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| ID | Type | Description | Link |
|---|---|---|---|
| ADEQUATE | Other Identifier | Alias Study Number |
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The purpose of this non-interventional study is to evaluate the efficacy of etanercept during routine clinical use over a maximum of 12 months in patients with rheumatoid arthritis (RA), psoriatic arthritis(PsA), axial spondyloarthritis(axSpA) or plaque psoriasis (PsO). In so doing, particular attention will be paid to the proportion of those patients who only attain the desired treatment goal after 12 weeks of treatment. The primary efficacy end point for the study is the proportion of patients who attain the desired treatment goal after 12 and 24 weeks,
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observation Group |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etanercept | Drug | Etanercept shall be used according to clinical practice and in line with the summary of product characteristics. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 12 | 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. | Week 12 |
| Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 24 | 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. | Week 24 |
| 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 | 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. | Week 12 up to Week 52 |
| 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 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Continued With Treatment up to Weeks 12, 24, 36 and 52: Treated Set (TS) | Baseline up to Weeks 12, 24, 36, 52 | |
| Percentage of Participants Who Continued With Treatment up to Weeks 12, 24, 36 and 52: Per-Protocol (PP) Set |
| Measure | Description | Time Frame |
|---|---|---|
| Erythrocyte Sedimentation Rate (ESR) at Weeks 12, 24, 36 and 52 | 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. | Weeks 12, 24, 36, 52 |
Inclusion Criteria:
Exclusion Criteria:
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Ambulatory and Hospital care patients treated for Rheumatoid Arthritis, Axial Spondyloarthritis, Psoriasis Arthritis or Plaque Psoriasis in Germany
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rheumatologisches MVZ Dresden GmbH im Gesundheitszentrum Dresden - Klotzsche (GZDK) | Dresden | Saxony | 01109 | Germany | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38308727 | Derived | Feist E, Baraliakos X, Behrens F, Thaci D, Plenske A, Klaus P, Meng T. Etanercept in Axial Spondyloarthritis, Psoriatic Arthritis, and Plaque Psoriasis: Real-World Outcome Data from German Non-interventional Study ADEQUATE. Rheumatol Ther. 2024 Apr;11(2):331-348. doi: 10.1007/s40744-023-00633-2. Epub 2024 Feb 3. | |
| 35113363 | Derived |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 30, 2015 |
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| Week 24 up to Week 52 |
| 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 | 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). | Week 12 |
| Number of Participants With Axial Spondyloarthritis (axSpA) Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than (<) 1.3 at 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. | Week 12 |
| 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 | 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.](streamdown:incomplete-link) | Week 12 |
| 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 | 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). | Week 24 |
| Number of Participants With Axial Spondyloarthritis (axSpA) Achieving Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than (<) 1.3 at Week 24 | 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. | Week 24 |
| 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 | 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.](streamdown:incomplete-link) | Week 24 |
| Baseline up to Weeks 12, 24, 36, 52 |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) up to Weeks 12, 24, 36 and 52: Treated Set | 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. | Baseline up to Weeks 12, 24, 36, 52 |
| Number of Participants With Treatment Emergent Adverse Events up to Weeks 12, 24, 36 and 52: Per-Protocol (PP) Set | 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. | Baseline up to Weeks 12, 24, 36, 52 |
| Number of Participants Achieving 28 Joint Disease Activity Score (DAS28) Remission at Weeks 12, 24, 36 and 52 | 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. Participants who had DAS28 <= 2.6 were considered in remission. | Weeks 12, 24, 36, 52 |
| Patient Global Assessment of Disease Activity (PtGA) Scores at Weeks 12, 24, 36 and 52 | 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. | Weeks 12, 24, 36, 52 |
| Mean Visual Analogue Scale (VAS) Fatigue Scores at Weeks 12, 24, 36 and 52 | Participants assessed their fatigue using a 0 - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue. | Weeks 12, 24, 36, 52 |
| Mean Visual Analogue Scale (VAS) Pain Scores at Weeks 12, 24, 36 and 52 | 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). | Weeks 12, 24, 36, 52 |
| Physician Global Assessment (PGA) of Disease Activity Scores at Weeks 12, 24, 36 and 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. | Weeks 12, 24, 36, 52 |
| Patient Health Quessionare-2 (PHQ-2) Scores at Weeks 12, 24, 36 and 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). | Weeks 12, 24, 36, 52 |
| 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 | 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. | Weeks 12, 24, 36, 52 |
| 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 | 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. | Weeks 12, 24, 36, 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 | 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. | Weeks 12, 24, 36, 52 |
| 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 | 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. | Weeks 12, 24, 36, 52 |
| Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at 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). | Weeks 12, 24, 36, 52 |
| Psoriatic Arthritis(PsA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at 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). | Weeks 12, 24, 36, 52 |
| Ankylosing Spondylitis(axSpA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at 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). | Weeks 12, 24, 36, 52 |
| Percentage of Participants Who Discontinued Treatment Due to Lack of Efficacy or Adverse Events | Percentage of participants who discontinued etanercept before completing the study, was reported. | Baseline up to Week 52 |
| Number of Participants Who Switched to Other Therapy After Treatment Discontinuation | Participants who switched from etanercept to either disease-modifying antirheumatic drugs (DMARDs) or alternative biologic drug were reported. | Baseline up to Week 52 |
| 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 | 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. | Weeks 12, 24, 36, 52 |
| Clinical Disease Activity Index (CDAI) Scores of Participants With Rheumatoid Arthritis (RA) at Weeks 12, 24, 36 and 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. | Weeks 12, 24, 36, 52 |
