Trial Outcomes & Findings for A Study To Evaluate The Efficacy Of Enbrel (REGISTERED) Etanercept Over A Period Of 12 Months In The Routine Treatment Of Patients With Rheumatoid Arthritis, Axial Spondyloarthritis, Psoriatic Arthritis, Or Plaque Psoriasis. (NCT NCT02486302)

Last Updated: 2019-06-24

Results Overview

Disease activity score based on 28-joints count (DAS28) calculated as weighted average of swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, erythrocyte sedimentation rate (ESR) (millimeter per hour \[mm/h\]) and patient's global assessment (PtGA) of disease activity (recorded on a visual analog scale \[VAS\] scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28 \<2.6 = remission, DAS28 less than or equal to (\<=) 3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity.

Recruitment status

COMPLETED

Target enrollment

1534 participants

Primary outcome timeframe

Week 12

Results posted on

2019-06-24

Participant Flow

Participant milestones

Participant milestones
Measure	Etanercept All participants with rheumatoid arthritis (RA), axial spondyloarthritis (axSpA), psoriatic arthritis (PsA), or plaque psoriasis (PsO) taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Overall Study STARTED	1534
Overall Study Treated	1523
Overall Study COMPLETED	858
Overall Study NOT COMPLETED	676

Reasons for withdrawal

Reasons for withdrawal
Measure	Etanercept All participants with rheumatoid arthritis (RA), axial spondyloarthritis (axSpA), psoriatic arthritis (PsA), or plaque psoriasis (PsO) taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Overall Study Discontinued prematurely	410
Overall Study Documentation not completed	255
Overall Study Excluded due to legal reasons	8
Overall Study Not treated	3

Baseline Characteristics

There is no information available for age for 6 participants (=missing values).

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Etanercept n=1465 Participants All participants with RA, axSpA, PsA, or PsO taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Age, Continuous	54.9 years STANDARD_DEVIATION 14.5 • n=1459 Participants • There is no information available for age for 6 participants (=missing values).
Sex: Female, Male Female	901 Participants n=1465 Participants
Sex: Female, Male Male	564 Participants n=1465 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Per-protocol (PP) set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with RA evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Etanercept n=794 Participants All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 12	194 Participants

PRIMARY outcome

Timeframe: Week 24

Population: PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with RA evaluable for this outcome measure.

DAS28 calculated as weighted average of SJC and TJC using the 28 joints count, ESR \[mm/h\] and PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity.

Outcome measures

Outcome measures
Measure	Etanercept n=664 Participants All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 24	203 Participants

PRIMARY outcome

Timeframe: Week 12 up to Week 52

Outcome measures

Outcome measures
Measure	Etanercept n=147 Participants All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 12 and Maintained Till 52 Weeks	58 Participants

PRIMARY outcome

Timeframe: Week 24 up to Week 52

Outcome measures

Outcome measures
Measure	Etanercept n=169 Participants All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 24 and Maintained Till 52 Weeks	88 Participants

PRIMARY outcome

Timeframe: Week 12

PASI:combined assessment of lesion severity \& area affected into single score as: 0(no disease)-72(maximal disease). Body divided into=head,upper/lower limbs,trunk;each area scored \& scores combined for final PASI. For each section % area of skin involved was estimated:0(0%)-6(90-100%) \& severity estimated by clinical signs of erythema,induration,desquamation; range 0(none)-4(very marked). Final PASI=sum of severity parameters for each section\*area score\*weighing factor(head=0.1,upper limbs=0.2,trunk=0.3,lower limbs=0.4). PASI75:\>=75% reduction in PASI from Baseline. PGA psoriasis:average assessment of erythema,induration,desquamation of all psoriatic lesions, scored on 5-point scale: 0(no psoriasis)-4(severe disease). Clear \& almost clear indicate score 0 or 1. DLQI:10-item questionnaire, measures impact of skin disease on participant's quality of life. Each question evaluated on 4-point scale as: 0(not at all)-3 (very much). Total DLQI score:0(no effect)-30(extremely large effect).

Outcome measures

Outcome measures
Measure	Etanercept n=70 Participants All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Number of Participants With PsO Who Achieved 75% Improvement From Baseline in Psoriasis Area & Severity Index(PASI75) Score or Physician's Global Assessment(PGA) of Clear or Almost Clear And Dermatology Life Quality Index(DLQI) Total Score of 0 or 1	5 Participants

PRIMARY outcome

Timeframe: Week 12

ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, PtGA (all assessed on a VAS (0-100cm, where 0 = no disease activity and 100=high disease activity), CRP (mg/L). ASDAS ranged as inactive disease: 0 \<= ASDAS \< 1.3; moderate disease activity: 1.3 \<= ASDAS \< 2.1; high disease activity: 2.1 \<= ASDAS \<= 3.5; very high disease activity: 3.5 \< ASDAS.

Outcome measures

Outcome measures
Measure	Etanercept n=200 Participants All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Number of Participants With Axial Spondyloarthritis (axSpA) Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than (<) 1.3 at Week 12	38 Participants

PRIMARY outcome

Timeframe: Week 12

DAS28 calculated as average of from SJC and TJC using the 28 joints count, ESR (mm/h), PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. A participant was classified as MAD if the participant met at least 5 of 7 following criteria: 1) TJC \<=1; 2) SJC =\<1; 3) PASI \<= 1 or body surface area (BSA) \<=3; 4) Participant pain on VAS \<= 15 (assessed pain using a 0 mm - 100 mm VAS scale where 0 mm = minimum possible pain \[best\] and 100 mm = maximum possible pain \[worst\]; 5) PtGA on VAS \<= 20 (all assessed on a VAS 0-100cm, where 0 = no disease activity and 100=high disease activity); 6) Health assessment questionnaire disability index (HAQ-DI) \<= 0.5(HAQ=3.16-\[0.028\* hannover functional questionnaire \[FFbH\]); 7) Tender enthesial points \<= 1.

Outcome measures

Outcome measures
Measure	Etanercept n=240 Participants All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Number of Participants With Psoriatic Arthritis (PsA) Who Achieved Either 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 or Met Minimal Disease Activity (MDA) Criteria at Week 12	92 Participants

PRIMARY outcome

Timeframe: Week 24

Outcome measures

Outcome measures
Measure	Etanercept n=59 Participants All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Number of Participants With Plaque Psoriasis (PsO) Who Achieved 75% Improvement in Psoriasis Area and Severity Index (PASI75) Score or a Physician's Global Assessment (PGA) of "Clear" or "Almost Clear" and DLQI Total Score of 0 or 1 at Week 24	11 Participants

PRIMARY outcome

Timeframe: Week 24

Outcome measures

Outcome measures
Measure	Etanercept n=152 Participants All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Number of Participants With Axial Spondyloarthritis (axSpA) Achieving Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than (<) 1.3 at Week 24	28 Participants

PRIMARY outcome

Timeframe: Week 24

DAS28 calculated as average of SJC and TJC using the 28 joints count, ESR (mm/h) and PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. A participant was classified as MAD if the participant met at least 5 of 7 following criteria: 1) TJC t\<=1; 2) SJC =\<1; 3) PASI \<= 1 or BSA \<=3; 4) Participant pain on VAS \<= 15 (assessed pain using a 0 mm - 100 mm VAS scale where 0 mm = minimum possible pain \[best\] and 100 mm = maximum possible pain \[worst\]; 5) PtGA on VAS \<= 20 (all assessed on a VAS 0-100cm, where 0 = no disease activity and 100=high disease activity); 6) HAQ-DI \<= 0.5(HAQ=3.16-\[0.028\*FFbH); 7) Tender enthesial points \<= 1.

Outcome measures

Outcome measures
Measure	Etanercept n=209 Participants All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Number of Participants With Psoriatic Arthritis (PsA) Achieving Either 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 or Met Minimal Disease Activity (MDA) Criteria at Week 24	106 Participants

SECONDARY outcome

Timeframe: Baseline up to Weeks 12, 24, 36, 52

Population: Treated set included all documented participants who were treated, had at least 1 post-baseline value and had an AE documented.

Outcome measures

Outcome measures
Measure	Etanercept n=1465 Participants All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Percentage of Participants Who Continued With Treatment up to Weeks 12, 24, 36 and 52: Treated Set (TS) Up to Week 12	89.5 percentage of participants
Percentage of Participants Who Continued With Treatment up to Weeks 12, 24, 36 and 52: Treated Set (TS) Up to Week 24	81.2 percentage of participants
Percentage of Participants Who Continued With Treatment up to Weeks 12, 24, 36 and 52: Treated Set (TS) Up to Week 36	75.6 percentage of participants
Percentage of Participants Who Continued With Treatment up to Weeks 12, 24, 36 and 52: Treated Set (TS) Up to Week 52	71.6 percentage of participants

SECONDARY outcome

Timeframe: Baseline up to Weeks 12, 24, 36, 52

Population: PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation.

Outcome measures

Outcome measures
Measure	Etanercept n=1453 Participants All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Percentage of Participants Who Continued With Treatment up to Weeks 12, 24, 36 and 52: Per-Protocol (PP) Set Up to Week 12	89.4 percentage of participants
Percentage of Participants Who Continued With Treatment up to Weeks 12, 24, 36 and 52: Per-Protocol (PP) Set Up to Week 24	81.1 percentage of participants
Percentage of Participants Who Continued With Treatment up to Weeks 12, 24, 36 and 52: Per-Protocol (PP) Set Up to Week 36	75.6 percentage of participants
Percentage of Participants Who Continued With Treatment up to Weeks 12, 24, 36 and 52: Per-Protocol (PP) Set Up to Week 52	71.6 percentage of participants

SECONDARY outcome

Timeframe: Baseline up to Weeks 12, 24, 36, 52

Population: Treated set included all documented participants who were treated, had at least 1 post-baseline value and had an AE documented.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were measured up to Week 12, 24, 36 and 52 of exposure with study drug that were absent before treatment or that worsened relative to pretreatment state. TEAEs included both SAEs and non-SAEs.

Outcome measures

Outcome measures
Measure	Etanercept n=1465 Participants All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) up to Weeks 12, 24, 36 and 52: Treated Set Up to Week 12	417 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) up to Weeks 12, 24, 36 and 52: Treated Set Up to Week 24	567 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) up to Weeks 12, 24, 36 and 52: Treated Set Up to Week 36	651 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) up to Weeks 12, 24, 36 and 52: Treated Set Up to Week 52	699 Participants

SECONDARY outcome

Timeframe: Baseline up to Weeks 12, 24, 36, 52

Population: PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were measured up to Week 12, 24, 36 and 52 of exposure with study drug that were absent before treatment or that worsened relative to pretreatment state. TEAEs included both SAEs and non-SAEs.

