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| ID | Type | Description | Link |
|---|---|---|---|
| B1801087 | Other Identifier | Alias Study Number |
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This study aims to provide a holistic assessment of patients receiving etanercept in a real-world setting.
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 Ankylosing Spondylitis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etanercept | Drug | The patients will be treated in accordance with the requirements of the labeling of etanercept 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 Partial Remission at Week 26 | Percentage of participants achieving partial remission was determined by assessment of spondyloarthritis international society (ASAS) criteria. Partial remission was defined as a score of less than 2 units (on a scale of 0-10, where 0= no disease activity and 10= high disease activity) in each of the 4 assessment in ASAS domains: participant global assessment of disease activity, pain, function, and inflammation. | Week 26 |
| Percentage of Participants Achieving Partial Remission at Week 52 | Percentage of participants achieving partial remission was determined by ASAS criteria. Partial remission defined as a score of less than 2 units (on a scale of 0-10, where 0= no disease activity and 10= high disease activity) in each of the 4 assessment in ASAS domains: participant global assessment of disease activity, pain, function, and inflammation. | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs) | 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 or incapacity; congenital anomaly. Percentage of participants with AEs included participants affected with both SAEs and non--SAEs. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with an established diagnosis of Ankylosing Spondylitis
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Benjamin Franklin | Berlin | 12200 | 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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A total of 1715 participants were enrolled for documentation. Of these 1715 participants enrolled, only 1685 participants were included in analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Etanercept | Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Safety population included all treated participants with available post-baseline safety data.
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| ID | Title | Description |
|---|---|---|
| BG000 | Etanercept | Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Partial Remission at Week 26 | Percentage of participants achieving partial remission was determined by assessment of spondyloarthritis international society (ASAS) criteria. Partial remission was defined as a score of less than 2 units (on a scale of 0-10, where 0= no disease activity and 10= high disease activity) in each of the 4 assessment in ASAS domains: participant global assessment of disease activity, pain, function, and inflammation. | Effectiveness population: all treated participants greater than or equal to (>=) 18 years of age, with confirmed diagnosis of ankylosing spondylitis, who received etanercept therapy for the first time and had post-baseline documentation. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome 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 non-serious in another subject, or one subject may have experienced both a serious and non-serious 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 who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ankylosing spondylitis | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1--800--718--1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
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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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|
| Baseline up to Week 52 |
| Percentage of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs) by Co-morbidity | Baseline up to Week 52 |
| Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 52 | BASDAI is a validated self-assessment tool used to determine disease activity in participant with AS. Utilizing a 11-point Likert-scale (0= none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The index was computed by adding questions 1 to 4 plus the mean of questions 5 and 6. The resulting 0 to 50 score was divided by 5 to give a final 0-10 BASDAI score (0 being no problem and 10 being the worst problem). | Baseline, Week 52 |
| Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 52 | BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Participants answered 10 questions, consisting of 8 specific questions regarding function in AS and 2 questions reflecting the participant's ability to cope with everyday life. Each question was answered on a 0-10 scale (0 being no problem and 10 being the worst problem), the sum of which (divided by 10) resulted in the BASFI score (0-10). | Baseline, Week 52 |
| Change From Baseline in Occiput-to-Wall Distance at Week 52 | Occiput-to-wall distance is the distance between the occiput (posterior or back portion of the head) and the wall when the participant stood with heels and shoulder against the wall and the back straight. | Baseline, Week 52 |
| Change From Baseline in Lateral Lumbar Flexion at Week 52 | Lateral lumbar flexion was determined by the difference of the finger-floor-distance in normal position and in lateral bending position. | Baseline, Week 52 |
| Change From Baseline in Patient's Global Assessment (PtGA) of Pain at Week 52 | Participants were asked to assess their global pain intensity within the past 7 days. Pain was evaluated on an 11-point Likert scale: min = 0 (best), max = 10 (worst). | Baseline, Week 52 |
| Change From Baseline in Patient Global Assessment (PtGA) of Disease Activity at Week 52 | Participants were asked to assess their disease activity within the past 7 days. Disease activity was evaluated on an 11-point Likert scale: min = 0 (best), max = 10 (worst). | Baseline, Week 52 |
| Change From Baseline in Physician Global Assessment (PGA) of Disease Activity at Week 52 | Physicians were asked to assess the disease activity of participants within the past 7 days. Disease activity was evaluated on an 11-point Likert scale: min = 0 (best), max = 10 (worst). | Baseline, Week 52 |
| Change From Baseline in Duration of Morning Stiffness at Week 52 | Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes. | Baseline, Week 52 |
| Percentage of Participants With Significant Reduction of Morning Stiffness | Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes. A significant reduction of duration of morning stiffness is defined as a reduction of the duration in minutes by at least 20 percent or reduction to 'no morning stiffness' (absence of morning stiffness). | Week 2, 6, 12, 26, 38, 52 |
| Percentage of Participants With Presence of Peripheral Arthritis | Peripheral arthritis is the inflammation of joints that involved asymmetrically. It involved the hips, shoulder girdle (glenohumeral, acromioclavicular, and sternoclavicular joints), joints of the chest wall (costovertebral joints, costosternal junctions) and symphysis pubis. | Baseline, Week 2, 6, 12, 26, 38, 52 |
| Change From Baseline in Number of Affected Joints by Peripheral Arthritis at Week 52 | Peripheral arthritis is the inflammation of joints that involved asymmetrically. It involved the hips, shoulder girdle (glenohumeral, acromioclavicular, and sternoclavicular joints), joints of the chest wall (costovertebral joints, costosternal junctions) and symphysis pubis. In case of no presence of peripheral arthritis the number of affected joints was set to 0. | Baseline, Week 52 |