| Simplified Disease Activity Index (SDAI) Scores of Participants With Rheumatoid Arthritis (RA) at Weeks 12, 24, 36 and 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. | Weeks 12, 24, 36, 52 |
| Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of Participants With Axial Spondyloarthritis (axSpA) at Weeks 12, 24, 36 and 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). | Weeks 12, 24, 36, 52 |
| Number of Affected Enthesis in Participants With Axial Spondyloarthritis (axSpA) and Psoriatic Arthritis(PsA) at Weeks 12, 24, 36 and 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. | Weeks 12, 24, 36, 52 |
| Occiput-to-wall Distance of Participants With Axial Spondyloarthritis (axSpA) at Weeks 12, 24, 36 and 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. | Weeks 12, 24, 36, 52 |
| 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 | 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. | Weeks 12, 24, 36, 52 |
| Mean of Total Number of Affected Fingers or Toes by Dactylitis in Participants With Psoriatic Arthritis (PsA) at Weeks 12, 24, 36 and 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. | Weeks 12, 24, 36, 52 |
| Change From Baseline in Psoriasis Area and Severity Index (PASI) in Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 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. | Baseline, Weeks 12, 24, 36, 52 |
| Median Time to Achieve Psoriasis Area and Severity Index 75 (PASI 75) Response in Participants With Plaque Psoriasis (PsO) | 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. | Baseline up to Week 24 |
| Psoriasis Area and Severity Index (PASI) Component Scores in Participants With Plaque Psoriasis (PsO) | 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). | Weeks 12, 24, 36, 52 |
| Psoriasis Area and Severity Index (PASI) Body Segment Scores in Participants With Plaque Psoriasis (PsO) | 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). | Weeks 12, 24, 36, 52 |
| Dermatology Life Quality Index (DLQI) Total Score for Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 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. | Weeks 12, 24, 36, 52 |
| Patient Assessment of Pruritus for Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52 | Participant's assessment of pruritus measured on a 100 mm VAS ranging from 0 as "no Pruritus" to 100 as "most severe pruritus". | Weeks 12, 24, 36, 52 |
| C-Reactive Protein (CRP) Levels at Weeks 12, 24, 36 and 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. |
| Weeks 12, 24, 36, 52 |
| Number of Participants With Rheumatoid Factor (RF) at Weeks 12, 24, 36 and 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. | Weeks 12, 24, 36, 52 |
| Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibodies at Weeks 12, 24, 36 and 52 | To assess the pharmacodynamics effect of etanercept on serum levels of autoantibodies, Anti-CCP antibodies levels were measured. | Weeks 12, 24, 36, 52 |
| Number of Participants With Positive Human Leukocyte Antigen B27(HLA-B27) at Baseline for Participants With Axial Spondyloarthritis(axSpA) | Participants with Axial Spondyloarthritis with Positive Human Leukocyte Antigen (HLA-B27) were reported. | Baseline |
| Number of Participants With Axial Spondyloarthritis (axSpA) Achieving Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than < 1.3 at Weeks 36 and 52 | 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. | Weeks 36, 52 |
| 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 | 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.](streamdown:incomplete-link) | Weeks 36, 52 |
| 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 | 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). | Weeks 36, 52 |
| Number of Participants With Rheumatoid Arthritis (RA) Achieving 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Weeks 36 and 52 | 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. Participants who had DAS28 <= 2.6 were considered in remission. | Weeks 36, 52 |
| private practise Hemmerich |
| Aachen |
| 52062 |
| Germany |
| private practise Kurthen | Aachen | 52064 | Germany |
| Gesundheits- und Pflegezentrum Alsfeld gGmbH | Alsfeld | 36304 | Germany |
| private practise Kupka | Altenburg | 4600 | Germany |
| Private Practise Boehm | Altenholz | 24161 | Germany |
| Private Practise Marycz | Amberg | 92224 | Germany |
| Klinikum Bad Bramstedt | Bad Bramstedt | 24576 | Germany |
| private practise Gause | Bad Bramstedt | 24576 | Germany |
| private practise Messis | Bad Homburg | 61348 | Germany |
| ACURA Rheumazentrum Bad Kreuznach | Bad Kreuznach | 55543 | Germany |
| private practise Hesse | Bad Kreuznach | 55543 | Germany |
| private practise Manger | Bamberg | 96047 | Germany |
| private practise Balzer | Bautzen | 2625 | Germany |
| private practise Winkler | Bautzen | 2625 | Germany |
| private practise Ochs | Bayreuth | 95444 | Germany |
| private practise Schmitt-Haendle | Bayreuth | 95444 | Germany |
| Charité Berlin Rheumatologie und Klinische Immunologie | Berlin | 10117 | Germany |
| Med. Versorgungszentrum Ambulantes Gesundheitszentrum Charite Campus Mitte | Berlin | 10117 | Germany |
| private practise Hasert | Berlin | 10117 | Germany |
| Praxis Roßbacher | Berlin | 10247 | Germany |
| private practise Bozorg | Berlin | 10713 | Germany |
| private practise Brandt-Jürgens | Berlin | 12161 | Germany |
| private practise Herzberg | Berlin | 12435 | Germany |
| private practise Remstedt | Berlin | 12435 | Germany |
| private practise Seifert | Berlin | 12555 | Germany |
| private practise Zinke | Berlin | 13055 | Germany |
| private practise Kors | Berlin | 13086 | Germany |
| Rheumaklinik Berlin-Buch | Berlin | 13125 | Germany |
| private practise Miehe | Berlin | 13507 | Germany |
| private practise Schnorfeil | Berlin | 14163 | Germany |
| private practise Koelnberger | Bogen | 94327 | Germany |
| private practise Barth | Borna | 4552 | Germany |
| private practise Eisterhues | Braunschweig | 38100 | Germany |
| Private Practise Ramaker-Brunke | Braunschweig | 38114 | Germany |
| private practise Mall | Bremen | 28195 | Germany |
| private practise Schwichtenberg | Bremen | 28779 | Germany |
| Private Practise Wagener | Bruchhausen-Vilsen | 27305 | Germany |
| private practise Feuchtenberger | Burghausen | 84489 | Germany |
| private practise Budde | Bückeburg | 31675 | Germany |
| Mvz Agliomed | Chemnitz | 09130 | Germany |
| private practise Schneider | Chemnitz | 9116 | Germany |
| private practise Wilden | Cologne | 50825 | Germany |
| Office of Parysa Alborz, MD | Cologne | 50937 | Germany |
| private practise Geißler | Cottbus | 3046 | Germany |
| private practise Kirrstetter | Deggendorf | 94469 | Germany |
| Kreiskrankenhaus Demmin GmbH | Demmin | 17109 | Germany |
| private practise Heidlas | Dessau | 6842 | Germany |
| private practise Bebnowski | Dortmund | 44309 | Germany |
| private practise Gerlach | Dresden | 1097 | Germany |
| private practise Lüthke | Dresden | 1097 | Germany |
| private practise Fischer | Dresden | 1277 | Germany |
| private practise Oppers | Dresden | 1277 | Germany |
| private practise Roch | Dresden | 1277 | Germany |
| private practise Fendler | Duisburg | 47057 | Germany |
| private practise Riesopp | Duisburg | 47249 | Germany |
| private practise Strothmeyer | Düsseldorf | 40211 | Germany |
| Bezirksklinikum Obermain | Ebensfeld | 96250 | Germany |
