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| ID | Type | Description | Link |
|---|---|---|---|
| B1801107 |
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The aim of this study is to evaluate if the data obtained in controlled clinical trials are confirmed when Enbrel is used in usual clinical practice in Belgium according to local reimbursement criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PsA Patients (New) | New patients |
| |
| PsA Patients | CU patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire | Other | This is a non-interventional study |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Baseline up to Year 1 | An adverse event (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. | Baseline up to Year 1 |
| Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 1 up to Year 2 | 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. | Year 1 up to Year 2 |
| Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 2 up to Year 3 | 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. | Year 2 up to Year 3 |
| Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 3 up to Year 4 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With at Least 1 Adverse Event (AE) Per Year | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. | Baseline up to Year 6 |
| Incidence of Adverse Events and Serious Adverse Events Per Participant-Year |
Not provided
Inclusion Criteria:
Exclusion Criteria:
NA
Not provided
Not provided
Not provided
rheumatology centers
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Leuven | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26212872 | Derived | de Vlam K, Boone C, The Prove Study Group A. Treatment adherence, efficacy, and safety of etanercept in patients with active psoriatic arthritis and peripheral involvement in Belgium for 66 months (PROVE study). Clin Exp Rheumatol. 2015 Sep-Oct;33(5):624-31. Epub 2015 Jul 23. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Etanercept | Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Etanercept | Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years. |
| 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 at Least 1 Serious Adverse Event (SAE): Baseline up to Year 1 | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Safety set included all the participants who signed informed consent form (ICF) and had at least one dose of study medication and had follow-up data. | Posted | Number | Percentage of participants | Baseline up to Year 1 |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Etanercept | Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 7.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 7.0 | 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 |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
Not provided
Not provided
Not provided
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Not provided
| Questionnaire |
| Other |
This is a non-interventional study |
|
| Year 3 up to Year 4 |
| Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 4 up to Year 5 | 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. | Year 4 up to Year 5 |
| Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 5 up to Year 6 | 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. | Year 5 up to Year 6 |
Participant-Year estimated by calculating all of the years that participants in a study were followed (mean study drug exposure duration multiplied by safety set population). Incidence calculated as AEs or SAEs divided by Participant-Year multiplied by 100. Incidence of AEs and SAEs were broken down by each follow-up time period. |
| Baseline up to Month 6, 12, 18, 30, 42, 54, 66 |
| Percentage of Participants With Psoriatic Arthritis (PsA) Receiving Enbrel Who Stayed on the Treatment | Baseline up to Month 78 |
| Number of Joints With Active Arthritis | Numbers of joints with active arthritis were defined as joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness. | Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78 |
| Quality of Life Assessed by Numerical Rating Scale (NRS) For Oligo-Articular Type Psoriatic Arthritis (PsA) - Participant Evaluation | Quality of life for oligo-articular type arthritis was assessed on a 11-point Numerical Rating Scale (NRS) ranging from 1 (best health status) to 10 (worst health status). NRS for the most affected joint as per participant was evaluated. | Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78 |
| Quality of Life Assessed by Numerical Rating Scale (NRS) For Oligo-Articular Type Psoriatic Arthritis (PsA) - Physician Evaluation | Quality of life for oligo-articular type arthritis was assessed on a 11-point NRS ranging from 1 (best health status) to 10 (worst health status). NRS for the most affected joint as per physician was evaluated. | Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78 |
| Quality of Life Assessed by Health Assessment Questionnaire (HAQ) For Poly-Articular Type Psoriatic Arthritis (PsA) | HAQ is a 20 item questionnaire to measure functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 items grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. Total score range 0-60, higher score indicating greater functional limitations. | Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78 |
| Non-responder |
|
| Reason not related to Etanercept |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 1 up to Year 2 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Safety set included all the participants who signed ICF and had at least one dose of study medication and had follow-up data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Number | Percentage of participants | Year 1 up to Year 2 |