| Percentage of Participants With Presence of Enthesitis | Enthesitis is the inflammation of the enthesis, where the joint capsules, ligaments or tendons attach to the bone. This inflammation can lead to severe pain and discomfort. | Baseline, Week 2, 6, 12, 26, 38, 52 |
| Change From Baseline in Number of Affected Body Parts by Enthesitis at Week 52 | Enthesitis is the inflammation of the enthesis, where the joint capsules, ligaments or tendons attach to the bone. This inflammation can lead to severe pain and discomfort. In case of no presence of enthesitis the number of affected body parts was set to 0. | Baseline, Week 52 |
| Change From Baseline in C-Reactive Protein (CRP) at Week 52 | The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. | Baseline, Week 52 |
| Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 52 | ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeter/hour (mm/hr). A higher rate is consistent with inflammation. | Baseline, Week 52 |
| Percentage of Participants With Assessment in Ankylosing Spondylitis 20 (ASAS-20) Response | ASAS measures symptomatic improvement in AS participants. ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20= at least >= 20 percent improvement from baseline and an absolute change >=1 unit on a 0-10 numeric scale (0=no disease activity; 10=high disease activity) in at least 3 of the domains (on a 0-10 numerical scale): Global assessment of disease activity by participant, participant's global pain intensity, function measured by BASFI and inflammation measured by the average of the last two Likert-scales in BASDAI concerning morning stiffness intensity and duration and no worsening in the remaining domain. | Week 12, 26, 38, 52 |
| Percentage of Participants With Assessment in Ankylosing Spondylitis 40 (ASAS-40) Response | ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants. ASAS =4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40= at least (>=) 40 percent improvement from baseline and an absolute change >=2 unit on a 0-10 numeric scale (0=no disease activity; 10=high disease activity) in at least 3 of the domains (on a 0-10 numerical scale): Global assessment of disease activity by participant, participant's global pain intensity, function measured by BASFI and inflammation measured by the average of the last two Likert-scales in BASDAI concerning morning stiffness intensity and duration and no worsening in the remaining domain. | Week 12, 26, 38, 52 |
| Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO) | EQ 5D: participant rated questionnaire to assess health-related quality of life. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (extreme problems). Score of each domain is transformed into a single TTO value using formula developed by Greiner et al and results in a total score range -0.205 to 0.999, higher score indicates a better health state. | Baseline, Week 26, 52 |
| Euro Quality of Life (EQ--5D)- Visual Analog Scale (VAS) | EQ-5D: participant rated questionnaire to assess health-related quality of life. Health. State Profile component assesses level of current health for 5 domains: mobility, self care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicate worst health state. Score of each domain is transformed into a single VAS score using formula developed by Greiner et al and results in a total score range of 0 to 100, where higher score indicates a better health state. | Baseline, Week 26, 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, 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, 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, 52 |
| Percentage of Participants With Prior or Concomitant Medication Use for Treatment of Ankylosing Spondylitis | Participants taking any non-study medications which were administered either prior to or during the study treatment for AS were reported. | Baseline up to Week 52 |
| Percentage of Participants With Discontinuation of Treatment Due to Adverse Events | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. | Baseline up to Week 52 |
| years |
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| Sex/Gender, Customized | Number | participants |
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Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
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| Primary | Percentage of Participants Achieving Partial Remission at Week 52 | Percentage of participants achieving partial remission was determined by ASAS criteria. Partial remission defined as a score of less than 2 units (on a scale of 0-10, where 0= no disease activity and 10= high disease activity) in each of the 4 assessment in ASAS domains: participant global assessment of disease activity, pain, function, and inflammation. | Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, who received etanercept therapy for the first time and had post-baseline documentation. Here 'N' signifies participants who were evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 52 |
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| Secondary | Percentage of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs) | 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 or incapacity; congenital anomaly. Percentage of participants with AEs included participants affected with both SAEs and non--SAEs. | Safety population included all treated participants with available post-baseline safety data. | Posted | Number | percentage of participants | Baseline up to Week 52 |
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| Secondary | Percentage of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs) by Co-morbidity | Safety population included all treated participants with available post--baseline safety data. | Posted | Number | percentage of participants | Baseline up to Week 52 |
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| Secondary | Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 52 | BASDAI is a validated self-assessment tool used to determine disease activity in participant with AS. Utilizing a 11-point Likert-scale (0= none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The index was computed by adding questions 1 to 4 plus the mean of questions 5 and 6. The resulting 0 to 50 score was divided by 5 to give a final 0-10 BASDAI score (0 being no problem and 10 being the worst problem). | Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 52 |
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| Secondary | Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 52 | BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Participants answered 10 questions, consisting of 8 specific questions regarding function in AS and 2 questions reflecting the participant's ability to cope with everyday life. Each question was answered on a 0-10 scale (0 being no problem and 10 being the worst problem), the sum of which (divided by 10) resulted in the BASFI score (0-10). | Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 52 |
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| Secondary | Change From Baseline in Occiput-to-Wall Distance at Week 52 | Occiput-to-wall distance is the distance between the occiput (posterior or back portion of the head) and the wall when the participant stood with heels and shoulder against the wall and the back straight. | Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points. | Posted | Mean | Standard Deviation | centimeter (cm) | Baseline, Week 52 |