| private practise Berendt | Eberswalde | 16225 | Germany |
| private practise Pech | Eberswalde | 16225 | Germany |
| Asklepios MVZ Nord SH GmbH, c/o AK St. Georg | Elmshorn | 25335 | Germany |
| Elbe Elster MVZ GmbH | Elsterwerda | 49110 | Germany |
| MVZ Kaestner + Kaestner GbR | Erfurt | 99096 | Germany |
| private practise Koch | Erfurt | 99096 | Germany |
| Universitaetsklinikum Essen, Klinik fuer Dermatologie | Essen | 45147 | Germany |
| private practise Freitag | Falkensee | 14612 | Germany |
| private practise Häckel | Frankenberg | 9669 | Germany |
| private practise Fritzsch | Frankfurt | 15230 | Germany |
| Klinikum der J.W. Goethe-Universität, Klinik für Dermatologie, Klinische Forschung | Frankfurt am Main | 60590 | Germany |
| private practise Höhne | Fraureuth | 8427 | Germany |
| private practise Müller | Freiberg | 9588 | Germany |
| private practise Behringer | Fulda | 36093 | Germany |
| private practise Bussmann | Geilenkirchen | 52511 | Germany |
| private practise Zeh | Geislingen A.d. Steige | 73312 | Germany |
| Private Practice Abahji | Germering | 82110 | Germany |
| Private Practise | Giessen | 35392 | Germany |
| Praxis Dres. Dr.Brinkmann, Schult, Samimi-Fard | Gladbeck | 45964 | Germany |
| private practise Kühne | Haldensleben I | 39340 | Germany |
| private practise Liebhaber | Halle | 6128 | Germany |
| MVZ Rheumatologie und Autoimmunmedizin GmbH | Hamburg | 20095 | Germany |
| MVZ Nord GmbH | Hamburg | 21073 | Germany |
| Katholisches Marienkrankenhaus Geriatrische Klinik | Hamburg | 22087 | Germany |
| Private Practise Höhle | Hamburg | 22147 | Germany |
| private practise Dahmen | Hamburg | 22415 | Germany |
| private practise Weinhardt | Hamburg | 22523 | Germany |
| private practise Aries | Hamburg | 22767 | Germany |
| Praxis Praxis Dr. Szabo & Kollegen | Hamm | 59065 | Germany |
| Private Practise Stille | Hanover | 30161 | Germany |
| private practise Stein | Hanover | 30167 | Germany |
| private practise Heilig | Heidelberg | 69120 | Germany |
| private practise Lassak-Siedl | Heidelberg | 69120 | Germany |
| Universitätsklinikum Heidelberg | Heidelberg | 69120 | Germany |
| private Practise Pawlak | Heilbad Heiligenstadt | 37308 | Germany |
| private practise Schleußner | Heilbad Heiligenstadt | 37308 | Germany |
| private practise Thies | Herrsching am Ammersee | 82211 | Germany |
| private practise Meier | Hofheim | 65719 | Germany |
| private practise Wernicke | Hohen Neuendorf | 16540 | Germany |
| Private Practice Streibl | Holzkirchen | 83607 | Germany |
| private practise Kapelle | Hoyerswerda | 2977 | Germany |
| Uniklinik Jena | Jena | 7747 | Germany |
| Private Practise Kremers | Jülich | 52428 | Germany |
| private practise Bräunig | Kahla | 7768 | Germany |
| Praxis Mauer | Kamenz | 1917 | Germany |
| Private Practise Turin | Karlstadt am Main | 97753 | Germany |
| private practise Schwab | Kiel | 24105 | Germany |
| private practise Merkel | Königs Wusterhausen | 15711 | Germany |
| private practise Straub | Kronach | 96317 | Germany |
| Kreiskrankenhaus Langenau | Langenau | 89129 | Germany |
| Boche-Hamann-Teich | Leipzig | 4109 | Germany |
| private practise Schwarze | Leipzig | 4129 | Germany |
| private practise Zeiger | Leipzig | 4275 | Germany |
| private practise Wiemers | Leipzig | 4317 | Germany |
| private practise Weiß | Lichtenstein | 9350 | Germany |
| private practise Holst | Ludwigslust | 19288 | Germany |
| Private Practise Legler | Lübeck | 23564 | Germany |
| private practise Kudela | Magdeburg | 39104 | Germany |
| private practise Raschke | Magdeburg | 39104 | Germany |
| private practise Sieburg | Magdeburg | 39104 | Germany |
| private practise Weimann | Magdeburg | 39110 | Germany |
| Hautklinik der Universitätsmedizin Mainz KöR,Clinical Research Center | Mainz | 55101 | Germany |
| private practise Zimmermann | Malchow | 17213 | Germany |
| Praxis Roßbach | Mansfeld OT Großörner | 06343 | Germany |
| private practise Harmuth | Marktredwitz | 95615 | Germany |
| Private Practise Bödekker | Marl | 45768 | Germany |
| private practise Reck | Mittelherwigsdorf | 2763 | Germany |
| private practise Vollmer | Mönchengladbach | 41061 | Germany |
| private practise Krüger | München | 81541 | Germany |
| Stadt Klinikum Muenchen | München | 81925 | Germany |
| private practise Raub | Münster | 48143 | Germany |
| private practise Berger | Naunhof | 4683 | Germany |
| private practise Klopsch | Neubrandenburg | 17033 | Germany |
| Rheumazentrum SH Mitte GbR | Neumünster | 24534 | Germany |
| private practise Scholz | Neustadt-Glewe | 19306 | Germany |
| private practise Kloos | Neuwied | 56564 | Germany |
| Private Practise Hein | Nienburg | 31582 | Germany |
| Private Practise Vogel | Nuremberg | 90482 | Germany |
| private practise Albert | Offenburg | 77652 | Germany |
| private practise Voglau | Oldenburg | 26123 | Germany |
| private practise Gräßler | Pirna | 1796 | Germany |
| private practise Welcker | Planegg | 82152 | Germany |
| private practise Baumann | Plauen | 8523 | Germany |
| Private Practise Petersen | Potsdam | 14469 | Germany |
| Rheumahaus Potsdam GbR | Potsdam | 14469 | Germany |
| Knappschaftskrankenhaus Püttlingen | Püttlingen | 66346 | Germany |
| private practise Wassenberg | Ratingen | 40882 | Germany |
| private practise Schwokowski | Ratzeburg | 23909 | Germany |
| private practise Rumpel | Regensburg | 93051 | Germany |
| private practise Schumann | Reken | 48734 | Germany |
| Private Practise Walter | Rendburg | 24768 | Germany |
| Private Practise Kotterik | Reutlingen | 72764 | Germany |
| Private Practise Hoene | Rostock | 18059 | Germany |
| private practise Richter | Rostock | 18059 | Germany |
| private practise Lankow | Rostock | 18069 | Germany |
| private practise Biewer | Saarbrücken | 66111 | Germany |
| Private Practise Mobius | Schwerin | 19053 | Germany |
| private practise Möbius | Schwerin | 19053 | Germany |
| private practise Ständer | Schwerin | 19053 | Germany |
| private practise Melzer | Seesen | 38723 | Germany |
| Company for Medical Study&Service Selters | Selters/Ww | 56242 | Germany |
| Private Practise Hoese | Stadthagen | 31655 | Germany |
| private practise Steinborn | Straubing | 94315 | Germany |
| private practise Engel | Stuttgart | 70178 | Germany |
| ZIRS - Zentrum für Interdisziplinäre Rheumatologie Stuttgart | Stuttgart | 70372 | Germany |
| Private Practice Fahr | Suhl | 98529 | Germany |
| private practise Pyra | Torgelow | 17358 | Germany |
| MVZ der Johanniter | Treuenbrietzen | 14929 | Germany |
| Praxis Dr. Haas | Tübingen | 72072 | Germany |
| Private Practice Jacki | Tübingen | 72072 | Germany |
| Universitätsklinikum Tübingen | Tübingen | 72076 | Germany |
| Berufsausübungsgemeinschaft Dr. med Petra Roll und Dr. Margarete Kratzsch | Ulm / Donau | 89073 | Germany |
| private practise Rinaldi | Ulm / Donau | 89073 | Germany |
| Praxis Dres. Winkler-Gyulay, Moeller | Unna | 59423 | Germany |
| private practise Otte | Wesel | 46483 | Germany |
| private practise Schuart | Wissen/ Luhe | 21423 | Germany |
| private practise Metz | Wittstock | 16909 | Germany |
| private practise Senger | Wunstorf | 31515 | Germany |
| Klinikverbund St. Antonius und St. Josef GmbH, Krankenhaus St. Josef | Wuppertal | 42105 | Germany |