Outcome measures

Outcome measures
Measure	Etanercept n=1453 Participants All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Number of Participants With Treatment Emergent Adverse Events up to Weeks 12, 24, 36 and 52: Per-Protocol (PP) Set Up to Week 12	416 Participants
Number of Participants With Treatment Emergent Adverse Events up to Weeks 12, 24, 36 and 52: Per-Protocol (PP) Set Up to Week 24	564 Participants
Number of Participants With Treatment Emergent Adverse Events up to Weeks 12, 24, 36 and 52: Per-Protocol (PP) Set Up to Week 36	646 Participants
Number of Participants With Treatment Emergent Adverse Events up to Weeks 12, 24, 36 and 52: Per-Protocol (PP) Set Up to Week 52	694 Participants

SECONDARY outcome

Timeframe: Weeks 12, 24, 36, 52

Outcome measures

Outcome measures
Measure	Etanercept n=1078 Participants All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Number of Participants Achieving 28 Joint Disease Activity Score (DAS28) Remission at Weeks 12, 24, 36 and 52 Week 12	278 Participants
Number of Participants Achieving 28 Joint Disease Activity Score (DAS28) Remission at Weeks 12, 24, 36 and 52 Week 24	305 Participants
Number of Participants Achieving 28 Joint Disease Activity Score (DAS28) Remission at Weeks 12, 24, 36 and 52 Week 36	263 Participants
Number of Participants Achieving 28 Joint Disease Activity Score (DAS28) Remission at Weeks 12, 24, 36 and 52 Week 52	271 Participants

SECONDARY outcome

Timeframe: Weeks 12, 24, 36, 52

Population: PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. "Number analyzed" signifies participants analyzed for this outcome measure at specified time points.

Participants answered question: "How do you assess your current disease activity?" Participants responded by using a 0 - 100 mm visual analog scale where 0 mm = no activity and 100 mm = highest possible activity.

Outcome measures

Outcome measures
Measure	Etanercept n=1453 Participants All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Patient Global Assessment of Disease Activity (PtGA) Scores at Weeks 12, 24, 36 and 52 Week 36	32.7 mm Standard Deviation 23.8
Patient Global Assessment of Disease Activity (PtGA) Scores at Weeks 12, 24, 36 and 52 Week 12	39.8 mm Standard Deviation 24.9
Patient Global Assessment of Disease Activity (PtGA) Scores at Weeks 12, 24, 36 and 52 Week 24	35.5 mm Standard Deviation 25.1
Patient Global Assessment of Disease Activity (PtGA) Scores at Weeks 12, 24, 36 and 52 Week 52	30.5 mm Standard Deviation 23.3

SECONDARY outcome

Timeframe: Weeks 12, 24, 36, 52

Participants assessed their fatigue using a 0 - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue.

Outcome measures

Outcome measures
Measure	Etanercept n=1453 Participants All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Mean Visual Analogue Scale (VAS) Fatigue Scores at Weeks 12, 24, 36 and 52 Week 12	40.9 mm Standard Deviation 30.1
Mean Visual Analogue Scale (VAS) Fatigue Scores at Weeks 12, 24, 36 and 52 Week 24	37.7 mm Standard Deviation 29.5
Mean Visual Analogue Scale (VAS) Fatigue Scores at Weeks 12, 24, 36 and 52 Week 36	36.1 mm Standard Deviation 28.9
Mean Visual Analogue Scale (VAS) Fatigue Scores at Weeks 12, 24, 36 and 52 Week 52	33.5 mm Standard Deviation 27.8

SECONDARY outcome

Timeframe: Weeks 12, 24, 36, 52

Population: PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Number analyzed signifies participants analyzed for this outcome at specified time points.

Participants assessed pain using a 0 mm - 100 mm VAS scale where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst).

Outcome measures

Outcome measures
Measure	Etanercept n=1453 Participants All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Mean Visual Analogue Scale (VAS) Pain Scores at Weeks 12, 24, 36 and 52 Week 12	38.3 mm Standard Deviation 26.9
Mean Visual Analogue Scale (VAS) Pain Scores at Weeks 12, 24, 36 and 52 Week 24	34.9 mm Standard Deviation 26.3
Mean Visual Analogue Scale (VAS) Pain Scores at Weeks 12, 24, 36 and 52 Week 36	32.9 mm Standard Deviation 25.6
Mean Visual Analogue Scale (VAS) Pain Scores at Weeks 12, 24, 36 and 52 Week 52	31.1 mm Standard Deviation 24.7

SECONDARY outcome

Timeframe: Weeks 12, 24, 36, 52

PGA of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity; 100 mm= high disease activity.

Outcome measures

Outcome measures
Measure	Etanercept n=1453 Participants All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Physician Global Assessment (PGA) of Disease Activity Scores at Weeks 12, 24, 36 and 52 Week 12	32.5 mm Standard Deviation 21.1
Physician Global Assessment (PGA) of Disease Activity Scores at Weeks 12, 24, 36 and 52 Week 24	26.9 mm Standard Deviation 20.5
Physician Global Assessment (PGA) of Disease Activity Scores at Weeks 12, 24, 36 and 52 Week 36	23.8 mm Standard Deviation 19.4
Physician Global Assessment (PGA) of Disease Activity Scores at Weeks 12, 24, 36 and 52 Week 52	21.7 mm Standard Deviation 18.9

SECONDARY outcome

Timeframe: Weeks 12, 24, 36, 52

The PHQ-2 is a brief depression screening instrument and enquire two factors: frequency of depressed mood and anhedonia (inability to feel pleasure in normally pleasurable activities) over the past 2 weeks, scoring each question on scale of 0 ("not at all") to 3 ("nearly every day"). Total PHQ-2 score ranged from 0-6 (0 indicate not at all: depression/anhedonia can be ruled out; 6 indicate nearly every day: worsening of depression/anhedonia).

Outcome measures

Outcome measures
Measure	Etanercept n=1453 Participants All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Patient Health Quessionare-2 (PHQ-2) Scores at Weeks 12, 24, 36 and 52 Week 12	2.0 units on a scale Standard Deviation 1.6
Patient Health Quessionare-2 (PHQ-2) Scores at Weeks 12, 24, 36 and 52 Week 24	1.8 units on a scale Standard Deviation 1.6
Patient Health Quessionare-2 (PHQ-2) Scores at Weeks 12, 24, 36 and 52 Week 36	1.7 units on a scale Standard Deviation 1.5
Patient Health Quessionare-2 (PHQ-2) Scores at Weeks 12, 24, 36 and 52 Week 52	1.6 units on a scale Standard Deviation 1.5

SECONDARY outcome

Timeframe: Weeks 12, 24, 36, 52

The PtGA of disease activity was measured on a VAS ranged from 0 mm to 100 mm, where 0 = no disease activity and 100=high disease activity. Participants assessed their fatigue during the last 7 days using a 0 mm - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Participants assessed pain using a 0 mm - 100 mm VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). The PHQ-2 is a brief depression screening instrument and enquire two factors: frequency of depressed mood and anhedonia over the past 2 weeks, scoring each question on scale of 0 ("not at all") to 3 ("nearly every day"). Total PHQ-2 ranged from 0-6. PGA disease activity was measured on a 0 mm to 100 mm VAS, with 0 mm = no disease activity and 100mm = maximum possible disease activity. Correlation coefficient between each of these parameters was measured using spearman correlation coefficient and reported.

Outcome measures

Outcome measures
Measure	Etanercept n=824 Participants All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 12: PtGA versus (vs.) Fatigue	0.514 spearman correlation coefficient Interval 0.456 to 0.567
Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 12: PtGA vs. Pain	0.825 spearman correlation coefficient Interval 0.799 to 0.847
Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 12: PtGA vs. PHQ-2	0.450 spearman correlation coefficient Interval 0.387 to 0.507
Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 12: PtGA vs. PGA	0.603 spearman correlation coefficient Interval 0.552 to 0.649
Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 12: Fatigue vs. Pain	0.586 spearman correlation coefficient Interval 0.535 to 0.633
Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 12: Fatigue vs. PHQ-2	0.577 spearman correlation coefficient Interval 0.525 to 0.624
Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 12: Fatigue vs. PGA	0.370 spearman correlation coefficient Interval 0.303 to 0.433
Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 12: Pain vs. PHQ-2	0.529 spearman correlation coefficient Interval 0.473 to 0.581
Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 12: Pain vs. PGA	0.612 spearman correlation coefficient Interval 0.562 to 0.657
Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 12: PHQ-2 vs. PGA	0.376 spearman correlation coefficient Interval 0.312 to 0.436
Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 24: PtGA vs. Fatigue	0.588 spearman correlation coefficient Interval 0.532 to 0.638
Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 24: PtGA vs. Pain	0.859 spearman correlation coefficient Interval 0.837 to 0.879
Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 24: PtGA vs. PHQ-2	0.526 spearman correlation coefficient Interval 0.465 to 0.582
Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 24: PtGA vs. PGA	0.600 spearman correlation coefficient Interval 0.545 to 0.65
Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 24: Fatigue vs. Pain	0.621 spearman correlation coefficient Interval 0.569 to 0.668
Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 24: Fatigue vs. PHQ-2	0.591 spearman correlation coefficient Interval 0.536 to 0.641
Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 24: Fatigue vs. PGA	0.389 spearman correlation coefficient Interval 0.317 to 0.456
Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 24: Pain vs. PHQ-2	0.558 spearman correlation coefficient Interval 0.5 to 0.611
Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 24: Pain vs. PGA	0.556 spearman correlation coefficient Interval 0.497 to 0.61
Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 24: PHQ-2 vs. PGA	0.379 spearman correlation coefficient Interval 0.309 to 0.445
Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 36: PtGA vs. Fatigue	0.664 spearman correlation coefficient Interval 0.611 to 0.71
Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 36: PtGA vs. Pain	0.839 spearman correlation coefficient Interval 0.81 to 0.863
Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 36: PtGA vs. PHQ-2	0.513 spearman correlation coefficient Interval 0.445 to 0.574
Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 36: PtGA vs. PGA	0.609 spearman correlation coefficient Interval 0.55 to 0.661
Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 36: Fatigue vs. Pain	0.646 spearman correlation coefficient Interval 0.591 to 0.694
Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 36: Fatigue vs. PHQ-2	0.614 spearman correlation coefficient Interval 0.556 to 0.665
Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 36: Fatigue vs. PGA	0.463 spearman correlation coefficient Interval 0.391 to 0.529
Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 36: Pain vs. PHQ-2	0.532 spearman correlation coefficient Interval 0.466 to 0.592
Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 36: Pain vs. PGA	0.576 spearman correlation coefficient Interval 0.514 to 0.632
Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 36: PHQ-2 vs. PGA	0.367 spearman correlation coefficient Interval 0.291 to 0.438
Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 52: PtGA vs. Fatigue	0.666 spearman correlation coefficient Interval 0.609 to 0.715
Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 52: PtGA vs. Pain	0.861 spearman correlation coefficient Interval 0.835 to 0.884
Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 52: PtGA vs. PHQ-2	0.507 spearman correlation coefficient Interval 0.434 to 0.574
Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 52: PtGA vs. PGA	0.632 spearman correlation coefficient Interval 0.571 to 0.685
Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 52: Fatigue vs. Pain	0.649 spearman correlation coefficient Interval 0.591 to 0.7
Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 52: Fatigue vs. PHQ-2	0.574 spearman correlation coefficient Interval 0.507 to 0.633
Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 52: Fatigue vs. PGA	0.485 spearman correlation coefficient Interval 0.409 to 0.554
Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 52: Pain vs. PHQ-2	0.545 spearman correlation coefficient Interval 0.475 to 0.607
Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 52: Pain vs. PGA	0.641 spearman correlation coefficient Interval 0.582 to 0.693
Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 52: PHQ-2 vs. PGA	0.445 spearman correlation coefficient Interval 0.367 to 0.515

