2% 44/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
General disorders DRUG INEFFECTIVE	3.9% 12/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
General disorders ASTHENIA	1.6% 5/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
General disorders FATIGUE	1.6% 5/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
General disorders OEDEMA PERIPHERAL	1.3% 4/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
General disorders CHEST DISCOMFORT	0.97% 3/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
General disorders CHEST PAIN	0.97% 3/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
General disorders PYREXIA	0.65% 2/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
General disorders THERAPEUTIC RESPONSE SHORTENED	0.65% 2/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
General disorders DRUG INTOLERANCE	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
General disorders FACE OEDEMA	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
General disorders FEELING DRUNK	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
General disorders FEELING OF BODY TEMPERATURE CHANGE	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
General disorders INFLAMMATION	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
General disorders INFLUENZA LIKE ILLNESS	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
General disorders INJECTION SITE PAIN	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
General disorders MALAISE	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
General disorders PAIN	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
General disorders SWELLING FACE	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Hepatobiliary disorders HEPATIC CYTOLYSIS	1.3% 4/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Hepatobiliary disorders HEPATIC FUNCTION ABNORMAL	1.3% 4/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Hepatobiliary disorders DRUG-INDUCED LIVER INJURY	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations BRONCHITIS	4.9% 15/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations HERPES ZOSTER	4.2% 13/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations URINARY TRACT INFECTION	2.6% 8/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations NASOPHARYNGITIS	1.9% 6/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations INFLUENZA	1.6% 5/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations SINUSITIS	1.6% 5/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations TOOTH INFECTION	0.97% 3/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations GINGIVITIS	0.65% 2/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations HORDEOLUM	0.65% 2/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations ORAL HERPES	0.65% 2/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations PARONYCHIA	0.65% 2/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations PNEUMONIA	0.65% 2/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations TOOTH ABSCESS	0.65% 2/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations ARTHRITIS INFECTIVE	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations CHRONIC SINUSITIS	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations CONJUNCTIVITIS	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations CYSTITIS	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations DERMATITIS INFECTED	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations DIVERTICULITIS	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations GASTROENTERITIS	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations GENITAL HERPES	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations GENITAL INFECTION FUNGAL	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations HERPES DERMATITIS	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations HERPES VIRUS INFECTION	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations LARYNGITIS	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations PYELONEPHRITIS	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations RECTAL ABSCESS	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations RESPIRATORY TRACT INFECTION	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations RHINITIS	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations RHINOTRACHEITIS	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations SINUSITIS BACTERIAL	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations SKIN INFECTION	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations STAPHYLOCOCCAL SKIN INFECTION	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations SUBCUTANEOUS ABSCESS	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations TINEA MANUUM	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations TONSILLITIS	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations TRACHEITIS	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Infections and infestations VULVOVAGINAL CANDIDIASIS	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Injury, poisoning and procedural complications FOOT FRACTURE	0.65% 2/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Injury, poisoning and procedural complications ANKLE FRACTURE	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Injury, poisoning and procedural complications ARTHROPOD BITE	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Injury, poisoning and procedural complications BURN ORAL CAVITY	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Injury, poisoning and procedural complications BURSITIS	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Injury, poisoning and procedural complications EYELID INJURY	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Injury, poisoning and procedural complications PRODUCT DOSE OMISSION IN ERROR	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Injury, poisoning and procedural complications SPINAL FRACTURE	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Investigations WEIGHT INCREASED	1.6% 5/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Investigations LABORATORY TEST ABNORMAL	0.65% 2/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Investigations TRANSAMINASES INCREASED	0.65% 2/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Investigations BLOOD PRESSURE ABNORMAL	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Investigations BLOOD UREA INCREASED	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Investigations CORONAVIRUS TEST POSITIVE	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Investigations GAMMA-GLUTAMYLTRANSFERASE INCREASED	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Investigations NEUTROPHIL COUNT DECREASED	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Investigations PREGNANCY TEST POSITIVE	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Investigations WEIGHT DECREASED	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Metabolism and nutrition disorders HYPERCHOLESTEROLAEMIA	