| Private Practise Sprekeler | Zeven | 27404 | Germany |
| private practise Fricke-Wagner | Zwickau | 8056 | Germany |
| private practise Alliger | Zwiesel | 94227 | Germany |
| Feist E, Baraliakos X, Behrens F, Thaci D, Klopsch T, Plenske A, Blindzellner LK, Klaus P, Meng T, Loschmann PA. Effectiveness of Etanercept in Rheumatoid Arthritis: Real-World Data from the German Non-interventional Study ADEQUATE with Focus on Treat-to-Target and Patient-Reported Outcomes. Rheumatol Ther. 2022 Apr;9(2):621-635. doi: 10.1007/s40744-021-00418-5. Epub 2022 Feb 3. |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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Treated set included all documented participants who were treated, had at least 1 post-baseline value and had an adverse event (AE) documented.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Etanercept | 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. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Continuous | There is no information available for age for 6 participants (=missing values). | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
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| Primary | Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 12 | 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. | 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. | Posted | Count of Participants | Participants | Week 12 |
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| Primary | Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 24 | 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. | 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. | Posted | Count of Participants | Participants | Week 24 |
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| Primary | 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 | 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. | 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. | Posted | Count of Participants | Participants | Week 12 up to Week 52 |
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| Primary | 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 | 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. | 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. | Posted | Count of Participants | Participants | Week 24 up to Week 52 |
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| Primary | 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 | 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). | 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 PsO. | Posted | Count of Participants | Participants | Week 12 |
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| Primary | Number of Participants With Axial Spondyloarthritis (axSpA) Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than (<) 1.3 at 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. | 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 axSpA evaluable for this outcome measure. | Posted | Count of Participants | Participants | Week 12 |
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| Primary | 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 | 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.](streamdown:incomplete-link) | 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 PsA evaluable for this outcome measure. | Posted | Count of Participants | Participants | Week 12 |
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| Primary | 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 | 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). | 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 PsO evaluable for this outcome measure. | Posted | Count of Participants | Participants | Week 24 |
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| Primary | Number of Participants With Axial Spondyloarthritis (axSpA) Achieving Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than (<) 1.3 at Week 24 | 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. | 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 axSpA evaluable for this outcome measure. | Posted | Count of Participants | Participants | Week 24 |
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| Primary | 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 | 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.](streamdown:incomplete-link) | 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 PsA evaluable for this outcome measure. | Posted | Count of Participants | Participants | Week 24 |
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| Secondary | Percentage of Participants Who Continued With Treatment up to Weeks 12, 24, 36 and 52: Treated Set (TS) | Treated set included all documented participants who were treated, had at least 1 post-baseline value and had an AE documented. | Posted | Number | percentage of participants | Baseline up to Weeks 12, 24, 36, 52 |
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| Secondary | Percentage of Participants Who Continued With Treatment up to Weeks 12, 24, 36 and 52: Per-Protocol (PP) Set | PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. | Posted | Number | percentage of participants | Baseline up to Weeks 12, 24, 36, 52 |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) up to Weeks 12, 24, 36 and 52: Treated Set | 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. | Treated set included all documented participants who were treated, had at least 1 post-baseline value and had an AE documented. | Posted | Count of Participants | Participants | Baseline up to Weeks 12, 24, 36, 52 |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events up to Weeks 12, 24, 36 and 52: Per-Protocol (PP) Set | 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. | PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. | Posted | Count of Participants | Participants | Baseline up to Weeks 12, 24, 36, 52 |
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| Secondary | Number of Participants Achieving 28 Joint Disease Activity Score (DAS28) Remission at Weeks 12, 24, 36 and 52 | 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. Participants who had DAS28 <= 2.6 were considered in remission. | 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 or PsA. "Number analyzed" signifies participants analyzed for this outcome measure at specified time points. | Posted | Count of Participants | Participants | Weeks 12, 24, 36, 52 |
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| Secondary | Patient Global Assessment of Disease Activity (PtGA) Scores at Weeks 12, 24, 36 and 52 | 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. | 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. | Posted | Mean | Standard Deviation | mm | Weeks 12, 24, 36, 52 |
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| Secondary | Mean Visual Analogue Scale (VAS) Fatigue Scores at Weeks 12, 24, 36 and 52 | Participants assessed their fatigue using a 0 - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue. | 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. | Posted | Mean | Standard Deviation | mm | Weeks 12, 24, 36, 52 |
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| Secondary | Mean Visual Analogue Scale (VAS) Pain Scores at Weeks 12, 24, 36 and 52 | 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). | 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. | Posted | Mean | Standard Deviation | mm | Weeks 12, 24, 36, 52 |
