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| ID | Type | Description | Link |
|---|---|---|---|
| B1801121 |
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The diagnosis, evaluation and treatment of rheumatoid arthritis (RA) continue to undergo rapid change. Randomized controlled trials such as the TEMPO study have demonstrated the efficacy and safety of the combination of etanercept and methotrexate. Importantly, the TEMPO study showed that patients treated with etanercept and methotrexate could reach the newer therapeutic goals of low disease activity and remission, and that the physicians, patients, and payers are no longer prepared to accept the goal of "Reduction of symptoms". RCT are important and powerful tools in assessing efficacy and safety but have their limitations in terms of generalisability. In order to assess health economics, clinical effectiveness and safety of etanercept, they need to be measured by performing observational studies of unselected patients. This study aims to provide a holistic assessment of patients receiving etanercept in a real world setting. This will include centers that would not normally take part in RCT. The study will assess treatment with etanercept with descriptive statistics of the following parameters: Health economic, Safety, Effectiveness. In addition, there was a previous study of similar design, but of only 3 months duration (101354), which will allow comparison with historical data. Since previous study, there have been a number of significant changes: Introduction of a new formulation for etanercept (Enbrel® 50mg · once weekly), Definition of early RA has been modified to short disease duration (from 3 months to 1 year).
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 |
|
| 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 |
|---|---|---|
| Percentage of Participants Achieving Functional Remission Determined by Hannover Functional Ability Questionnaire (FFbH) at Week 26 | Hannover Functional Ability Questionnaire (FFbH) consists 18 questions to assess daily activities in last 7 days. Each question is answered by the participant as "Yes, I can perform the activity without difficulty" (score assigned = 2), "Yes, but with some difficulties" (score assigned = 1) and "No or only with help" (score assigned = 0). Final FFbH score (FFbH functional capacity) is then computed according to formula: (Sum of all single scores * 100% [percent]) / (2 * number of answered questions) ranging between 0-100; higher score indicates better daily activities. FFbH functional remission is defined as FFbH functional capacity of >= 83%. | Week 26 |
| Percentage of Participants Achieving Functional Remission Determined by Hannover Functional Ability Questionnaire (FFbH) at Week 52 | Hannover Functional Ability Questionnaire (FFbH) consists 18 questions to assess daily activities in last 7 days. Each question is answered by the participant as "Yes, I can perform the activity without difficulty" (score assigned = 2), "Yes, but with some difficulties" (score assigned = 1) and "No or only with help" (score assigned = 0). Final FFbH score (FFbH functional capacity) is then computed according to formula: (Sum of all single scores * 100%) / (2 * number of answered questions), ranging between 0-100; higher score indicates better daily activities. FFbH functional remission is defined as FFbH functional capacity of >= 83%. | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeter (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. | Baseline, Week 26, Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Low Disease Activity Determined by Disease Activity Score 28 Based on 28-joints Count (DAS 28) | DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and Patient global assessment of disease activity (recorded on a VAS of 0 mm [very good] to 100 mm [very bad]). Total score range: 0 to 10, higher score indicated more disease activity. DAS28 defined low disease activity was classified as a score of <=3.2. |
Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Münster | North Rhine-Westphalia | 48149 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29843776 | Derived | Druce KL, Aikman L, Dilleen M, Burden A, Szczypa P, Basu N. Fatigue independently predicts different work disability dimensions in etanercept-treated rheumatoid arthritis and ankylosing spondylitis patients. Arthritis Res Ther. 2018 May 29;20(1):96. doi: 10.1186/s13075-018-1598-8. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Etanercept | Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Safety population included all participants with available documentations.
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| ID | Title | Description |
|---|---|---|
| BG000 | Etanercept | Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Evaluable participants for this Baseline measure were 4868. |
| 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 | Percentage of Participants Achieving Functional Remission Determined by Hannover Functional Ability Questionnaire (FFbH) at Week 26 | Hannover Functional Ability Questionnaire (FFbH) consists 18 questions to assess daily activities in last 7 days. Each question is answered by the participant as "Yes, I can perform the activity without difficulty" (score assigned = 2), "Yes, but with some difficulties" (score assigned = 1) and "No or only with help" (score assigned = 0). Final FFbH score (FFbH functional capacity) is then computed according to formula: (Sum of all single scores * 100% [percent]) / (2 * number of answered questions) ranging between 0-100; higher score indicates better daily activities. FFbH functional remission is defined as FFbH functional capacity of >= 83%. | Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of rheumatoid arthritis, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 26 |
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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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 | Etanercept | Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.1 | Non-systematic Assessment |
Prioritization of endpoints as primary or secondary was not specified in protocol and was based on study team's inputs.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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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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|
| Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO) | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health state profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol group assigns a utility value for each domain in the profile. EQ-5D score is transformed to EQ-5D-TTO score ranging from -0.205 to 0.999; higher score indicates a better health state. | Baseline, Week 26, Week 52 |
| Work Productivity and Activity Impairment - Special Health Problems (WPAI:SHP) | WPAI:SHP is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to rheumatoid arthritis for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity. | Baseline, Week 26, Week 52 |
| Healthcare Resource Utilization | Participants' utilization of healthcare resources was evaluated as number of events for healthcare resources utilization including: number of visits to general practitioners, visits to rheumatologist, visits to other medical specialists, inpatient hospitalizations, inpatient rehabilitations, inpatient follow-up treatment, outpatient rehabilitations, physiotherapy, and other healthcare utilizations. At baseline, number of events for participants' healthcare resources utilization during last 12 months before enrollment into the study were documented. After enrollment, number of events for participants' healthcare resources utilization were documented for last 6 months after previous documentation. | Baseline, Week 26, Week 52 |
| Duration of Healthcare Resources Utilization | Participants' duration of healthcare resources utilization was evaluated as number of days for healthcare resources utilization including: duration of visits to general practitioners, to rheumatologist, to other medical specialists, inpatient hospitalizations, inpatient rehabilitations, inpatient follow-up treatment, outpatient rehabilitations, physiotherapy, and other healthcare utilizations. At baseline, number of days for participants' healthcare resources utilizations during last 12 months before enrollment into the study were documented. After enrollment, number of days for participants' healthcare resources utilization were documented for last 6 months after previous documentation. | Baseline, Week 26, Week 52 |
| Duration of Working Disability | Duration of working disability was assessed as number of days a participant was disable to work. Duration of work disability was considered as "0" if participant was not disable to work during period of assessment. At baseline, participants' duration of working disability during last 12 months before enrollment into the study was documented. After enrollment, participants' duration of working disability was documented for last 6 months after previous documentation. | Baseline, Week 26, Week 52 |
| Disease Activity Score Based on 28-Joints Count (DAS28) | DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and Patient global assessment of disease activity (recorded on a VAS of 0 mm [very good] to 100 mm [very bad]). Total score range: 0 to 10, higher score indicated more disease activity. DAS28 less than (<) 2.6 = remission, DAS28 less than or equal to (<=) 3.2 = low disease activity, DAS28 greater than or equal to (>=) 3.2 to <=5.1 = moderate disease activity, DAS28 greater than (>) 5.1 = high disease activity. | Baseline, Week 2, 6, 12, 26, 38, 52 |
| Swollen Joints Count (SJC) | Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. | Baseline, Week 2, 6, 12, 26, 38, 52 |
| Tender Joints Count (TJC) | Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. | Baseline, Week 2, 6, 12, 26, 38, 52 |
| Erythrocyte Sedimentation Rate (ESR) | ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hour. A higher rate is consistent with inflammation. | Baseline, Week 2, 6, 12, 26, 38, 52 |
| Percentage of Participants With Remission Determined by Disease Activity Score Based on 28-Joints Count (DAS 28) | DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and Patient global assessment of disease activity (recorded on a VAS of 0 mm [very good] to 100 mm [very bad]). Total score range: 0 to 10, higher score indicated more disease activity. DAS28 defined remission was classified as a score of <2.6. | Week 2, 6, 12, 26, 38, 52 |