1.6% 5/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Metabolism and nutrition disorders DECREASED APPETITE	0.65% 2/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Metabolism and nutrition disorders DYSLIPIDAEMIA	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Metabolism and nutrition disorders HYPERTRIGLYCERIDAEMIA	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Musculoskeletal and connective tissue disorders RHEUMATOID ARTHRITIS	3.2% 10/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Musculoskeletal and connective tissue disorders ARTHRALGIA	2.6% 8/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Musculoskeletal and connective tissue disorders JOINT EFFUSION	1.3% 4/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Musculoskeletal and connective tissue disorders ARTHRITIS	0.97% 3/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Musculoskeletal and connective tissue disorders BACK PAIN	0.97% 3/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	0.97% 3/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Musculoskeletal and connective tissue disorders BURSITIS	0.65% 2/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Musculoskeletal and connective tissue disorders OSTEOARTHRITIS	0.65% 2/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Musculoskeletal and connective tissue disorders TENDON DISORDER	0.65% 2/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Musculoskeletal and connective tissue disorders INTERVERTEBRAL DISC DISORDER	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Musculoskeletal and connective tissue disorders MYALGIA	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Musculoskeletal and connective tissue disorders OSTEOPOROSIS	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Musculoskeletal and connective tissue disorders SYNOVIAL CYST	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Musculoskeletal and connective tissue disorders SYNOVITIS	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SEBORRHOEIC KERATOSIS	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SKIN PAPILLOMA	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Nervous system disorders HEADACHE	4.5% 14/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Nervous system disorders SCIATICA	0.97% 3/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Nervous system disorders MIGRAINE	0.65% 2/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Nervous system disorders NEURALGIA	0.65% 2/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Nervous system disorders NEUROPATHY PERIPHERAL	0.65% 2/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Nervous system disorders CARPAL TUNNEL SYNDROME	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Nervous system disorders CERVICOBRACHIAL SYNDROME	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Nervous system disorders DISTURBANCE IN ATTENTION	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Nervous system disorders DIZZINESS	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Psychiatric disorders NIGHTMARE	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Renal and urinary disorders GLOMERULONEPHRITIS MEMBRANOUS	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Renal and urinary disorders RENAL IMPAIRMENT	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Reproductive system and breast disorders PROSTATITIS	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	2.3% 7/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Respiratory, thoracic and mediastinal disorders COUGH	1.3% 4/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Respiratory, thoracic and mediastinal disorders LUNG DISORDER	1.3% 4/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Respiratory, thoracic and mediastinal disorders DYSPNOEA EXERTIONAL	0.97% 3/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Respiratory, thoracic and mediastinal disorders EMPHYSEMA	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Respiratory, thoracic and mediastinal disorders LUNG OPACITY	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Respiratory, thoracic and mediastinal disorders PULMONARY MASS	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Respiratory, thoracic and mediastinal disorders RHINITIS ALLERGIC	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Skin and subcutaneous tissue disorders RASH	1.9% 6/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Skin and subcutaneous tissue disorders ALOPECIA	0.65% 2/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Skin and subcutaneous tissue disorders DERMATITIS ACNEIFORM	0.65% 2/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Skin and subcutaneous tissue disorders ECCHYMOSIS	0.65% 2/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Skin and subcutaneous tissue disorders ECZEMA	0.65% 2/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Skin and subcutaneous tissue disorders PRURITUS	0.65% 2/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Skin and subcutaneous tissue disorders RASH PRURITIC	0.65% 2/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Skin and subcutaneous tissue disorders HYPERHIDROSIS	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Skin and subcutaneous tissue disorders NIGHT SWEATS	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Skin and subcutaneous tissue disorders ONYCHOLYSIS	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Skin and subcutaneous tissue disorders PRURIGO	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Skin and subcutaneous tissue disorders SKIN BURNING SENSATION	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Skin and subcutaneous tissue disorders SKIN EXFOLIATION	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Skin and subcutaneous tissue disorders SKIN HYPERPIGMENTATION	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Skin and subcutaneous tissue disorders URTICARIA	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Surgical and medical procedures DENTAL IMPLANTATION	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Surgical and medical procedures THERAPY CESSATION	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Vascular disorders FLUSHING	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Vascular disorders HAEMATOMA	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Vascular disorders HOT FLUSH	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Vascular disorders HYPERTENSION	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Vascular disorders PHLEBITIS	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Vascular disorders SUPERFICIAL VEIN THROMBOSIS	0.32% 1/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
Gastrointestinal disorders DIARRHOEA	1.6% 5/309 • Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.

Additional Information

Pfizer Inc.

Pfizer ClinicalTrials.gov Call Center

Phone: 1-800-718-1021

Email: [email protected]

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