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It is known from the COMET-trial that patients who start Enbrel treatment early have a great chance of reaching clinical remission and radiographic nonprogression. It is still unclear, however, how many patients with early arthritis achieve remission and radiographic nonprogression under the conditions of routine rheumatologic care and the local recommendations of Enbrel treatment (pre-treatment of at least 2 DMARDs, one of them MTX).
Therefore, no robust x-ray data are available to show/demonstrate
Non-interventional study: subjects to be selected according to the usual clinical practice of their physician
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Rheumatoid Arthritis |
| ||
| Patients with Psoriasis Arthritis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etanercept | Drug | The patients will be treated in accordance with the requirements of the labelling of Enbrel® in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Van Der Heijde Total Modified Total Sharp Score (mTSS) or Adapted mTSS at End of Phase 1 (Week 78): Efficacy Analysis Set (EAS) | To assess radiological damage mTSS score was used in participants with rheumatoid arthritis and mTSS adapted score was used in participants with psoriatic arthritis. Radiographs of the hands and feet were assessed by central raters. Total mTSS score range was 0 (no radiological damage) to 448 (extreme radiological damage); and total mTSS adapted score range was 0 (no radiological damage) to 528 (extreme radiological damage), where higher mTSS and mTSS adapted scores indicate a worse health status in participants with rheumatoid arthritis and participants with psoriatic arthritis, respectively. | Baseline, Week 78 |
| Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at End of Phase 1 (Week 78): Completer Analysis Set (CAS) | To assess radiological damage, mTSS score was used in participants with rheumatoid arthritis and mTSS adapted score was used in participants with psoriatic arthritis. Radiographs of the hands and feet were assessed by central raters. Total mTSS score range was 0 (no radiological damage) to 448 (extreme radiological damage); and total mTSS adapted score range was 0 (no radiological damage) to 528 (extreme radiological damage), where higher mTSS and mTSS adapted scores indicate a worse health status in participants with rheumatoid arthritis and participants with psoriatic arthritis, respectively. | Baseline, Week 78 |
| Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at the End of Phase 2 (Week 156): EAS | To assess radiological damage, mTSS score was used in participants with rheumatoid arthritis and mTSS adapted score was used in participants with psoriatic arthritis. Radiographs of the hands and feet were assessed by central raters. Total mTSS score range was 0 (no radiological damage) to 448 (extreme radiological damage); and total mTSS adapted score range was 0 (no radiological damage) to 528 (extreme radiological damage), where higher mTSS and mTSS adapted scores indicate a worse health status in participants with rheumatoid arthritis and participants with psoriatic arthritis, respectively. |
| Measure | Description | Time Frame |
|---|---|---|
| Linear Relationship Between Normalized Radiographic Progression and Disease Duration | Linear relationship between radiographic progression and disease duration was evaluated using a linear regression model. Dependent variable was normalized progression under treatment with Etanercept and independent variable was disease duration. | Baseline up to Week 78 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Treatment-Emergent Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events. |
Inclusion Criteria:
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
Exclusion Criteria:
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Only patients for whom the decision has already been made to initiate treatment with Enbrel® can be enrolled in this observational trial. These patients must have a proven diagnosis of Rheumatoid Arthritis or Psoriasis Arthritis
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36251174 | Derived | Wassenberg S, Rau R, Klopsch T, Plenske A, Jobst J, Klaus P, Meng T, Loschmann PA. Etanercept is Effective and Halts Radiographic Progression in Rheumatoid Arthritis and Psoriatic Arthritis: Final Results from a German Non-interventional Study (PRERA). Rheumatol Ther. 2023 Feb;10(1):117-133. doi: 10.1007/s40744-022-00491-4. Epub 2022 Oct 17. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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Participants those who were recruited despite of an unknown or unclear disease diagnosis, were only included in safety analysis for the study, not for efficacy evaluation.
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants With Rheumatoid Arthritis | Participants with rheumatoid arthritis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156. |
| FG001 | Participants With Psoriatic Arthritis | Participants with psoriatic arthritis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156. |
| FG002 | Participants With Unclear Diagnosis | Participants with unclear diagnosis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1 (78 Weeks) |
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| |||||||||||||||||||||
| Phase 2 (78 Weeks) |
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Safety analysis set included all participants who received at least 1 dose of Etanercept.
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants With Rheumatoid Arthritis | Participants with rheumatoid arthritis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Van Der Heijde Total Modified Total Sharp Score (mTSS) or Adapted mTSS at End of Phase 1 (Week 78): Efficacy Analysis Set (EAS) | To assess radiological damage mTSS score was used in participants with rheumatoid arthritis and mTSS adapted score was used in participants with psoriatic arthritis. Radiographs of the hands and feet were assessed by central raters. Total mTSS score range was 0 (no radiological damage) to 448 (extreme radiological damage); and total mTSS adapted score range was 0 (no radiological damage) to 528 (extreme radiological damage), where higher mTSS and mTSS adapted scores indicate a worse health status in participants with rheumatoid arthritis and participants with psoriatic arthritis, respectively. | Efficacy analysis set for Phase 1= all participants who had received at least 1 dose of Etanercept and had baseline X-ray (Rx1) and end of phase 1 X-ray (Rx2). Here, "Overall Number of Participants Analyzed" =number of participants evaluable for this outcome measure; "Number Analyzed"=number of participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 78 |
Baseline up to Week 156
Same event may appear both an AE and SAE. However, what is presented are distinct events. Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants With Rheumatoid Arthritis | Participants with rheumatoid arthritis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 17.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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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 | Sep 20, 2011 | Mar 16, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000068800 | Etanercept |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
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|
| Etanercept | Drug | The patients will be treated in accordance with the requirements of the labelling of Enbrel® in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment. |
|
|
| Baseline, Week 156 |
| Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at End of Phase 2 (Week 156): CAS | To assess radiological damage, mTSS score was used in participants with rheumatoid arthritis and mTSS adapted score was used in participants with psoriatic arthritis. Radiographs of the hands and feet were assessed by central raters. Total mTSS score range was 0 (no radiological damage) to 448 (extreme radiological damage); and total mTSS adapted score range was 0 (no radiological damage) to 528 (extreme radiological damage), where higher mTSS and mTSS adapted scores indicate a worse health status in participants with rheumatoid arthritis and participants with psoriatic arthritis, respectively. | Baseline, Week 156 |
| Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 1 (Week 78): EAS | The normalized change in total scores (mTSS or mTSS adapted) were computed as normalized per year (normalized progression). The change of normalized progression was classified as: increase (greater than [>] 0.5), no change (-0.5 to 0.5) and decrease (less than [<] -0.5). Participants with no change or a decrease were considered to be in radiographic remission. | Pre-treatment, Week 78 |
| Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 1 (Week 78): CAS | The normalized change in total scores (mTSS or mTSS adapted) were computed as normalized per year (normalized progression). The change of normalized progression was classified as: increase (>0.5), no change (-0.5 to 0.5) and decrease (<-0.5). Participants with no change or a decrease were considered to be in radiographic remission. | Pre-treatment, Week 78 |
| Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 2 (Week 156): EAS | The normalized change in total scores (mTSS or mTSS adapted) were computed as normalized per year (normalized progression). The change of normalized progression was classified as: increase (>0.5), no change (-0.5 to 0.5) and decrease (<-0.5). Participants with no change or a decrease were considered to be in radiographic remission. | Pre-treatment, Week 156 |
| Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at the End of Phase 2 (Week 156): CAS | The normalized change in total scores (mTSS or mTSS adapted) were computed as normalized per year (normalized progression). The change of normalized progression was classified as: increase (>0.5), no change (-0.5 to 0.5) and decrease (<-0.5). Participants with no change or a decrease were considered to be in radiographic remission. | Pre-treatment, Week 156 |
| Effect on Normalized Radiographic Progression With Respect to Baseline Positivity of Anti-citrullinated Protein Antibody (ACPA) - Rheumatoid Factor (RF) | Effect on normalized radiographic progression with respect to ACPA-RF was evaluated using an analysis of variance (ANOVA) model. Dependent variable was normalized progression under treatment with Etanercept and independent variable was groups of positive testing of ACPA and RF at baseline. | Baseline up to Week 78 |
| Effect on Normalized Radiographic Progression With Respect to Baseline Usage of Concomitant Medication | Effect on normalized radiographic progression with respect to use of concomitant medication at baseline was evaluated using an ANOVA model. Dependent variable was normalized progression under treatment with Etanercept and independent variable was groups of concomitant medication as found among the medication given concomitantly during study that is recorded at baseline. | Baseline up to Week 78 |
| Effect on Normalized Radiographic Progression With Respect to Previous Treatment With Biologics | Effect on normalized radiographic progression of previous treatment with biologics was evaluated using an ANOVA model. Dependent variable was normalized progression under treatment with Etanercept and independent variable was previous treatment with biologics. | Baseline up to Week 78 |
| Effect on Normalized Radiographic Progression With Respect to Baseline Disease Activity Score-28 (DAS-28) | Effect on radiographic progression with respect to baseline DAS-28 was evaluated using ANOVA model. Dependent variable was normalized progression under treatment with Etanercept and independent variable was baseline DAS-28. Baseline DAS-28 is less than or equal to (<=) 5.1 or >5.1. DAS28: score range from 0 (none) to 9.4 (extreme disease activity); low =2.6 to 3.2, moderate =3.2 to 5.1, and high disease activity >5.1. DAS28 score of <2.6 indicates disease remission. | Baseline up to Week 78 |