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| Secondary | Physician Global Assessment (PGA) of Disease Activity Scores at Weeks 12, 24, 36 and 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. | 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. | Posted | Mean | Standard Deviation | mm | Weeks 12, 24, 36, 52 |
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| Secondary | Patient Health Quessionare-2 (PHQ-2) Scores at Weeks 12, 24, 36 and 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). | 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. | Posted | Mean | Standard Deviation | units on a scale | Weeks 12, 24, 36, 52 |
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| Secondary | 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 | 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. | 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. "Number analyzed" signifies participants analyzed for this outcome measure at specified time points. | Posted | Number | 95% Confidence Interval | spearman correlation coefficient | Weeks 12, 24, 36, 52 |
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| Secondary | 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 | 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. | 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 axSpA. "Number analyzed" signifies participants analyzed for this outcome measure at specified time points. | Posted | Number | 95% Confidence Interval | spearman correlation coefficient | Weeks 12, 24, 36, 52 |
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| Secondary | 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 | 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. | 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 PsA. Number analyzed signifies participants analyzed for this outcome measure at specified time points. | Posted | Number | 95% Confidence Interval | spearman correlation coefficient | Weeks 12, 24, 36, 52 |
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| Secondary | 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 | 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. | 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 PsO. "Number analyzed" signifies participants analyzed for this outcome measure at specified time points. | Posted | Number | 95% Confidence Interval | spearman correlation coefficient | Weeks 12, 24, 36, 52 |
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| Secondary | Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at 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). | 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. "Number analyzed" signifies participants analyzed for this outcome measure at specified time points. | Posted | Number | 95% Confidence Interval | spearman correlation coefficient | Weeks 12, 24, 36, 52 |
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| Secondary | Psoriatic Arthritis(PsA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at 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). | 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 PsA. "Number analyzed" signifies participants analyzed for this outcome measure at specified time points. | Posted | Number | 95% Confidence Interval | spearman correlation coefficient | Weeks 12, 24, 36, 52 |
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| Secondary | Ankylosing Spondylitis(axSpA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at 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). | 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 axSpA. "Number analyzed" signifies participants analyzed for this outcome measure at specified time points. | Posted | Number | 95% Confidence Interval | spearman correlation coefficient | Weeks 12, 24, 36, 52 |
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| Secondary | Percentage of Participants Who Discontinued Treatment Due to Lack of Efficacy or Adverse Events | Percentage of participants who discontinued etanercept before completing the study, was reported. | Treated set included all documented participants who were treated, had at least 1 post-baseline value and had an AE documented. | Posted | Number | percentage of participants | Baseline up to Week 52 |
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| Secondary | Number of Participants Who Switched to Other Therapy After Treatment Discontinuation | Participants who switched from etanercept to either disease-modifying antirheumatic drugs (DMARDs) or alternative biologic drug were reported. | 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. | Posted | Count of Participants | Participants | Baseline up to Week 52 |
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| Secondary | 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 | 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. | 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, axSpA or PsA. "Number analyzed" signifies participants analyzed for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | units on a scale | Weeks 12, 24, 36, 52 |
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| Secondary | Clinical Disease Activity Index (CDAI) Scores of Participants With Rheumatoid Arthritis (RA) at Weeks 12, 24, 36 and 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. | 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. "Number analyzed" signifies participants analyzed for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | units on a scale | Weeks 12, 24, 36, 52 |
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| Secondary | Simplified Disease Activity Index (SDAI) Scores of Participants With Rheumatoid Arthritis (RA) at Weeks 12, 24, 36 and 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. | 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. "Number analyzed" signifies participants analyzed for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | units on a scale | Weeks 12, 24, 36, 52 |
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| Secondary | Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of Participants With Axial Spondyloarthritis (axSpA) at Weeks 12, 24, 36 and 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). | 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 axSpA. "Number analyzed" signifies participants analyzed for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | units on a scale | Weeks 12, 24, 36, 52 |
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| Secondary | Number of Affected Enthesis in Participants With Axial Spondyloarthritis (axSpA) and Psoriatic Arthritis(PsA) at Weeks 12, 24, 36 and 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. | 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 axSpA or PsA. "Number analyzed" signifies participants analyzed for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | enthesis | Weeks 12, 24, 36, 52 |
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| Secondary | Occiput-to-wall Distance of Participants With Axial Spondyloarthritis (axSpA) at Weeks 12, 24, 36 and 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. | 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 axSpA. "Number analyzed" signifies participants analyzed for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | cm | Weeks 12, 24, 36, 52 |