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| Secondary | Change From Baseline in Lateral Lumbar Flexion at Week 52 | Lateral lumbar flexion was determined by the difference of the finger-floor-distance in normal position and in lateral bending position. | Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points. | Posted | Mean | Standard Deviation | cm | Baseline, Week 52 |
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| Secondary | Change From Baseline in Patient's Global Assessment (PtGA) of Pain at Week 52 | Participants were asked to assess their global pain intensity within the past 7 days. Pain was evaluated on an 11-point Likert scale: min = 0 (best), max = 10 (worst). | Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 52 |
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| Secondary | Change From Baseline in Patient Global Assessment (PtGA) of Disease Activity at Week 52 | Participants were asked to assess their disease activity within the past 7 days. Disease activity was evaluated on an 11-point Likert scale: min = 0 (best), max = 10 (worst). | Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 52 |
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| Secondary | Change From Baseline in Physician Global Assessment (PGA) of Disease Activity at Week 52 | Physicians were asked to assess the disease activity of participants within the past 7 days. Disease activity was evaluated on an 11-point Likert scale: min = 0 (best), max = 10 (worst). | Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 52 |
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| Secondary | Change From Baseline in Duration of Morning Stiffness at Week 52 | Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes. | Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points. | Posted | Mean | Standard Deviation | minutes | Baseline, Week 52 |
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| Secondary | Percentage of Participants With Significant Reduction of Morning Stiffness | Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes. A significant reduction of duration of morning stiffness is defined as a reduction of the duration in minutes by at least 20 percent or reduction to 'no morning stiffness' (absence of morning stiffness). | Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'N' signifies participants evaluable for this outcome measure and 'n' signifies participants evaluable for this measure at given time points. | Posted | Number | percentage of participants | Week 2, 6, 12, 26, 38, 52 |
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| Secondary | Percentage of Participants With Presence of Peripheral Arthritis | Peripheral arthritis is the inflammation of joints that involved asymmetrically. It involved the hips, shoulder girdle (glenohumeral, acromioclavicular, and sternoclavicular joints), joints of the chest wall (costovertebral joints, costosternal junctions) and symphysis pubis. | Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'N' signifies participants evaluable for this outcome measure and 'n' signifies participants evaluable for this measure at given time points. | Posted | Number | percentage of participants | Baseline, Week 2, 6, 12, 26, 38, 52 |
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| Secondary | Change From Baseline in Number of Affected Joints by Peripheral Arthritis at Week 52 | Peripheral arthritis is the inflammation of joints that involved asymmetrically. It involved the hips, shoulder girdle (glenohumeral, acromioclavicular, and sternoclavicular joints), joints of the chest wall (costovertebral joints, costosternal junctions) and symphysis pubis. In case of no presence of peripheral arthritis the number of affected joints was set to 0. | Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'N' signifies participants evaluable for this outcome measure and 'n' signifies participants evaluable for this measure at given time points. | Posted | Mean | Standard Deviation | joints | Baseline, Week 52 |
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| Secondary | Percentage of Participants With Presence of Enthesitis | Enthesitis is the inflammation of the enthesis, where the joint capsules, ligaments or tendons attach to the bone. This inflammation can lead to severe pain and discomfort. | Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'N' signifies participants evaluable for this outcome measure and 'n' signifies participants evaluable for this measure at given time points. | Posted | Number | percentage of participants | Baseline, Week 2, 6, 12, 26, 38, 52 |
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| Secondary | Change From Baseline in Number of Affected Body Parts by Enthesitis at Week 52 | Enthesitis is the inflammation of the enthesis, where the joint capsules, ligaments or tendons attach to the bone. This inflammation can lead to severe pain and discomfort. In case of no presence of enthesitis the number of affected body parts was set to 0. | Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points. | Posted | Mean | Standard Deviation | body parts | Baseline, Week 52 |
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| Secondary | Change From Baseline in C-Reactive Protein (CRP) at Week 52 | The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. | Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points. | Posted | Mean | Standard Deviation | milligram per deciliter (mg/dL) | Baseline, Week 52 |
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| Secondary | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 52 | ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeter/hour (mm/hr). A higher rate is consistent with inflammation. | Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points. | Posted | Mean | Standard Deviation | mm/hr | Baseline, Week 52 |
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| Secondary | Percentage of Participants With Assessment in Ankylosing Spondylitis 20 (ASAS-20) Response | ASAS measures symptomatic improvement in AS participants. ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20= at least >= 20 percent improvement from baseline and an absolute change >=1 unit on a 0-10 numeric scale (0=no disease activity; 10=high disease activity) in at least 3 of the domains (on a 0-10 numerical scale): Global assessment of disease activity by participant, participant's global pain intensity, function measured by BASFI and inflammation measured by the average of the last two Likert-scales in BASDAI concerning morning stiffness intensity and duration and no worsening in the remaining domain. | Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 12, 26, 38, 52 |
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|
|
| Secondary | Percentage of Participants With Assessment in Ankylosing Spondylitis 40 (ASAS-40) Response | ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants. ASAS =4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40= at least (>=) 40 percent improvement from baseline and an absolute change >=2 unit on a 0-10 numeric scale (0=no disease activity; 10=high disease activity) in at least 3 of the domains (on a 0-10 numerical scale): Global assessment of disease activity by participant, participant's global pain intensity, function measured by BASFI and inflammation measured by the average of the last two Likert-scales in BASDAI concerning morning stiffness intensity and duration and no worsening in the remaining domain. | Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 12, 26, 38, 52 |
|
|
|