|
|
|
| Primary | Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 2 up to Year 3 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Safety set included all the participants who signed ICF and had at least one dose of study medication and had follow-up data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Number | Percentage of participants | Year 2 up to Year 3 |
|
|
|
| Primary | Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 3 up to Year 4 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Safety set included all the participants who signed ICF and had at least one dose of study medication and had follow-up data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Number | Percentage of participants | Year 3 up to Year 4 |
|
|
|
| Primary | Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 4 up to Year 5 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Safety set included all the participants who signed ICF and had at least one dose of study medication and had follow-up data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Number | Percentage of participants | Year 4 up to Year 5 |
|
|
|
| Primary | Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 5 up to Year 6 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Safety set included all the participants who signed ICF and had at least one dose of study medication and had follow-up data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Number | Percentage of participants | Year 5 up to Year 6 |
|
|
|
| Secondary | Percentage of Participants With at Least 1 Adverse Event (AE) Per Year | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. | Safety set included all the participants who signed ICF and had at least one dose of study medication and had follow-up data. 'n' signifies those participants who were evaluable for this measure at given time points. | Posted | Number | Percentage of participants | Baseline up to Year 6 |
|
|
|
| Secondary | Incidence of Adverse Events and Serious Adverse Events Per Participant-Year | Participant-Year estimated by calculating all of the years that participants in a study were followed (mean study drug exposure duration multiplied by safety set population). Incidence calculated as AEs or SAEs divided by Participant-Year multiplied by 100. Incidence of AEs and SAEs were broken down by each follow-up time period. | Safety set included all the participants who signed ICF and had at least one dose of study medication and had follow-up data. 'n' signifies those participants who were evaluable for this measure at given time points. | Posted | Number | Events per participant year | Baseline up to Month 6, 12, 18, 30, 42, 54, 66 |
|
|
|
| Secondary | Percentage of Participants With Psoriatic Arthritis (PsA) Receiving Enbrel Who Stayed on the Treatment | Efficacy set included all the participants who signed ICF. | Posted | Number | Percentage of participants | Baseline up to Month 78 |
|
|
|
| Secondary | Number of Joints With Active Arthritis | Numbers of joints with active arthritis were defined as joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness. | Efficacy set included all the participants who signed ICF. 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points. | Posted | Mean | Standard Deviation | Joints | Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78 |
|
|
|
| Secondary | Quality of Life Assessed by Numerical Rating Scale (NRS) For Oligo-Articular Type Psoriatic Arthritis (PsA) - Participant Evaluation | Quality of life for oligo-articular type arthritis was assessed on a 11-point Numerical Rating Scale (NRS) ranging from 1 (best health status) to 10 (worst health status). NRS for the most affected joint as per participant was evaluated. | Efficacy set included all the participants who signed ICF. 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78 |
|
|
|
| Secondary | Quality of Life Assessed by Numerical Rating Scale (NRS) For Oligo-Articular Type Psoriatic Arthritis (PsA) - Physician Evaluation | Quality of life for oligo-articular type arthritis was assessed on a 11-point NRS ranging from 1 (best health status) to 10 (worst health status). NRS for the most affected joint as per physician was evaluated. | Efficacy set included all the participants who signed ICF. 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78 |
|
|
|
| Secondary | Quality of Life Assessed by Health Assessment Questionnaire (HAQ) For Poly-Articular Type Psoriatic Arthritis (PsA) | HAQ is a 20 item questionnaire to measure functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 items grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. Total score range 0-60, higher score indicating greater functional limitations. | Efficacy set included all the participants who signed ICF. 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78 |
|
|
|
| 65 |
| 301 |
| 179 |
| 301 |
| Angina pectoris | Cardiac disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Vestibular neuronitis | Ear and labyrinth disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Corneal erosion | Eye disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Colonic polyp | Gastrointestinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Crohn's disease | Gastrointestinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Condition aggravated | General disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Hepatic steatosis | Hepatobiliary disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Arthritis bacterial | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Escherichia sepsis | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Hepatitis C | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Herpes zoster ophthalmic | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Keratitis herpetic | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Localised infection | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Osteomyelitis | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Prostatic abscess | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 7.0 | Non-systematic Assessment |
