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| ID | Type | Description | Link |
|---|---|---|---|
| B1801127 |
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The purpose of this study is to evaluate the safety and effectiveness of etanercept under usual care settings in patients with PsA treated by rheumatologists.
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 Psoriatic Arthritis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etanercept | Drug | The patients will be treated in accordance with the requirements of the labelling of Enbrel® in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and Week 52 (end of the observation period) that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial. | Baseline up to Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Percent Body Surface Area (BSA) Affected by Psoriasis at Week 52 | Baseline, Week 52 | |
| Change From Baseline in Disease Activity Score Based on 28 Joints Count (DAS 28) at Week 52 | DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 100 mm; higher scores indicated greater affectation due to disease activity). DAS28 total score range: 0-10, where DAS28 less than or equal to (=<) 3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate disease activity and >5.1 = high disease activity. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Patient Global Assessment of Disease Activity at Week 52 | Measured using a 100 mm visual analog scale (VAS) ranging from 0 mm = very good to 100 mm = very bad. | Baseline, Week 52 |
Inclusion Criteria:
Exclusion Criteria:
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Only patients for whom the decision has already been made to initiate treatment with Enbrel® can be enrolled in this observational trial. These patients must have a proven diagnosis of Psoriatic Arthritis
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Toerwang-Samerberg | 83122 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29606665 | Derived | Behrens F, Meier L, Prinz JC, Jobst J, Lippe R, Loschmann PA, Lorenz HM. Simultaneous Response in Several Domains in Patients with Psoriatic Disease Treated with Etanercept as Monotherapy or in Combination with Conventional Synthetic Disease-modifying Antirheumatic Drugs. J Rheumatol. 2018 Jun;45(6):802-810. doi: 10.3899/jrheum.170932. Epub 2018 Apr 1. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants With Psoriatic Arthritis | Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety analysis set included all participants who were enrolled in this study and had safety data available. Out of a total of 1285 participants included in the safety analysis set, data for baseline measure (age) was available only for 1274 participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Participants With Psoriatic Arthritis | Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year. |
| 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 With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and Week 52 (end of the observation period) that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial. | Safety analysis set included all participants who were enrolled in this study and had safety data available. | Posted | Number | percentage of participants | Baseline up to Week 52 |
|
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants With Psoriatic Arthritis | Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v10.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA v10.0 | Non-systematic Assessment |
Results for Psoriasis Area and Severity Index (PASI) was not reported since it was not to be analyzed by rheumatologists as part of this study, as per planned analysis.
| 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 |
|---|---|
| D015535 | Arthritis, Psoriatic |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
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| ID | Term |
|---|---|
| D000068800 | Etanercept |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
Not provided
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| Baseline, Week 52 |
| Change From Baseline in Ritchie Index at Week 52 | Ritchie index: the numerical measurement of joint tenderness (28 joints) in participants with arthritis. The number of quantitative evaluations of the pain experienced by the participants when the joints were subjected to firm pressure when exerted over the articular margin or in some instances by passive movement of the joint. Participant's reaction to pressure exerted by the physician were documented on 4-point scale, 0=not tender, 1=tender, 2=tender and caused wince, 3=reflexive effort to withdraw. Ritchie index was calculated as the total of the individual grades for all joints; ranged from 0 to 84, where higher score indicated higher tenderness. | Baseline, Week 52 |
| Change From Baseline in Physician Global Assessment of Disease Activity at Week 52 | Physician global assessment of disease activity was measured on a 0 to 100 millimeter (mm) visual analog scale (VAS), with 0 mm = no disease activity to 100 mm = most possible disease activity. | Baseline, Week 52 |
| Number of Participants With Nail Involvement | Number of participants with psoriatic arthritis affecting the nails are reported. | Baseline, Week 12, 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 Patient Assessment of Itching at Week 52 | Participants rated the severity of their psoriasis itching on a 0 (none) to 100 (most possible) scale. | Baseline, Week 52 |
| Change From Baseline in Patient Assessment of Pain at Week 52 | Participants rated the severity of their psoriatic arthritis-related pain on a 0 (none) to 100 (most possible) scale. | Baseline, Week 52 |
| Change From Baseline in 12-Item Short Form Health Survey (SF-12) at Week 52 | SF-12 questionnaire was used to determine participants' quality of life (QoL). It comprised 12 items which covered 8 concepts: physical functionality, role impairment due to physical problems, physical pain, perception of general health, vitality, social functionality, role impairment due to emotional problems, and psychological wellbeing. Results were presented in the form of 2 meta-scores, the physical component and the mental component, each ranged from 0 to 100. Higher scores=better QoL, positive changes from baseline=improvement in QoL. | Baseline, Week 52 |
| years |
|
| Sex/Gender, Customized | Number | participants |
|
Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year. |
|
|
| Secondary | Change From Baseline in Percent Body Surface Area (BSA) Affected by Psoriasis at Week 52 | Efficacy analysis set included all participants who were greater than (>) 18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point. | Posted | Mean | Standard Deviation | percentage of BSA | Baseline, Week 52 |
|
|
|
| Secondary | Change From Baseline in Disease Activity Score Based on 28 Joints Count (DAS 28) at Week 52 | DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 100 mm; higher scores indicated greater affectation due to disease activity). DAS28 total score range: 0-10, where DAS28 less than or equal to (=<) 3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate disease activity and >5.1 = high disease activity. | Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 52 |
|
|
|