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| Secondary | 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 | 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. | 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 PsO, PsA. "Number analyzed" signifies participants analyzed for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | percentage of BSA | Weeks 12, 24, 36, 52 |
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| Secondary | Mean of Total Number of Affected Fingers or Toes by Dactylitis in Participants With Psoriatic Arthritis (PsA) at Weeks 12, 24, 36 and 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. | 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 PsA. "Number analyzed" signifies participants analyzed for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | finger or toes | Weeks 12, 24, 36, 52 |
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| Secondary | Change From Baseline in Psoriasis Area and Severity Index (PASI) in Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 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. | 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 PsO. "Number analyzed" signifies participants analyzed for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Weeks 12, 24, 36, 52 |
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| Secondary | Median Time to Achieve Psoriasis Area and Severity Index 75 (PASI 75) Response in Participants With Plaque Psoriasis (PsO) | 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. | 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 PsO. | Posted | Median | Standard Deviation | days | Baseline up to Week 24 |
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| Secondary | Psoriasis Area and Severity Index (PASI) Component Scores in Participants With Plaque Psoriasis (PsO) | 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). | 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 PsO. "Number analyzed" signifies participants analyzed for this outcome measure at specified categories. | Posted | Mean | Standard Deviation | units on a scale | Weeks 12, 24, 36, 52 |
|
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| Secondary | Psoriasis Area and Severity Index (PASI) Body Segment Scores in Participants With Plaque Psoriasis (PsO) | 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). | 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 PsO. "Number analyzed" signifies participants analyzed for this outcome measure at specified categories. | Posted | Mean | Standard Deviation | units on a scale | Weeks 12, 24, 36, 52 |
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| Secondary | Dermatology Life Quality Index (DLQI) Total Score for Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 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. | 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 PsO. "Number analyzed" signifies participants analyzed for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | units on a scale | Weeks 12, 24, 36, 52 |
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| Secondary | Patient Assessment of Pruritus for Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52 | Participant's assessment of pruritus measured on a 100 mm VAS ranging from 0 as "no Pruritus" to 100 as "most severe pruritus". | 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 PsO. "Number analyzed" signifies participants analyzed for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | units on a scale | Weeks 12, 24, 36, 52 |
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| Other Pre-specified | Erythrocyte Sedimentation Rate (ESR) at Weeks 12, 24, 36 and 52 | 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. | 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. | Posted | Mean | Standard Deviation | mm/hr | Weeks 12, 24, 36, 52 |
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| Other Pre-specified | C-Reactive Protein (CRP) Levels at Weeks 12, 24, 36 and 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. | 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. | Posted | Mean | Standard Deviation | mg/L | Weeks 12, 24, 36, 52 |
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| Other Pre-specified | Number of Participants With Rheumatoid Factor (RF) at Weeks 12, 24, 36 and 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. | 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, axSpA or PsA. "Number analyzed" signifies participants analyzed for this outcome measure at specified time points. | Posted | Count of Participants | Participants | Weeks 12, 24, 36, 52 |
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| Other Pre-specified | Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibodies at Weeks 12, 24, 36 and 52 | To assess the pharmacodynamics effect of etanercept on serum levels of autoantibodies, Anti-CCP antibodies levels were measured. | 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, AxS or PsA. "Number analyzed" signifies participants analyzed for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | unit per milliliter (U/mL) | Weeks 12, 24, 36, 52 |
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| Other Pre-specified | Number of Participants With Positive Human Leukocyte Antigen B27(HLA-B27) at Baseline for Participants With Axial Spondyloarthritis(axSpA) | Participants with Axial Spondyloarthritis with Positive Human Leukocyte Antigen (HLA-B27) were reported. | 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 axSpA. | Posted | Count of Participants | Participants | Baseline |
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| Other Pre-specified | Number of Participants With Axial Spondyloarthritis (axSpA) Achieving Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than < 1.3 at Weeks 36 and 52 | 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. | 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 axSpA. "Number analyzed" signifies participants analyzed for this outcome measure at specified time points. | Posted | Count of Participants | Participants | Weeks 36, 52 |
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| Other Pre-specified | 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 | 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.](streamdown:incomplete-link) | 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 PsA. "Number analyzed" signifies participants analyzed for this outcome measure at specified time points. | Posted | Count of Participants | Participants | Weeks 36, 52 |
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| Other Pre-specified | 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 | 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). | 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 PsO. "Number analyzed" signifies participants analyzed for this outcome measure at specified time points. | Posted | Count of Participants | Participants | Weeks 36, 52 |