SECONDARY outcome

Timeframe: Weeks 12, 24, 36, 52

Outcome measures

Outcome measures
Measure	Etanercept n=305 Participants All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 12:PtGA vs. Fatigue	0.582 spearman correlation coefficient Interval 0.492 to 0.658
Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 12: PtGA vs. Pain	0.899 spearman correlation coefficient Interval 0.872 to 0.921
Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 12: PtGA vs. PHQ-2	0.526 spearman correlation coefficient Interval 0.427 to 0.611
Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 12: PtGA vs. PGA	0.606 spearman correlation coefficient Interval 0.52 to 0.679
Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 12: Fatigue vs. Pain	0.547 spearman correlation coefficient Interval 0.453 to 0.628
Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 12: Fatigue vs. PHQ-2	0.487 spearman correlation coefficient Interval 0.384 to 0.576
Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 12: Fatigue vs. PGA	0.369 spearman correlation coefficient Interval 0.256 to 0.47
Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 12: Pain vs. PHQ-2	0.530 spearman correlation coefficient Interval 0.433 to 0.614
Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 12: Pain vs. PGA	0.617 spearman correlation coefficient Interval 0.533 to 0.688
Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 12: PHQ-2 vs. PGA	0.392 spearman correlation coefficient Interval 0.285 to 0.488
Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 24: PtGA vs. Fatigue	0.668 spearman correlation coefficient Interval 0.584 to 0.737
Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 24: PtGA vs. Pain	0.904 spearman correlation coefficient Interval 0.874 to 0.926
Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 24: PtGA vs. PHQ-2	0.495 spearman correlation coefficient Interval 0.383 to 0.591
Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 24: PtGA vs. PGA	0.495 spearman correlation coefficient Interval 0.383 to 0.591
Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 24: Fatigue vs. Pain	0.664 spearman correlation coefficient Interval 0.578 to 0.734
Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 24: Fatigue vs. PHQ-2	0.634 spearman correlation coefficient Interval 0.543 to 0.709
Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 24: Fatigue vs. PGA	0.445 spearman correlation coefficient Interval 0.326 to 0.548
Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 24: Pain vs. PHQ-2	0.492 spearman correlation coefficient Interval 0.379 to 0.588
Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 24: Pain vs. PGA	0.515 spearman correlation coefficient Interval 0.405 to 0.608
Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 24: PHQ-2 vs. PGA	0.449 spearman correlation coefficient Interval 0.335 to 0.549
Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 36: PtGA vs. Fatigue	0.720 spearman correlation coefficient Interval 0.641 to 0.782
Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 36: PtGA vs. Pain	0.914 spearman correlation coefficient Interval 0.886 to 0.935
Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 36: PtGA vs. PHQ-2	0.630 spearman correlation coefficient Interval 0.533 to 0.709
Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 36: PtGA vs. PGA	0.586 spearman correlation coefficient Interval 0.481 to 0.672
Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 36: Fatigue vs. Pain	0.728 spearman correlation coefficient Interval 0.65 to 0.789
Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 36: Fatigue vs. PHQ-2	0.691 spearman correlation coefficient Interval 0.606 to 0.759
Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 36: Fatigue vs. PGA	0.530 spearman correlation coefficient Interval 0.415 to 0.626
Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 36: Pain vs. PHQ-2	0.637 spearman correlation coefficient Interval 0.54 to 0.715
Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 36: Pain vs. PGA	0.591 spearman correlation coefficient Interval 0.487 to 0.677
Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 36: PHQ-2 vs. PGA	0.483 spearman correlation coefficient Interval 0.366 to 0.583
Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 52: PtGA vs. Fatigue	0.717 spearman correlation coefficient Interval 0.634 to 0.782
Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 52: PtGA vs. Pain	0.912 spearman correlation coefficient Interval 0.882 to 0.934
Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 52: PtGA vs. PHQ-2	0.586 spearman correlation coefficient Interval 0.476 to 0.676
Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 52: PtGA vs. PGA	0.548 spearman correlation coefficient Interval 0.432 to 0.644
Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 52: Fatigue vs. Pain	0.743 spearman correlation coefficient Interval 0.666 to 0.803
Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 52: Fatigue vs. PHQ-2	0.676 spearman correlation coefficient Interval 0.584 to 0.749
Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 52: Fatigue vs. PGA	0.457 spearman correlation coefficient Interval 0.328 to 0.567
Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 52: Pain vs. PHQ-2	0.629 spearman correlation coefficient Interval 0.527 to 0.711
Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 52: Pain vs. PGA	0.603 spearman correlation coefficient Interval 0.497 to 0.69
Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 52: PHQ-2 vs. PGA	0.420 spearman correlation coefficient Interval 0.29 to 0.533

SECONDARY outcome

Timeframe: Weeks 12, 24, 36, 52

Outcome measures

Outcome measures
Measure	Etanercept n=254 Participants All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 12: PtGA vs. Fatigue	0.630 spearman correlation coefficient Interval 0.542 to 0.703
Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 12: PtGA vs. Pain	0.892 spearman correlation coefficient Interval 0.862 to 0.916
Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 12: PtGA vs. PHQ-2	0.609 spearman correlation coefficient Interval 0.518 to 0.686
Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 12: PtGA vs. PGA	0.509 spearman correlation coefficient Interval 0.402 to 0.601
Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 12: Fatigue vs. Pain	0.664 spearman correlation coefficient Interval 0.583 to 0.731
Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 12: Fatigue vs. PHQ-2	0.601 spearman correlation coefficient Interval 0.508 to 0.678
Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 12: Fatigue vs. PGA	0.324 spearman correlation coefficient Interval 0.198 to 0.438
Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 12: Pain vs. PHQ-2	0.628 spearman correlation coefficient Interval 0.54 to 0.701
Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 12: Pain vs. PGA	0.529 spearman correlation coefficient Interval 0.425 to 0.618
Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 12: PHQ-2 vs. PGA	0.381 spearman correlation coefficient Interval 0.262 to 0.488
Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 24: PtGA vs. Fatigue	0.656 spearman correlation coefficient Interval 0.565 to 0.73
Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 24: PtGA vs. Pain	0.881 spearman correlation coefficient Interval 0.844 to 0.909
Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 24: PtGA vs. PHQ-2	0.562 spearman correlation coefficient Interval 0.454 to 0.652
Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 24: PtGA vs. PGA	0.559 spearman correlation coefficient Interval 0.451 to 0.649
Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 24: Fatigue vs. Pain	0.674 spearman correlation coefficient Interval 0.586 to 0.744
Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 24: Fatigue vs. PHQ-2	0.620 spearman correlation coefficient Interval 0.521 to 0.7
Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 24: Fatigue vs. PGA	0.374 spearman correlation coefficient Interval 0.243 to 0.49
Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 24: Pain vs. PHQ-2	0.607 spearman correlation coefficient Interval 0.507 to 0.69
Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 24: Pain vs. PGA	0.630 spearman correlation coefficient Interval 0.534 to 0.708
Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 24: PHQ-2 vs. PGA	0.410 spearman correlation coefficient Interval 0.285 to 0.52
Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 36: PtGA vs. Fatigue	0.692 spearman correlation coefficient Interval 0.603 to 0.762
Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 36: PtGA vs. Pain	0.913 spearman correlation coefficient Interval 0.884 to 0.935
Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 36: PtGA vs. PHQ-2	0.645 spearman correlation coefficient Interval 0.546 to 0.724
Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 36: PtGA vs. PGA	0.513 spearman correlation coefficient Interval 0.392 to 0.614
Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 36: Fatigue vs. Pain	0.724 spearman correlation coefficient Interval 0.642 to 0.788
Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 36: Fatigue vs. PHQ-2	0.710 spearman correlation coefficient Interval 0.624 to 0.777
Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 36: Fatigue vs. PGA	0.423 spearman correlation coefficient Interval 0.29 to 0.539
Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 36: Pain vs. PHQ-2	0.658 spearman correlation coefficient Interval 0.561 to 0.735
Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 36: Pain vs. PGA	0.532 spearman correlation coefficient Interval 0.414 to 0.631
Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 36: PHQ-2 vs. PGA	0.357 spearman correlation coefficient Interval 0.218 to 0.48
Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 52: PtGA vs. Fatigue	0.753 spearman correlation coefficient Interval 0.671 to 0.815
Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 52: PtGA vs. Pain	0.908 spearman correlation coefficient Interval 0.874 to 0.933
Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 52: PtGA vs. PHQ-2	0.696 spearman correlation coefficient Interval 0.599 to 0.771
Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 52: PtGA vs. PGA	0.565 spearman correlation coefficient Interval 0.439 to 0.666
Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 52: Fatigue vs. Pain	0.760 spearman correlation coefficient Interval 0.68 to 0.82
Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 52: Fatigue vs. PHQ-2	0.726 spearman correlation coefficient Interval 0.637 to 0.794
Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 52: Fatigue vs. PGA	0.430 spearman correlation coefficient Interval 0.285 to 0.553
Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 52: Pain vs. PHQ-2	0.683 spearman correlation coefficient Interval 0.584 to 0.761
Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 52: Pain vs. PGA	0.581 spearman correlation coefficient Interval 0.459 to 0.679
Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 52: PHQ-2 vs. PGA	0.498 spearman correlation coefficient Interval 0.364 to 0.609