| Secondary | Change From Baseline in Ritchie Index at Week 52 | Ritchie index: the numerical measurement of joint tenderness (28 joints) in participants with arthritis. The number of quantitative evaluations of the pain experienced by the participants when the joints were subjected to firm pressure when exerted over the articular margin or in some instances by passive movement of the joint. Participant's reaction to pressure exerted by the physician were documented on 4-point scale, 0=not tender, 1=tender, 2=tender and caused wince, 3=reflexive effort to withdraw. Ritchie index was calculated as the total of the individual grades for all joints; ranged from 0 to 84, where higher score indicated higher tenderness. | Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 52 |
|
|
|
| Secondary | Change From Baseline in Physician Global Assessment of Disease Activity at Week 52 | Physician global assessment of disease activity was measured on a 0 to 100 millimeter (mm) visual analog scale (VAS), with 0 mm = no disease activity to 100 mm = most possible disease activity. | Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point. | Posted | Mean | Standard Deviation | millimeter | Baseline, Week 52 |
|
|
|
| Secondary | Number of Participants With Nail Involvement | Number of participants with psoriatic arthritis affecting the nails are reported. | Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point. | Posted | Number | participants | Baseline, Week 12, 52 |
|
|
|
| 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. | Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point. | Posted | Mean | Standard Deviation | milligram per deciliter (mg/dL) | Baseline, Week 52 |
|
|
|
| Secondary | Change From Baseline in Patient Assessment of Itching at Week 52 | Participants rated the severity of their psoriasis itching on a 0 (none) to 100 (most possible) scale. | Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 52 |
|
|
|
| Secondary | Change From Baseline in Patient Assessment of Pain at Week 52 | Participants rated the severity of their psoriatic arthritis-related pain on a 0 (none) to 100 (most possible) scale. | Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 52 |
|
|
|
| Secondary | Change From Baseline in 12-Item Short Form Health Survey (SF-12) at Week 52 | SF-12 questionnaire was used to determine participants' quality of life (QoL). It comprised 12 items which covered 8 concepts: physical functionality, role impairment due to physical problems, physical pain, perception of general health, vitality, social functionality, role impairment due to emotional problems, and psychological wellbeing. Results were presented in the form of 2 meta-scores, the physical component and the mental component, each ranged from 0 to 100. Higher scores=better QoL, positive changes from baseline=improvement in QoL. | Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 52 |
|
|
|
| Other Pre-specified | Change From Baseline in Patient Global Assessment of Disease Activity at Week 52 | Measured using a 100 mm visual analog scale (VAS) ranging from 0 mm = very good to 100 mm = very bad. | Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point. | Posted | Mean | Standard Deviation | millimeter | Baseline, Week 52 |
|
|
|
| 77 |
| 1,285 |
| 453 |
| 1,285 |
| Atrial fibrillation | Cardiac disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Bradyarrhythmia | Cardiac disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Cyanosis | Cardiac disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Tachyarrhythmia | Cardiac disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Adrenal mass | Endocrine disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Abdominal wall disorder | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Barrett's oesophagus | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Condition aggravated | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Drug ineffective | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Impaired healing | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Necrosis | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Nonspecific reaction | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Abscess limb | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Abscess neck | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Gastroenteritis Norwalk virus | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Peritonsillar abscess | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Pulmonary tuberculosis | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Cartilage injury | Injury, poisoning and procedural complications | MedDRA v10.0 | Non-systematic Assessment |
|
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA v10.0 | Non-systematic Assessment |
|
| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA v10.0 | Non-systematic Assessment |
|
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA v10.0 | Non-systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA v10.0 | Non-systematic Assessment |
|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA v10.0 | Non-systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA v10.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Bone disorder | Musculoskeletal and connective tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Fracture delayed union | Musculoskeletal and connective tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Adrenal adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v10.0 | Non-systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v10.0 | Non-systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v10.0 | Non-systematic Assessment |
|
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v10.0 | Non-systematic Assessment |
|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v10.0 | Non-systematic Assessment |
|
| Metastatic malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v10.0 | Non-systematic Assessment |
|
| Ovarian adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v10.0 | Non-systematic Assessment |
|
| Pancreatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v10.0 | Non-systematic Assessment |
|
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v10.0 | Non-systematic Assessment |
|
| Amyotrophic lateral sclerosis | Nervous system disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Aphasia | Nervous system disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Carotid artery occlusion | Nervous system disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Cerebral ischaemia | Nervous system disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Demyelination | Nervous system disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Encephalitis | Nervous system disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Multiple sclerosis | Nervous system disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Myelitis | Nervous system disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Optic neuritis | Nervous system disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Calculus ureteric | Renal and urinary disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Alveolitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Pulmonary sarcoidosis | Respiratory, thoracic and mediastinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Pemphigoid | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Pustular psoriasis | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Skin reaction | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Alcohol rehabilitation | Surgical and medical procedures | MedDRA v10.0 | Non-systematic Assessment |