| Percentage of Participants With Response Determined by Disease Activity Score Based on 28-Joints Count (DAS 28) | The DAS28-based European League Against Rheumatism (EULAR) response criteria was used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and level of disease activity reached (final values). Good responders: change from baseline >1.2 with DAS28 final value <=3.2; moderate responders: change from baseline >1.2 with DAS28 final values >3.2 to <=5.1 and >5.1 or change from baseline >0.6 to <=1.2 with DAS28 final values <=3.2 and >3.2 to <=5.1; non-responders: change from baseline <=0.6 with DAS28 final values <=3.2, >3.2 to <=5.1 and >5.1 or change from baseline >0.6 to <=1.2 with DAS28 final values >5.1. Good and moderate responders were considered to have DAS28 response. | Week 2, 6, 12, 26, 38, 52 |
| Duration of Morning Stiffness | Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If stiffness persisted the entire day, 999 minutes was recorded [largest value possible to document] which may also include values up to 1440 minutes [= complete day]). | Baseline, Week 2, 6, 12, 26, 38, 52 |
| Patient Global Assessment of Arthritis Pain | Participants assessed arthritis pain using a 0 mm - 100 mm Visual Analog Scale (VAS) where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). | Baseline, Week 2, 6, 12, 26, 38, 52 |
| Physician Global Assessment of Disease Activity | Physician global assessment of disease activity was measured on a 0 mm to 100 mm Visual Analog Scale (VAS), with 0 mm = no disease activity and 100mm = maximum possible disease activity. | Baseline, Week 2, 6, 12, 26, 38, 52 |
| Patient Global Assessment of Disease Activity | Patient global assessment of disease activity was measured using a 100 mm Visual Analog Scale (VAS) ranging from 0 mm= very good to 100 mm = very bad. | Baseline, Week 2, 6, 12, 26, 38, 52 |
| C-Reactive Protein (CRP) | The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. | Baseline, Week 2, 6, 12, 26, 38, 52 |
| Fatigue Visual Analog Scale (VAS) | Participants assessed their fatigue during the last 7 days using a 0 mm - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue. | Baseline, Week 26, 52 |
| Week 2, 6, 12, 26, 38, 52 |
| Number of Participants With Adverse Events (AEs) or 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. An 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. AEs included SAEs as well as non-serious AEs which occurred during the study. | Week 2 up to Week 52 |
| Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) With or Without Concomitant Methotrexate (MTX) Therapy | Participants with or without concomitant methotrexate (MTX) treatment were reported for AEs or SAEs. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An 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. | Week 2 up to Week 52 |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Etanercept | Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52. |
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| Primary | Percentage of Participants Achieving Functional Remission Determined by Hannover Functional Ability Questionnaire (FFbH) at Week 52 | Hannover Functional Ability Questionnaire (FFbH) consists 18 questions to assess daily activities in last 7 days. Each question is answered by the participant as "Yes, I can perform the activity without difficulty" (score assigned = 2), "Yes, but with some difficulties" (score assigned = 1) and "No or only with help" (score assigned = 0). Final FFbH score (FFbH functional capacity) is then computed according to formula: (Sum of all single scores * 100%) / (2 * number of answered questions), ranging between 0-100; higher score indicates better daily activities. FFbH functional remission is defined as FFbH functional capacity of >= 83%. | Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of rheumatoid arthritis, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 52 |
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| Secondary | Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeter (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. | Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points. | Posted | Mean | Standard Deviation | mm | Baseline, Week 26, Week 52 |
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| Secondary | Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO) | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health state profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol group assigns a utility value for each domain in the profile. EQ-5D score is transformed to EQ-5D-TTO score ranging from -0.205 to 0.999; higher score indicates a better health state. | Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 26, Week 52 |
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| Secondary | Work Productivity and Activity Impairment - Special Health Problems (WPAI:SHP) | WPAI:SHP is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to rheumatoid arthritis for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity. | Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points. | Posted | Mean | Standard Deviation | percentage of impairment | Baseline, Week 26, Week 52 |
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| Secondary | Healthcare Resource Utilization | Participants' utilization of healthcare resources was evaluated as number of events for healthcare resources utilization including: number of visits to general practitioners, visits to rheumatologist, visits to other medical specialists, inpatient hospitalizations, inpatient rehabilitations, inpatient follow-up treatment, outpatient rehabilitations, physiotherapy, and other healthcare utilizations. At baseline, number of events for participants' healthcare resources utilization during last 12 months before enrollment into the study were documented. After enrollment, number of events for participants' healthcare resources utilization were documented for last 6 months after previous documentation. | Effectiveness population. Here 'N' (number of participants analyzed) = overall participants evaluable for any event for this measure and 'n'= participants evaluable for specified event at specified time points. | Posted | Mean | Standard Deviation | events | Baseline, Week 26, Week 52 |
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| Secondary | Duration of Healthcare Resources Utilization | Participants' duration of healthcare resources utilization was evaluated as number of days for healthcare resources utilization including: duration of visits to general practitioners, to rheumatologist, to other medical specialists, inpatient hospitalizations, inpatient rehabilitations, inpatient follow-up treatment, outpatient rehabilitations, physiotherapy, and other healthcare utilizations. At baseline, number of days for participants' healthcare resources utilizations during last 12 months before enrollment into the study were documented. After enrollment, number of days for participants' healthcare resources utilization were documented for last 6 months after previous documentation. | Effectiveness population. Here 'N' (number of participants analyzed) = overall participants evaluable for any event for this measure and 'n'= participants evaluable for specified event at specified time points. | Posted | Median | Full Range | days | Baseline, Week 26, Week 52 |
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| Secondary | Duration of Working Disability | Duration of working disability was assessed as number of days a participant was disable to work. Duration of work disability was considered as "0" if participant was not disable to work during period of assessment. At baseline, participants' duration of working disability during last 12 months before enrollment into the study was documented. After enrollment, participants' duration of working disability was documented for last 6 months after previous documentation. | Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points. | Posted | Median | Full Range | days | Baseline, Week 26, Week 52 |
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| Secondary | Disease Activity Score Based on 28-Joints Count (DAS28) | DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and Patient global assessment of disease activity (recorded on a VAS of 0 mm [very good] to 100 mm [very bad]). Total score range: 0 to 10, higher score indicated more disease activity. DAS28 less than (<) 2.6 = remission, DAS28 less than or equal to (<=) 3.2 = low disease activity, DAS28 greater than or equal to (>=) 3.2 to <=5.1 = moderate disease activity, DAS28 greater than (>) 5.1 = high disease activity. | Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 2, 6, 12, 26, 38, 52 |
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| Secondary | Swollen Joints Count (SJC) | Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. | Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points. | Posted | Mean | Standard Deviation | joints | Baseline, Week 2, 6, 12, 26, 38, 52 |
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| Secondary | Tender Joints Count (TJC) | Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. | Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points. | Posted | Mean | Standard Deviation | joints | Baseline, Week 2, 6, 12, 26, 38, 52 |
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| Secondary | Erythrocyte Sedimentation Rate (ESR) | ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hour. A higher rate is consistent with inflammation. | Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points. | Posted | Mean | Standard Deviation | millimeter per hour (mm/h) | Baseline, Week 2, 6, 12, 26, 38, 52 |
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| Secondary | Percentage of Participants With Remission Determined by Disease Activity Score Based on 28-Joints Count (DAS 28) | DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and Patient global assessment of disease activity (recorded on a VAS of 0 mm [very good] to 100 mm [very bad]). Total score range: 0 to 10, higher score indicated more disease activity. DAS28 defined remission was classified as a score of <2.6. | Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 2, 6, 12, 26, 38, 52 |
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| Secondary | Percentage of Participants With Response Determined by Disease Activity Score Based on 28-Joints Count (DAS 28) | The DAS28-based European League Against Rheumatism (EULAR) response criteria was used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and level of disease activity reached (final values). Good responders: change from baseline >1.2 with DAS28 final value <=3.2; moderate responders: change from baseline >1.2 with DAS28 final values >3.2 to <=5.1 and >5.1 or change from baseline >0.6 to <=1.2 with DAS28 final values <=3.2 and >3.2 to <=5.1; non-responders: change from baseline <=0.6 with DAS28 final values <=3.2, >3.2 to <=5.1 and >5.1 or change from baseline >0.6 to <=1.2 with DAS28 final values >5.1. Good and moderate responders were considered to have DAS28 response. | Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 2, 6, 12, 26, 38, 52 |