| Change From Baseline in Total Erosion Score at End of Phase 1 (Week 78) and Phase 2 (Week 156) | Total erosion score as per van der Hejde method consisted of 2 dimensions: a) hands (32 erosion locations, each location graded from 0 [no erosion] to 5 [maximum severity], sum of grading of each location resulted in score of 0 to 160); and b) feet (12 erosion locations, each location graded from 0 [no erosion] to 10 [maximum severity], sum of grading of each location resulted in score of 0 to 120). Sum of erosion scores of hand (0 to 160) and feet (0 to 120) gave a total erosion score as 0 to 280, where 0 was no erosion at all and 280 was worst possible condition, higher scores indicated severe joint destruction. | Baseline, Week 78, 156 |
| Change From Baseline in Total Joint Space Narrow Score at End of Phase 1 (Week 78) and Phase 2 (Week 156) | Total joint space narrow score as per van der Hejde method consisted of 2 dimensions: a) hands (30 joint space locations, each location graded from 0 [normal joint space] to 4 [bony ankylosis], sum of grading of each location resulted in score of 0 to 120); and b) feet (12 erosion locations, each location graded from 0 [no erosion] to 4 [bony ankylosis], sum of grading of each location resulted in score of 0 to 48). Sum of joint space narrow scores of hand (0 to 120) and feet (0 to 48) gave a total joint space narrow score as 0 to 168, where 0 was normal joint space and 168 was maximum narrowing in joints, higher scores indicated severe joint destruction. | Baseline, Week 78, 156 |
| Change From Baseline in Hannover Functional Ability Questionnaire (FFbH) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | FFbH is a self-administered patient questionnaire composed by 18 questions on functional ability in activities of daily living. Each question was answered by the participant as "Yes, I can perform the activity without difficulty" (score assigned =2), "Yes, but with difficulties" (score assigned =1) and "No or only with external help" (score assigned =0). Final FFbH score (%) was then computed according to formula: (Sum of scores*100) divided by (2*number of valid answers), ranging between 0 (no functional capacity) to 100 (full functional capacity); higher scores indicate better daily activities. FFbH functional remission was defined as FFbH functional capacity of >= 83%. | Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156 |
| Change From Baseline in Disease Activity Score-28 (DAS-28) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | DAS28 was calculated from swollen joint count and tender joint count using 28 joint count, C-reactive protein (CRP) in milligram per liter (mg/L) and participant global assessment (PtGA) of disease activity measured on a 100 mm visual analog scale (VAS) ranging from 0 (good condition) to 100 (worst condition), where higher scores indicate worse health condition). DAS28 total score range: 0 (no disease activity) to 9.4 (maximum disease activity), higher score indicates more disease activity. DAS-28 score of 2.6 to 3.2= low, 3.2 to 5.1= moderate and >5.1= high disease activity. DAS-28 score of <2.6= disease remission. DAS28-4(CRP) = (0.56*sqrt[TJC28] + 0.28*sqrt[SJC28] + 0.36*ln[CRP+1]) + 0.014*GH + 0.96) and DAS28-4(ESR) = (0.56*sqrt[TJC28] + 0.28*sqrt[SJC28] + 0.70*ln[ESR] + 0.014*GH), where sqrt = square root, ln = natural logarithm. | Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156 |
| Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Rheumatoid Arthritis | CDAI was calculated from tender and swollen joints using 28 joint count, participant global assessment (PtGA) and physician global assessment (PhyGA). PtGA and PhyGA both were assessed on 0-100 mm VAS scale, where higher scores indicated greater affection due to disease activity. CDAI total score ranged from 0 to 76, where higher scores indicated higher disease activity. CDAI score of <=10 indicates low disease activity and a score of <= 2.8 indicates remission. | Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156 |
| Change From Baseline in Simple Disease Activity Index (SDAI) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Rheumatoid Arthritis | SDAI was calculated from tender and swollen joints using 28 joint count, participant global assessment (PtGA), physician global assessment and (PhyGA) and CRP (in mg/L). PtGA and PhyGA both were assessed on 0-100 mm VAS scale, where higher scores indicated greater affection due to disease activity. SDAI total score ranged from 0 to 86, where higher scores indicated higher disease activity. SDAI score of <=11 indicates low disease activity and a score of <=3.3 indicates remission. | Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156 |
| Percentage of Participants With Rheumatoid Arthritis, With Low Disease Activity Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) | CDAI was calculated from tender and swollen joints using 28 joint count, PtGA and PhyGA. CDAI total score ranged from 0 to 76, where higher scores indicated higher disease activity. CDAI score of <=10 indicates low disease activity and a score of <= 2.8 indicates remission. SDAI was calculated from tender and swollen joints using 28 joint count, PtGA, PhyGA and CRP (in mg/L). SDAI total score ranged from 0 to 86, where higher scores indicated higher disease activity. SDAI score of <=11 indicates low disease activity and a score of <=3.3 indicates remission. PtGA and PhyGA both were assessed on 0-100 mm VAS scale, where higher scores indicated greater affection due to disease activity. | Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156 |
| Percentage of Participants With Rheumatoid Arthritis, With Remission Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) | CDAI was calculated from tender and swollen joints using 28 joint count, PtGA and PhyGA. CDAI total score ranged from 0 to 76, where higher scores indicated higher disease activity. CDAI score of <=10 indicates low disease activity and a score of <= 2.8 indicates remission. SDAI was calculated from tender and swollen joints using 28 joint count, PtGA, PhyGA and CRP (in mg/L). SDAI total score ranged from 0 to 86, where higher scores indicated higher disease activity. SDAI score of <=11 indicates low disease activity and a score of <=3.3 indicates remission. PtGA and PhyGA both were assessed on 0-100 mm VAS scale, where higher scores indicated greater affection due to disease activity. | Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156 |
| Change From Baseline in Participant Pain Visual Analogue Scale (VAS) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | VAS: participants placed a mark indicating the intensity of their pain on a scale of 0 (no pain) to 100 mm (worst possible pain). Higher scores indicate greater level of pain. | Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156 |
| Change From Baseline in Physician Global Assessment (PhyGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | PhyGA: physician marked intensity of participants' pain on a visual analogue scale of 0 (no disease activity) to 100 mm (worst possible condition). Higher scores indicate greater level of disease activity. | Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156 |
| Change From Baseline in Participant Global Assessment (PtGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | PtGA: participant assessed their disease activity using a 100 mm visual analog scale ranging from 0 = very good to 100 = worst. Higher scores indicate worse health status. | Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156 |
| Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | EQ-5D: participant rated questionnaire to assess generic health status in two parts: single utility score and visual analog scale. For utility score, participants rated their current health state on 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression with each dimension having three levels of function: 1 indicates no problem; 2 indicates some problem; 3 indicates extreme problem. | Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156 |
| Duration of Morning Stiffness in Participants With Temporary Rigidity | Rigidity was temporary when 'Yes' was given for the question if daily activities could be done without stiffness; rigidity was permanent when 'No' was given for the question if daily activities could be done without stiffness. | Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156 |
| Number of Participants Categorized in Different Classes Depending Upon Percentage of Body Surface Area (BSA) Affected by Psoriatic Arthritis | Participants with psoriatic arthritis were distributed in following different classes depending upon percentage (%) of BSA affected: 1) less than (<) 3 %, 2) 3-10%, 3) 11-20% and 4) >20%. Psoriatic arthritis affecting <3% BSA was considered as mild, 3 to 10 % as moderate and >10 percent as severe. | Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156 |
| Change From Baseline in Nail Involvement at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Psoriatic Arthritis | In this outcome measure change in number of nails affected by psoriatic arthritis at specified week compared to baseline is reported. Nails included both finger nails and toe nails. | Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156 |
| Change From Baseline in Inflamed Dactylitic Digits at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Psoriatic Arthritis | In this outcome measure change in number of inflamed dactylitic digits at specified week compared to baseline is reported. Dactylitis is inflammation of dactylitic digits (fingers and toes). | Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156 |
| Number of Participants With Use of Glucocorticoids and Disease Modifying Antirheumatic Drugs (DMARDs) Baseline Versus Phase 1 (Week 78) and Baseline Versus Phase 2 (Week 156) | In this outcome measure number of participants with use of glucocorticoids and DMARDs at baseline and specified weeks are reported. If participants used glucocorticoids and DMARDs, it was denoted by "Yes" and if they did not use, it was denoted by "No". Data have been reported separately for glucocorticoids and DMARDs at specified weeks respectively, in 4 categories as: 1) Baseline: No and Specified Week: No, 2) Baseline: Yes and Specified Week: No, 3) Baseline: No and Specified Week: Yes, 4) Baseline: Yes and Specified Week: Yes. | Baseline, Week 78, 156 |
| Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Continuation of Treatment With Etanercept | In this outcome number of participants who participated or not participated in RUDI and PIT and impact of their participation in continuation or termination of treatment with Etanercept is reported. For participants whom data was not recorded is reported under category "No Data". | Baseline up to Week 156 |
| Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | In this outcome number of participants who participated or not participated in RUDI and PIT and impact of their participation in quality of life parameters using EQ-5D health questionnaire is reported. For participants whom data was not recorded is reported under category "No Data". EQ-5D: participant rated questionnaire to assess generic health status in two parts: single utility score and visual analog scale. For utility score, participants rated their current health state on 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression with each dimension having three levels of function: 1 indicates no problem; 2 indicates some problem; 3 indicates extreme problem. | Baseline up to Week 156 |
| Baseline up to Week 156 |
| Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events. AEs were classified according to the severity in 3 categories a)mild: AEs not interfered with participant's usual function b)moderate: AEs interfered to some extent with participant's usual function c)severe: AEs interfered significantly with participant's usual function. Participants may be counted in more than 1 category. | Baseline up to Week 156 |