|
| Vascular operation | Surgical and medical procedures | MedDRA v10.0 | Non-systematic Assessment |
|
| Accelerated hypertension | Vascular disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Lymphocele | Vascular disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Venous insufficiency | Vascular disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Cardiac discomfort | Cardiac disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Cardiovascular disorder | Cardiac disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Cyanosis | Cardiac disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Type IIb hyperlipidaemia | Congenital, familial and genetic disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Ear discomfort | Ear and labyrinth disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Toxic nodular goitre | Endocrine disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Abnormal sensation in eye | Eye disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Blepharitis | Eye disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Cataract | Eye disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Conjunctivitis allergic | Eye disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Eye inflammation | Eye disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Iridocyclitis | Eye disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Iritis | Eye disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Keratitis | Eye disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Scleritis | Eye disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Sicca syndrome | Eye disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Uveitis | Eye disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Visual acuity reduced | Eye disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Duodenal polyp | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Frequent bowel movements | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Mucous stools | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Oral mucosal blistering | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Paraesthesia oral | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Periodontitis | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Stomach discomfort | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Condition aggravated | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Drug ineffective | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Facial pain | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Feeling cold | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Feeling hot | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Injection site discolouration | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Injection site hypersensitivity | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Injection site induration | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Injection site inflammation | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Injection site irritation | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Injection site macule | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Injection site oedema | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Injection site pain | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Injection site papule | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Injection site rash | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Injection site urticaria | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Injection site warmth | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Local swelling | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Mucosal haemorrhage | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Paradoxical pain | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Performance status decreased | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Sensation of foreign body | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Swelling | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Hepatic steatosis | Hepatobiliary disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Hepatocellular damage | Hepatobiliary disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Food allergy | Immune system disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Type IV hypersensitivity reaction | Immune system disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Acute tonsillitis | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Arthritis infective | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Bacterial infection | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Campylobacter infection | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Candidiasis | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Conjunctivitis infective | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Febrile infection | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Fungal skin infection | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Gastrointestinal infection | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Helicobacter infection | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Herpes virus infection | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Infection in an immunocompromised host | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Laryngopharyngitis | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Nail bed infection | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Onychomycosis | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Oral infection | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Pertussis | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Purulence | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Rash pustular | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Sinobronchitis | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Staphylococcal skin infection | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Tinea pedis | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Toxoplasmosis | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Tracheitis | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Vaginal candidiasis | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Animal bite | Injury, poisoning and procedural complications | MedDRA v10.0 | Non-systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA v10.0 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA v10.0 | Non-systematic Assessment |
|
| Epicondylitis | Injury, poisoning and procedural complications | MedDRA v10.0 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA v10.0 | Non-systematic Assessment |
|
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA v10.0 | Non-systematic Assessment |
|
| Joint sprain | Injury, poisoning and procedural complications | MedDRA v10.0 | Non-systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA v10.0 | Non-systematic Assessment |
|
| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA v10.0 | Non-systematic Assessment |
|
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA v10.0 | Non-systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA v10.0 | Non-systematic Assessment |
|