|
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA 7.0 | Non-systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 7.0 | Non-systematic Assessment |
|
| Scapula fracture | Injury, poisoning and procedural complications | MedDRA 7.0 | Non-systematic Assessment |
|
| Splenic rupture | Injury, poisoning and procedural complications | MedDRA 7.0 | Non-systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 7.0 | Non-systematic Assessment |
|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 7.0 | Non-systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA 7.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Bone cyst | Musculoskeletal and connective tissue disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Joint destruction | Musculoskeletal and connective tissue disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 7.0 | Non-systematic Assessment |
|
| Lung adenocarcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 7.0 | Non-systematic Assessment |
|
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 7.0 | Non-systematic Assessment |
|
| Amnestic disorder | Nervous system disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Cognitive disorder | Nervous system disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Demyelination | Nervous system disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Multiple sclerosis | Nervous system disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Renal colic | Renal and urinary disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Alveolitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Arthrodesis | Surgical and medical procedures | MedDRA 7.0 | Non-systematic Assessment |
|
| Bladder operation | Surgical and medical procedures | MedDRA 7.0 | Non-systematic Assessment |
|
| Bunion operation | Surgical and medical procedures | MedDRA 7.0 | Non-systematic Assessment |
|
| Cataract operation | Surgical and medical procedures | MedDRA 7.0 | Non-systematic Assessment |
|
| Cholecystectomy | Surgical and medical procedures | MedDRA 7.0 | Non-systematic Assessment |
|
| Chondroplasty | Surgical and medical procedures | MedDRA 7.0 | Non-systematic Assessment |
|
| Hernia repair | Surgical and medical procedures | MedDRA 7.0 | Non-systematic Assessment |
|
| Internal fixation of fracture | Surgical and medical procedures | MedDRA 7.0 | Non-systematic Assessment |
|
| Knee arthroplasty | Surgical and medical procedures | MedDRA 7.0 | Non-systematic Assessment |
|
| Prostatic operation | Surgical and medical procedures | MedDRA 7.0 | Non-systematic Assessment |
|
| Sinus operation | Surgical and medical procedures | MedDRA 7.0 | Non-systematic Assessment |
|
| Synovectomy | Surgical and medical procedures | MedDRA 7.0 | Non-systematic Assessment |
|
| Toe operation | Surgical and medical procedures | MedDRA 7.0 | Non-systematic Assessment |
|
| Varicose vein operation | Surgical and medical procedures | MedDRA 7.0 | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Macrocytosis | Blood and lymphatic system disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Conjunctival hyperaemia | Eye disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Uveitis | Eye disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Visual acuity reduced | Eye disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Visual disturbance | Eye disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Colonic polyp | Gastrointestinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Crohn's disease | Gastrointestinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Epiploic appendagitis | Gastrointestinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Frequent bowel movements | Gastrointestinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Gastrooesophagitis | Gastrointestinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Gingivitis | Gastrointestinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Hiatus hernia | Gastrointestinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Periodontitis | Gastrointestinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Reflux oesophagitis | Gastrointestinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Stomach discomfort | Gastrointestinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Drug intolerance | General disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Haemorrhagic cyst | General disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Impaired healing | General disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Injection site irritation | General disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Injection site rash | General disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Rebound effect | General disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Cirrhosis alcoholic | Hepatobiliary disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Hepatic steatosis | Hepatobiliary disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Allergy to arthropod sting | Immune system disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Atopy | Immune system disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Acute tonsillitis | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Anogenital