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| ID | Type | Description | Link |
|---|---|---|---|
| B1801106 |
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The study was terminated because at least one year follow-up was achieved for each patient and the achievement of 965 exposure years to the drug.
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This is a Phase 4 open label, non-interventional, multi-center study to evaluate the safety of Enbrel (etanercept) treatment in patients receiving etanercept 25mg sc twice weekly or 50mg of etanercept once weekly. The improvement of health-related quality of life will also be evaluated.
Patients already prescribed to receive etanercept for the first time for treatment of Rheumatoid Arthritis, Ankylosing Spondylitis or Psoriatic Arthritis according to the Summary of Product Characteristics (SmPC).
Patients have been recruited sequentially based on eligibility criteria up to the number limit assigned to each site.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| etanercept | Patients already prescribed to receive etanercept for the first time for treatment of Rheumatoid Arthritis, Ankylosing Spondylitis or Psoriatic Arthritis according to the Summary of Product Characteristics (SmPC). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| There is no Intervention. The study is observational. | Other | The study is observational and the prescription follows the SmPC of etanercept. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Baseline up to Month 24 |
| Number of Participants Who Discontinued Treatment | Baseline up to Month 24 | |
| Number of Participants by Reasons for Discontinuation of Treatment | Baseline up to Month 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Health Assessment Questionnaire (HAQ) at 24 Month | HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores as 'normal' (no difficulty=0), 'adequate' (some difficulty= 1), 'limited' (much difficulty=2), and 'unable to do' (=3) based on degree of difficulty they experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. HAQ total scores were expressed as overall mean score ranging from 0 to 3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; greater than 1=significant functional limitation. |
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Inclusion Criteria:
Exclusion Criteria:
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Rheumatoid Arthritis Patients, Psoriatic Arthritis Patients, Ankylosing Spondylitis Patients
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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 | Thessaloniki | Asvestohori | 570 10 | Greece | ||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Etanercept | Etanercept administered subcutaneously (s.c.) at a dose of 25 milligram (mg) twice weekly or 50 mg once weekly for 24 months. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Baseline, Month 24 |
| Change From Baseline in Patient Global Assessment (PtGA) Visual Analog Scale (VAS) at 24 Month | PtGA measured using a 100 mm VAS ranging from 0 = very good to 100 = very bad. | Baseline, Month 24 |
| Change From Baseline in Physician Global Assessment (PGA) VAS at 24 Month | PGA was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity to 100 mm = worst disease activity possible. | Baseline, Month 24 |
| Athens |
| Maroussi |
| 145 61 |
| Greece |
| Pfizer Investigational Site | Athens | 115 26 | Greece |
| Pfizer Investigational Site | Athens | 115 27 | Greece |
| Pfizer Investigational Site | Athens | 16673 | Greece |
| Pfizer Investigational Site | Athens | 184 54 | Greece |
| Pfizer Investigational Site | Karditsa | 43100 | Greece |
| Pfizer Investigational Site | Larissa | 411 10 | Greece |
| Pfizer Investigational Site | Thessaloniki | 546 42 | Greece |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Etanercept | Etanercept administered subcutaneously (s.c.) at a dose of 25 milligram (mg) twice weekly or 50 mg once weekly for 24 months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean age of the participants is based on N=795. | Mean | Standard Deviation | Years |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Safety population included all participants who received at least one dose of etanercept. | Posted | Number | Participants | Baseline up to Month 24 |
|
|
| |||||||||||||||||||||||||||||||||
| Primary | Number of Participants Who Discontinued Treatment | Safety population included all participants who received at least one dose of etanercept. | Posted | Number | Participants | Baseline up to Month 24 |
|
|
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants by Reasons for Discontinuation of Treatment | Safety population included all participants who received at least one dose of etanercept. | Posted | Number | Participants | Baseline up to Month 24 |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Health Assessment Questionnaire (HAQ) at 24 Month | HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores as 'normal' (no difficulty=0), 'adequate' (some difficulty= 1), 'limited' (much difficulty=2), and 'unable to do' (=3) based on degree of difficulty they experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. HAQ total scores were expressed as overall mean score ranging from 0 to 3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; greater than 1=significant functional limitation. | Data was not analyzed as the usage of the questionnaire was not considered to be part of usual clinical practice at the time of the study and thus was not to be used in the framework of a non-interventional trial. | Posted | Number | Units on a Scale | Baseline, Month 24 |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Patient Global Assessment (PtGA) Visual Analog Scale (VAS) at 24 Month | PtGA measured using a 100 mm VAS ranging from 0 = very good to 100 = very bad. | Data was not analyzed as the usage of the scale was not considered to be part of usual clinical practice at the time of the study and thus was not to be used in the framework of a non-interventional trial. | Posted | Number | Millimetre (mm) | Baseline, Month 24 |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Physician Global Assessment (PGA) VAS at 24 Month | PGA was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity to 100 mm = worst disease activity possible. | Data was not analyzed as the usage of the scale was not considered to be part of usual clinical practice at the time of the study and thus was not to be used in the framework of a non-interventional trial. | Posted | Number | mm | Baseline, Month 24 |
|
|
Not provided
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Etanercept | Etanercept administered subcutaneously (s.c.) at a dose of 25 milligram (mg) twice weekly or 50 mg once weekly for 24 months. | 36 | 880 | 455 | 880 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute coronary syndrome | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Uveitis | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Tooth abscess | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Hip fracture | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Intervertebral disc space narrowing | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Cervix carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Small cell lung cancer stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA | Non-systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Pyelonephritis | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Salpingitis | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Lung neoplasm malignant | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Respiratory tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Alopecia universalis | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Cholecystectomy | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