| Number of Participants With Discontinuation of Etanercept Treatment | Number of participants those who discontinued Etanercept treatment at Week 78 and 156 are reported in this outcome measure. | Week 78, 156 |
| Number of Participants With Treatment-Emergent Treatment Related Adverse Events | Treatment-related AE was any untoward medical occurrence in a participant who received study drug. 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. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events. Relatedness to study treatment was assessed by the investigator. | Baseline up to Week 156 |
| Number of Participants With Results of Tolerability Assessment by Physician and Participant | Physicians and participants rated the tolerability of Etanercept treatment by means of a 4-point scale as: 1) very good, 2) good, 3) moderate and 4) insufficient. | Week 78, 156 |
| Number of Participants With Pregnancy, Puerperium and Perinatal Conditions | In this outcome measure total number of participants with pregnancy, puerperium and perinatal conditions are reported. Pregnancy, puerperium and perinatal conditions included pregnancy, abortion, abortion spontaneous or premature baby. | Baseline up to Week 156 |
| Number of Participants Who Used Concomitant Medication | Number of participants who used medication other than Etanercept for relief of pain. It was determined by the treating physician. | Baseline up to Week 156 |
| Adverse Event |
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| Lack of Efficacy |
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| NOT COMPLETED |
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| BG001 | Participants With Psoriatic Arthritis | Participants with psoriatic arthritis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156. |
| BG002 | Participants With Unclear Diagnosis | Participants with unclear diagnosis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156. |
| BG003 | Total | Total of all reporting groups |
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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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| OG000 | Participants With Rheumatoid Arthritis | Participants with rheumatoid arthritis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156. |
| OG001 | Participants With Psoriatic Arthritis | Participants with psoriatic arthritis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156. |
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| Primary | Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at End of Phase 1 (Week 78): Completer Analysis Set (CAS) | To assess radiological damage, mTSS score was used in participants with rheumatoid arthritis and mTSS adapted score was used in participants with psoriatic arthritis. Radiographs of the hands and feet were assessed by central raters. Total mTSS score range was 0 (no radiological damage) to 448 (extreme radiological damage); and total mTSS adapted score range was 0 (no radiological damage) to 528 (extreme radiological damage), where higher mTSS and mTSS adapted scores indicate a worse health status in participants with rheumatoid arthritis and participants with psoriatic arthritis, respectively. | Completer analysis set for Phase 1: all participants who had received at least 1 dose of Etanercept and had clinical data for Rx1 and Rx2 and provided data for end of Phase 1 of study. "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure. "Number Analyzed"= participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 78 |
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| Primary | Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at the End of Phase 2 (Week 156): EAS | To assess radiological damage, mTSS score was used in participants with rheumatoid arthritis and mTSS adapted score was used in participants with psoriatic arthritis. Radiographs of the hands and feet were assessed by central raters. Total mTSS score range was 0 (no radiological damage) to 448 (extreme radiological damage); and total mTSS adapted score range was 0 (no radiological damage) to 528 (extreme radiological damage), where higher mTSS and mTSS adapted scores indicate a worse health status in participants with rheumatoid arthritis and participants with psoriatic arthritis, respectively. | Efficacy analysis set for Phase 2 included all participants who had received at least 1 dose of Etanercept and had Rx1 and end of Phase 2 X-ray (Rx3). Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 156 |
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| Primary | Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at End of Phase 2 (Week 156): CAS | To assess radiological damage, mTSS score was used in participants with rheumatoid arthritis and mTSS adapted score was used in participants with psoriatic arthritis. Radiographs of the hands and feet were assessed by central raters. Total mTSS score range was 0 (no radiological damage) to 448 (extreme radiological damage); and total mTSS adapted score range was 0 (no radiological damage) to 528 (extreme radiological damage), where higher mTSS and mTSS adapted scores indicate a worse health status in participants with rheumatoid arthritis and participants with psoriatic arthritis, respectively. | Completer analysis set for Phase 2 included all participants who had received at least 1 dose of Etanercept, and had clinical data for the obligatory X-ray (Rx1) and Rx3, and completed Phase 2 of the study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 156 |
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| Primary | Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 1 (Week 78): EAS | The normalized change in total scores (mTSS or mTSS adapted) were computed as normalized per year (normalized progression). The change of normalized progression was classified as: increase (greater than [>] 0.5), no change (-0.5 to 0.5) and decrease (less than [<] -0.5). Participants with no change or a decrease were considered to be in radiographic remission. | Efficacy analysis set for Phase 1 included all participants who had received at least 1 dose of Etanercept and had Rx1 and Rx2. Here, "Overall Number of Participants Analyzed" = number of participants evaluable for this outcome measure and "Number Analyzed" = number of participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | Scores per year | Pre-treatment, Week 78 |
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| Primary | Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 1 (Week 78): CAS | The normalized change in total scores (mTSS or mTSS adapted) were computed as normalized per year (normalized progression). The change of normalized progression was classified as: increase (>0.5), no change (-0.5 to 0.5) and decrease (<-0.5). Participants with no change or a decrease were considered to be in radiographic remission. | CAS for phase 1 included all participants who had received at least 1 dose of Etanercept, and had Rx1 and Rx2, and provided data for end of Phase 1 of study. Here, "Overall Number of Participants Analyzed"=number of participants evaluable for this outcome measure and "Number Analyzed"=number of participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | Scores per year | Pre-treatment, Week 78 |
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| Primary | Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 2 (Week 156): EAS | The normalized change in total scores (mTSS or mTSS adapted) were computed as normalized per year (normalized progression). The change of normalized progression was classified as: increase (>0.5), no change (-0.5 to 0.5) and decrease (<-0.5). Participants with no change or a decrease were considered to be in radiographic remission. | Efficacy analysis set for Phase 2 included all participants who had received at least 1 dose of Etanercept and had Rx1 and Rx3. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Scores per year | Pre-treatment, Week 156 |
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| Primary | Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at the End of Phase 2 (Week 156): CAS | The normalized change in total scores (mTSS or mTSS adapted) were computed as normalized per year (normalized progression). The change of normalized progression was classified as: increase (>0.5), no change (-0.5 to 0.5) and decrease (<-0.5). Participants with no change or a decrease were considered to be in radiographic remission. | CAS for phase 2 included all participants who had received at least 1 dose of Etanercept, and had Rx1 and Rx2, and completed phase 2 of the study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Scores per year | Pre-treatment, Week 156 |
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| Secondary | Linear Relationship Between Normalized Radiographic Progression and Disease Duration | Linear relationship between radiographic progression and disease duration was evaluated using a linear regression model. Dependent variable was normalized progression under treatment with Etanercept and independent variable was disease duration. | Efficacy analysis set for Phase 1 included participants who received at least 1 dose of Etanercept and had Rx1 and Rx2. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. | Posted | Number | Regression coefficient | Baseline up to Week 78 |
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| Secondary | Effect on Normalized Radiographic Progression With Respect to Baseline Positivity of Anti-citrullinated Protein Antibody (ACPA) - Rheumatoid Factor (RF) | Effect on normalized radiographic progression with respect to ACPA-RF was evaluated using an analysis of variance (ANOVA) model. Dependent variable was normalized progression under treatment with Etanercept and independent variable was groups of positive testing of ACPA and RF at baseline. | Efficacy analysis set for Phase 1 included participants who received at least 1 dose of Etanercept and had Rx1 and Rx2. Here, "Overall Number of Participants Analyzed" = number of participants evaluable for this outcome measure and "Number Analyzed" = number of participants evaluable for the specified rows. | Posted | Least Squares Mean | 95% Confidence Interval | Scores per year | Baseline up to Week 78 |
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| Secondary | Effect on Normalized Radiographic Progression With Respect to Baseline Usage of Concomitant Medication | Effect on normalized radiographic progression with respect to use of concomitant medication at baseline was evaluated using an ANOVA model. Dependent variable was normalized progression under treatment with Etanercept and independent variable was groups of concomitant medication as found among the medication given concomitantly during study that is recorded at baseline. | Efficacy analysis set for Phase 1 included participants who received at least 1 dose of Etanercept and had Rx1 and Rx2. Here, "Overall Number of Participants Analyzed" = number of participants evaluable for this outcome measure and "Number Analyzed" = number of participants evaluable for the specified rows. | Posted | Least Squares Mean | 95% Confidence Interval | Scores per year | Baseline up to Week 78 |
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| Secondary | Effect on Normalized Radiographic Progression With Respect to Previous Treatment With Biologics | Effect on normalized radiographic progression of previous treatment with biologics was evaluated using an ANOVA model. Dependent variable was normalized progression under treatment with Etanercept and independent variable was previous treatment with biologics. | Efficacy analysis set for Phase 1 included participants who received at least 1 dose of Etanercept and had Rx1 and Rx2. Here, "Overall Number of Participants Analyzed" = number of participants evaluable for this outcome measure and "Number Analyzed" = number of participants evaluable for the specified rows. | Posted | Least Squares Mean | 95% Confidence Interval | Scores per year | Baseline up to Week 78 |