warts | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Cystitis escherichia | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Epiglottitis | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Eye infection | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Gastrointestinal fungal infection | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Gastrointestinal infection | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Genital infection male | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Helicobacter gastritis | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Molluscum contagiosum | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Nail infection | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Onychomycosis | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Oral fungal infection | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Orchitis | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Otitis externa | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Parotitis | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Pneumonia mycoplasmal | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Respiratory tract infection fungal | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Respiratory tract infection viral | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Tinea versicolour | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Tracheitis | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Urethritis | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Vaginal infection | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Viral sinusitis | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA 7.0 | Non-systematic Assessment |
|
| Accident at work | Injury, poisoning and procedural complications | MedDRA 7.0 | Non-systematic Assessment |
|
| Animal bite | Injury, poisoning and procedural complications | MedDRA 7.0 | Non-systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 7.0 | Non-systematic Assessment |
|
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 7.0 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 7.0 | Non-systematic Assessment |
|
| Epicondylitis | Injury, poisoning and procedural complications | MedDRA 7.0 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 7.0 | Non-systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 7.0 | Non-systematic Assessment |
|
| Foreign body in eye | Injury, poisoning and procedural complications | MedDRA 7.0 | Non-systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | MedDRA 7.0 | Non-systematic Assessment |
|
| Heat stroke | Injury, poisoning and procedural complications | MedDRA 7.0 | Non-systematic Assessment |
|
| Impacted fracture | Injury, poisoning and procedural complications | MedDRA 7.0 | Non-systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | MedDRA 7.0 | Non-systematic Assessment |
|
| Joint sprain | Injury, poisoning and procedural complications | MedDRA 7.0 | Non-systematic Assessment |
|
| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA 7.0 | Non-systematic Assessment |
|
| Muscle rupture | Injury, poisoning and procedural complications | MedDRA 7.0 | Non-systematic Assessment |
|
| Patella fracture | Injury, poisoning and procedural complications | MedDRA 7.0 | Non-systematic Assessment |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 7.0 | Non-systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 7.0 | Non-systematic Assessment |
|
| Synovial rupture | Injury, poisoning and procedural complications | MedDRA 7.0 | Non-systematic Assessment |
|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 7.0 | Non-systematic Assessment |
|
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 7.0 | Non-systematic Assessment |
|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 7.0 | Non-systematic Assessment |
|
| Traumatic fracture | Injury, poisoning and procedural complications | MedDRA 7.0 | Non-systematic Assessment |
|
| Ulnar nerve injury | Injury, poisoning and procedural complications | MedDRA 7.0 | Non-systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 7.0 | Non-systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA 7.0 | Non-systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 7.0 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 7.0 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 7.0 | Non-systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA 7.0 | Non-systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 7.0 | Non-systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 7.0 | Non-systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA 7.0 | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 7.0 | Non-systematic Assessment |
|
| Intraocular pressure increased | Investigations | MedDRA 7.0 | Non-systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA 7.0 | Non-systematic Assessment |
|
| Monoclonal immunoglobulin present | Investigations | MedDRA 7.0 | Non-systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA 7.0 | Non-systematic Assessment |
|
| Weight increased | Investigations | MedDRA 7.0 | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 7.0 | Non-systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Gouty tophus | Musculoskeletal and connective tissue disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Muscle rigidity | Musculoskeletal and connective tissue disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Tendon disorder | Musculoskeletal and connective tissue disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Adrenal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 7.0 | Non-systematic Assessment |
|