SECONDARY outcome

Timeframe: Weeks 12, 24, 36, 52

Outcome measures

Outcome measures
Measure	Etanercept n=70 Participants All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 12: PtGA vs. Fatigue	0.350 spearman correlation coefficient Interval 0.107 to 0.55
Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 12: PtGA vs. Pain	0.606 spearman correlation coefficient Interval 0.414 to 0.742
Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 12: PtGA vs. PHQ-2	0.563 spearman correlation coefficient Interval 0.353 to 0.715
Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 12: PtGA vs. PGA	0.606 spearman correlation coefficient Interval 0.415 to 0.741
Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 12: Fatigue vs. Pain	0.679 spearman correlation coefficient Interval 0.515 to 0.791
Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 12: Fatigue vs. PHQ-2	0.681 spearman correlation coefficient Interval 0.512 to 0.795
Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 12: Fatigue vs. PGA	0.175 spearman correlation coefficient Interval -0.075 to 0.403
Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 12: Pain vs. PHQ-2	0.647 spearman correlation coefficient Interval 0.464 to 0.772
Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 12: Pain vs. PGA	0.384 spearman correlation coefficient Interval 0.147 to 0.575
Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 12: PHQ-2 vs. PGA	0.265 spearman correlation coefficient Interval 0.016 to 0.479
Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 24: PtGA vs. Fatigue	0.651 spearman correlation coefficient Interval 0.45 to 0.784
Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 24: PtGA vs. Pain	0.692 spearman correlation coefficient Interval 0.508 to 0.812
Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 24: PtGA vs. PHQ-2	0.485 spearman correlation coefficient Interval 0.231 to 0.672
Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 24: PtGA vs. PGA	0.713 spearman correlation coefficient Interval 0.537 to 0.825
Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 24: Fatigue vs. Pain	0.802 spearman correlation coefficient Interval 0.669 to 0.881
Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 24: Fatigue vs. PHQ-2	0.577 spearman correlation coefficient Interval 0.348 to 0.736
Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 24: Fatigue vs. PGA	0.377 spearman correlation coefficient Interval 0.107 to 0.591
Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 24: Pain vs. PHQ-2	0.466 spearman correlation coefficient Interval 0.208 to 0.658
Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 24: Pain vs. PGA	0.470 spearman correlation coefficient Interval 0.216 to 0.659
Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 24: PHQ-2 vs. PGA	0.219 spearman correlation coefficient Interval -0.062 to 0.465
Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 36: PtGA vs. Fatigue	0.627 spearman correlation coefficient Interval 0.377 to 0.785
Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 36: PtGA vs. Pain	0.687 spearman correlation coefficient Interval 0.463 to 0.822
Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 36: PtGA vs. PHQ-2	0.585 spearman correlation coefficient Interval 0.319 to 0.759
Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 36: PtGA vs. PGA	0.519 spearman correlation coefficient Interval 0.233 to 0.716
Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 36: Fatigue vs. Pain	0.744 spearman correlation coefficient Interval 0.553 to 0.855
Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 36: Fatigue vs. PHQ-2	0.812 spearman correlation coefficient Interval 0.661 to 0.895
Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 36: Fatigue vs. PGA	0.288 spearman correlation coefficient Interval -0.034 to 0.55
Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 36: Pain vs. PHQ-2	0.659 spearman correlation coefficient Interval 0.426 to 0.803
Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 36: Pain vs. PGA	0.411 spearman correlation coefficient Interval 0.104 to 0.64
Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 36: PHQ-2 vs. PGA	0.167 spearman correlation coefficient Interval -0.15 to 0.45
Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 52: PtGA vs. Fatigue	0.418 spearman correlation coefficient Interval 0.074 to 0.665
Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 52: PtGA vs. Pain	0.625 spearman correlation coefficient Interval 0.35 to 0.794
Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 52: PtGA vs. PHQ-2	0.464 spearman correlation coefficient Interval 0.137 to 0.693
Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 52: PtGA vs. PGA	0.753 spearman correlation coefficient Interval 0.544 to 0.868
Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 52: Fatigue vs. Pain	0.579 spearman correlation coefficient Interval 0.281 to 0.768
Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 52: Fatigue vs. PHQ-2	0.598 spearman correlation coefficient Interval 0.307 to 0.78
Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 52: Fatigue vs. PGA	0.278 spearman correlation coefficient Interval -0.083 to 0.568
Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 52: Pain vs. PHQ-2	0.404 spearman correlation coefficient Interval 0.064 to 0.653
Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 52: Pain vs. PGA	0.421 spearman correlation coefficient Interval 0.085 to 0.664
Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Week 52: PHQ-2 vs. PGA	0.208 spearman correlation coefficient Interval -0.132 to 0.5

SECONDARY outcome

Timeframe: Weeks 12, 24, 36, 52

FFbH consists 18 questions to assess daily activities in last 7 days. Each question is answered by the participant as "Yes, I can perform the activity without difficulty" (score assigned = 2), "Yes, but with some difficulties" (score assigned = 1) and "No or only with help" (score assigned = 0). Final FFbH score (FFbH functional capacity) was then computed according to formula: (Sum of all single scores \* 100% \[percent\]) / (2 \* number of answered questions) ranged between 0-100; higher score indicates better daily activities. Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes \[24 hours\*60 minutes\] was recorded).

Outcome measures

Outcome measures
Measure	Etanercept n=824 Participants All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52 Week 12: FFbH vs. Morning stiffness	-0.439 spearman correlation coefficient Interval -0.498 to -0.375
Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52 Week 24: FFbH vs. Morning stiffness	-0.486 spearman correlation coefficient Interval -0.547 to -0.42
Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52 Week 36: FFbH vs. Morning stiffness	-0.520 spearman correlation coefficient Interval -0.582 to -0.451
Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52 Week 52: FFbH vs. Morning stiffness	-0.502 spearman correlation coefficient Interval -0.571 to -0.427

SECONDARY outcome

Timeframe: Weeks 12, 24, 36, 52

Outcome measures

Outcome measures
Measure	Etanercept n=254 Participants All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Psoriatic Arthritis(PsA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52 Week 12: FFbH vs. Morning stiffness	-0.493 spearman correlation coefficient Interval -0.589 to -0.381
Psoriatic Arthritis(PsA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52 Week 24: FFbH vs. Morning stiffness	-0.640 spearman correlation coefficient Interval -0.719 to -0.542
Psoriatic Arthritis(PsA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52 Week 36: FFbH vs. Morning stiffness	-0.615 spearman correlation coefficient Interval -0.703 to -0.504
Psoriatic Arthritis(PsA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52 Week 52: FFbH vs. Morning stiffness	-0.560 spearman correlation coefficient Interval -0.667 to -0.428

SECONDARY outcome

Timeframe: Weeks 12, 24, 36, 52

Outcome measures

Outcome measures
Measure	Etanercept n=305 Participants All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Ankylosing Spondylitis(axSpA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52 Week 12: FFbH vs. Morning stiffness	-0.523 spearman correlation coefficient Interval -0.608 to -0.425
Ankylosing Spondylitis(axSpA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52 Week 24: FFbH vs. Morning stiffness	-0.523 spearman correlation coefficient Interval -0.617 to -0.413
Ankylosing Spondylitis(axSpA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52 Week 36: FFbH vs. Morning stiffness	-0.565 spearman correlation coefficient Interval -0.658 to -0.453
Ankylosing Spondylitis(axSpA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52 Week 52: FFbH vs. Morning stiffness	-0.600 spearman correlation coefficient Interval -0.69 to -0.489

SECONDARY outcome

Timeframe: Baseline up to Week 52

Population: Treated set included all documented participants who were treated, had at least 1 post-baseline value and had an AE documented.

Percentage of participants who discontinued etanercept before completing the study, was reported.

Outcome measures

Outcome measures
Measure	Etanercept n=1465 Participants All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Percentage of Participants Who Discontinued Treatment Due to Lack of Efficacy or Adverse Events Due to lack of Efficacy	15.2 percentage of participants
Percentage of Participants Who Discontinued Treatment Due to Lack of Efficacy or Adverse Events Due to Adverse Events	8.5 percentage of participants

SECONDARY outcome

Timeframe: Baseline up to Week 52

Population: Treated set included all documented participants who were treated, had at least 1 post-baseline value and had an AE documented. Overall number of participants analyzed signifies participants from treated set who discontinued treatment with Etanercept.

Participants who switched from etanercept to either disease-modifying antirheumatic drugs (DMARDs) or alternative biologic drug were reported.

Outcome measures

Outcome measures
Measure	Etanercept n=410 Participants All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Number of Participants Who Switched to Other Therapy After Treatment Discontinuation Baricitinib	3 Participants
Number of Participants Who Switched to Other Therapy After Treatment Discontinuation Biological NOS	5 Participants
Number of Participants Who Switched to Other Therapy After Treatment Discontinuation Certolizumab	26 Participants
Number of Participants Who Switched to Other Therapy After Treatment Discontinuation Etanercept Biosimilar	10 Participants
Number of Participants Who Switched to Other Therapy After Treatment Discontinuation Golimumab	6 Participants
Number of Participants Who Switched to Other Therapy After Treatment Discontinuation Hydroxychloroquin	1 Participants
Number of Participants Who Switched to Other Therapy After Treatment Discontinuation Leflunomid	4 Participants
Number of Participants Who Switched to Other Therapy After Treatment Discontinuation Methotrexate (MTX)	6 Participants
Number of Participants Who Switched to Other Therapy After Treatment Discontinuation MTX, Adalimumab	2 Participants
Number of Participants Who Switched to Other Therapy After Treatment Discontinuation MTX, Prednisolon	3 Participants
Number of Participants Who Switched to Other Therapy After Treatment Discontinuation MTX, Tocilizumab	1 Participants
Number of Participants Who Switched to Other Therapy After Treatment Discontinuation Prednisolon	13 Participants
Number of Participants Who Switched to Other Therapy After Treatment Discontinuation Prednisolon, Diclofenac	1 Participants
Number of Participants Who Switched to Other Therapy After Treatment Discontinuation Remsima (Infliximab-Biosimilar)	1 Participants
Number of Participants Who Switched to Other Therapy After Treatment Discontinuation Rituximab	12 Participants
Number of Participants Who Switched to Other Therapy After Treatment Discontinuation Roactemra	10 Participants
Number of Participants Who Switched to Other Therapy After Treatment Discontinuation Secukinumab	27 Participants
Number of Participants Who Switched to Other Therapy After Treatment Discontinuation Sulfasalazin	1 Participants
Number of Participants Who Switched to Other Therapy After Treatment Discontinuation Sulfasalazin, Leflunomid	1 Participants
Number of Participants Who Switched to Other Therapy After Treatment Discontinuation Tapentadol	2 Participants
Number of Participants Who Switched to Other Therapy After Treatment Discontinuation Tocilizumab	25 Participants
Number of Participants Who Switched to Other Therapy After Treatment Discontinuation Tofacitinib	2 Participants
Number of Participants Who Switched to Other Therapy After Treatment Discontinuation Ustekinumab	7 Participants
Number of Participants Who Switched to Other Therapy After Treatment Discontinuation Etoricoxib	1 Participants
Number of Participants Who Switched to Other Therapy After Treatment Discontinuation Ibuprofen	2 Participants
Number of Participants Who Switched to Other Therapy After Treatment Discontinuation Ibuprofen, Metamizol	1 Participants
Number of Participants Who Switched to Other Therapy After Treatment Discontinuation Ibuprofen, Prednisolon, Oxycodon, Pregabalin	1 Participants
Number of Participants Who Switched to Other Therapy After Treatment Discontinuation Inflectra (Infliximab Biosimilar)	1 Participants
Number of Participants Who Switched to Other Therapy After Treatment Discontinuation Infliximab	1 Participants
Number of Participants Who Switched to Other Therapy After Treatment Discontinuation NSAR	1 Participants
Number of Participants Who Switched to Other Therapy After Treatment Discontinuation Corticosteroid	1 Participants
Number of Participants Who Switched to Other Therapy After Treatment Discontinuation PUVA	1 Participants
Number of Participants Who Switched to Other Therapy After Treatment Discontinuation Unknown	5 Participants
Number of Participants Who Switched to Other Therapy After Treatment Discontinuation None	56 Participants
Number of Participants Who Switched to Other Therapy After Treatment Discontinuation Missing values	92 Participants
Number of Participants Who Switched to Other Therapy After Treatment Discontinuation Abatacept	15 Participants
Number of Participants Who Switched to Other Therapy After Treatment Discontinuation Adalimumab	53 Participants
Number of Participants Who Switched to Other Therapy After Treatment Discontinuation Apremilast	7 Participants
Number of Participants Who Switched to Other Therapy After Treatment Discontinuation Azathioprin	1 Participants
Number of Participants Who Switched to Other Therapy After Treatment Discontinuation Azathioprin, Leflunomid, Diclofenac	1 Participants
Number of Participants Who Switched to Other Therapy After Treatment Discontinuation Azathioprin, Prednisolon	1 Participants

SECONDARY outcome

Timeframe: Weeks 12, 24, 36, 52

FFbH consisted 18 questions to assess daily activities in last 7 days. Each question was answered by the participant as "Yes, I can perform the activity without difficulty" (score assigned = 2), "Yes, but with some difficulties" (score assigned = 1) and "No or only with help" (score assigned = 0). Final FFbH score (FFbH functional capacity) was then computed according to formula: (Sum of all single scores \* 100% \[percent\]) / (2 \* number of answered questions) ranged between 0-100; higher score indicated better daily activities.