| 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. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (extreme problems). Score of each domain is transformed into a single TTO value using formula developed by Greiner et al and results in a total score range -0.205 to 0.999, higher score indicates a better health state. | Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 26, 52 |
|
|
|
| Secondary | Euro Quality of Life (EQ--5D)- Visual Analog Scale (VAS) | EQ-5D: participant rated questionnaire to assess health-related quality of life. Health. State Profile component assesses level of current health for 5 domains: mobility, self care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicate worst health state. Score of each domain is transformed into a single VAS score using formula developed by Greiner et al and results in a total score range of 0 to 100, where higher score indicates a better health state. | Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 26, 52 |
|
|
|
| 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: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points. | Posted | Mean | Standard Deviation | percentage of impairment | Baseline, Week 26, 52 |
|
|
|
| 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: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'N' signifies participants evaluable for this outcome measure and 'n' signifies participants evaluable for this measure at given time points. | Posted | Mean | Standard Deviation | events | Baseline, Week 26, 52 |
|
|
|
| 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: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points. | Posted | Mean | Standard Deviation | days | Baseline, Week 26, 52 |
|
|
|
| Secondary | Percentage of Participants With Prior or Concomitant Medication Use for Treatment of Ankylosing Spondylitis | Participants taking any non-study medications which were administered either prior to or during the study treatment for AS were reported. | Safety population included all treated participants with available post-baseline safety data. | Posted | Number | percentage of participants | Baseline up to Week 52 |
|
|
|
| Secondary | Percentage of Participants With Discontinuation of Treatment Due to Adverse Events | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. | Safety population included all treated participants with available post--baseline safety data. | Posted | Number | percentage of participants | Baseline up to Week 52 |
|
|
|
| 128 |
| 1,685 |
| 588 |
| 1,685 |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Spondylitis | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Dupuytren's contracture | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Joint ankylosis | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Joint instability | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Osteochondrosis | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v17.1 | Non-systematic Assessment |
|
| Malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v17.1 | Non-systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v17.1 | Non-systematic Assessment |
|
| Adenoma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v17.1 | Non-systematic Assessment |
|
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v17.1 | Non-systematic Assessment |
|
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v17.1 | Non-systematic Assessment |
|
| Glioblastoma multiforme | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v17.1 | Non-systematic Assessment |
|
| Haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v17.1 | Non-systematic Assessment |
|
| Intracranial haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v17.1 | Non-systematic Assessment |
|
| Metastasis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v17.1 | Non-systematic Assessment |
|
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v17.1 | Non-systematic Assessment |
|
| Oropharyngeal neoplasm benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v17.1 | Non-systematic Assessment |
|
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v17.1 | Non-systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v17.1 | Non-systematic Assessment |
|
| Thyroid neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v17.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Abdominal abscess | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Anal abscess | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Arthritis bacterial | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Campylobacter gastroenteritis | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Clostridium difficile colitis | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Meningitis aseptic | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Meningitis viral | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Pilonidal cyst | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Drug exposure during pregnancy | Injury, poisoning and procedural complications | MedDRA v17.1 | Non-systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA v17.1 | Non-systematic Assessment |
|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA v17.1 | Non-systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA v17.1 | Non-systematic Assessment |
|
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA v17.1 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA v17.1 | Non-systematic Assessment |
|
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA v17.1 | Non-systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | MedDRA v17.1 | Non-systematic Assessment |
|
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA v17.1 | Non-systematic Assessment |
|
| Lymphatic duct rupture | Injury, poisoning and procedural complications | MedDRA v17.1 | Non-systematic Assessment |
|
| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA v17.1 | Non-systematic Assessment |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA v17.1 | Non-systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA v17.1 | Non-systematic Assessment |
|
| Seroma | Injury, poisoning and procedural complications | MedDRA v17.1 | Non-systematic Assessment |
|
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA v17.1 | Non-systematic Assessment |
|
| Sports injury | Injury, poisoning and procedural complications | MedDRA v17.1 | Non-systematic Assessment |
|
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA v17.1 | Non-systematic Assessment |
|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA v17.1 | Non-systematic Assessment |
|
| Crohn's disease | Gastrointestinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Anal fistula | Gastrointestinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Pancreatitis chronic | Gastrointestinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Papilla of Vater stenosis | Gastrointestinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Subileus | Gastrointestinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Umbilical hernia | Gastrointestinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Migraine with aura | Nervous system disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Aphasia | Nervous system disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Carotid artery occlusion | Nervous system disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Demyelination | Nervous system disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Dysaesthesia | Nervous system disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Hemianopia homonymous | Nervous system disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Leukoencephalopathy | Nervous system disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Monoplegia | Nervous system disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Movement disorder | Nervous system disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Paraplegia | Nervous system disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Thalamic infarction | Nervous system disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| VIIth nerve paralysis | Nervous system disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Mitral valve incompetence | Cardiac disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Condition aggravated | General disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Drug ineffective | General disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Impaired healing | General disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Injection site hypersensitivity | General disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Hip surgery | Surgical and medical procedures | MedDRA v17.1 | Non-systematic Assessment |