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|
|
| Secondary | Duration of Morning Stiffness | Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If stiffness persisted the entire day, 999 minutes was recorded [largest value possible to document] which may also include values up to 1440 minutes [= complete day]). | Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points. | Posted | Median | Full Range | minutes | Baseline, Week 2, 6, 12, 26, 38, 52 |
|
|
|
| Secondary | Patient Global Assessment of Arthritis Pain | Participants assessed arthritis pain using a 0 mm - 100 mm Visual Analog Scale (VAS) where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). | Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points. | Posted | Mean | Standard Deviation | mm | Baseline, Week 2, 6, 12, 26, 38, 52 |
|
|
|
| Secondary | Physician Global Assessment of Disease Activity | Physician global assessment of disease activity was measured on a 0 mm to 100 mm Visual Analog Scale (VAS), with 0 mm = no disease activity and 100mm = maximum possible disease activity. | Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points. | Posted | Mean | Standard Deviation | mm | Baseline, Week 2, 6, 12, 26, 38, 52 |
|
|
|
| Secondary | Patient Global Assessment of Disease Activity | Patient global assessment of disease activity was measured using a 100 mm Visual Analog Scale (VAS) ranging from 0 mm= very good to 100 mm = very bad. | Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points. | Posted | Mean | Standard Deviation | mm | Baseline, Week 2, 6, 12, 26, 38, 52 |
|
|
|
| Secondary | C-Reactive Protein (CRP) | The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. | Safety analysis population included all participants with available documentations. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and 'n' signifies participants evaluable at specified time points. | Posted | Mean | Standard Deviation | milligram per deciliter (mg/dL) | Baseline, Week 2, 6, 12, 26, 38, 52 |
|
|
|
| Secondary | Fatigue Visual Analog Scale (VAS) | Participants assessed their fatigue during the last 7 days using a 0 mm - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue. | Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points. | Posted | Mean | Standard Deviation | mm | Baseline, Week 26, 52 |
|
|
|
| Other Pre-specified | Percentage of Participants With Low Disease Activity Determined by Disease Activity Score 28 Based on 28-joints Count (DAS 28) | DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and Patient global assessment of disease activity (recorded on a VAS of 0 mm [very good] to 100 mm [very bad]). Total score range: 0 to 10, higher score indicated more disease activity. DAS28 defined low disease activity was classified as a score of <=3.2. | Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 2, 6, 12, 26, 38, 52 |
|
|
|
| Other Pre-specified | Number of Participants With Adverse Events (AEs) or 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. An 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. AEs included SAEs as well as non-serious AEs which occurred during the study. | Safety analysis population included all participants with available documentations. | Posted | Number | participants | Week 2 up to Week 52 |
|
|
|
| Other Pre-specified | Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) With or Without Concomitant Methotrexate (MTX) Therapy | Participants with or without concomitant methotrexate (MTX) treatment were reported for AEs or SAEs. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An 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. | Safety analysis population included all participants with available documentations. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and 'n' signifies participants evaluable for specified category. | Posted | Number | participants | Week 2 up to Week 52 |
|
|
|
| 649 |
| 4,871 |
| 1,921 |
| 4,871 |
| Bone marrow failure | Blood and lymphatic system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Bone marrow toxicity | Blood and lymphatic system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Nephrogenic anaemia | Blood and lymphatic system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Normochromic normocytic anaemia | Blood and lymphatic system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Sideroblastic anaemia | Blood and lymphatic system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Acute coronary syndrome | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Aortic valve incompetence | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Atrioventricular block second degree | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Bradyarrhythmia | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Bundle branch block right | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Cardiogenic shock | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Coronary artery stenosis | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Coronary artery thrombosis | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Hypertensive heart disease | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Intracardiac thrombus | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Left ventricular failure | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Myocarditis | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Myocarditis post infection | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Pericarditis | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Pulmonary valve incompetence | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Tachyarrhythmia | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Ventricular extrasystoles | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Spondylolisthesis | Congenital, familial and genetic disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Von Willebrand's disease | Congenital, familial and genetic disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Deafness | Ear and labyrinth disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Hearing impaired | Ear and labyrinth disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Vestibular neuronitis | Ear and labyrinth disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Goitre | Endocrine disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Hyperparathyroidism secondary | Endocrine disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Toxic nodular goitre | Endocrine disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Chorioretinopathy | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Dacryoadenitis acquired | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Keratoconjunctivitis sicca | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Macular degeneration | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Optic ischaemic neuropathy | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Retinal detachment | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Visual acuity reduced | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Visual disturbance | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Appendicitis perforated | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Crohn's disease | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Diverticular perforation | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Diverticulum intestinal | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Diverticulum intestinal haemorrhagic | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Duodenal perforation | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Gastritis haemorrhagic | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Ileus paralytic | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Inflammatory bowel disease | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Leukoplakia oral | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Pancreatitis chronic | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Pancreatitis necrotising | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Pancreatitis relapsing | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Peritonitis | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Proctitis ulcerative | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Reflux oesophagitis | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Small intestinal perforation | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Subileus | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Umbilical hernia | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Concomitant disease progression | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Condition aggravated | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Death | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Disease progression | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Drug effect decreased | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Drug ineffective | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Generalised oedema | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Impaired healing | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Inflammation of wound | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Mass | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Multi-organ failure | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Necrosis | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Nodule | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Oedema mucosal | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Sudden cardiac death | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Systemic inflammatory response syndrome | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Hepatomegaly | Hepatobiliary disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Abscess | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Abscess intestinal | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Abscess limb | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Acid fast bacilli infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Acute tonsillitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Arthritis bacterial | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Arthritis infective | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Bacterial infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Body tinea | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Breast abscess | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Bursitis infective | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Candida pneumonia | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Candidiasis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Chlamydial infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Clostridial infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Clostridium difficile colitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Diabetic gangrene | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Empyema | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Endocarditis staphylococcal | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Enterocolitis bacterial | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Enterocolitis infectious | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Escherichia infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Escherichia urinary tract infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Gastroenteritis Norwalk virus | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Gastroenteritis rotavirus | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Gastrointestinal infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Genital abscess | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Helicobacter gastritis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Herpes zoster ophthalmic | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Impetigo | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Infected cyst | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Intervertebral discitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Klebsiella infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Liver abscess | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Lobar pneumonia | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Lung abscess | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Meningitis staphylococcal | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Myringitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Necrotising fasciitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Neuroborreliosis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Oesophageal candidiasis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Osteomyelitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Phlebitis infective | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Pilonidal cyst | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Pleural infection bacterial | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Post procedural infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Pyoderma | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Pyothorax | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Relapsing fever | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Septic arthritis staphylococcal | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Staphylococcal sepsis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Stenotrophomonas infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Streptococcal infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Streptococcal sepsis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Superinfection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Superinfection bacterial | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Vulval abscess | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Wound infection staphylococcal | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Device dislocation | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Device failure | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Dislocation of joint prosthesis | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Dislocation of vertebra | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Failure of implant | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Fractured sacrum | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Incision site erythema | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Muscle rupture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Optic nerve injury | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Postoperative wound complication | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Procedural complication | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Pubic rami fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Synovial rupture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Vascular graft occlusion | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Vascular procedure complication | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Blood pressure abnormal | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Urine analysis abnormal | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Diabetic foot | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Lactose intolerance | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Vitamin B12 deficiency | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Atlantoaxial instability | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Cartilage development disorder | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Chondromalacia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Enthesopathy | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Fistula | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Joint destruction | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Juvenile arthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Kyphosis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Lupus-like syndrome | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Myopathy | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Neuropathic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Osteochondrosis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Osteoporotic fracture | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Polyarthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Pseudarthrosis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Rheumatoid nodule | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Sjogren's syndrome | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Spinal disorder | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Synovial disorder | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Abdominal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
|
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
|
| Angiomyolipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
|
| Benign breast neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
|
| Bladder cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
|
| Bowen's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
|
| Breast cancer in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
|
| Breast cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
|
| Bronchial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
|
| Carcinoid tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
|
| Cervix carcinoma stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
|
| Hypopharyngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
|
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
|
| Lung adenocarcinoma stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
|
| Lung squamous cell carcinoma stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
|
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
|
| Lymphoplasmacytoid lymphoma/immunocytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
|
| Malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
|
| Mantle cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
|
| Metastases to lymph nodes | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
|
| Metastatic bronchial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
|
| Metastatic malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
|
| Metastatic squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
|
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
|
| Neuroendocrine carcinoma of the skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
|
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
|
| Oropharyngeal cancer stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
|
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
|
| Prostate cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
|
| Renal cell carcinoma stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
|
| Salivary gland adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
|
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
|
| Superficial spreading melanoma stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
|
| Thyroid neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Cerebral ischaemia | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Cerebral ventricle dilatation | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Cerebrovascular disorder | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Complex regional pain syndrome | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Critical illness polyneuropathy | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Cubital tunnel syndrome | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Demyelination | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Depressed level of consciousness | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Dysaesthesia | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Encephalopathy | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Essential tremor | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Facial paresis | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Grand mal convulsion | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Intercostal neuralgia | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Nerve compression | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Paresis | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Peripheral sensorimotor neuropathy | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Polyneuropathy | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Quadriparesis | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Radicular pain | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Radicular syndrome | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Radiculopathy | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Ruptured cerebral aneurysm | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Speech disorder | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Tarsal tunnel syndrome | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Thalamic infarction | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Vascular encephalopathy | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Vasculitis cerebral | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Intra-uterine death | Pregnancy, puerperium and perinatal conditions | MedDRA 15.1 | Non-systematic Assessment |
|
| Placental insufficiency | Pregnancy, puerperium and perinatal conditions | MedDRA 15.1 | Non-systematic Assessment |