Outcome measures

Outcome measures
Measure	Etanercept n=1383 Participants All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Hannover Functional Questionnaire (FFbH) Functional Capacity Score of Participants With Rheumatoid Arthritis (RA), Axial Spondyloarthritis (axSpA), Psoriasis Arthritis (PsA) at Weeks 12, 24, 36, 52 Week 12	71.4 units on a scale Standard Deviation 22.2
Hannover Functional Questionnaire (FFbH) Functional Capacity Score of Participants With Rheumatoid Arthritis (RA), Axial Spondyloarthritis (axSpA), Psoriasis Arthritis (PsA) at Weeks 12, 24, 36, 52 Week 24	72.2 units on a scale Standard Deviation 22.4
Hannover Functional Questionnaire (FFbH) Functional Capacity Score of Participants With Rheumatoid Arthritis (RA), Axial Spondyloarthritis (axSpA), Psoriasis Arthritis (PsA) at Weeks 12, 24, 36, 52 Week 36	73.4 units on a scale Standard Deviation 22.3
Hannover Functional Questionnaire (FFbH) Functional Capacity Score of Participants With Rheumatoid Arthritis (RA), Axial Spondyloarthritis (axSpA), Psoriasis Arthritis (PsA) at Weeks 12, 24, 36, 52 Week 52	73.7 units on a scale Standard Deviation 22.5

SECONDARY outcome

Timeframe: Weeks 12, 24, 36, 52

The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity. CDAI total score = 0-76. CDAI \<= 2.8 indicates disease remission, \>2.8 to 10 = low disease activity, \>10 to 22 = moderate disease activity, and \>22 = high disease activity.

Outcome measures

Outcome measures
Measure	Etanercept n=824 Participants All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Clinical Disease Activity Index (CDAI) Scores of Participants With Rheumatoid Arthritis (RA) at Weeks 12, 24, 36 and 52 Week 12	12.7 units on a scale Standard Deviation 9.7
Clinical Disease Activity Index (CDAI) Scores of Participants With Rheumatoid Arthritis (RA) at Weeks 12, 24, 36 and 52 Week 24	11.0 units on a scale Standard Deviation 9.4
Clinical Disease Activity Index (CDAI) Scores of Participants With Rheumatoid Arthritis (RA) at Weeks 12, 24, 36 and 52 Week 36	10.1 units on a scale Standard Deviation 8.9
Clinical Disease Activity Index (CDAI) Scores of Participants With Rheumatoid Arthritis (RA) at Weeks 12, 24, 36 and 52 Week 52	9.2 units on a scale Standard Deviation 9.1

SECONDARY outcome

Timeframe: Weeks 12, 24, 36, 52

The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity, and C-reactive protein (CRP) (mg/dL). SDAI total score= 0-86. SDAI \<=3.3 indicates disease remission, \>3.4 to 11 = low disease activity, \>11 to 26 = moderate disease activity, and \>26 = high disease activity.

Outcome measures

Outcome measures
Measure	Etanercept n=824 Participants All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Simplified Disease Activity Index (SDAI) Scores of Participants With Rheumatoid Arthritis (RA) at Weeks 12, 24, 36 and 52 Week 12	14.3 units on a scale Standard Deviation 11.0
Simplified Disease Activity Index (SDAI) Scores of Participants With Rheumatoid Arthritis (RA) at Weeks 12, 24, 36 and 52 Week 24	12.0 units on a scale Standard Deviation 11.3
Simplified Disease Activity Index (SDAI) Scores of Participants With Rheumatoid Arthritis (RA) at Weeks 12, 24, 36 and 52 Week 36	11.1 units on a scale Standard Deviation 9.7
Simplified Disease Activity Index (SDAI) Scores of Participants With Rheumatoid Arthritis (RA) at Weeks 12, 24, 36 and 52 Week 52	10.1 units on a scale Standard Deviation 10.2

SECONDARY outcome

Timeframe: Weeks 12, 24, 36, 52

BASDAI is a validated self-assessment tool used to determine disease activity in participant with ankylosing spondylitis. Utilizing a VAS of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0(no symptoms)-10(very severe symptoms).

Outcome measures

Outcome measures
Measure	Etanercept n=305 Participants All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of Participants With Axial Spondyloarthritis (axSpA) at Weeks 12, 24, 36 and 52 Week 12	3.8 units on a scale Standard Deviation 2.3
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of Participants With Axial Spondyloarthritis (axSpA) at Weeks 12, 24, 36 and 52 Week 24	3.5 units on a scale Standard Deviation 2.3
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of Participants With Axial Spondyloarthritis (axSpA) at Weeks 12, 24, 36 and 52 Week 36	3.2 units on a scale Standard Deviation 2.1
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of Participants With Axial Spondyloarthritis (axSpA) at Weeks 12, 24, 36 and 52 Week 52	3.3 units on a scale Standard Deviation 2.2

SECONDARY outcome

Timeframe: Weeks 12, 24, 36, 52

An enthesis is the site where the joint capsules, ligaments or tendons attach to the bone. Enthesitis is the inflammation of the entheses. This inflammation can lead to severe pain and discomfort.

Outcome measures

Outcome measures
Measure	Etanercept n=559 Participants All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Number of Affected Enthesis in Participants With Axial Spondyloarthritis (axSpA) and Psoriatic Arthritis(PsA) at Weeks 12, 24, 36 and 52 Week 12	1.0 enthesis Standard Deviation 1.8
Number of Affected Enthesis in Participants With Axial Spondyloarthritis (axSpA) and Psoriatic Arthritis(PsA) at Weeks 12, 24, 36 and 52 Week 24	0.6 enthesis Standard Deviation 1.2
Number of Affected Enthesis in Participants With Axial Spondyloarthritis (axSpA) and Psoriatic Arthritis(PsA) at Weeks 12, 24, 36 and 52 Week 36	0.4 enthesis Standard Deviation 1.1
Number of Affected Enthesis in Participants With Axial Spondyloarthritis (axSpA) and Psoriatic Arthritis(PsA) at Weeks 12, 24, 36 and 52 Week 52	0.3 enthesis Standard Deviation 1.0

SECONDARY outcome

Timeframe: Weeks 12, 24, 36, 52

Occiput-to-wall distance was the distance between the occiput (posterior or back portion of the head) and the wall when the participant stood with heels and shoulder against the wall and the back straight.

Outcome measures

Outcome measures
Measure	Etanercept n=305 Participants All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Occiput-to-wall Distance of Participants With Axial Spondyloarthritis (axSpA) at Weeks 12, 24, 36 and 52 Week 12	6.7 cm Standard Deviation 10.7
Occiput-to-wall Distance of Participants With Axial Spondyloarthritis (axSpA) at Weeks 12, 24, 36 and 52 Week 24	6.6 cm Standard Deviation 11.3
Occiput-to-wall Distance of Participants With Axial Spondyloarthritis (axSpA) at Weeks 12, 24, 36 and 52 Week 36	6.3 cm Standard Deviation 11.2
Occiput-to-wall Distance of Participants With Axial Spondyloarthritis (axSpA) at Weeks 12, 24, 36 and 52 Week 52	6.0 cm Standard Deviation 11.0

SECONDARY outcome

Timeframe: Weeks 12, 24, 36, 52

Percentage of BSA affected by psoriasis was estimated using the palm method: one of the participant's palm to proximal interphalangeal and thumb = 1 percent (%) of total BSA. Regions of the body were assigned specific number of palms with percentage \[Head and neck = 10% (10 palms), upper extremities = 20% (20 palms), Trunk (axillae and groin) = 30% (30 palms), lower extremities (buttocks) = 40% (40 palms)\]. The total BSA affected was the summation of individual regions affected.

Outcome measures

Outcome measures
Measure	Etanercept n=324 Participants All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Mean Percentage of Total Body Surface Area (BSA) for Participants With Plaque Psoriasis (PsO) and Psoriasis Arthritis (PsA) at Weeks 12, 24, 36 and 52 Week 12	8.5 percentage of BSA Standard Deviation 12.8
Mean Percentage of Total Body Surface Area (BSA) for Participants With Plaque Psoriasis (PsO) and Psoriasis Arthritis (PsA) at Weeks 12, 24, 36 and 52 Week 24	5.9 percentage of BSA Standard Deviation 9.2
Mean Percentage of Total Body Surface Area (BSA) for Participants With Plaque Psoriasis (PsO) and Psoriasis Arthritis (PsA) at Weeks 12, 24, 36 and 52 Week 36	4.8 percentage of BSA Standard Deviation 7.1
Mean Percentage of Total Body Surface Area (BSA) for Participants With Plaque Psoriasis (PsO) and Psoriasis Arthritis (PsA) at Weeks 12, 24, 36 and 52 Week 52	5.4 percentage of BSA Standard Deviation 10.9

SECONDARY outcome

Timeframe: Weeks 12, 24, 36, 52

Each of the 10 fingers and 10 toes was evaluated for dactylitis. Score ranged from 0 to 20, where affected numbers of fingers and toes were evaluated.

Outcome measures

Outcome measures
Measure	Etanercept n=254 Participants All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Mean of Total Number of Affected Fingers or Toes by Dactylitis in Participants With Psoriatic Arthritis (PsA) at Weeks 12, 24, 36 and 52 Week 12	1.4 finger or toes Standard Deviation 2.1
Mean of Total Number of Affected Fingers or Toes by Dactylitis in Participants With Psoriatic Arthritis (PsA) at Weeks 12, 24, 36 and 52 Week 24	0.7 finger or toes Standard Deviation 1.3
Mean of Total Number of Affected Fingers or Toes by Dactylitis in Participants With Psoriatic Arthritis (PsA) at Weeks 12, 24, 36 and 52 Week 36	0.7 finger or toes Standard Deviation 1.4
Mean of Total Number of Affected Fingers or Toes by Dactylitis in Participants With Psoriatic Arthritis (PsA) at Weeks 12, 24, 36 and 52 Week 52	0.6 finger or toes Standard Deviation 1.3

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 24, 36, 52

Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% involvement to 6= 90-100% involvement. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section\*area score\*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease.