|
| Implantable defibrillator insertion | Surgical and medical procedures | MedDRA v17.1 | Non-systematic Assessment |
|
| Inguinal hernia repair | Surgical and medical procedures | MedDRA v17.1 | Non-systematic Assessment |
|
| Myringoplasty | Surgical and medical procedures | MedDRA v17.1 | Non-systematic Assessment |
|
| Removal of foreign body | Surgical and medical procedures | MedDRA v17.1 | Non-systematic Assessment |
|
| Spinal fusion surgery | Surgical and medical procedures | MedDRA v17.1 | Non-systematic Assessment |
|
| Tonsillectomy | Surgical and medical procedures | MedDRA v17.1 | Non-systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Bile duct stone | Hepatobiliary disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Biliary colic | Hepatobiliary disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Psychogenic pain disorder | Psychiatric disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Acute stress disorder | Psychiatric disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Major depression | Psychiatric disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Psychotic disorder | Psychiatric disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Calculus ureteric | Renal and urinary disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Renal colic | Renal and urinary disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Urinary tract obstruction | Renal and urinary disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Iritis | Eye disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Cataract | Eye disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Maculopathy | Eye disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Goitre | Endocrine disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Arthroscopy | Investigations | MedDRA v17.1 | Non-systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA v17.1 | Non-systematic Assessment |
|
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA v17.1 | Non-systematic Assessment |
|
| Premature baby | Pregnancy, puerperium and perinatal conditions | MedDRA v17.1 | Non-systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Bone marrow disorder | Blood and lymphatic system disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Skull malformation | Congenital, familial and genetic disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Sarcoidosis | Immune system disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Cervical polyp | Reproductive system and breast disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v17.1 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Febrile infection | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Acute tonsillitis | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Fungal skin infection | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Genital herpes | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Infection susceptibility increased | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Rash pustular | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Streptococcal infection | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Tracheobronchitis | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Acarodermatitis | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Cellulitis of male external genital organ | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Erythrasma | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Gastrointestinal candidiasis | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Gastrointestinal infection | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Genital candidiasis | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Hepatitis B | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Injection site infection | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Oophoritis | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Otitis externa | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Perirectal abscess | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Peritonsillar abscess | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Pilonidal cyst | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Pseudofolliculitis barbae | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Respiratory tract infection viral | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Soft tissue infection | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Tinea pedis | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Vaginal candidiasis | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Viral tonsillitis | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Wound infection staphylococcal | Infections and infestations | MedDRA v17.1 | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Condition aggravated | General disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Injection site irritation | General disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Injection site hypersensitivity | General disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Local swelling | General disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Drug ineffective | General disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Drug intolerance | General disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Impaired healing | General disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Injection site pain | General disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Injection site urticaria | General disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Injection site induration | General disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Injection site macule | General disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Injection site warmth | General disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Tenderness | General disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Application site erythema | General disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Feeling hot | General disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Granuloma | General disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Injection site dermatitis | General disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Injection site discolouration | General disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Injection site necrosis | General disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Injection site oedema | General disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Injection site paraesthesia | General disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Injection site