| Scratch | Injury, poisoning and procedural complications | MedDRA v10.0 | Non-systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA v10.0 | Non-systematic Assessment |
|
| Tendon injury | Injury, poisoning and procedural complications | MedDRA v10.0 | Non-systematic Assessment |
|
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA v10.0 | Non-systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA v10.0 | Non-systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA v10.0 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA v10.0 | Non-systematic Assessment |
|
| Antinuclear antibody increased | Investigations | MedDRA v10.0 | Non-systematic Assessment |
|
| Arthroscopy | Investigations | MedDRA v10.0 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA v10.0 | Non-systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA v10.0 | Non-systematic Assessment |
|
| Body temperature increased | Investigations | MedDRA v10.0 | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA v10.0 | Non-systematic Assessment |
|
| Haematocrit increased | Investigations | MedDRA v10.0 | Non-systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA v10.0 | Non-systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA v10.0 | Non-systematic Assessment |
|
| Mean cell haemoglobin increased | Investigations | MedDRA v10.0 | Non-systematic Assessment |
|
| Mean cell volume increased | Investigations | MedDRA v10.0 | Non-systematic Assessment |
|
| Red blood cell count decreased | Investigations | MedDRA v10.0 | Non-systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA v10.0 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA v10.0 | Non-systematic Assessment |
|
| Weight increased | Investigations | MedDRA v10.0 | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA v10.0 | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Bone disorder | Musculoskeletal and connective tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Joint ankylosis | Musculoskeletal and connective tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Lupus-like syndrome | Musculoskeletal and connective tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Muscle atrophy | Musculoskeletal and connective tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Sacroiliitis | Musculoskeletal and connective tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Burning sensation | Nervous system disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Carpal tunnel syndrome | Nervous system disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Cervicobrachial syndrome | Nervous system disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Dysaesthesia | Nervous system disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Facial paresis | Nervous system disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Grand mal convulsion | Nervous system disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Hyperaesthesia | Nervous system disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Intercostal neuralgia | Nervous system disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Pseudoradicular syndrome | Nervous system disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Retrograde amnesia | Nervous system disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Reversible ischaemic neurological deficit | Nervous system disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Tension headache | Nervous system disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Trigeminal neuralgia | Nervous system disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA v10.0 | Non-systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Alcoholism | Psychiatric disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Depressed mood | Psychiatric disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Disorientation | Psychiatric disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Renal colic | Renal and urinary disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Prostatitis | Reproductive system and breast disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Nasal mucosal disorder | Respiratory, thoracic and mediastinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Throat tightness | Respiratory, thoracic and mediastinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Alopecia areata | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Dermatitis psoriasiform | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Guttate psoriasis | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Increased tendency to bruise | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Lichenoid keratosis | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Livedo reticularis | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Nail bed tenderness | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Nail discolouration | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Nail dystrophy | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Pustular psoriasis | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Rosacea | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Scab | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Skin burning sensation | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Skin necrosis | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Skin nodule | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Skin reaction | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Urticaria generalised | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Bone operation | Surgical and medical procedures | MedDRA v10.0 | Non-systematic Assessment |
|
| Carpal tunnel decompression | Surgical and medical procedures | MedDRA v10.0 | Non-systematic Assessment |
|
| Cataract operation | Surgical and medical procedures | MedDRA v10.0 | Non-systematic Assessment |
|
| Dental operation | Surgical and medical procedures | MedDRA v10.0 | Non-systematic Assessment |
|
| Inguinal hernia repair | Surgical and medical procedures | MedDRA v10.0 | Non-systematic Assessment |
|
| Intervertebral disc operation | Surgical and medical procedures | MedDRA v10.0 | Non-systematic Assessment |
|
| Joint injection | Surgical and medical procedures | MedDRA v10.0 | Non-systematic Assessment |
|
| Knee arthroplasty | Surgical and medical procedures | MedDRA v10.0 | Non-systematic Assessment |
|
| Limb operation | Surgical and medical procedures | MedDRA v10.0 | Non-systematic Assessment |
|
| Meniscus operation | Surgical and medical procedures | MedDRA v10.0 | Non-systematic Assessment |
|
| Ossiculoplasty | Surgical and medical procedures | MedDRA v10.0 | Non-systematic Assessment |
|
| Tooth extraction | Surgical and medical procedures | MedDRA v10.0 | Non-systematic Assessment |
|
| Transfusion | Surgical and medical procedures | MedDRA v10.0 | Non-systematic Assessment |
|
| Varicose vein operation | Surgical and medical procedures | MedDRA v10.0 | Non-systematic Assessment |
|
| Circulatory collapse | Vascular disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Varicose vein | Vascular disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Venous thrombosis limb | Vascular disorders | MedDRA v10.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D001847 |
| Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D007592 | Joint Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| Title | Measurements |
|---|---|
|
|
| Change at Week 52: Mental component (n=717) |
|