|
| Premature labour | Pregnancy, puerperium and perinatal conditions | MedDRA 15.1 | Non-systematic Assessment |
|
| Adjustment disorder | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Alcohol abuse | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Restlessness | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Schizophrenia | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Acute prerenal failure | Renal and urinary disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Calculus bladder | Renal and urinary disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Calculus ureteric | Renal and urinary disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Calculus urinary | Renal and urinary disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Crush syndrome | Renal and urinary disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Nephropathy toxic | Renal and urinary disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Renal cyst | Renal and urinary disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Renal disorder | Renal and urinary disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Tubulointerstitial nephritis | Renal and urinary disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Endometrial hyperplasia | Reproductive system and breast disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Endometriosis | Reproductive system and breast disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Uterine disorder | Reproductive system and breast disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Uterine malposition | Reproductive system and breast disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Alveolitis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Alveolitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Dyspnoea at rest | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Hypoventilation | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Tonsillar disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Cutaneous vasculitis | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Cutis laxa | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Leukocytoclastic vasculitis | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Panniculitis | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Pustular psoriasis | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Stasis dermatitis | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Systemic lupus erythematosus rash | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Abdominal operation | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Ankle arthroplasty | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Arthrodesis | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Bunion operation | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Cardioversion | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Cataract operation | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Cholecystectomy | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Ciliary body operation | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Colostomy closure | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Coronary arterial stent insertion | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Elbow operation | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Eye operation | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Foot operation | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Gastric bypass | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Hip arthroplasty | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Hysterectomy | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Intervertebral disc operation | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Joint arthroplasty | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Knee arthroplasty | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Retinopexy | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Skin graft | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Spinal corpectomy | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Spinal fusion surgery | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Spinal laminectomy | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Spinal operation | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Stent placement | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Synovectomy | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Synoviorthesis | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Tendon operation | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Tendon sheath incision | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Toe operation | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Tonsillectomy | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Uterine dilation and curettage | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Aneurysm | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Aortic arteriosclerosis | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Arterial disorder | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Arterial thrombosis limb | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Blood pressure inadequately controlled | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Circulatory collapse | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Femoral arterial stenosis | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Ischaemia | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Pelvic venous thrombosis | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Peripheral ischaemia | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Shock | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Thrombophlebitis | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Vasculitis | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Vasospasm | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Venous thrombosis | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Venous thrombosis limb | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Spontaneous haematoma | Blood and lymphatic system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Cardiac discomfort | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Cardiomegaly | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Cardiovascular disorder | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Coronary artery insufficiency | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Coarctation of the aorta | Congenital, familial and genetic disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Spondylolisthesis | Congenital, familial and genetic disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Ear discomfort | Ear and labyrinth disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Ear haemorrhage | Ear and labyrinth disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| External ear pain | Ear and labyrinth disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Inner ear disorder | Ear and labyrinth disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Meniere's disease | Ear and labyrinth disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Sudden hearing loss | Ear and labyrinth disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Toxic nodular goitre | Endocrine disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Abnormal sensation in eye | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Corneal infiltrates | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Dacryoadenitis acquired | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Erythema of eyelid | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Eye disorder | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Eye haemorrhage | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Eye inflammation | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Eye swelling | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Foreign body sensation in eyes | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Iritis | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Keratitis | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Macular degeneration | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Scleritis | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Scotoma | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Sicca syndrome | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Ulcerative keratitis | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Uveitis | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Visual disturbance | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Abdominal tenderness | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Abnormal faeces | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Bowel movement irregularity | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Coeliac artery compression syndrome | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Colonic polyp | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Dental discomfort | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Diverticulum intestinal | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Duodenitis | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Eructation | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Faeces discoloured | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Frequent bowel movements | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Gastric disorder | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Gastritis erosive | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Gingival blister | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Gingivitis | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Glossodynia | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Hiatus hernia | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Ileal ulcer | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Inflammatory bowel disease | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Lip swelling | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Oedema mouth | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Oesophageal pain | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Oral discomfort | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Oral disorder | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Oral mucosal blistering | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Oral mucosal erythema | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Paraesthesia oral | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Parotid gland enlargement | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Periodontitis | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Reflux oesophagitis | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Saliva altered | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Stomach discomfort | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Stomach granuloma | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Tongue coated | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Tongue disorder | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Tooth disorder | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Application site erythema | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Application site pruritus | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Condition aggravated | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Drug ineffective | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Face oedema | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Fat tissue increased | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Feeling hot | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Impaired healing | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Induration | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Inflammation | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Inflammation of wound | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Injection site bruising | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Injection site extravasation | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Injection site hypersensitivity | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Injection site induration | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Injection site inflammation | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Injection site irritation | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Injection site macule | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Injection site papule | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Injection site rash | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Injection site urticaria | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Injection site warmth | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Irritability | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Local reaction | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Local swelling | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Mucosal dryness | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Performance status decreased | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Prostration | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Rebound effect | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Sensation of foreign body | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Sense of oppression | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Swelling | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Tenderness | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Thirst | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Hepatic pain | Hepatobiliary disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Hepatitis | Hepatobiliary disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Hepatomegaly | Hepatobiliary disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Hepatotoxicity | Hepatobiliary disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Abscess | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Abscess jaw | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Acute tonsillitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Arthritis bacterial | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Arthritis infective | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Bacterial infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Borrelia infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Breast abscess | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Bronchitis bacterial | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Campylobacter infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Chronic sinusitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Conjunctivitis bacterial | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Conjunctivitis infective | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Ear infection bacterial | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Eczema infected | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Erythema infectiosum | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Escherichia infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Eye infection bacterial | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Febrile infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Fungal skin infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Gastroenteritis Norwalk virus | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Gastrointestinal candidiasis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Gastrointestinal infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Genital abscess | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Genital herpes | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Genital infection fungal | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Gingival infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Groin abscess | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Helicobacter gastritis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Herpes ophthalmic | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Herpes virus infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Herpes zoster ophthalmic | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Infected insect bite | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Infection in an immunocompromised host | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Injection site cellulitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Injection site pustule | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Lobar pneumonia | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Localised infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Lymph node abscess | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Lymphangitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Molluscum contagiosum | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Onychomycosis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Oral fungal infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Oropharyngeal candidiasis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Otitis externa | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Parotitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Perianal fungal infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Pharyngitis bacterial | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Pneumonia haemophilus | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Pulpitis dental | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Pyelocystitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Pyoderma | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Rash pustular | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Scarlet fever | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Sinobronchitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Skin bacterial infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Soft tissue infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Staphylococcal skin infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Tinea pedis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Tracheobronchitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection bacterial | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Urogenital trichomoniasis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Vaginal candidiasis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Varicella | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Accident at work | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Animal bite | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Drug exposure during pregnancy | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Epicondylitis | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Joint sprain | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Open wound | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Post concussion syndrome | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Postoperative thrombosis | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Seroma | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Skeletal injury | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Skin injury | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Splinter | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Stress fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Traumatic haematoma | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Venomous sting | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Arthroscopy | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Beta globulin increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Blood albumin decreased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Blood albumin increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Blood creatine increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Blood phosphorus decreased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Blood smear test abnormal | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Blood urine present | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Body temperature increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Cardiac murmur | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Glycosylated haemoglobin increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Haematocrit decreased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Heart rate increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Hysteroscopy | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Intraocular pressure increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Investigation | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Laparoscopy | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Low density lipoprotein increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Lymphocyte count increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Mean cell volume increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Monocyte count increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Mycobacteria blood test positive | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| N-terminal pro-brain natriuretic peptide (NT-proBNP) | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Neutrophil count increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Nitrite urine present | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Protein total increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Red blood cell count