| |
| Parathyroidectomy | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
| |
| Thyroidectomy | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Infectious mononucleosis | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Lymphocytosis | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Splenomegaly | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Oedema peripheral | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Sinus arrhythmia | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
| |
| Cushing's syndrome | Endocrine disorders | MedDRA | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Iridocyclitis | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Aptyalism | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Epigastric discomfort | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Gastric infection | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Gastroenteritis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Gastroenteritis viral | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Gingivitis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA | Non-systematic Assessment |
| |
| Condition aggravated | General disorders | MedDRA | Non-systematic Assessment |
| |
| Discomfort | General disorders | MedDRA | Non-systematic Assessment |
| |
| Drug ineffective | General disorders | MedDRA | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Non-systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA | Non-systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA | Non-systematic Assessment |
| |
| Injection site irritation | General disorders | MedDRA | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA | Non-systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA | Non-systematic Assessment |
| |
| Injection site rash | General disorders | MedDRA | Non-systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA | Non-systematic Assessment |
| |
| Local reaction | General disorders | MedDRA | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Non-systematic Assessment |
| |
| Hepatic steatosis | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
| |
| Hepatomegaly | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
| |
| Hypertransaminasaemia (Lab Technical Error) | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
| |
| Peliosis hepatis | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
| |
| Drug eruption | Immune system disorders | MedDRA | Non-systematic Assessment |
| |
| Eyelid oedema | Immune system disorders | MedDRA | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA | Non-systematic Assessment |
| |
| Urticaria | Immune system disorders | MedDRA | Non-systematic Assessment |
| |
| Febrile infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Herpes ophthalmic | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Oral fungal infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pilonidal cyst | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Animal bite | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Joint sprain | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Alanine aminotransferase decreased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Anti-HBs antibody positive | Investigations | MedDRA | Non-systematic Assessment |
| |
| Aspartate aminotransferase decreased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Basophil count decreased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Basophil count increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Blood alkaline phosphatase decreased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Blood calcium increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Blood calcium increased (Lab Technical Error) | Investigations | MedDRA | Non-systematic Assessment |
| |
| Blood cholesterol decreased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Blood creatinine decreased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Blood glucose decreased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Blood phosphorus increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Blood phosphorus increased (Lab Technical Error) | Investigations | MedDRA | Non-systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Blood potassium increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Blood pressure systolic decreased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Blood sodium increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Blood triglycerides decreased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Blood urea decreased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Blood urine present | Investigations | MedDRA | Non-systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Differential white blood cell count abnormal | Investigations | MedDRA | Non-systematic Assessment |
| |
| Eosinophil count increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Haematocrit decreased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Haematocrit normal | Investigations | MedDRA | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| High density lipoprotein decreased | Investigations | MedDRA | Non-systematic Assessment |
| |
| High density lipoprotein increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Low density lipoprotein decreased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Low density lipoprotein increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Lymphocyte count increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Monocyte count increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Neutrophil count increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Platelet count increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Red blood cell count decreased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Red blood cell sedimentation rate increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Transaminases decreased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA | Non-systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| White blood cell count normal | Investigations | MedDRA | Non-systematic Assessment |
| |
