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| ID | Type | Description | Link |
|---|---|---|---|
| B1801126 |
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The purpose of this study is to evaluate the safety profile and the effectiveness of etanercept under usual care settings in patients with PsA treated by dermatologists.
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 Psoriasis Area and Severity Index (PASI) at Week 52 | PASI: combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections (head, arms, trunk, and legs); each area was scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI=sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4; total score ranged from 0 (no disease) to 72 (maximal disease). |
Not provided
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 | München | 81377 | Germany |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants With Psoriatic Arthritis | Participants with psoriatic arthritis treated by dermatologist 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. Out of a total of 149 participants, data for baseline measure (age) was available only for 146 participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Participants With Psoriatic Arthritis | Participants with psoriatic arthritis treated by dermatologist 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. | Posted | Number | percentage of participants | Baseline up to Week 52 |
|
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 | Participants With Psoriatic Arthritis | Participants with psoriatic arthritis treated by dermatologist 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 |
|---|---|---|---|---|---|
| Pancreatitis | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery disease | Cardiac disorders | MedDRA v10.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068800 | Etanercept |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
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|
| 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. | 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: Female, Male | Count of Participants | Participants |
|
Participants with psoriatic arthritis treated by dermatologist 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 Psoriasis Area and Severity Index (PASI) at Week 52 | PASI: combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections (head, arms, trunk, and legs); each area was scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI=sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4; total score ranged from 0 (no disease) to 72 (maximal disease). | 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 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 |
|
|
|
| 2 |
| 149 |
| 34 |
| 149 |
| Gallbladder pain | Hepatobiliary disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Pleural infection | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Malignant ascites | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v10.0 | Non-systematic Assessment |
|
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v10.0 | Non-systematic Assessment |
|
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v10.0 | Non-systematic Assessment |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Stomach discomfort | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal 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 |
|
| Fatigue | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Injection site inflammation | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Genital herpes | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Herpes virus infection | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Oral herpes | 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 |
|
| Tinea versicolour | 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 |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA v10.0 | Non-systematic Assessment |
|
| Limb crushing injury | Injury, poisoning and procedural complications | MedDRA v10.0 | Non-systematic Assessment |
|
| Alanine aminotransferase | Investigations | MedDRA v10.0 | Non-systematic Assessment |
|
| Arthroscopy | Investigations | MedDRA v10.0 | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA v10.0 | Non-systematic Assessment |
|
| Serum ferritin decreased | Investigations | MedDRA v10.0 | Non-systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA v10.0 | Non-systematic Assessment |
|
| Weight increased | Investigations | MedDRA v10.0 | Non-systematic Assessment |
|
| Haemochromatosis | Metabolism and nutrition disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Myalgia | 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 |
|
| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Burning sensation | Nervous system disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Headache | 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 |
|
| Alcoholism | Psychiatric disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast 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 |
|
| Hypoventilation | Respiratory, thoracic and mediastinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Skin tightness | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Ligament operation | Surgical and medical procedures | MedDRA v10.0 | Non-systematic Assessment |
|
| Tonsillectomy | Surgical and medical procedures | MedDRA v10.0 | Non-systematic Assessment |
|
| Transurethral prostatectomy | Surgical and medical procedures | MedDRA v10.0 | Non-systematic Assessment |
|
| Blood pressure fluctuation | Vascular disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Hot flush | 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=89) |
|