decreased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Red blood cell sedimentation rate increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Red cell distribution width increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Streptococcal identification test positive | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Thyroid gland scan abnormal | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Tuberculosis test positive | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Vitamin C increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Vitamin D decreased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Weight increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| White blood cell count | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| White blood cells urine positive | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Fluid retention | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Iron deficiency | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Xanthelasma | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Arthrofibrosis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Chondrocalcinosis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Chondropathy | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Dactylitis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Joint crepitation | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Kyphosis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Lordosis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Metatarsalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Muscle atrophy | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Muscle disorder | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Myosclerosis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Nodal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Osteochondrosis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Rheumatoid nodule | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Scleroderma | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Sensation of heaviness | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Soft tissue disorder | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Tendon disorder | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Tenosynovitis stenosans | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Benign neoplasm of cervix uteri | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
|
| Benign neoplasm of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
|
| Fibroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
|
| Lentigo | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
|
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
|
| Malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
|
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
|
| Neoplasm skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
|
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
|
| Ageusia | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Altered state of consciousness | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Burning sensation | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Carotid arteriosclerosis | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Cervical root pain | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Cervicobrachial syndrome | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Cervicogenic headache | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Cluster headache | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Dysaesthesia | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Hemicephalalgia | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Hyperaesthesia | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Intercostal neuralgia | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Mental impairment | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Nerve root compression | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Nervous system disorder | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Neuropathy | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Parosmia | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Polyneuropathy | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Radial nerve palsy | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Reduced dexterity | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Restless legs syndrome | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Sensory disturbance | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Syncope vasovagal | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Vascular encephalopathy | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 15.1 | Non-systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Alcohol abuse | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Anxiety disorder | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Aversion | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Depressed mood | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Hallucination | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Initial insomnia | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Middle insomnia | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Nervousness | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Panic attack | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Psychogenic pain disorder | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Restlessness | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Stress | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Acute prerenal failure | Renal and urinary disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Calculus ureteric | Renal and urinary disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| IgA nephropathy | Renal and urinary disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Micturition urgency | Renal and urinary disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Nephritis | Renal and urinary disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Renal failure chronic | Renal and urinary disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Urge incontinence | Renal and urinary disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Amenorrhoea | Reproductive system and breast disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Genital erythema | Reproductive system and breast disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Menopausal symptoms | Reproductive system and breast disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Menstrual disorder | Reproductive system and breast disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Menstruation irregular | Reproductive system and breast disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Metrorrhagia | Reproductive system and breast disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Orchitis noninfective | Reproductive system and breast disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Ovarian adhesion | Reproductive system and breast disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Prostatitis | Reproductive system and breast disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Pruritus genital | Reproductive system and breast disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Uterine cyst | Reproductive system and breast disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Uterine haemorrhage | Reproductive system and breast disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Vaginal discharge | Reproductive system and breast disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Vaginal erythema | Reproductive system and breast disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Vulvovaginal dryness | Reproductive system and breast disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Increased upper airway secretion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Laryngeal polyp | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Lung hyperinflation | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Nasal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Nasal mucosal disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Nasal polyps | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Nocturnal dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Pharyngeal erythema | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Pharyngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Pleural rub | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Pulmonary sarcoidosis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Respiratory tract irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Rhonchi | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Sputum discoloured | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Suffocation feeling | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Throat tightness | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Alopecia areata | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Blood blister | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Cutaneous lupus erythematosus | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Dermatitis bullous | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Dermatitis psoriasiform | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Dermatosis | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Dyshidrosis | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Eczema weeping | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Erythema nodosum | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Exfoliative rash | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Female pattern baldness | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Generalised erythema | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Hypoaesthesia facial | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Increased tendency to bruise | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Intertrigo | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Leukocytoclastic vasculitis | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Lichen planus | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Lichenoid keratosis | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Melanosis | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Nail bed inflammation | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Panniculitis | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Periorbital oedema | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Photodermatosis | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Pigmentation disorder | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Pruritus allergic | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Purpura | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Pustular psoriasis | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Rash vesicular | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Rosacea | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Scar | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Scar pain | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Skin atrophy | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Skin burning sensation | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Skin haemorrhage | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Skin inflammation | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Skin nodule | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Skin odour abnormal | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Skin reaction | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Skin swelling | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Skin warm | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Stasis dermatitis | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Systemic lupus erythematosus rash | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Telangiectasia | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Ankle operation | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Apicectomy | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Arthrectomy | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Arthrodesis | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Bladder neoplasm surgery | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Bone lesion excision | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Bunion operation | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Bursa removal | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Cataract operation | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Catheterisation cardiac | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Colostomy closure | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Corneal transplant | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Dental implantation | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Dental operation | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Dental treatment | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Endodontic procedure | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Eye operation | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Fasciectomy | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Female sterilisation | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Foot operation | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Hip arthroplasty | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Hip surgery | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Hospitalisation | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Hysterectomy | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Inguinal hernia repair | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Joint arthroplasty | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Knee arthroplasty | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Knee operation | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Limb operation | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Malignant tumour excision | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Meniscus removal | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Myomectomy | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Nail operation | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Nasal cyst removal | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Nasal operation | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Osteotomy | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Palatal operation | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Peripheral nerve destruction | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Prostatectomy | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Rehabilitation therapy | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Removal of internal fixation | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Renal stone removal | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Rheumatoid nodule removal | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Shoulder arthroplasty | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Sinus operation | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Skin neoplasm excision | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Spinal decompression | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Spinal laminectomy | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Spinal operation | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Surgery | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Synovectomy | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Synoviorthesis | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Tendon operation | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Tendon sheath incision | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Tendon sheath lesion excision | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Therapeutic procedure | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Toe operation | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Tooth extraction | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Uterine dilation and curettage | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Varicose vein operation | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Vascular stent insertion | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Wisdom teeth removal | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Wrist surgery | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Blood pressure fluctuation | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Circulatory collapse | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Lymphoedema | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Pallor | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Thrombophlebitis | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Varicose vein | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Vasculitis | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Venous thrombosis | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not 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 |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|
| Baseline: Activity impairment (n = 4716) |
|
| Week 26: Work Time Missed (n = 946) |
|
| Week 26: Impairment While Working (n = 1267) |
|
| Week 26: Overall work impairment (n = 909) |
|
| Week 26: Activity impairment (n = 3640) |
|
| Week 52: Work Time Missed (n = 815) |
|
| Week 52: Impairment While Working (n = 1076) |
|
| Week 52: Overall work impairment (n = 790) |
|
| Week 52: Activity impairment (n = 3011) |
|
|
| Baseline: In-patient Hospitalization (n = 2622) |
|
| Baseline: In-patient Rehabilitation (n = 2047) |
|
| Baseline: Follow-up Treatment (n = 1861) |
|
| Baseline: Out-patient Rehabilitation (n = 1854) |
|
| Baseline: Physiotherapy (n = 2577) |
|
| Baseline: Other Health Care Resources (n = 1169) |
|
| Week 26: General Practitioner Visit (n = 3139) |
|
| Week 26: Rheumatologist Visit (n = 3424) |
|
| Week 26: Other Specialist Visit (n = 2432) |
|
| Week 26: In-patient Hospitalization (n = 1893) |
|
| Week 26: In-patient Rehabilitation (n = 1772) |
|
| Week 26: Follow-up Treatment (n = 1692) |
|
| Week 26: Out-patient Rehabilitation (n = 1675) |
|
| Week 26: Physiotherapy (n = 2095) |
|
| Week 26: Other Health Care Resources (n = 1251) |
|
| Week 52: General Practitioner Visit (n = 2622) |
|
| Week 52: Rheumatologist Visit (n = 2859) |
|
| Week 52: Other Specialist Visit (n = 2013) |
|
| Week 52: In-patient Hospitalization (n = 1583) |
|
| Week 52: In-patient Rehabilitation (n = 1485) |
|
| Week 52: Follow-up Treatment (n = 1451) |
|
| Week 52: Out-patient Rehabilitation (n = 1440) |
|
| Week 52: Physiotherapy (n = 1746) |
|
| Week 52: Other Health Care Resources (n = 1064) |
|
|
| Baseline: In-patient Hospitalization (n = 1747) |
|
| Baseline: In-patient Rehabilitation (n = 1030) |
|
| Baseline: Follow-up Treatment (n = 826) |
|
| Baseline: Out-patient Rehabilitation (n = 838) |
|
| Baseline: Physiotherapy (n = 1333) |
|
| Baseline: Other Health Care Resources (n = 645) |
|
| Week 26: General Practitioner Visit (n = 1505) |
|
| Week 26: Rheumatologist Visit (n = 1649) |
|
| Week 26: Other Specialist Visit (n = 1201) |
|
| Week 26: In-patient Hospitalization (n = 1113) |
|
| Week 26: In-patient Rehabilitation (n = 977) |
|
| Week 26: Follow-up Treatment (n = 893) |
|
| Week 26: Out-patient Rehabilitation (n = 883) |
|
| Week 26: Physiotherapy (n = 1211) |
|
| Week 26: Other Health Care Resources (n = 817) |
|
| Week 52: General Practitioner Visit (n = 1255) |
|
| Week 52: Rheumatologist Visit (n = 1379) |
|
| Week 52: Other Specialist Visit (n = 999) |
|
| Week 52: In-patient Hospitalization (n = 947) |
|
| Week 52: In-patient Rehabilitation (n = 829) |
|
| Week 52: Follow-up Treatment (n = 791) |
|
| Week 52: Out-patient Rehabilitation (n = 789) |
|
| Week 52: Physiotherapy (n = 1022) |
|
| Week 52: Other Health Care Resources (n = 698) |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Week 12 (n = 3363) |
|
| Week 26 (n = 3116) |
|
| Week 38 (n = 2719) |
|
| Week 52 (n = 2608) |
|
| Title | Measurements |
|---|---|
|
| Week 12 (n = 4209) |
|
| Week 26 (n = 3764) |
|
| Week 38 (n = 3302) |
|
| Week 52 (n = 3110) |
|
| Title | Measurements |
|---|---|
|
| Week 12 (n = 4216) |
|
| Week 26 (n = 3790) |
|
| Week 38 (n = 3313) |
|
| Week 52 (n = 3129) |
|
| Title | Measurements |
|---|---|
|
| Week 12 (n = 3456) |
|
| Week 26 (n = 3198) |
|
| Week 38 (n = 2782) |
|
| Week 52 (n = 2665) |
|
| Title | Measurements |
|---|---|
|
| Week 26 (n = 3116) |
|
| Week 38 (n = 2719) |
|
| Week 52 (n = 2608) |
|
| Title | Measurements |
|---|---|
|
| Week 26 (n = 2866) |
|
| Week 38 (n = 2513) |
|
| Week 52 (n = 2415) |
|
| Title | Measurements |
|---|---|
|
| Week 12 (n = 4228) |
|
| Week 26 (n = 3792) |
|
| Week 38 (n = 3315) |
|
| Week 52 (n = 3131) |
|
| Title | Measurements |
|---|---|
|
| Week 12 (n = 4263) |
|
| Week 26 (n = 3818) |
|
| Week 38 (n = 3352) |
|
| Week 52 (n = 3150) |
|
| Title | Measurements |
|---|---|
|
| Week 12 (n = 4224) |
|
| Week 26 (n = 3787) |
|
| Week 38 (n = 3322) |
|
| Week 52 (n = 3125) |
|
| Title | Measurements |
|---|---|
|
| Week 12 (n = 4268) |
|
| Week 26 (n = 3823) |
|
| Week 38 (n = 3351) |
|
| Week 52 (n = 3158) |
|
| Title | Measurements |
|---|---|
|
| Week 12 (n = 3422) |
|
| Week 26 (n = 3166) |
|
| Week 38 (n = 2773) |
|
| Week 52 (n = 2650) |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Week 26 (n = 3116) |
|
| Week 38 (n = 2719) |
|
| Week 52 (n = 2608) |
|
| Title | Measurements |
|---|---|
|
| SAEs: With Concomitant MTX (n = 2455) |
|