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 7.0 | Non-systematic Assessment |
|
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 7.0 | Non-systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 7.0 | Non-systematic Assessment |
|
| Balance disorder | Nervous system disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Carotid artery stenosis | Nervous system disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Syncope vasovagal | Nervous system disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Vertebral artery stenosis | Nervous system disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Alcoholism | Psychiatric disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Depressed mood | Psychiatric disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Nervousness | Psychiatric disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Obsessive-compulsive disorder | Psychiatric disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Stress | Psychiatric disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Calculus urinary | Renal and urinary disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Micturition urgency | Renal and urinary disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Nephroangiosclerosis | Renal and urinary disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Renal colic | Renal and urinary disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Balanitis | Reproductive system and breast disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Breast mass | Reproductive system and breast disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Epididymitis | Reproductive system and breast disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Prostatitis | Reproductive system and breast disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Retracted nipple | Reproductive system and breast disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Uterine polyp | Reproductive system and breast disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Varicocele | Reproductive system and breast disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Diaphragmatic hernia | Respiratory, thoracic and mediastinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Obliterative bronchiolitis | Respiratory, thoracic and mediastinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Vasomotor rhinitis | Respiratory, thoracic and mediastinal disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Neurodermatitis | Skin and subcutaneous tissue disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Rosacea | Skin and subcutaneous tissue disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Skin haemorrhage | Skin and subcutaneous tissue disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Tobacco abuse | Social circumstances | MedDRA 7.0 | Non-systematic Assessment |
|
| Colon polypectomy | Surgical and medical procedures | MedDRA 7.0 | Non-systematic Assessment |
|
| Finger repair operation | Surgical and medical procedures | MedDRA 7.0 | Non-systematic Assessment |
|
| Foot operation | Surgical and medical procedures | MedDRA 7.0 | Non-systematic Assessment |
|
| Gastric banding | Surgical and medical procedures | MedDRA 7.0 | Non-systematic Assessment |
|
| Knee arthroplasty | Surgical and medical procedures | MedDRA 7.0 | Non-systematic Assessment |
|
| Knee operation | Surgical and medical procedures | MedDRA 7.0 | Non-systematic Assessment |
|
| Meniscus removal | Surgical and medical procedures | MedDRA 7.0 | Non-systematic Assessment |
|
| Osteotomy | Surgical and medical procedures | MedDRA 7.0 | Non-systematic Assessment |
|
| Shoulder operation | Surgical and medical procedures | MedDRA 7.0 | Non-systematic Assessment |
|
| Sinus operation | Surgical and medical procedures | MedDRA 7.0 | Non-systematic Assessment |
|
| Skin lesion excision | Surgical and medical procedures | MedDRA 7.0 | Non-systematic Assessment |
|
| Toe operation | Surgical and medical procedures | MedDRA 7.0 | Non-systematic Assessment |
|
| Tooth extraction | Surgical and medical procedures | MedDRA 7.0 | Non-systematic Assessment |
|
| Aortic arteriosclerosis | Vascular disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 7.0 | Non-systematic Assessment |
|
| Varicose vein | Vascular disorders | MedDRA 7.0 | 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 |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| Title | Measurements |
|---|---|
|
| Year 3 to Year 4 (n=198) |
|
| Year 4 to Year 5 (n=178) |
|
| Year 5 to Year 6 (n=159) |
|
| Title | Measurements |
|---|---|
|
| Incidence of AEs till Month 30 |
|
| Incidence of AEs till Month 42 |
|
| Incidence of AEs till Month 54 |
|
| Incidence of AEs till Month 66 |
|
| Incidence of SAEs till Month 6 |
|
| Incidence of SAEs till Month 12 |
|
| Incidence of SAEs till Month 18 |
|
| Incidence of SAEs till Month 30 |
|
| Incidence of SAEs till Month 42 |
|
| Incidence of SAEs till Month 54 |
|
| Incidence of SAEs till Month 66 |
|
| Title | Measurements |
|---|---|
|
| Month 18 (n=261) |
|
| Month 30 (n=215) |
|
| Month 42 (n=189) |
|
| Month 54 (n=169) |
|
| Month 66 (n=152) |
|
| Month 78 (n=5) |
|
| Title | Measurements |
|---|---|
|
| Month 18 (n=24) |
|
| Month 30 (n=18) |
|
| Month 42 (n=13) |
|
| Month 54 (n=9) |
|
| Month 66 (n=5) |
|
| Month 78 (n=0) |
|
| Title | Measurements |
|---|---|
|
| Month 18 (n=24) |
|
| Month 30 (n=18) |
|
| Month 42 (n=13) |
|
| Month 54 (n=9) |
|
| Month 66 (n=5) |
|
| Month 78 (n=0) |
|
| Title | Measurements |
|---|---|
|
| Month 18 (n=209) |
|
| Month 30 (n=182) |
|
| Month 42 (n=166) |
|
| Month 54 (n=149) |
|
| Month 66 (n=135) |
|
| Month 78 (n=4) |
|