rash | General disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Local reaction | General disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Localised oedema | General disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Sensation of foreign body | General disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Erythema nodosum | Skin and subcutaneous tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Exfoliative rash | Skin and subcutaneous tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Generalised erythema | Skin and subcutaneous tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Nail psoriasis | Skin and subcutaneous tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Periorbital oedema | Skin and subcutaneous tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Pustular psoriasis | Skin and subcutaneous tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Skin reaction | Skin and subcutaneous tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Rash vesicular | Skin and subcutaneous tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Skin burning sensation | Skin and subcutaneous tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Skin induration | Skin and subcutaneous tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Skin nodule | Skin and subcutaneous tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Ankylosing spondylitis | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Enthesopathy | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Myosclerosis | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Chondropathy | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Dactylitis | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Facet joint syndrome | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Gouty tophus | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Muscle disorder | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Osteitis | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Sacroiliitis | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Crohn's disease | Gastrointestinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Periodontitis | Gastrointestinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Gingival pain | Gastrointestinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Abdominal tenderness | Gastrointestinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Anal fissure | Gastrointestinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Anal fistula | Gastrointestinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Breath odour | Gastrointestinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Chapped lips | Gastrointestinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Epiploic appendagitis | Gastrointestinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Frequent bowel movements | Gastrointestinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Glossodynia | Gastrointestinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Lip dry | Gastrointestinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Proctalgia | Gastrointestinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Radicular cyst | Gastrointestinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Stomach discomfort | Gastrointestinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Umbilical hernia | Gastrointestinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Carpal tunnel syndrome | Nervous system disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Cervical root pain | Nervous system disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Cervicobrachial syndrome | Nervous system disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Movement disorder | Nervous system disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Sensory disturbance | Nervous system disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Amnesia | Nervous system disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Areflexia | Nervous system disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Autonomic nervous system imbalance | Nervous system disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Dysaesthesia | Nervous system disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Hyperaesthesia | Nervous system disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Intercostal neuralgia | Nervous system disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Meralgia paraesthetica | Nervous system disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Restless legs syndrome | Nervous system disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Syncope vasovagal | Nervous system disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA v17.1 | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA v17.1 | Non-systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA v17.1 | Non-systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA v17.1 | Non-systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA v17.1 | Non-systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA v17.1 | Non-systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA v17.1 | Non-systematic Assessment |
|
| Weight increased | Investigations | MedDRA v17.1 | Non-systematic Assessment |
|
| Arthroscopy | Investigations | MedDRA v17.1 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA v17.1 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA v17.1 | Non-systematic Assessment |
|
| Investigation | Investigations | MedDRA v17.1 | Non-systematic Assessment |
|
| Antinuclear antibody positive | Investigations | MedDRA v17.1 | Non-systematic Assessment |
|
| Bacterial test positive | Investigations | MedDRA v17.1 | Non-systematic Assessment |
|
| Biopsy prostate | Investigations | MedDRA v17.1 | Non-systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA v17.1 | Non-systematic Assessment |
|
| Blood urine present | Investigations | MedDRA v17.1 | Non-systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA v17.1 | Non-systematic Assessment |
|
| DNA antibody positive | Investigations | MedDRA v17.1 | Non-systematic Assessment |
|
| Diagnostic procedure | Investigations | MedDRA v17.1 | Non-systematic Assessment |
|
| ECG signs of myocardial ischaemia | Investigations | MedDRA v17.1 | Non-systematic Assessment |
|
| Heart rate increased | Investigations | MedDRA v17.1 | Non-systematic Assessment |
|
| Laboratory test abnormal | Investigations | MedDRA v17.1 | Non-systematic Assessment |
|
| Lipase increased | Investigations | MedDRA v17.1 | Non-systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA v17.1 | Non-systematic Assessment |
|
| Red blood cell sedimentation rate increased | Investigations | MedDRA v17.1 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA v17.1 | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA v17.1 | Non-systematic Assessment |
|
| Blood pressure diastolic increased | Investigations | MedDRA v17.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Rhonchi | Respiratory, thoracic and mediastinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Sputum discoloured | Respiratory, thoracic and mediastinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Painful respiration | Respiratory, thoracic and mediastinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Throat tightness | Respiratory, thoracic and mediastinal disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Iritis | Eye disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Visual disturbance | Eye disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Uveitis | Eye disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Abnormal sensation in eye | Eye disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Cataract | Eye disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Iridocyclitis | Eye disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Eye swelling | Eye disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Hospitalisation | Surgical and medical procedures | MedDRA v17.1 | Non-systematic Assessment |