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| Other Pre-specified | Number of Participants With Rheumatoid Arthritis (RA) Achieving 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Weeks 36 and 52 | 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. Participants who had DAS28 <= 2.6 were considered in remission. | 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. "Number analyzed" signifies participants analyzed for this outcome measure at specified time points. | Posted | Count of Participants | Participants | Weeks 36, 52 |
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|
Baseline up to Week 52
Same event may appear as both an AE & a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant & as non-serious in another participant, or one participant may have experienced both a serious & non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value & had an AE documented. All-cause mortality data included all anticipated & unanticipated deaths due to any cause.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Etanercept | 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. | 5 | 1,465 | 151 | 1,465 | 606 | 1,465 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Rheumatic disorder | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Ankylosing spondylitis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Facet joint syndrome | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Joint destruction | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Meniscal degeneration | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Metatarsalgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Spondylitis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Drug ineffective | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Condition aggravated | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Disease recurrence | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Drug effect decreased | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Injection site warmth | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Implantation of medial unicondylar sliding prosthesis knee left | Surgical and medical procedures | MedDRA 21.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Therapy non-responder | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Arthritis infective | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Borrelia infection | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Bronchitis bacterial | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Epididymitis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Escherichia infection | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Febrile infection | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Hepatitis e | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Mycobacterial infection | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Nasal abscess | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Peritonsillar abscess | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Post procedural pneumonia | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Tracheobronchitis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment | Only one participant died due to fall. |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| |
| Maternal exposure during pregnancy | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| |
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| |
| Tracheal deviation | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Cardiovascular disorder | Cardiac disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment | Only one participant died due to pulmonary embolism. |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Nasal septum haematoma | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Diverticulum intestinal | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Peripheral artery stenosis | Vascular disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Raynaud's phenomenon | Vascular disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Vasculitis | Vascular disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Hepatitis toxic | Hepatobiliary disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Axonal neuropathy | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Facial paresis | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Renal function test abnormal | Investigations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Troponin increased | Investigations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Benign pancreatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Non-systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Non-systematic Assessment |
| |
| Small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Non-systematic Assessment |
| |
| Nephritis | Renal and urinary disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Ureteric stenosis | Renal and urinary disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Inner ear disorder | Ear and labyrinth disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Vestibular disorder | Ear and labyrinth disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Abortion | Pregnancy, puerperium and perinatal conditions | MedDRA 21.0 | Non-systematic Assessment |
| |
| Foetal growth restriction | Pregnancy, puerperium and perinatal conditions | MedDRA 21.0 | Non-systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drug ineffective | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Condition aggravated | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Drug effect decreased | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Injection site hypersensitivity | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Drug effect incomplete | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Injection site rash | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Local reaction | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Swelling | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Treatment failure | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Adverse event | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Discomfort | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Disease recurrence | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Drug intolerance | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Face oedema | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Hyperthermia | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Inflammation | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Injection site discharge | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Injection site discolouration | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Injection site inflammation | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Injection site irritation | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Mucosal dryness | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 21.0 | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Sensation of foreign body | General disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Pulpitis dental | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Sinobronchitis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Skin candida | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Diabetic foot infection | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Febrile infection | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Groin abscess | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Hepatitis e | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Papilloma viral infection | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Parotitis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Superinfection bacterial | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Tracheobronchitis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Urinary tract infection enterococcal | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Vulvovaginal candidiasis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Skin reaction | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Pustular psoriasis | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Dermatitis exfoliative generalised | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Dermatosis | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Generalised erythema | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Hidradenitis | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Papule | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Rosacea | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Skin burning sensation | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Skin erosion | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Stasis dermatitis | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Vascular skin disorder | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Xanthelasma | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Infected bite | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Enthesopathy | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Osteitis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Tendon disorder | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Cervical spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Dactylitis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Intervertebral disc space narrowing | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Mastication disorder | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Rheumatic disorder | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Rheumatoid nodule | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Sacroiliitis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Sjogren's syndrome | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Soft tissue disorder | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Spondylitis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Trigger finger | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Gastrointestinal inflammation | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Gastrointestinal sounds abnormal | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Loose tooth | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Steatorrhoea | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Tongue discomfort | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Tooth disorder | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Burning sensation | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Head discomfort | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Cerebrovascular disorder | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Complex regional pain syndrome | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Coordination abnormal | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Cubital tunnel syndrome | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Intercostal neuralgia | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Movement disorder | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Spinal cord disorder | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Trigeminal neuralgia | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Laryngeal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Pharyngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Snoring | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Vocal cord inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Maternal exposure during pregnancy | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| |
| Epicondylitis | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| |
| Inflammation of wound | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| |
| Ligament injury | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| |
| Maternal exposure before pregnancy | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| |
| Muscle rupture | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Blood thyroid stimulating hormone abnormal | Investigations | MedDRA 21.0 | Non-systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Heart rate increased | Investigations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Intraocular pressure increased | Investigations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Renal function test abnormal | Investigations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Aggression | Psychiatric disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Apathy | Psychiatric disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Somatic symptom disorder | Psychiatric disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Iritis | Eye disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Eye swelling | Eye disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Uveitis | Eye disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Vitamin d deficiency | Metabolism and nutrition disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Metabolic syndrome | Metabolism and nutrition disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Increased tendency to bruise | Blood and lymphatic system disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Granulocytopenia | Blood and lymphatic system disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Immune thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Bladder disorder | Renal and urinary disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Cystitis noninfective | Renal and urinary disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Leukocyturia | Renal and urinary disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Extrasystoles | Cardiac disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Tachyarrhythmia | Cardiac disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Non-systematic Assessment |
| |
| Haemangioma of liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Non-systematic Assessment |
| |
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Non-systematic Assessment |
| |
| Deafness | Ear and labyrinth disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Oligohydramnios | Pregnancy, puerperium and perinatal conditions | MedDRA 21.0 | Non-systematic Assessment |
| |
| Uterine haematoma | Reproductive system and breast disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Peripheral venous disease | Vascular disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 21.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Nov 12, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D015535 | Arthritis, Psoriatic |
| D000089183 | Axial Spondyloarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D000844 | Ankylosis |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068800 | Etanercept |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
Not provided
Not provided
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