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| Secondary | Effect on Normalized Radiographic Progression With Respect to Baseline Disease Activity Score-28 (DAS-28) | Effect on radiographic progression with respect to baseline DAS-28 was evaluated using ANOVA model. Dependent variable was normalized progression under treatment with Etanercept and independent variable was baseline DAS-28. Baseline DAS-28 is less than or equal to (<=) 5.1 or >5.1. DAS28: score range from 0 (none) to 9.4 (extreme disease activity); low =2.6 to 3.2, moderate =3.2 to 5.1, and high disease activity >5.1. DAS28 score of <2.6 indicates disease remission. | Efficacy analysis set for Phase 1 included participants who received at least 1 dose of Etanercept and had Rx1 and Rx2. Here, "Overall Number of Participants Analyzed" = number of participants evaluable for this outcome measure and "Number Analyzed" = number of participants evaluable for the specified rows. | Posted | Least Squares Mean | 95% Confidence Interval | Scores per year | Baseline up to Week 78 |
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| Secondary | Change From Baseline in Total Erosion Score at End of Phase 1 (Week 78) and Phase 2 (Week 156) | Total erosion score as per van der Hejde method consisted of 2 dimensions: a) hands (32 erosion locations, each location graded from 0 [no erosion] to 5 [maximum severity], sum of grading of each location resulted in score of 0 to 160); and b) feet (12 erosion locations, each location graded from 0 [no erosion] to 10 [maximum severity], sum of grading of each location resulted in score of 0 to 120). Sum of erosion scores of hand (0 to 160) and feet (0 to 120) gave a total erosion score as 0 to 280, where 0 was no erosion at all and 280 was worst possible condition, higher scores indicated severe joint destruction. | Efficacy analysis set included participants who received at least 1 dose of Etanercept and had Rx1 and Rx2 or had Rx1 and Rx3. Here, "Overall Number of Participants Analyzed" = number of participants evaluable for this outcome measure and "Number Analyzed" = number of participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 78, 156 |
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| Secondary | Change From Baseline in Total Joint Space Narrow Score at End of Phase 1 (Week 78) and Phase 2 (Week 156) | Total joint space narrow score as per van der Hejde method consisted of 2 dimensions: a) hands (30 joint space locations, each location graded from 0 [normal joint space] to 4 [bony ankylosis], sum of grading of each location resulted in score of 0 to 120); and b) feet (12 erosion locations, each location graded from 0 [no erosion] to 4 [bony ankylosis], sum of grading of each location resulted in score of 0 to 48). Sum of joint space narrow scores of hand (0 to 120) and feet (0 to 48) gave a total joint space narrow score as 0 to 168, where 0 was normal joint space and 168 was maximum narrowing in joints, higher scores indicated severe joint destruction. | Efficacy analysis set included participants who received at least 1 dose of Etanercept and had Rx1 and Rx2 or have Rx1 and Rx3. Here, "Overall Number of Participants Analyzed" = number of participants evaluable for this outcome measure and "Number Analyzed" = number of participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 78, 156 |
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| Secondary | Change From Baseline in Hannover Functional Ability Questionnaire (FFbH) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | FFbH is a self-administered patient questionnaire composed by 18 questions on functional ability in activities of daily living. Each question was answered by the participant as "Yes, I can perform the activity without difficulty" (score assigned =2), "Yes, but with difficulties" (score assigned =1) and "No or only with external help" (score assigned =0). Final FFbH score (%) was then computed according to formula: (Sum of scores*100) divided by (2*number of valid answers), ranging between 0 (no functional capacity) to 100 (full functional capacity); higher scores indicate better daily activities. FFbH functional remission was defined as FFbH functional capacity of >= 83%. | Full analysis set included all participants who received at least 1 dose of Etanercept and had at least 1 effectiveness measurement after start of treatment. Here, "Number Analyzed" signifies number of participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156 |
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| Secondary | Change From Baseline in Disease Activity Score-28 (DAS-28) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | DAS28 was calculated from swollen joint count and tender joint count using 28 joint count, C-reactive protein (CRP) in milligram per liter (mg/L) and participant global assessment (PtGA) of disease activity measured on a 100 mm visual analog scale (VAS) ranging from 0 (good condition) to 100 (worst condition), where higher scores indicate worse health condition). DAS28 total score range: 0 (no disease activity) to 9.4 (maximum disease activity), higher score indicates more disease activity. DAS-28 score of 2.6 to 3.2= low, 3.2 to 5.1= moderate and >5.1= high disease activity. DAS-28 score of <2.6= disease remission. DAS28-4(CRP) = (0.56*sqrt[TJC28] + 0.28*sqrt[SJC28] + 0.36*ln[CRP+1]) + 0.014*GH + 0.96) and DAS28-4(ESR) = (0.56*sqrt[TJC28] + 0.28*sqrt[SJC28] + 0.70*ln[ESR] + 0.014*GH), where sqrt = square root, ln = natural logarithm. | Full analysis set included all participants who received at least 1 dose of Etanercept and had at least 1 effectiveness measurement after start of treatment. Here, "Number Analyzed" signifies number of participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156 |
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| Secondary | Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Rheumatoid Arthritis | CDAI was calculated from tender and swollen joints using 28 joint count, participant global assessment (PtGA) and physician global assessment (PhyGA). PtGA and PhyGA both were assessed on 0-100 mm VAS scale, where higher scores indicated greater affection due to disease activity. CDAI total score ranged from 0 to 76, where higher scores indicated higher disease activity. CDAI score of <=10 indicates low disease activity and a score of <= 2.8 indicates remission. | Full analysis set: all participants who received at least 1 dose of Etanercept and had at least 1 effectiveness measurement after start of treatment. "Number Analyzed" = number of participants evaluable for the specified time points. Data for this outcome measure was to be collected and evaluated only for participants with rheumatoid arthritis. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156 |
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| Secondary | Change From Baseline in Simple Disease Activity Index (SDAI) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Rheumatoid Arthritis | SDAI was calculated from tender and swollen joints using 28 joint count, participant global assessment (PtGA), physician global assessment and (PhyGA) and CRP (in mg/L). PtGA and PhyGA both were assessed on 0-100 mm VAS scale, where higher scores indicated greater affection due to disease activity. SDAI total score ranged from 0 to 86, where higher scores indicated higher disease activity. SDAI score of <=11 indicates low disease activity and a score of <=3.3 indicates remission. | Full analysis set: all participants who received at least 1 dose of Etanercept and had at least 1 effectiveness measurement after start of treatment. "Number Analyzed" = number of participants evaluable for the specified time points. Data for this outcome measure was to be collected and evaluated only for participants with rheumatoid arthritis. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156 |
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| Secondary | Percentage of Participants With Rheumatoid Arthritis, With Low Disease Activity Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) | CDAI was calculated from tender and swollen joints using 28 joint count, PtGA and PhyGA. CDAI total score ranged from 0 to 76, where higher scores indicated higher disease activity. CDAI score of <=10 indicates low disease activity and a score of <= 2.8 indicates remission. SDAI was calculated from tender and swollen joints using 28 joint count, PtGA, PhyGA and CRP (in mg/L). SDAI total score ranged from 0 to 86, where higher scores indicated higher disease activity. SDAI score of <=11 indicates low disease activity and a score of <=3.3 indicates remission. PtGA and PhyGA both were assessed on 0-100 mm VAS scale, where higher scores indicated greater affection due to disease activity. | Full analysis set: all participants who received at least 1 dose of Etanercept and had at least 1 effectiveness measurement after start of treatment. "Number Analyzed" = number of participants evaluable for the specified time points. Data for this outcome measure was to be collected and evaluated only for participants with rheumatoid arthritis. | Posted | Number | Percentage of participants | Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156 |
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| Secondary | Percentage of Participants With Rheumatoid Arthritis, With Remission Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) | CDAI was calculated from tender and swollen joints using 28 joint count, PtGA and PhyGA. CDAI total score ranged from 0 to 76, where higher scores indicated higher disease activity. CDAI score of <=10 indicates low disease activity and a score of <= 2.8 indicates remission. SDAI was calculated from tender and swollen joints using 28 joint count, PtGA, PhyGA and CRP (in mg/L). SDAI total score ranged from 0 to 86, where higher scores indicated higher disease activity. SDAI score of <=11 indicates low disease activity and a score of <=3.3 indicates remission. PtGA and PhyGA both were assessed on 0-100 mm VAS scale, where higher scores indicated greater affection due to disease activity. | Full analysis set. Here, "Overall Number of Participants Analyzed" = number of participants evaluable for this outcome measure and "Number Analyzed" = number of participants evaluable for the specified time points. Data for this outcome measure was to be collected and evaluated only for participants with rheumatoid arthritis. | Posted | Number | Percentage of participants | Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156 |
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| Secondary | Change From Baseline in Participant Pain Visual Analogue Scale (VAS) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | VAS: participants placed a mark indicating the intensity of their pain on a scale of 0 (no pain) to 100 mm (worst possible pain). Higher scores indicate greater level of pain. | Full analysis set included all participants who received at least 1 dose of Etanercept and had at least 1 effectiveness measurement after start of treatment. Here, "Number Analyzed" signifies number of participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | millimeter | Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156 |
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| Secondary | Change From Baseline in Physician Global Assessment (PhyGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | PhyGA: physician marked intensity of participants' pain on a visual analogue scale of 0 (no disease activity) to 100 mm (worst possible condition). Higher scores indicate greater level of disease activity. | Full analysis set included all participants who received at least 1 dose of Etanercept and had at least 1 effectiveness measurement after start of treatment. Here, "Number Analyzed" signifies number of participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | millimeter | Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156 |