|
| Carpal tunnel decompression | Surgical and medical procedures | MedDRA v17.1 | Non-systematic Assessment |
|
| Synoviorthesis | Surgical and medical procedures | MedDRA v17.1 | Non-systematic Assessment |
|
| Abortion induced | Surgical and medical procedures | MedDRA v17.1 | Non-systematic Assessment |
|
| Angioplasty | Surgical and medical procedures | MedDRA v17.1 | Non-systematic Assessment |
|
| Ankle operation | Surgical and medical procedures | MedDRA v17.1 | Non-systematic Assessment |
|
| Arterial stent insertion | Surgical and medical procedures | MedDRA v17.1 | Non-systematic Assessment |
|
| Baker's cyst excision | Surgical and medical procedures | MedDRA v17.1 | Non-systematic Assessment |
|
| Cataract operation | Surgical and medical procedures | MedDRA v17.1 | Non-systematic Assessment |
|
| Catheterisation cardiac | Surgical and medical procedures | MedDRA v17.1 | Non-systematic Assessment |
|
| Dental operation | Surgical and medical procedures | MedDRA v17.1 | Non-systematic Assessment |
|
| Dental treatment | Surgical and medical procedures | MedDRA v17.1 | Non-systematic Assessment |
|
| Hip arthroplasty | Surgical and medical procedures | MedDRA v17.1 | Non-systematic Assessment |
|
| Infiltration anaesthesia | Surgical and medical procedures | MedDRA v17.1 | Non-systematic Assessment |
|
| Knee arthroplasty | Surgical and medical procedures | MedDRA v17.1 | Non-systematic Assessment |
|
| Ligament operation | Surgical and medical procedures | MedDRA v17.1 | Non-systematic Assessment |
|
| Neurolysis | Surgical and medical procedures | MedDRA v17.1 | Non-systematic Assessment |
|
| Osteotomy | Surgical and medical procedures | MedDRA v17.1 | Non-systematic Assessment |
|
| Skin operation | Surgical and medical procedures | MedDRA v17.1 | Non-systematic Assessment |
|
| Spinal deformity correction | Surgical and medical procedures | MedDRA v17.1 | Non-systematic Assessment |
|
| Surgery | Surgical and medical procedures | MedDRA v17.1 | Non-systematic Assessment |
|
| Tendon operation | Surgical and medical procedures | MedDRA v17.1 | Non-systematic Assessment |
|
| Tendon sheath incision | Surgical and medical procedures | MedDRA v17.1 | Non-systematic Assessment |
|
| Tonsillectomy | Surgical and medical procedures | MedDRA v17.1 | Non-systematic Assessment |
|
| Tooth extraction | Surgical and medical procedures | MedDRA v17.1 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA v17.1 | Non-systematic Assessment |
|
| Drug exposure during pregnancy | Injury, poisoning and procedural complications | MedDRA v17.1 | Non-systematic Assessment |
|
| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA v17.1 | Non-systematic Assessment |
|
| Accident | Injury, poisoning and procedural complications | MedDRA v17.1 | Non-systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA v17.1 | Non-systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA v17.1 | Non-systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA v17.1 | Non-systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA v17.1 | Non-systematic Assessment |
|
| Joint sprain | Injury, poisoning and procedural complications | MedDRA v17.1 | Non-systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA v17.1 | Non-systematic Assessment |
|
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA v17.1 | Non-systematic Assessment |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA v17.1 | Non-systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA v17.1 | Non-systematic Assessment |
|
| Skeletal injury | Injury, poisoning and procedural complications | MedDRA v17.1 | Non-systematic Assessment |
|
| Skin injury | Injury, poisoning and procedural complications | MedDRA v17.1 | Non-systematic Assessment |
|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA v17.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Cardiovascular insufficiency | Vascular disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Thrombophlebitis | Vascular disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Varicose vein | Vascular disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Depressed mood | Psychiatric disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Alcohol abuse | Psychiatric disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Libido decreased | Psychiatric disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Mood swings | Psychiatric disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Panic attack | Psychiatric disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Somatoform disorder | Psychiatric disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Tobacco abuse | Psychiatric disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Cardiovascular disorder | Cardiac disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Mitral valve incompetence | Cardiac disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Cardiac discomfort | Cardiac disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Mitral valve prolapse | Cardiac disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA v17.1 | Non-systematic Assessment |
|
| Delivery | Pregnancy, puerperium and perinatal conditions | MedDRA v17.1 | Non-systematic Assessment |
|
| First trimester pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA v17.1 | Non-systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Sarcoidosis | Immune system disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Cow's milk intolerance | Metabolism and nutrition disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Obesity | Metabolism and nutrition disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Anaemia macrocytic | Blood and lymphatic system disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Ear pruritus | Ear and labyrinth disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Inner ear inflammation | Ear and labyrinth disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Sudden hearing loss | Ear and labyrinth disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Colon adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v17.1 | Non-systematic Assessment |
|
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v17.1 | Non-systematic Assessment |
|
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v17.1 | Non-systematic Assessment |
|
| Superficial spreading melanoma stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v17.1 | Non-systematic Assessment |
|
| Calculus urinary | Renal and urinary disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Renal colic | Renal and urinary disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Genital erythema | Reproductive system and breast disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Menstruation irregular | Reproductive system and breast disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Androgen deficiency | Endocrine disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Cushing's syndrome | Endocrine disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Hepatic steatosis | Hepatobiliary disorders | MedDRA v17.1 | Non-systematic Assessment |
|
| Campylobacter infection | Infections and infestations | MedDRA v17.1 | 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.