Outcome measures

Outcome measures
Measure	Etanercept n=70 Participants All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Change From Baseline in Psoriasis Area and Severity Index (PASI) in Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52 Baseline	16.8 units on a scale Standard Deviation 10.1
Change From Baseline in Psoriasis Area and Severity Index (PASI) in Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52 Change at Week 12	-9.6 units on a scale Standard Deviation 10.3
Change From Baseline in Psoriasis Area and Severity Index (PASI) in Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52 Change at Week 24	-13.0 units on a scale Standard Deviation 10.6
Change From Baseline in Psoriasis Area and Severity Index (PASI) in Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52 Change at Week 36	-14.4 units on a scale Standard Deviation 10.9
Change From Baseline in Psoriasis Area and Severity Index (PASI) in Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52 Change at Week 52	-14.8 units on a scale Standard Deviation 11.0

SECONDARY outcome

Timeframe: Baseline up to Week 24

PASI: combined assessment of lesion severity \& area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself \& scores combined for final PASI. For each section % area of skin involved was estimated:0(0%) - 6(90-100%) \& severity estimated by clinical signs of erythema, induration, desquamation; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section\*area score\*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI75: at least a 75 % reduction in PASI relative to Baseline.

Outcome measures

Outcome measures
Measure	Etanercept n=70 Participants All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Median Time to Achieve Psoriasis Area and Severity Index 75 (PASI 75) Response in Participants With Plaque Psoriasis (PsO)	100 days Standard Deviation 85.6

SECONDARY outcome

Timeframe: Weeks 12, 24, 36, 52

PASI: combined assessment of lesion severity \& area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself \& scores combined for final PASI. For each section % area of skin involved was estimated:0(0%) - 6(90-100%) \& severity estimated by component score of erythema, induration, desquamation; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section\*area score\*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).

Outcome measures

Outcome measures
Measure	Etanercept n=70 Participants All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Psoriasis Area and Severity Index (PASI) Component Scores in Participants With Plaque Psoriasis (PsO) Week 12, Erythema	1.4 units on a scale Standard Deviation 0.7
Psoriasis Area and Severity Index (PASI) Component Scores in Participants With Plaque Psoriasis (PsO) Week 12: Induration	1.2 units on a scale Standard Deviation 0.7
Psoriasis Area and Severity Index (PASI) Component Scores in Participants With Plaque Psoriasis (PsO) Week 12: Desquamation	1.1 units on a scale Standard Deviation 0.7
Psoriasis Area and Severity Index (PASI) Component Scores in Participants With Plaque Psoriasis (PsO) Week 24: Erythema	1.0 units on a scale Standard Deviation 0.7
Psoriasis Area and Severity Index (PASI) Component Scores in Participants With Plaque Psoriasis (PsO) Week 24: Induration	0.9 units on a scale Standard Deviation 0.6
Psoriasis Area and Severity Index (PASI) Component Scores in Participants With Plaque Psoriasis (PsO) Week 24: Desquamation	0.9 units on a scale Standard Deviation 0.7
Psoriasis Area and Severity Index (PASI) Component Scores in Participants With Plaque Psoriasis (PsO) Week 36: Erythema	0.7 units on a scale Standard Deviation 0.6
Psoriasis Area and Severity Index (PASI) Component Scores in Participants With Plaque Psoriasis (PsO) Week 36: Induration	0.6 units on a scale Standard Deviation 0.5
Psoriasis Area and Severity Index (PASI) Component Scores in Participants With Plaque Psoriasis (PsO) Week 36: Desquamation	0.6 units on a scale Standard Deviation 0.5
Psoriasis Area and Severity Index (PASI) Component Scores in Participants With Plaque Psoriasis (PsO) Week 52: Erythema	0.7 units on a scale Standard Deviation 0.7
Psoriasis Area and Severity Index (PASI) Component Scores in Participants With Plaque Psoriasis (PsO) Week 52: Induration	0.5 units on a scale Standard Deviation 0.5
Psoriasis Area and Severity Index (PASI) Component Scores in Participants With Plaque Psoriasis (PsO) Week 52: Desquamation	0.6 units on a scale Standard Deviation 0.6

SECONDARY outcome

Timeframe: Weeks 12, 24, 36, 52

Outcome measures

Outcome measures
Measure	Etanercept n=70 Participants All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Psoriasis Area and Severity Index (PASI) Body Segment Scores in Participants With Plaque Psoriasis (PsO) Week 12, Head	0.4 units on a scale Standard Deviation 0.8
Psoriasis Area and Severity Index (PASI) Body Segment Scores in Participants With Plaque Psoriasis (PsO) Week 12: Trunk	1.6 units on a scale Standard Deviation 2.0
Psoriasis Area and Severity Index (PASI) Body Segment Scores in Participants With Plaque Psoriasis (PsO) Week 12: Upper extremities	1.4 units on a scale Standard Deviation 1.6
Psoriasis Area and Severity Index (PASI) Body Segment Scores in Participants With Plaque Psoriasis (PsO) Week 12: Lower extremities	3.5 units on a scale Standard Deviation 3.7
Psoriasis Area and Severity Index (PASI) Body Segment Scores in Participants With Plaque Psoriasis (PsO) Week 24: Head	0.2 units on a scale Standard Deviation 0.5
Psoriasis Area and Severity Index (PASI) Body Segment Scores in Participants With Plaque Psoriasis (PsO) Week 24: Trunk	0.6 units on a scale Standard Deviation 0.8
Psoriasis Area and Severity Index (PASI) Body Segment Scores in Participants With Plaque Psoriasis (PsO) Week 24: Upper extremities	0.9 units on a scale Standard Deviation 1.0
Psoriasis Area and Severity Index (PASI) Body Segment Scores in Participants With Plaque Psoriasis (PsO) Week 24: Lower extremities	2.3 units on a scale Standard Deviation 2.7
Psoriasis Area and Severity Index (PASI) Body Segment Scores in Participants With Plaque Psoriasis (PsO) Week 36: Head	0.2 units on a scale Standard Deviation 0.4
Psoriasis Area and Severity Index (PASI) Body Segment Scores in Participants With Plaque Psoriasis (PsO) Week 36: Trunk	0.5 units on a scale Standard Deviation 0.9
Psoriasis Area and Severity Index (PASI) Body Segment Scores in Participants With Plaque Psoriasis (PsO) Week 36: Upper extremities	0.5 units on a scale Standard Deviation 0.5
Psoriasis Area and Severity Index (PASI) Body Segment Scores in Participants With Plaque Psoriasis (PsO) Week 36: Lower extremities	1.5 units on a scale Standard Deviation 2.0
Psoriasis Area and Severity Index (PASI) Body Segment Scores in Participants With Plaque Psoriasis (PsO) Week 52: Head	0.1 units on a scale Standard Deviation 0.3
Psoriasis Area and Severity Index (PASI) Body Segment Scores in Participants With Plaque Psoriasis (PsO) Week 52: Trunk	0.5 units on a scale Standard Deviation 1.0
Psoriasis Area and Severity Index (PASI) Body Segment Scores in Participants With Plaque Psoriasis (PsO) Week 52: Upper extremities	0.5 units on a scale Standard Deviation 0.5
Psoriasis Area and Severity Index (PASI) Body Segment Scores in Participants With Plaque Psoriasis (PsO) Week 52: Lower extremities	1.4 units on a scale Standard Deviation 1.9

SECONDARY outcome

Timeframe: Weeks 12, 24, 36, 52

The DLQI was a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): no effect at DLQI \< 2; small effect at 2 \<=DLQI \<= 5; moderate effect at 6 \<=DLQI \<= 10; very large effect at 11\<=DLQI \<= 20; extremely large effect at 21 \<= DLQI \<= 30.

Outcome measures

Outcome measures
Measure	Etanercept n=70 Participants All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Dermatology Life Quality Index (DLQI) Total Score for Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52 Week 12	8.3 units on a scale Standard Deviation 7.4
Dermatology Life Quality Index (DLQI) Total Score for Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52 Week 24	5.5 units on a scale Standard Deviation 5.8
Dermatology Life Quality Index (DLQI) Total Score for Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52 Week 36	4.8 units on a scale Standard Deviation 5.5
Dermatology Life Quality Index (DLQI) Total Score for Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52 Week 52	3.7 units on a scale Standard Deviation 4.6

SECONDARY outcome

Timeframe: Weeks 12, 24, 36, 52

Participant's assessment of pruritus measured on a 100 mm VAS ranging from 0 as "no Pruritus" to 100 as "most severe pruritus".

Outcome measures

Outcome measures
Measure	Etanercept n=70 Participants All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Patient Assessment of Pruritus for Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52 Week 12	35.5 units on a scale Standard Deviation 30.9
Patient Assessment of Pruritus for Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52 Week 24	22.4 units on a scale Standard Deviation 23.8
Patient Assessment of Pruritus for Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52 Week 36	24.2 units on a scale Standard Deviation 26.6
Patient Assessment of Pruritus for Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52 Week 52	14.8 units on a scale Standard Deviation 15.8

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 12, 24, 36, 52

Population: PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. 'Number analyzed" signifies participants analyzed for this outcome measure at specified time points.

ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.

Outcome measures

Outcome measures
Measure	Etanercept n=1453 Participants All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Erythrocyte Sedimentation Rate (ESR) at Weeks 12, 24, 36 and 52 Week 12	19.7 mm/hr Standard Deviation 18.4
Erythrocyte Sedimentation Rate (ESR) at Weeks 12, 24, 36 and 52 Week 24	19.4 mm/hr Standard Deviation 18.8
Erythrocyte Sedimentation Rate (ESR) at Weeks 12, 24, 36 and 52 Week 36	18.4 mm/hr Standard Deviation 17.4
Erythrocyte Sedimentation Rate (ESR) at Weeks 12, 24, 36 and 52 Week 52	18.2 mm/hr Standard Deviation 17.6

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 12, 24, 36, 52

The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.

Outcome measures

Outcome measures
Measure	Etanercept n=1453 Participants All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
C-Reactive Protein (CRP) Levels at Weeks 12, 24, 36 and 52 Week 12	10.9 mg/L Standard Deviation 33.9
C-Reactive Protein (CRP) Levels at Weeks 12, 24, 36 and 52 Week 24	10.9 mg/L Standard Deviation 37.4
C-Reactive Protein (CRP) Levels at Weeks 12, 24, 36 and 52 Week 36	10.2 mg/L Standard Deviation 31.4
C-Reactive Protein (CRP) Levels at Weeks 12, 24, 36 and 52 Week 52	9.7 mg/L Standard Deviation 30.3

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 12, 24, 36, 52

RF is the auto antibody directed against immunoglobulin G (IgG) and its concentration is observed in human serum or plasma. RF value higher than 20 units per milliliter (U/mL) is considered positive.

Outcome measures

Outcome measures
Measure	Etanercept n=1383 Participants All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Number of Participants With Rheumatoid Factor (RF) at Weeks 12, 24, 36 and 52 Week 12	310 Participants
Number of Participants With Rheumatoid Factor (RF) at Weeks 12, 24, 36 and 52 Week 24	259 Participants
Number of Participants With Rheumatoid Factor (RF) at Weeks 12, 24, 36 and 52 Week 36	208 Participants
Number of Participants With Rheumatoid Factor (RF) at Weeks 12, 24, 36 and 52 Week 52	173 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 12, 24, 36, 52

To assess the pharmacodynamics effect of etanercept on serum levels of autoantibodies, Anti-CCP antibodies levels were measured.