| Metrorrhagia | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Iron deficiency anaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Oedema peripheral | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Demyelination plaque | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Finger deformity | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Joint ankylosis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Mobility decreased | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Muscle weakness | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Polyarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Scoliosis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Sjogren's syndrome | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Synovial disorder | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Bladder papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Gallbladder polyp | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Haemangioma of liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Head titubation | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Hypoaesthesia facial | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Vertigo | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Emotional disorder | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Fear of disease | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Somnolence | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Escherichia urinary tract infection | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Renal failure chronic | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Breast mass | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Epididymitis | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Genital rash | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Libido disorder | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Metrorrhagia | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Acute tonsillitis | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| H1N1 influenza | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Laryngitis | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Respiratory tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Respiratory tract infection viral | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Sinusitis | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Tonsillitis | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Dermatitis bullous | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Dermatitis psoriasiform | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Nail psoriasis | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Neurodermatitis | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Onychomycosis | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Rash pustular | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Skin striae | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Stevens-Johnson syndrome | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Tinea versicolour | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Contusion | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Peripheral coldness | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Venous insufficiency | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| (localized) arthritis | General disorders | Reported term | Non-systematic Assessment |
| |
| acute sciatica and lumbago | General disorders | Reported term | Non-systematic Assessment |
| |
| Breast tumor | General disorders | Reported term | Non-systematic Assessment |
| |
| Decreased morning stiffness | General disorders | Reported term | Non-systematic Assessment |
| |
| deformities of upper limbs bilaterally | General disorders | Reported term | Non-systematic Assessment |
| |
| elbow Psoriasis | General disorders | Reported term | Non-systematic Assessment |
| |
| hip arthritis | General disorders | Reported term | Non-systematic Assessment |
| |
| hip pain and restriction of mobility | General disorders | Reported term | Non-systematic Assessment |
| |
| Hypothermic lower limbs without pulse | General disorders | Reported term | Non-systematic Assessment |
| |
| Improvement of spine mobility | General disorders | Reported term | Non-systematic Assessment |
| |
| Increased inflammatory markers | General disorders | Reported term | Non-systematic Assessment |
| |
| injury of gluteal muscle | General disorders | Reported term | Non-systematic Assessment |
| |
| jaundice (biliary cirrhosis) | General disorders | Reported term | Non-systematic Assessment |
| |
| joint pain, enthesitis | General disorders | Reported term | Non-systematic Assessment |
| |
| localized nettle rash | General disorders | Reported term | Non-systematic Assessment |
| |
| localized tender joints | General disorders | Reported term | Non-systematic Assessment |
| |
| Lower limb deformities | General disorders | Reported term | Non-systematic Assessment |
| |
| Measurement of the thoracic cage | General disorders | Reported term | Non-systematic Assessment |
| |
| Mild conjunctivitis | General disorders | Reported term | Non-systematic Assessment |
| |
| mild synovitis | General disorders | Reported term | Non-systematic Assessment |
| |
| mobile, painful axillary lymph node | General disorders | Reported term | Non-systematic Assessment |
| |
| Oligoarthritis | General disorders | Reported term | Non-systematic Assessment |
| |
| Pain and restriction of mobility | General disorders | Reported term | Non-systematic Assessment |
| |
| Paresthetic thigh pain | General disorders | Reported term | Non-systematic Assessment |
| |
| pelvic fracture (fall) | General disorders | Reported term | Non-systematic Assessment |
| |
| pelvic restriction of mobility | General disorders | Reported term | Non-systematic Assessment |
| |
| Permanent disability in hand | General disorders | Reported term | Non-systematic Assessment |
| |
| Plantar aponeurosis | General disorders | Reported term | Non-systematic Assessment |
| |
| possible carpal tube syndrome | General disorders | Reported term | Non-systematic Assessment |
| |
| relapsed rash psoriasiform | General disorders | Reported term | Non-systematic Assessment |
| |
| Remission of scalp psoriasis | General disorders | Reported term | Non-systematic Assessment |
| |
| restriction of hip mobility | General disorders | Reported term | Non-systematic Assessment |
| |
| Restriction of movement of thoracic cage | General disorders | Reported term | Non-systematic Assessment |
| |
| Restriction of shoulder mobility bilaterally | General disorders | Reported term | Non-systematic Assessment |
| |
| Scalp pruritus | General disorders | Reported term | Non-systematic Assessment |
| |
| sciatica and lumbago | General disorders | Reported term | Non-systematic Assessment |
| |
| secondary osteoarthritis | General disorders | Reported term | Non-systematic Assessment |
| |
| Shrinkage of tendon | General disorders | Reported term | Non-systematic Assessment |
| |
| Swollen joints with restriction of mobility | General disorders | Reported term | Non-systematic Assessment |
| |
| synovitis of limbs | General disorders | Reported term | Non-systematic Assessment |
| |
| tender and swollen joints | General disorders | Reported term | Non-systematic Assessment |
| |
| tender hip | General disorders | Reported term | Non-systematic Assessment |
| |
| tender joints of lower limb | General disorders | Reported term | Non-systematic Assessment |
| |
| tender spine | General disorders | Reported term | Non-systematic Assessment |
| |
| Unstable gait | General disorders | Reported term | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
Wyeth has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| D015535 | Arthritis, Psoriatic |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
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