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This is an observational safety study tracking psoriasis patients on etanercept (Enbrel) for 5 years.
This is a prospective, multi-center, observational surveillance registry to evaluate data on the long-term safety of etanercept (Enbrel) use in the treatment of psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Etanercept | Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etanercept | Drug | Observational study - no drug administered |
|
| Measure | Description | Time Frame |
|---|---|---|
| Five-year Cumulative Incidence of Serious Adverse Events and Serious Infectious Events | A serious adverse event (SAE), including a serious infectious event (SIE), is defined as one that suggests a significant hazard or side effect, regardless of the investigator or sponsor's opinion on the relationship to a drug product. This includes, but may not be limited to, any event that (at any dose) is fatal, life threatening, requires inpatient hospitalization that includes a minimum of an overnight stay or prolongation of existing hospitalization, is a persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. Cumulative incidences were calculated using Kaplan-Meier methodology for all participants who received at least 1 registry dose of etanercept. For SAEs and SIEs, time to event was re-defined from calendar time to cumulative time up to the event, excluding time intervals and events when the participant was not on etanercept treatment (ie, based on etenercept exposure time). | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Five-year Cumulative Incidence for Events of Medical Interest (EMIs) | Protocol defined EMIs included: • All malignancies, including basal cell carcinoma (BCC) and squamous cell carcinoma (SCC); • Tuberculosis; • Opportunistic infections treated with intravenous therapy; • Histoplasmosis infections treated with oral antibiotics; • Coccidioidomycosis infections treated with oral antibiotics; • Central nervous system (CNS) demyelinating disorders; • Lupus disease; • Coronary artery disease; • Worsening of psoriasis as defined by change in psoriasis morphology and withdrawal of therapy; • Any event or laboratory abnormality that represents an event of medical significance. Cumulative incidences were calculated using Kaplan-Meier methods where time to event was defined as the time from the first dose of etanercept to the start date of the first occurrence of the event, regardless of exposure (ie, based on observation time). Estimates were adjusted using left truncation methodology to help address any bias due to participants with prior etanercept exposure. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients with plaque psoriasis, who are currently receiving Enbrel or who are intending to start or restart Enbrel therapy at multi-centers.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Kimball AB, Pariser D, Yamauchi PS, Menter A, Teller CF, Shi Y, Creamer K, McCroskery P, Kricorian G, Gelfand JM. OBSERVE-5, an Observational Post-Marketing SafetySurveillance Registry of Etanercept for the treatment of Psoriasis: A Model for Studying New Psoriasis Therapies. Psoriasis Forum. 2010;16(3):3-7. | ||
| 23357569 | Background | Kimball AB, Pariser D, Yamauchi PS, Menter A, Teller CF, Shi Y, Yong M, Creamer K, Hooper M, Aras G, Kricorian G, Gelfand JM. OBSERVE-5 interim analysis: an observational postmarketing safety registry of etanercept for the treatment of psoriasis. J Am Acad Dermatol. 2013 May;68(5):756-64. doi: 10.1016/j.jaad.2012.10.055. Epub 2013 Jan 26. | |
| 25264239 |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Etanercept | Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Full Analysis Set, which consisted of all participants who received at least one dose of etanercept during the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Etanercept | Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments. |
| 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 | Five-year Cumulative Incidence of Serious Adverse Events and Serious Infectious Events | A serious adverse event (SAE), including a serious infectious event (SIE), is defined as one that suggests a significant hazard or side effect, regardless of the investigator or sponsor's opinion on the relationship to a drug product. This includes, but may not be limited to, any event that (at any dose) is fatal, life threatening, requires inpatient hospitalization that includes a minimum of an overnight stay or prolongation of existing hospitalization, is a persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. Cumulative incidences were calculated using Kaplan-Meier methodology for all participants who received at least 1 registry dose of etanercept. For SAEs and SIEs, time to event was re-defined from calendar time to cumulative time up to the event, excluding time intervals and events when the participant was not on etanercept treatment (ie, based on etenercept exposure time). | Posted | Number | 95% Confidence Interval | proportion of participants | 5 years |
|
5 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
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 received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068800 | Etanercept |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
Not provided
Not provided
Not provided
Not provided
Not provided
Whole blood, serum, plasma.