Outcome measures

Outcome measures
Measure	Etanercept n=1383 Participants All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibodies at Weeks 12, 24, 36 and 52 Week 12	236.2 unit per milliliter (U/mL) Standard Deviation 695.7
Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibodies at Weeks 12, 24, 36 and 52 Week 24	202.2 unit per milliliter (U/mL) Standard Deviation 615.6
Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibodies at Weeks 12, 24, 36 and 52 Week 36	178.6 unit per milliliter (U/mL) Standard Deviation 635.3
Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibodies at Weeks 12, 24, 36 and 52 Week 52	176.2 unit per milliliter (U/mL) Standard Deviation 714.4

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Participants with Axial Spondyloarthritis with Positive Human Leukocyte Antigen (HLA-B27) were reported.

Outcome measures

Outcome measures
Measure	Etanercept n=305 Participants All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Number of Participants With Positive Human Leukocyte Antigen B27(HLA-B27) at Baseline for Participants With Axial Spondyloarthritis(axSpA)	223 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 36, 52

Outcome measures

Outcome measures
Measure	Etanercept n=305 Participants All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Number of Participants With Axial Spondyloarthritis (axSpA) Achieving Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than < 1.3 at Weeks 36 and 52 Week 36	35 Participants
Number of Participants With Axial Spondyloarthritis (axSpA) Achieving Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than < 1.3 at Weeks 36 and 52 Week 52	32 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 36, 52

Outcome measures

Outcome measures
Measure	Etanercept n=254 Participants All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Number of Participants With Psoriatic Arthritis (PsA) Achieving Either 28 Joint Disease Activity Score (DAS28) Less Than < 2.6 or Meet Minimal Disease Activity (MDA) Criteria at Weeks 36 and 52 Week 36	93 Participants
Number of Participants With Psoriatic Arthritis (PsA) Achieving Either 28 Joint Disease Activity Score (DAS28) Less Than < 2.6 or Meet Minimal Disease Activity (MDA) Criteria at Weeks 36 and 52 Week 52	87 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 36, 52

Outcome measures

Outcome measures
Measure	Etanercept n=70 Participants All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Number of Participants With Plaque Psoriasis (PsO) Achieving PASI75 Score or a PGA of "Clear" or "Almost Clear" And DLQI Total Score of 0 or 1 at Weeks 36 and 52 Week 36	13 Participants
Number of Participants With Plaque Psoriasis (PsO) Achieving PASI75 Score or a PGA of "Clear" or "Almost Clear" And DLQI Total Score of 0 or 1 at Weeks 36 and 52 Week 52	14 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 36, 52

Outcome measures

Outcome measures
Measure	Etanercept n=824 Participants All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Number of Participants With Rheumatoid Arthritis (RA) Achieving 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Weeks 36 and 52 Week 36	173 Participants
Number of Participants With Rheumatoid Arthritis (RA) Achieving 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Weeks 36 and 52 Week 52	187 Participants

Adverse Events

Etanercept

Serious events: 151 serious events

Other events: 606 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	Etanercept n=1465 participants at risk All participants with RA, axSpA, PsA, or PsO taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.75% 11/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.34% 5/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Arthritis	0.20% 3/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Joint swelling	0.20% 3/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.20% 3/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Arthralgia	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Foot deformity	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Pain in extremity	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Rheumatic disorder	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Ankylosing spondylitis	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Facet joint syndrome	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Fibromyalgia	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Joint destruction	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Joint effusion	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Meniscal degeneration	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Metatarsalgia	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Osteoporosis	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Psoriatic arthropathy	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Spondylitis	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Synovial cyst	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
General disorders Drug ineffective	0.34% 5/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
General disorders Condition aggravated	1.1% 16/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
General disorders Death	0.20% 3/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
General disorders Injection site reaction	0.20% 3/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
General disorders Pain	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
General disorders Disease progression	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
General disorders Disease recurrence	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
General disorders Drug effect decreased	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
General disorders Injection site erythema	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
General disorders Injection site swelling	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
General disorders Injection site warmth	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Surgical and medical procedures Implantation of medial unicondylar sliding prosthesis knee left	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
General disorders Oedema peripheral	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
General disorders Therapy non-responder	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Bronchitis	0.27% 4/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Pneumonia	0.27% 4/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Diverticulitis	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Tonsillitis	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Urosepsis	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Abscess limb	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Appendicitis	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Arthritis infective	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Borrelia infection	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Bronchitis bacterial	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Bronchopulmonary aspergillosis	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Cellulitis	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Epididymitis	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Escherichia infection	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Febrile infection	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Gangrene	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Gastroenteritis	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Hepatitis e	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Herpes zoster	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Influenza	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Mycobacterial infection	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Nasal abscess	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Nasopharyngitis	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Paronychia	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Peritonsillar abscess	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Post procedural pneumonia	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Respiratory tract infection	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Sepsis	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Tracheobronchitis	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Tuberculosis	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Urinary tract infection	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Injury, poisoning and procedural complications Tendon rupture	0.20% 3/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Injury, poisoning and procedural complications Fall	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Injury, poisoning and procedural complications Femur fracture	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Injury, poisoning and procedural complications Meniscus injury	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Injury, poisoning and procedural complications Ankle fracture	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Injury, poisoning and procedural complications Craniocerebral injury	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Injury, poisoning and procedural complications Facial bones fracture	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Injury, poisoning and procedural complications Fibula fracture	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Injury, poisoning and procedural complications Humerus fracture	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Injury, poisoning and procedural complications Ligament rupture	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Injury, poisoning and procedural complications Maternal exposure during pregnancy	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Injury, poisoning and procedural complications Pelvic fracture	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Injury, poisoning and procedural complications Post procedural haematoma	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Injury, poisoning and procedural complications Road traffic accident	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Injury, poisoning and procedural complications Spinal fracture	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Injury, poisoning and procedural complications Tibia fracture	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Injury, poisoning and procedural complications Tracheal deviation	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Injury, poisoning and procedural complications Upper limb fracture	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Injury, poisoning and procedural complications Wound dehiscence	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Injury, poisoning and procedural complications Wrist fracture	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Cardiac disorders Atrial fibrillation	0.27% 4/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Cardiac disorders Arrhythmia	0.20% 3/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Cardiac disorders Cardiac failure	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Cardiac disorders Coronary artery disease	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Cardiac disorders Myocardial infarction	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Cardiac disorders Tachycardia	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Cardiac disorders Acute myocardial infarction	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Cardiac disorders Cardiovascular disorder	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Cardiac disorders Pericardial effusion	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Cardiac disorders Right ventricular failure	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Respiratory, thoracic and mediastinal disorders Asthma	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Respiratory, thoracic and mediastinal disorders Nasal septum haematoma	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Gastrointestinal disorders Colitis ulcerative	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Gastrointestinal disorders Crohn's disease	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Gastrointestinal disorders Abdominal pain upper	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Gastrointestinal disorders Diverticulum intestinal	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Gastrointestinal disorders Large intestine perforation	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Gastrointestinal disorders Pancreatitis	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Gastrointestinal disorders Stomatitis	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Skin and subcutaneous tissue disorders Psoriasis	0.20% 3/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Skin and subcutaneous tissue disorders Acne	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Skin and subcutaneous tissue disorders Alopecia	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Skin and subcutaneous tissue disorders Rash generalised	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Skin and subcutaneous tissue disorders Skin disorder	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Skin and subcutaneous tissue disorders Urticaria	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Vascular disorders Aortic stenosis	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Vascular disorders Circulatory collapse	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Vascular disorders Haematoma	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Vascular disorders Hypertensive crisis	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Vascular disorders Peripheral arterial occlusive disease	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Vascular disorders Peripheral artery stenosis	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Vascular disorders Raynaud's phenomenon	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Vascular disorders Vasculitis	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Vascular disorders Venous thrombosis limb	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Hepatobiliary disorders Cholelithiasis	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Hepatobiliary disorders Cholestasis	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Hepatobiliary disorders Drug-induced liver injury	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Hepatobiliary disorders Hepatic cirrhosis	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Hepatobiliary disorders Hepatitis toxic	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Hepatobiliary disorders Jaundice	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Nervous system disorders Cerebrovascular accident	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Nervous system disorders Axonal neuropathy	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Nervous system disorders Facial paresis	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Nervous system disorders Migraine	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Nervous system disorders Sciatica	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Blood and lymphatic system disorders Leukopenia	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Blood and lymphatic system disorders Lymphadenitis	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Blood and lymphatic system disorders Lymphadenopathy	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Blood and lymphatic system disorders Thrombocytopenia	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Investigations Hepatic enzyme increased	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Investigations Renal function test abnormal	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Investigations Troponin increased	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign pancreatic neoplasm	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Renal and urinary disorders Nephritis	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Renal and urinary disorders Nephrolithiasis	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Renal and urinary disorders Ureteric stenosis	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Ear and labyrinth disorders Inner ear disorder	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Ear and labyrinth disorders Vestibular disorder	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Immune system disorders Drug hypersensitivity	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Eye disorders Diplopia	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Eye disorders Visual impairment	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Pregnancy, puerperium and perinatal conditions Abortion	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Pregnancy, puerperium and perinatal conditions Foetal growth restriction	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Endocrine disorders Goitre	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Psychiatric disorders Restlessness	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Reproductive system and breast disorders Breast pain	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.