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| Secondary | Change From Baseline in Participant Global Assessment (PtGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | PtGA: participant assessed their disease activity using a 100 mm visual analog scale ranging from 0 = very good to 100 = worst. Higher scores indicate worse health status. | Full analysis set included all participants who received at least 1 dose of Etanercept and had at least 1 effectiveness measurement after start of treatment. Here, "Number Analyzed" signifies number of participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | millimeter | Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156 |
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| Secondary | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | EQ-5D: participant rated questionnaire to assess generic health status in two parts: single utility score and visual analog scale. For utility score, participants rated their current health state on 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression with each dimension having three levels of function: 1 indicates no problem; 2 indicates some problem; 3 indicates extreme problem. | Full analysis set included all participants who received at least 1 dose of Etanercept and had at least 1 effectiveness measurement after start of treatment. Here, "Number Analyzed" signifies number of participants evaluable for the specified rows. | Posted | Count of Participants | Participants | Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156 |
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| Secondary | Duration of Morning Stiffness in Participants With Temporary Rigidity | Rigidity was temporary when 'Yes' was given for the question if daily activities could be done without stiffness; rigidity was permanent when 'No' was given for the question if daily activities could be done without stiffness. | Full analysis set included all participants who received at least 1 dose of Etanercept and had at least 1 effectiveness measurement after start of treatment. Here, "Number Analyzed" signifies number of participants evaluable for the specified time points. | Posted | Median | Full Range | Hours | Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156 |
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| Secondary | Number of Participants Categorized in Different Classes Depending Upon Percentage of Body Surface Area (BSA) Affected by Psoriatic Arthritis | Participants with psoriatic arthritis were distributed in following different classes depending upon percentage (%) of BSA affected: 1) less than (<) 3 %, 2) 3-10%, 3) 11-20% and 4) >20%. Psoriatic arthritis affecting <3% BSA was considered as mild, 3 to 10 % as moderate and >10 percent as severe. | Full analysis set. Here, "Number Analyzed" signifies number of participants evaluable for the specified time points. Data for this outcome measure was to be collected and evaluated only for participants with psoriatic arthritis. | Posted | Count of Participants | Participants | Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156 |
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| Secondary | Change From Baseline in Nail Involvement at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Psoriatic Arthritis | In this outcome measure change in number of nails affected by psoriatic arthritis at specified week compared to baseline is reported. Nails included both finger nails and toe nails. | Full analysis set. Here, "Number Analyzed" signifies number of participants evaluable for the specified time points. Data for this outcome measure was to be collected and evaluated only for participants with psoriatic arthritis. | Posted | Mean | Standard Deviation | Nails | Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156 |
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| Secondary | Change From Baseline in Inflamed Dactylitic Digits at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Psoriatic Arthritis | In this outcome measure change in number of inflamed dactylitic digits at specified week compared to baseline is reported. Dactylitis is inflammation of dactylitic digits (fingers and toes). | Full analysis set. Here, "Number Analyzed" signifies number of participants evaluable for the specified time points. Data for this outcome measure was to be collected and evaluated only for participants with psoriatic arthritis. | Posted | Mean | Standard Deviation | Dactylitic digits | Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156 |
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| Secondary | Number of Participants With Use of Glucocorticoids and Disease Modifying Antirheumatic Drugs (DMARDs) Baseline Versus Phase 1 (Week 78) and Baseline Versus Phase 2 (Week 156) | In this outcome measure number of participants with use of glucocorticoids and DMARDs at baseline and specified weeks are reported. If participants used glucocorticoids and DMARDs, it was denoted by "Yes" and if they did not use, it was denoted by "No". Data have been reported separately for glucocorticoids and DMARDs at specified weeks respectively, in 4 categories as: 1) Baseline: No and Specified Week: No, 2) Baseline: Yes and Specified Week: No, 3) Baseline: No and Specified Week: Yes, 4) Baseline: Yes and Specified Week: Yes. | Full analysis set included all participants who received at least 1 dose of Etanercept and had at least 1 effectiveness measurement after start of treatment. Here, "Number Analyzed" = number of participants evaluable for the specified rows. | Posted | Count of Participants | Participants | Baseline, Week 78, 156 |
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| Secondary | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Continuation of Treatment With Etanercept | In this outcome number of participants who participated or not participated in RUDI and PIT and impact of their participation in continuation or termination of treatment with Etanercept is reported. For participants whom data was not recorded is reported under category "No Data". | Full analysis set included all participants who received at least 1 dose of Etanercept and had at least 1 effectiveness measurement after start of treatment. Here, "Overall Number of participants analyzed" = number of participants evaluable for this measure and "Number Analyzed" = number of participants evaluable for the specified rows. | Posted | Count of Participants | Participants | Baseline up to Week 156 |
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| Secondary | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | In this outcome number of participants who participated or not participated in RUDI and PIT and impact of their participation in quality of life parameters using EQ-5D health questionnaire is reported. For participants whom data was not recorded is reported under category "No Data". EQ-5D: participant rated questionnaire to assess generic health status in two parts: single utility score and visual analog scale. For utility score, participants rated their current health state on 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression with each dimension having three levels of function: 1 indicates no problem; 2 indicates some problem; 3 indicates extreme problem. | Full analysis set included all participants who received at least 1 dose of Etanercept and had at least 1 effectiveness measurement after start of treatment. Here, "Overall Number of participants analyzed" = number of participants evaluable for this measure and "Number Analyzed" = number of participants evaluable for the specified rows. | Posted | Count of Participants | Participants | Baseline up to Week 156 |
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| Other Pre-specified | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Treatment-Emergent Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events. | Safety analysis set included all patients who received at least 1 dose of Etanercept. | Posted | Count of Participants | Participants | Baseline up to Week 156 |
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| Other Pre-specified | Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events. AEs were classified according to the severity in 3 categories a)mild: AEs not interfered with participant's usual function b)moderate: AEs interfered to some extent with participant's usual function c)severe: AEs interfered significantly with participant's usual function. Participants may be counted in more than 1 category. | Safety analysis set included all patients who received at least 1 dose of Etanercept. Here, "Overall Number of Participants Analyzed" signifies number of participants who had at least 1 treatment AE. | Posted | Count of Participants | Participants | Baseline up to Week 156 |
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| Other Pre-specified | Number of Participants With Discontinuation of Etanercept Treatment | Number of participants those who discontinued Etanercept treatment at Week 78 and 156 are reported in this outcome measure. | Safety analysis set included all patients who received at least 1 dose of Etanercept. Here, "Number Analyzed" signifies number of participants evaluable for specified time points. | Posted | Count of Participants | Participants | Week 78, 156 |
|
|
|
| Other Pre-specified | Number of Participants With Treatment-Emergent Treatment Related Adverse Events | Treatment-related AE was any untoward medical occurrence in a participant who received study drug. 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. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events. Relatedness to study treatment was assessed by the investigator. | Safety analysis set included all patients who received at least 1 dose of Etanercept. Here, "Overall Number of Participants Analyzed" signifies number of participants who had at least 1 treatment AE. | Posted | Count of Participants | Participants | Baseline up to Week 156 |
|
|
|
| Other Pre-specified | Number of Participants With Results of Tolerability Assessment by Physician and Participant | Physicians and participants rated the tolerability of Etanercept treatment by means of a 4-point scale as: 1) very good, 2) good, 3) moderate and 4) insufficient. | Safety analysis set included all patients who received at least 1 dose of Etanercept. Here, "Number Analyzed" signifies number of participants evaluable for specified rows. | Posted | Count of Participants | Participants | Week 78, 156 |
|
|
|
| Other Pre-specified | Number of Participants With Pregnancy, Puerperium and Perinatal Conditions | In this outcome measure total number of participants with pregnancy, puerperium and perinatal conditions are reported. Pregnancy, puerperium and perinatal conditions included pregnancy, abortion, abortion spontaneous or premature baby. | Safety analysis set included all patients who received at least 1 dose of Etanercept. | Posted | Count of Participants | Participants | Baseline up to Week 156 |
|
|
|
| Other Pre-specified | Number of Participants Who Used Concomitant Medication | Number of participants who used medication other than Etanercept for relief of pain. It was determined by the treating physician. | Safety analysis set included all patients who received at least 1 dose of Etanercept. | Posted | Count of Participants | Participants | Baseline up to Week 156 |
|
|
|
| 6 |
| 1,378 |
| 159 |
| 1,378 |
| 579 |
| 1,378 |
| EG001 | Participants With Psoriatic Arthritis | Participants with psoriatic arthritis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156. | 0 | 440 | 47 | 440 | 167 | 440 |
| EG002 | Participants With Unclear Diagnosis | Participants with unclear diagnosis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156. | 0 | 3 | 0 | 3 | 1 | 3 |