| D013122 |
| Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
| 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 |
|---|---|
|
| Week 26 (n=1395) |
|
| Week 38 (n=1235) |
|
| Week 52 (n=1186) |
|
| Title | Measurements |
|---|---|
|
| Week 12 (n=1480) |
|
| Week 26 (n=1395) |
|
| Week 38 (n=1235) |
|
| Week 52 (n=1186) |
|
| Title | Measurements |
|---|---|
|
| Week 12 (n=1480) |
|
| Week 26 (n=1395) |
|
| Week 38 (n=1235) |
|
| Week 52 (n=1186) |
|
| Title | Measurements |
|---|---|
|
| Week 52 (n=1186) |
|
| Title | Measurements |
|---|---|
|
| Week 52 (n=1186) |
|
|
|
|
| Baseline: Activity impairment (n = 1624) |
|
| Week 26: Work Time Missed (n = 666) |
|
| Week 26: Impairment While Working (n = 799) |
|
| Week 26: Overall work impairment (n = 657) |
|
| Week 26: Activity impairment (n = 1331) |
|
| Week 52: Work Time Missed (n = 588) |
|
| Week 52: Impairment While Working (n = 706) |
|
| Week 52: Overall work impairment (n = 578) |
|
| Week 52: Activity impairment (n = 1137) |
|
|
| Baseline: In-patient Hospitalization (n = 1658) |
|
| Baseline: In-patient Rehabilitation (n = 1657) |
|
| Baseline: Follow-up Treatment (n = 1662) |
|
| Baseline: Out-patient Rehabilitation (n = 1661) |
|
| Baseline: Physiotherapy (n = 1659) |
|
| Baseline: Out-patient Hospitalization (n = 1663) |
|
| Baseline: Ergotherapy (n = 1663) |
|
| Baseline: Other Health Care Resources (n = 1662) |
|
| Baseline: Sum Over All Care Resources (n = 1663) |
|
| Week 26: General Practitioner Visit (n = 1389) |
|
| Week 26: Rheumatologist Visit (n = 1392) |
|
| Week 26: Other Specialist Visit (n = 1393) |
|
| Week 26: In-patient Hospitalization (n = 1395) |
|
| Week 26: In-patient Rehabilitation (n = 1392) |
|
| Week 26: Follow-up Treatment (n = 1395) |
|
| Week 26: Out-patient Rehabilitation (n = 1395) |
|
| Week 26: Physiotherapy (n = 1395) |
|
| Week 26: Out-patient Hospitalization (n = 1394) |
|
| Week 26: Ergotherapy (n = 1395) |
|
| Week 26: Other Health Care Resources (n = 1390) |
|
| Week 26: Sum Over All Care Resources (n = 1395) |
|
| Week 52: General Practitioner Visit (n = 1184) |
|
| Week 52: Rheumatologist Visit (n = 1184) |
|
| Week 52: Other Specialist Visit (n = 1183) |
|
| Week 52: In-patient Hospitalization (n = 1186) |
|
| Week 52: In-patient Rehabilitation (n = 1186) |
|
| Week 52: Follow-up Treatment (n = 1186) |
|
| Week 52: Out-patient Rehabilitation (n = 1186) |
|
| Week 52: Physiotherapy (n = 1186) |
|
| Week 52: Out-patient Hospitalization (n = 1186) |
|
| Week 52: Ergotherapy (n = 1186) |
|
| Week 52: Other Health Care Resources (n = 1185) |
|
| Week 52: Sum Over All Care Resources (n = 1186) |
|
|
| Baseline: In-patient Hospitalization (n = 1633) |
|
| Baseline: In-patient Rehabilitation (n = 1648) |
|
| Baseline: Follow-up Treatment (n = 1661) |
|
| Baseline: Out-patient Rehabilitation (n = 1654) |
|
| Baseline: Physiotherapy (n = 1551) |
|
| Baseline: Out-patient Hospitalization (n = 1661) |
|
| Baseline: Ergotherapy (n = 1663) |
|
| Baseline: Other Health Care Resources (n = 1641) |
|
| Baseline: Sum Over All Care Resources (n = 1663) |
|
| Week 26: General Practitioner Visit (n = 917) |
|
| Week 26: Rheumatologist Visit (n = 834) |
|
| Week 26: Other Specialist Visit (n = 1190) |
|
| Week 26: In-patient Hospitalization (n = 1390) |
|
| Week 26: In-patient Rehabilitation (n = 1391) |
|
| Week 26: Follow-up Treatment (n = 1395) |
|
| Week 26: Out-patient Rehabilitation (n = 1394) |
|
| Week 26: Physiotherapy (n = 1350) |
|
| Week 26: Out-patient Hospitalization (n = 1395) |
|
| Week 26: Ergotherapy (n = 1393) |
|
| Week 26: Other Health Care Resources (n = 1376) |
|
| Week 26: Sum Over All Care Resources (n = 1395) |
|
| Week 52: General Practitioner Visit (n = 762) |
|
| Week 52: Rheumatologist Visit (n = 716) |
|
| Week 52: Other Specialist Visit (n = 1009) |
|
| Week 52: In-patient Hospitalization (n = 1177) |
|
| Week 52: In-patient Rehabilitation (n = 1185) |
|
| Week 52: Follow-up Treatment (n = 1186) |
|
| Week 52: Out-patient Rehabilitation (n = 1186) |
|
| Week 52: Physiotherapy (n = 1151) |
|
| Week 52: Out-patient Hospitalization (n = 1186) |
|
| Week 52: Ergotherapy (n = 1186) |
|
| Week 52: Other Health Care Resources (n = 1162) |
|
| Week 52: Sum Over All Care Resources (n = 1186) |
|