Other adverse events

Other adverse events
Measure	Etanercept n=1465 participants at risk All participants with RA, axSpA, PsA, or PsO taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Injury, poisoning and procedural complications Contusion	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Injury, poisoning and procedural complications Epicondylitis	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Injury, poisoning and procedural complications Fall	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Injury, poisoning and procedural complications Humerus fracture	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
General disorders Drug ineffective	13.9% 203/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
General disorders Condition aggravated	2.4% 35/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
General disorders Injection site erythema	2.3% 34/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
General disorders Injection site reaction	1.5% 22/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
General disorders Fatigue	0.89% 13/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
General disorders Injection site pruritus	0.82% 12/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
General disorders Pyrexia	0.68% 10/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
General disorders Drug effect decreased	0.61% 9/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
General disorders Pain	0.55% 8/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
General disorders Injection site hypersensitivity	0.48% 7/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
General disorders Oedema peripheral	0.48% 7/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
General disorders Injection site pain	0.41% 6/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
General disorders Injection site swelling	0.41% 6/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
General disorders Drug effect incomplete	0.34% 5/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
General disorders Injection site induration	0.20% 3/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
General disorders Chest discomfort	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
General disorders Chest pain	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
General disorders Chills	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
General disorders Disease progression	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
General disorders Injection site rash	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
General disorders Local reaction	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
General disorders Swelling	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
General disorders Treatment failure	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
General disorders Adverse event	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
General disorders Asthenia	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
General disorders Discomfort	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
General disorders Disease recurrence	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
General disorders Drug intolerance	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
General disorders Face oedema	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
General disorders Gait disturbance	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
General disorders Hyperthermia	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
General disorders Inflammation	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
General disorders Influenza like illness	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
General disorders Injection site discharge	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
General disorders Injection site discolouration	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
General disorders Injection site inflammation	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
General disorders Injection site irritation	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
General disorders Malaise	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
General disorders Mucosal dryness	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Pregnancy, puerperium and perinatal conditions Pregnancy	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
General disorders Oedema	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
General disorders Sensation of foreign body	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Nasopharyngitis	4.2% 62/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Bronchitis	1.4% 20/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Respiratory tract infection	1.1% 16/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Upper respiratory tract infection	0.75% 11/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Infection	0.68% 10/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Herpes zoster	0.55% 8/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Sinusitis	0.55% 8/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Cystitis	0.48% 7/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Pulpitis dental	0.34% 5/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Tonsillitis	0.34% 5/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Pneumonia	0.27% 4/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Gastrointestinal infection	0.20% 3/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Rhinitis	0.20% 3/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Urinary tract infection	0.20% 3/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Conjunctivitis	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Erysipelas	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Fungal infection	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Fungal skin infection	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Paronychia	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Rash pustular	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Sinobronchitis	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Skin candida	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Subcutaneous abscess	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Bacterial infection	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Cellulitis	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Diabetic foot infection	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Escherichia urinary tract infection	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Febrile infection	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Furuncle	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Gastroenteritis	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Groin abscess	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Hepatitis e	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Herpes simplex	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Influenza	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Laryngitis	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Localised infection	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Oral herpes	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Papilloma viral infection	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Parotitis	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Pharyngitis	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Superinfection bacterial	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Tooth infection	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Tracheobronchitis	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Urinary tract infection enterococcal	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Viral infection	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Vulvovaginal candidiasis	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Skin and subcutaneous tissue disorders Pruritus	1.1% 16/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Skin and subcutaneous tissue disorders Erythema	0.82% 12/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Skin and subcutaneous tissue disorders Rash	0.82% 12/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.41% 6/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Skin and subcutaneous tissue disorders Alopecia	0.34% 5/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Skin and subcutaneous tissue disorders Psoriasis	0.34% 5/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.27% 4/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Skin and subcutaneous tissue disorders Skin disorder	0.27% 4/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Skin and subcutaneous tissue disorders Skin reaction	0.27% 4/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Skin and subcutaneous tissue disorders Urticaria	0.27% 4/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Skin and subcutaneous tissue disorders Pustular psoriasis	0.20% 3/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Skin and subcutaneous tissue disorders Skin irritation	0.20% 3/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Skin and subcutaneous tissue disorders Dermatitis	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Skin and subcutaneous tissue disorders Pruritus generalised	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Skin and subcutaneous tissue disorders Skin ulcer	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Skin and subcutaneous tissue disorders Dermatitis exfoliative generalised	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Skin and subcutaneous tissue disorders Dermatosis	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Skin and subcutaneous tissue disorders Dry skin	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Skin and subcutaneous tissue disorders Eczema	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Skin and subcutaneous tissue disorders Generalised erythema	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Skin and subcutaneous tissue disorders Hidradenitis	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Skin and subcutaneous tissue disorders Papule	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Skin and subcutaneous tissue disorders Rash erythematous	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Skin and subcutaneous tissue disorders Rash macular	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Skin and subcutaneous tissue disorders Rash papular	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Skin and subcutaneous tissue disorders Rosacea	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Skin and subcutaneous tissue disorders Skin burning sensation	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Skin and subcutaneous tissue disorders Skin discolouration	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Skin and subcutaneous tissue disorders Skin erosion	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Skin and subcutaneous tissue disorders Stasis dermatitis	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Skin and subcutaneous tissue disorders Swelling face	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Skin and subcutaneous tissue disorders Vascular skin disorder	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Skin and subcutaneous tissue disorders Xanthelasma	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Infections and infestations Infected bite	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	1.6% 23/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Arthralgia	0.61% 9/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Joint swelling	0.34% 5/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Bursitis	0.27% 4/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.27% 4/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Joint effusion	0.20% 3/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Limb discomfort	0.20% 3/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.20% 3/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Pain in extremity	0.20% 3/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.20% 3/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Synovitis	0.20% 3/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Arthritis	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Back pain	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Enthesopathy	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Fibromyalgia	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Osteitis	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Tendon disorder	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Arthropathy	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Dactylitis	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Intervertebral disc space narrowing	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Mastication disorder	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Muscular weakness	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Myalgia	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Neck pain	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Osteoporosis	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Psoriatic arthropathy	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Rheumatic disorder	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Rheumatoid nodule	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Sacroiliitis	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Sjogren's syndrome	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Soft tissue disorder	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Spinal pain	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Spondylitis	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Tenosynovitis	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Musculoskeletal and connective tissue disorders Trigger finger	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Gastrointestinal disorders Diarrhoea	0.82% 12/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Gastrointestinal disorders Nausea	0.82% 12/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Gastrointestinal disorders Abdominal discomfort	0.20% 3/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Gastrointestinal disorders Abdominal pain	0.20% 3/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Gastrointestinal disorders Constipation	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Gastrointestinal disorders Dry mouth	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Gastrointestinal disorders Gastrointestinal disorder	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Gastrointestinal disorders Stomatitis	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Gastrointestinal disorders Vomiting	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Gastrointestinal disorders Abdominal pain upper	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Gastrointestinal disorders Dyspepsia	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Gastrointestinal disorders Dysphagia	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Gastrointestinal disorders Flatulence	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Gastrointestinal disorders Gastric ulcer	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Gastrointestinal disorders Gastrointestinal inflammation	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Gastrointestinal disorders Gastrointestinal sounds abnormal	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Gastrointestinal disorders Irritable bowel syndrome	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Gastrointestinal disorders Loose tooth	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Gastrointestinal disorders Mouth ulceration	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Gastrointestinal disorders Steatorrhoea	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Gastrointestinal disorders Tongue discomfort	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Gastrointestinal disorders Tooth disorder	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Nervous system disorders Headache	0.68% 10/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Nervous system disorders Dizziness	0.27% 4/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Nervous system disorders Carpal tunnel syndrome	0.20% 3/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Nervous system disorders Burning sensation	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Nervous system disorders Head discomfort	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Nervous system disorders Paraesthesia	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Nervous system disorders Balance disorder	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Nervous system disorders Cerebrovascular disorder	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Nervous system disorders Complex regional pain syndrome	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Nervous system disorders Coordination abnormal	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Nervous system disorders Cubital tunnel syndrome	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Nervous system disorders Intercostal neuralgia	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Nervous system disorders Memory impairment	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Nervous system disorders Movement disorder	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Nervous system disorders Spinal cord disorder	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Nervous system disorders Trigeminal neuralgia	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Respiratory, thoracic and mediastinal disorders Cough	0.61% 9/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.34% 5/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.27% 4/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Respiratory, thoracic and mediastinal disorders Laryngeal inflammation	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Respiratory, thoracic and mediastinal disorders Pharyngeal oedema	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Respiratory, thoracic and mediastinal disorders Snoring	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Respiratory, thoracic and mediastinal disorders Vocal cord inflammation	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Injury, poisoning and procedural complications Maternal exposure during pregnancy	0.34% 5/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Injury, poisoning and procedural complications Ligament sprain	0.20% 3/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Injury, poisoning and procedural complications Wound	0.20% 3/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Injury, poisoning and procedural complications Inflammation of wound	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Injury, poisoning and procedural complications Ligament injury	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Injury, poisoning and procedural complications Maternal exposure before pregnancy	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Injury, poisoning and procedural complications Muscle rupture	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Injury, poisoning and procedural complications Post procedural complication	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Injury, poisoning and procedural complications Procedural pain	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Injury, poisoning and procedural complications Rib fracture	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Injury, poisoning and procedural complications Spinal compression fracture	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Injury, poisoning and procedural complications Tendon rupture	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Investigations Alanine aminotransferase increased	0.20% 3/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Investigations Gamma-glutamyltransferase increased	0.20% 3/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Investigations Aspartate aminotransferase increased	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Investigations Liver function test increased	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Investigations Transaminases increased	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Investigations Blood creatinine increased	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Investigations Blood thyroid stimulating hormone abnormal	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Investigations C-reactive protein increased	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Investigations Heart rate increased	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Investigations Hepatic enzyme increased	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Investigations Intraocular pressure increased	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Investigations Renal function test abnormal	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Investigations Weight decreased	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Psychiatric disorders Depression	0.55% 8/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Psychiatric disorders Sleep disorder	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Psychiatric disorders Aggression	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Psychiatric disorders Apathy	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Psychiatric disorders Panic attack	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Psychiatric disorders Somatic symptom disorder	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Eye disorders Iritis	0.27% 4/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Eye disorders Visual impairment	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Eye disorders Eye swelling	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Eye disorders Glaucoma	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Eye disorders Uveitis	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Eye disorders Vision blurred	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Metabolism and nutrition disorders Vitamin d deficiency	0.27% 4/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Metabolism and nutrition disorders Gout	0.20% 3/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Metabolism and nutrition disorders Hypercholesterolaemia	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Metabolism and nutrition disorders Hyperuricaemia	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Metabolism and nutrition disorders Metabolic syndrome	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Blood and lymphatic system disorders Thrombocytopenia	0.20% 3/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Blood and lymphatic system disorders Increased tendency to bruise	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Blood and lymphatic system disorders Leukopenia	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Blood and lymphatic system disorders Granulocytopenia	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Blood and lymphatic system disorders Immune thrombocytopenic purpura	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Blood and lymphatic system disorders Pancytopenia	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Renal and urinary disorders Haematuria	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Renal and urinary disorders Bladder disorder	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Renal and urinary disorders Chronic kidney disease	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Renal and urinary disorders Cystitis noninfective	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Renal and urinary disorders Dysuria	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Renal and urinary disorders Leukocyturia	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Renal and urinary disorders Renal colic	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Renal and urinary disorders Renal failure	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Cardiac disorders Angina pectoris	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Cardiac disorders Arrhythmia	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Cardiac disorders Palpitations	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Cardiac disorders Extrasystoles	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Cardiac disorders Tachyarrhythmia	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Immune system disorders Hypersensitivity	0.34% 5/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Immune system disorders Anaphylactic reaction	0.14% 2/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma of liver	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Ear and labyrinth disorders Deafness	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Ear and labyrinth disorders Vertigo	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Pregnancy, puerperium and perinatal conditions Oligohydramnios	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Reproductive system and breast disorders Uterine haematoma	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Vascular disorders Peripheral venous disease	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Ear and labyrinth disorders Tinnitus	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.
Eye disorders Cataract	0.07% 1/1465 • Baseline up to Week 52 Same event may appear as both an AE \& a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant \& as non-serious in another participant, or one participant may have experienced both a serious \& non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value \& had an AE documented. All-cause mortality data included all anticipated \& unanticipated deaths due to any cause.

Additional Information

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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