| Acute myocardial infarction | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Trisomy 8 | Congenital, familial and genetic disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Vertigo positional | Ear and labyrinth disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Hearing impaired | Ear and labyrinth disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Hypoacusis | Ear and labyrinth disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Vestibular disorder | Ear and labyrinth disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Macular hole | Eye disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Abdominal adhesions | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Crohn's disease | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Gastrointestinal necrosis | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Oesophageal ulcer haemorrhage | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Rectal polyp | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Condition aggravated | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Disease progression | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Death | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Disease recurrence | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Drug ineffective | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Medical device complication | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Necrosis | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Autoimmune hepatitis | Hepatobiliary disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Hepatotoxicity | Hepatobiliary disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Abscess | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Osteomyelitis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Abscess oral | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Acute tonsillitis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Arteriosclerotic gangrene | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Arthritis bacterial | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Bursitis infective | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Endocarditis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Febrile infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Intervertebral discitis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Lobar pneumonia | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Sinusitis aspergillus | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Staphylococcal skin infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Animal bite | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Comminuted fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Fractured coccyx | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Impacted fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Patella fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Pneumothorax traumatic | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Poisoning | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Skull fractured base | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Sternal fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Venous injury | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Blood pressure abnormal | Investigations | MedDRA 17.0 | Non-systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA 17.0 | Non-systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
|
| Weight increased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Obesity | Metabolism and nutrition disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Facet joint syndrome | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Loose body in joint | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Meniscal degeneration | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Metatarsalgia | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Neuropathic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Spinal disorder | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Non-systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Non-systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Non-systematic Assessment |
|
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Non-systematic Assessment |
|
| Benign lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Non-systematic Assessment |
|
| Breast cancer female | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Non-systematic Assessment |
|
| Bronchial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Non-systematic Assessment |
|
| Chest wall tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Non-systematic Assessment |
|
| Colon adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Non-systematic Assessment |
|
| Lentigo maligna | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Non-systematic Assessment |
|
| Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Non-systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Non-systematic Assessment |
|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Non-systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Non-systematic Assessment |
|
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Non-systematic Assessment |
|
| Renal oncocytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Non-systematic Assessment |
|
| Thyroid neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Non-systematic Assessment |
|
| Warty dyskeratoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Non-systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Facial paresis | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Akathisia | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Borderline mental impairment | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Carotid artery stenosis | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Clinically isolated syndrome | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Abortion | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Non-systematic Assessment |
|
| Cubital tunnel syndrome | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Non-systematic Assessment |
|
| Depressed level of consciousness | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Premature baby | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Non-systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Meralgia paraesthetica | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Nerve compression | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Neuritis | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Polyneuropathy | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Tension headache | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Vascular encephalopathy | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Nephritis | Renal and urinary disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Prerenal failure | Renal and urinary disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Renal cyst | Renal and urinary disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Uterine prolapse | Reproductive system and breast disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Nasal septum deviation | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Pneumothorax spontaneous | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Pulmonary sarcoidosis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Pulmonary vein occlusion | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Pyoderma gangrenosum | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Subcutaneous emphysema | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Arthrodesis | Surgical and medical procedures | MedDRA 17.0 | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Shock haemorrhagic | Vascular disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Thrombophlebitis | Vascular disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Bicytopenia | Blood and lymphatic system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Cardiovascular disorder | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Cyanosis | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Vertigo positional | Ear and labyrinth disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Vestibular disorder | Ear and labyrinth disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Goitre | Endocrine disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Scleritis | Eye disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Uveitis | Eye disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Chalazion | Eye disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Corneal disorder | Eye disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Episcleritis | Eye disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Erythema of eyelid | Eye disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Eye inflammation | Eye disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Iridocyclitis | Eye disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Keratitis | Eye disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Macular degeneration | Eye disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Vitreous haemorrhage | Eye disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Biliary colic | Hepatobiliary disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Hepatitis cholestatic | Hepatobiliary disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Atopy | Immune system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Iron deficiency | Metabolism and nutrition disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Vitamin B12 deficiency | Metabolism and nutrition disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Cystitis noninfective | Renal and urinary disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Nocturia | Renal and urinary disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Obstructive uropathy | Renal and urinary disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Breast cyst | Reproductive system and breast disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Breast pain | Reproductive system and breast disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Menstrual discomfort | Reproductive system and breast disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Vaginal inflammation | Reproductive system and breast disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Gingival ulceration | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Drug ineffective | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Injection site hypersensitivity | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Condition aggravated | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Local swelling | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Cyst | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Injection site dermatitis | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Injection site rash | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Injection site urticaria | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Swelling | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Impaired healing | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Injection site discomfort | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Local reaction | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Administration site reaction | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Adverse drug reaction | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Face oedema | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Feeling cold | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Injection site irritation | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Injection site vesicles | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Instillation site reaction | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Mucosal dryness | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Performance status decreased | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Erythema migrans | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Gastrointestinal infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Pulpitis dental | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Rash pustular | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Abscess | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Acute tonsillitis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Gastrointestinal viral infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Herpes virus infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Periodontitis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Abdominal wall abscess | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Abscess limb | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Abscess neck | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Abscess oral | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Adenoviral hepatitis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Bacterial infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Borrelia infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Cytomegalovirus infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Dental fistula | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Febrile infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Gastric infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Hand-foot-and-mouth disease | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Infection susceptibility increased | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Latent tuberculosis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Mastoiditis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Oesophageal candidiasis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Oral infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Respiratory tract infection viral | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Salpingo-oophoritis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Tracheobronchitis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Vaginal infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Vulvovaginal candidiasis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Epicondylitis | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Dislocation of vertebra | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Face injury | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Ligament injury | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Maternal exposure during pregnancy | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Patella fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Pneumoconiosis | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Post procedural fistula | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Skin injury | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Vaccination complication | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA 17.0 | Non-systematic Assessment |
|
| Red blood cell sedimentation rate increased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
|
| Arthroscopy | Investigations | MedDRA 17.0 | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
|
| Weight increased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
|
| Activated partial thromboplastin time prolonged | Investigations | MedDRA 17.0 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
|
| Biopsy liver | Investigations | MedDRA 17.0 | Non-systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
|
| Blood pressure abnormal | Investigations | MedDRA 17.0 | Non-systematic Assessment |
|
| Bone scan abnormal | Investigations | MedDRA 17.0 | Non-systematic Assessment |
|
| C-reactive protein | Investigations | MedDRA 17.0 | Non-systematic Assessment |
|
| Gamma-glutamyltransferase abnormal | Investigations | MedDRA 17.0 | Non-systematic Assessment |
|
| Glycosylated haemoglobin increased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
|
| Lymphoblast morphology abnormal | Investigations | MedDRA 17.0 | Non-systematic Assessment |
|
| Radioisotope scan | Investigations | MedDRA 17.0 | Non-systematic Assessment |
|
| Respiratory rate increased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Rheumatic disorder | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Osteoporotic fracture | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Sjogren's syndrome | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Dactylitis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Polyarthritis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Rheumatic fever | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Jaw cyst | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Mobility decreased | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Rheumatoid nodule | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Sacroiliitis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Seronegative arthritis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Soft tissue disorder | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Spondylitis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Trigger finger | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Thyroid neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Non-systematic Assessment |
|
| Benign neoplasm of prostate | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Non-systematic Assessment |
|
| Chronic lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Non-systematic Assessment |
|
| Fibroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Non-systematic Assessment |
|
| Leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Non-systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Non-systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Restless legs syndrome | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Hypertonia | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Cervicobrachial syndrome | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Morton's neuralgia | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Polyneuropathy | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Radiculopathy | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Tension headache | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Restlessness | Psychiatric disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Aggression | Psychiatric disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Bipolar I disorder | Psychiatric disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Depressed mood | Psychiatric disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Disorientation | Psychiatric disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Emotional distress | Psychiatric disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Irritability | Psychiatric disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Listless | Psychiatric disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Panic attack | Psychiatric disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Alveolitis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Nasal disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Nasal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Pulmonary infarction | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Sinus disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Pustular psoriasis | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Skin reaction | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Cutaneous vasculitis | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Erythema nodosum | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Leukoplakia | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Onycholysis | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Pigmentation disorder | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Rosacea | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Skin burning sensation | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Cataract operation | Surgical and medical procedures | MedDRA 17.0 | Non-systematic Assessment |
|
| Dental operation | Surgical and medical procedures | MedDRA 17.0 | Non-systematic Assessment |
|
| Joint injection | Surgical and medical procedures | MedDRA 17.0 | Non-systematic Assessment |
|
| Surgery | Surgical and medical procedures | MedDRA 17.0 | Non-systematic Assessment |
|
| Synovectomy | Surgical and medical procedures | MedDRA 17.0 | Non-systematic Assessment |
|
| Tooth extraction | Surgical and medical procedures | MedDRA 17.0 | Non-systematic Assessment |
|
| Wound treatment | Surgical and medical procedures | MedDRA 17.0 | Non-systematic Assessment |
|
| Bunion operation | Surgical and medical procedures | MedDRA 17.0 | Non-systematic Assessment |
|
| Carpal tunnel decompression | Surgical and medical procedures | MedDRA 17.0 | Non-systematic Assessment |
|
| Cyst removal | Surgical and medical procedures | MedDRA 17.0 | Non-systematic Assessment |
|
| Dental implantation | Surgical and medical procedures | MedDRA 17.0 | Non-systematic Assessment |
|
| Elbow operation | Surgical and medical procedures | MedDRA 17.0 | Non-systematic Assessment |
|
| Endodontic procedure | Surgical and medical procedures | MedDRA 17.0 | Non-systematic Assessment |
|
| Glaucoma surgery | Surgical and medical procedures | MedDRA 17.0 | Non-systematic Assessment |
|
| Hernia repair | Surgical and medical procedures | MedDRA 17.0 | Non-systematic Assessment |
|
| Hip arthroplasty | Surgical and medical procedures | MedDRA 17.0 | Non-systematic Assessment |
|
| Inguinal hernia repair | Surgical and medical procedures | MedDRA 17.0 | Non-systematic Assessment |
|
| Joint surgery | Surgical and medical procedures | MedDRA 17.0 | Non-systematic Assessment |
|
| Knee arthroplasty | Surgical and medical procedures | MedDRA 17.0 | Non-systematic Assessment |
|
| Lens extraction | Surgical and medical procedures | MedDRA 17.0 | Non-systematic Assessment |
|
| Polypectomy | Surgical and medical procedures | MedDRA 17.0 | Non-systematic Assessment |
|
| Rehabilitation therapy | Surgical and medical procedures | MedDRA 17.0 | Non-systematic Assessment |
|
| Removal of internal fixation | Surgical and medical procedures | MedDRA 17.0 | Non-systematic Assessment |
|
| Rheumatoid nodule removal | Surgical and medical procedures | MedDRA 17.0 | Non-systematic Assessment |
|
| Skin neoplasm excision | Surgical and medical procedures | MedDRA 17.0 | Non-systematic Assessment |
|
| Synoviorthesis | Surgical and medical procedures | MedDRA 17.0 | Non-systematic Assessment |
|
| Tendon operation | Surgical and medical procedures | MedDRA 17.0 | Non-systematic Assessment |
|
| Tonsillectomy | Surgical and medical procedures | MedDRA 17.0 | Non-systematic Assessment |
|
| Wisdom teeth removal | Surgical and medical procedures | MedDRA 17.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Venous thrombosis | Vascular disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Arterial stenosis | Vascular disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Intra-abdominal haematoma | Vascular disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Labile hypertension | Vascular disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Lymphoedema | Vascular disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Peripheral vascular disorder | Vascular disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Thrombophlebitis | Vascular disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Varicose vein | Vascular disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Anal fissure | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Crohn's disease | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Duodenitis | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Haemorrhoids thrombosed | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Lumbar hernia | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Retching | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Tooth disorder | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Tooth loss | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Bursitis infective | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Chronic sinusitis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Essential hypertension | Vascular disorders | MedDRA 17.0 | 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.
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| 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 |
| 18 to 64 years |
|
| 65 years or more |
|
| No data |
|
| Male |
|
| No Data |
|
| Change at Week 78 |
|
|
| Change at Week 78 |
|
|
| 0.222 |
| Other |
| Change at Week 78 |
|
|
| 0.218 |
| Other |
| Other |
| ACPA or RF positive |
|
|
| ACPA and RF positive |
|
|
| 0.181 |
| Other |
| Concomitant Medication at baseline: No |
|
|
| 0.969 |
| Other |
| No previous treatment with biologics |
|
|
| 0.386 |
| Other |
| Baseline DAS-28 > 5.1 |
|
|
| 0.849 |
| Other |
| Change at Week 78 |
|
|
| Change at Week 156 |
|
|
| Change at Week 78 |
|
|
| Change at Week 156 |
|
|
| Change at Week 13 |
|
|
| Change at Week 26 |
|
|
| Change at Week 39 |
|
|
| Change at Week 52 |
|
|
| Change at Week 65 |
|
|
| Change at Week 78 |
|
|
| Change at Week 104 |
|
|
| Change at Week 130 |
|
|
| Change at Week 156 |
|
|
| Change at Week 13 |
|
|
| Change at Week 26 |
|
|
| Change at Week 39 |
|
|
| Change at Week 52 |
|
|
| Change at Week 65 |
|
|
| Change at Week 78 |
|
|
| Change at Week 104 |
|
|
| Change at Week 130 |
|
|
| Change at Week 156 |
|
|
|
| Change at Week 26 |
|
|
| Change at Week 39 |
|
|
| Change at Week 52 |
|
|
| Change at Week 65 |
|
|
| Change at Week 78 |
|
|
| Change at Week 104 |
|
|
| Change at Week 130 |
|
|
| Change at Week 156 |
|
|
|
| Change at Week 26 |
|
|
| Change at Week 39 |
|
|
| Change at Week 52 |
|
|
| Change at Week 65 |
|
|
| Change at Week 78 |
|
|
| Change at Week 103 |
|
|
| Change at Week 130 |
|
|
| Change at Week 156 |
|
|
|
| Week 26: CDAI |
|
|
| Week 39: CDAI |
|
|
| Week 52: CDAI |
|
|
| Week 65: CDAI |
|
|
| Week 78: CDAI |
|
|
| Week 103: CDAI |
|
|
| Week 130: CDAI |
|
|
| Week 165: CDAI |
|
|
| Baseline: SDAI |
|
|
| Week 13: SDAI |
|
|
| Week 26: SDAI |
|
|
| Week 39: SDAI |
|
|
| Week 52: SDAI |
|
|
| Week 65: SDAI |
|
|
| Week 78: SDAI |
|
|
| Week 103: SDAI |
|
|
| Week 130: SDAI |
|
|
| Week 165: SDAI |
|
|
|
| Week 26: CDAI |
|
|
| Week 39: CDAI |
|
|
| Week 52: CDAI |
|
|
| Week 65: CDAI |
|
|
| Week 78: CDAI |
|
|
| Week 103: CDAI |
|
|
| Week 130: CDAI |
|
|
| Week 165: CDAI |
|
|
| Baseline: SDAI |
|
|
| Week 13: SDAI |
|
|
| Week 26: SDAI |
|
|
| Week 39: SDAI |
|
|
| Week 52: SDAI |
|
|
| Week 65: SDAI |
|
|
| Week 78: SDAI |
|
|
| Week 103: SDAI |
|
|
| Week 130: SDAI |
|
|
| Week 165: SDAI |
|
|
| Change at Week 13 |
|
|
| Change at Week 26 |
|
|
| Change at Week 39 |
|
|
| Change at Week 52 |
|
|
| Change at Week 65 |
|
|
| Change at Week 78 |
|
|
| Change at Week 104 |
|
|
| Change at Week 130 |
|
|
| Change at Week 156 |
|
|
| Change at Week 13 |
|
|
| Change at Week 26 |
|
|
| Change at Week 39 |
|
|
| Change at Week 52 |
|
|
| Change at Week 65 |
|
|
| Change at Week 78 |
|
|
| Change at Week 104 |
|
|
| Change at Week 130 |
|
|
| Change at Week 156 |
|
|
| Change at Week 13 |
|
|
| Change at Week 26 |
|
|
| Change at Week 39 |
|
|
| Change at Week 52 |
|
|
| Change at Week 65 |
|
|
| Change at Week 78 |
|
|
| Change at Week 104 |
|
|
| Change at Week 130 |
|
|
| Change at Week 156 |
|
|
| Some problems |
|
| Extreme problems |
|
| No data |
|
| Baseline: Self-care |
|
|
| Baseline: Usual Activities |
|
|
| Baseline: Pain/Discomfort |
|
|
| Baseline: Anxiety/Depression |
|
|
| Week 13: Mobility |
|
|
| Week 13: Self-care |
|
|
| Week 13: Usual Activities |
|
|
| Week 13: Pain/Discomfort |
|
|
| Week 13:Anxiety/ Depression |
|
|
| Week 26: Mobility |
|
|
| Week 26: Self-care |
|
|
| Week 26: Usual Activities |
|
|
| Week 26: Pain/Discomfort |
|
|
| Week 26: Anxiety/Depression |
|
|
| Week 39: Mobility |
|
|
| Week 39: Self-care |
|
|
| Week 39: Usual Activities |
|
|
| Week 39: Pain/Discomfort |
|
|
| Week 39: Anxiety/ Depression |
|
|
| Week 52: Mobility |
|
|
| Week 52: Self-care |
|
|
| Week 52: Usual Activities |
|
|
| Week 52: Pain/Discomfort |
|
|
| Week 52: Anxiety/Depression |
|
|
| Week 65: Mobility |
|
|
| Week 65: Self-care |
|
|
| Week 65: Usual Activities |
|
|
| Week 65: Pain/Discomfort |
|
|
| Week 65: Anxiety/ Depression |
|
|
| Week 78: Mobility |
|
|
| Week 78: Self-care |
|
|
| Week 78: Usual Activities |
|
|
| Week 78: Pain/Discomfort |
|
|
| Week 78: Anxiety/Depression |
|
|
| Week 104: Mobility |
|
|
| Week 104: Self-care |
|
|
| Week 104: Usual Activities |
|
|
| Week 104: Pain/Discomfort |
|
|
| Week 104: Anxiety/ Depression |
|
|
| Week 130: Mobility |
|
|
| Week 130: Self-care |
|
|
| Week 130: Usual Activities |
|
|
| Week 130: Pain/Discomfort |
|
|
| Week 130: Anxiety/Depression |
|
|
| Week 156: Mobility |
|
|
| Week 156: Self-care |
|
|
| Week 156: Usual Activities |
|
|
| Week 156: Pain/Discomfort |
|
|
| Week 156: Anxiety/ Depression |
|
|
| Week 13 |
|
|
| Week 26 |
|
|
| Week 39 |
|
|
| Week 52 |
|
|
| Week 65 |
|
|
| Week 78 |
|
|
| Week 104 |
|
|
| Week 130 |
|
|
| Week 156 |
|
|
| 11-20% |
|
| >20% |
|
| Week 13 |
|
|
| Week 26 |
|
|
| Week 39 |
|
|
| Week 52 |
|
|
| Week 65 |
|
|
| Week 78 |
|
|
| Week 104 |
|
|
| Week 130 |
|
|
| Week 156 |
|
|
|
| Change at Week 26 |
|
|
| Change at Week 39 |
|
|
| Change at Week 52 |
|
|
| Change at Week 65 |
|
|
| Change at Week 78 |
|
|
| Change at Week 104 |
|
|
| Change at Week 130 |
|
|
| Change at Week 156 |
|
|
|
| Change at Week 26 |
|
|
| Change at Week 39 |
|
|
| Change at Week 52 |
|
|
| Change at Week 65 |
|
|
| Change at Week 78 |
|
|
| Change at Week 104 |
|
|
| Change at Week 130 |
|
|
| Change at Week 156 |
|
|
| Baseline: Yes and Specified Week: No |
|
| Baseline: No and Specified Week: Yes |
|
| Baseline: Yes and Specified Week: Yes |
|
| DMARDs Usage Baseline Versus Week 78 |
|
|
| Glucocorticoids Usage Baseline Versus Week 156 |
|
|
| DMARDs Usage Baseline Versus Week 156 |
|
|
| Treatment Terminated |
|
| No Data |
|
| Rudi and PIT= No |
|
|
| Some problems |
|
| Extreme problem |
|
| No data |
|
| Rudi and PIT= No: Mobility |
|
|
| Rudi and PIT= Yes: Self-care |
|
|
| Rudi and PIT= No: Self-care |
|
|
| Rudi and PIT= Yes: Usual Activities |
|
|
| Rudi and PIT= No: Usual Activities |
|
|
| Rudi and PIT= Yes: Pain/Discomfort |
|
|
| Rudi and PIT= No: Pain/Discomfort |
|
|
| Rudi and PIT= Yes: Anxiety/Depression |
|
|
| Rudi and PIT= No: Anxiety/Depression |
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Severe |
|
| No Data |
|
| Week 156 |
|
|
| Good |
|
| Moderate |
|
| Insufficient |
|
| Week 78: Participant Assessment |
|
|
| Week 156: Physician Assessment |
|
|
| Week 156: Participant Assessment |
|
|