| 5 years |
| Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Psoriasis Score of 0 (Clear) or 1 (Almost Clear) | The sPGA scale is designed to evaluate the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA is assessed on a scale of 0 to 5 (0 = clear, 5 = severe). | Baseline and at 3 and 5 years |
| Percentage of Participants With a Patient's Global Assessment of Psoriasis Score of 0 or 1 | The patient's global assessment of psoriasis is a self-administered numeric scale is designed to evaluate participants' perception of their psoriasis on a scale from 0 (good) to 5 (severe). | Baseline and at 3 and 5 years |
| Percentage of Participants With a Dermatology Life Quality Index (DLQI) Response | The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. A DLQI response is defined as a 5 point improvement from Baseline or a score of 0. | Baseline, Year 3 and Year 5 |
| Euroqol-5D (EQ-5D) Total Score | EQ-5D is a self-reported questionnaire that consists of five single-item health domains, mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The answers are recorded as choices of 1, 2, or 3 for each question, with 1 signifying no problem, 2 signifying some problem, and 3 signifying major problem. Using the US scoring algorithm, the possible total EQ-5D score ranges from -0.11 (ie, answered '3' for all questions) to 1.0 (ie, answered '1' for all questions), where 1.0 represents perfect health. | Baseline, Year 3 and Year 5 |
| Euroqol-5D (EQ-5D) Visual Analog Scale (VAS) | The EQ-5D visual analog scale (VAS) is a 100 mm scale with 100 representing 'best imaginable health state' and 0 representing 'worst imaginable health state'. Participants were asked to indicate on this scale how good or bad their health was today. | Baseline, Year 3 and Year 5 |
| Healthcare Resource Use | This self-administered questionnaire is designed to measure the amount of healthcare resource utilization by the participant in the past 4 weeks. The average answers to the following questions are reported:
| Baseline, Year 3 and Year 5 |
| Work Productivity and Activity Impairment (WPAI) | The WPAI questionnaire has six questions to assess whether the participant was currently employed (Q1); how many hours from work were missed due to problems associated with psoriasis (Q2) or any other reason (Q3); hours actually worked (Q4); degree that psoriasis affected productivity while working (Q5); and degree that psoriasis affected regular activities (Q6) over the past 7 days. Four separate overall scores were calculated, including absenteeism (work time missed due to health), presenteeism (impairment at work due to health), work productivity loss (overall work impairment due to health), and activity impairment due to health. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity (ie, worse outcomes). | Baseline, Year 3 and Year 5 |
| Percentage of Body Surface Area Affected by Psoriasis | Body Surface Area (BSA) is a numerical score used to measure the physician's assessment of the percentage of the participant's total BSA involved with psoriasis. | Baseline, Year 3 and Year 5 |
| Background |
| Kimball AB, Rothman KJ, Kricorian G, Pariser D, Yamauchi PS, Menter A, Teller CF, Aras G, Accortt NA, Hooper M, Rice KC, Gelfand JM. OBSERVE-5: observational postmarketing safety surveillance registry of etanercept for the treatment of psoriasis final 5-year results. J Am Acad Dermatol. 2015 Jan;72(1):115-22. doi: 10.1016/j.jaad.2014.08.050. Epub 2014 Sep 26. |
| 24251402 | Background | Kimball AB, Schenfeld J, Accortt NA, Anthony MS, Rothman KJ, Pariser D. Incidence rates of malignancies and hospitalized infectious events in patients with psoriasis with or without treatment and a general population in the U.S.A.: 2005-09. Br J Dermatol. 2014 Feb;170(2):366-73. doi: 10.1111/bjd.12744. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Etanercept |
Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments. |
|
|
| Secondary | Five-year Cumulative Incidence for Events of Medical Interest (EMIs) | Protocol defined EMIs included: • All malignancies, including basal cell carcinoma (BCC) and squamous cell carcinoma (SCC); • Tuberculosis; • Opportunistic infections treated with intravenous therapy; • Histoplasmosis infections treated with oral antibiotics; • Coccidioidomycosis infections treated with oral antibiotics; • Central nervous system (CNS) demyelinating disorders; • Lupus disease; • Coronary artery disease; • Worsening of psoriasis as defined by change in psoriasis morphology and withdrawal of therapy; • Any event or laboratory abnormality that represents an event of medical significance. Cumulative incidences were calculated using Kaplan-Meier methods where time to event was defined as the time from the first dose of etanercept to the start date of the first occurrence of the event, regardless of exposure (ie, based on observation time). Estimates were adjusted using left truncation methodology to help address any bias due to participants with prior etanercept exposure. | Full analysis set | Posted | Number | 95% Confidence Interval | proportion of participants | 5 years |
|
|
|
| Secondary | Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Psoriasis Score of 0 (Clear) or 1 (Almost Clear) | The sPGA scale is designed to evaluate the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA is assessed on a scale of 0 to 5 (0 = clear, 5 = severe). | Participants who received at least one registry dose of etanercept, excluding participants who were enrolled at sites that were closed for cause, and with available data at each time point (indicated by n). | Posted | Number | percentage of participants | Baseline and at 3 and 5 years |
|
|
|
| Secondary | Percentage of Participants With a Patient's Global Assessment of Psoriasis Score of 0 or 1 | The patient's global assessment of psoriasis is a self-administered numeric scale is designed to evaluate participants' perception of their psoriasis on a scale from 0 (good) to 5 (severe). | Participants who received at least one registry dose of etanercept, excluding participants who were enrolled at sites that were closed for cause, and with available data at each time point (indicated by n). | Posted | Number | percentage of participants | Baseline and at 3 and 5 years |
|
|
|
| Secondary | Percentage of Participants With a Dermatology Life Quality Index (DLQI) Response | The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. A DLQI response is defined as a 5 point improvement from Baseline or a score of 0. | Participants who received at least one registry dose of etanercept, excluding participants who were enrolled at sites that were closed for cause, and with available data at each time point (indicated by n). | Posted | Number | percentage of participants | Baseline, Year 3 and Year 5 |
|
|
|
| Secondary | Euroqol-5D (EQ-5D) Total Score | EQ-5D is a self-reported questionnaire that consists of five single-item health domains, mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The answers are recorded as choices of 1, 2, or 3 for each question, with 1 signifying no problem, 2 signifying some problem, and 3 signifying major problem. Using the US scoring algorithm, the possible total EQ-5D score ranges from -0.11 (ie, answered '3' for all questions) to 1.0 (ie, answered '1' for all questions), where 1.0 represents perfect health. | Participants who received at least one registry dose of etanercept, excluding participants who were enrolled at sites that were closed for cause, and with available data at each time point (indicated by n). | Posted | Mean | Standard Error | units on a scale | Baseline, Year 3 and Year 5 |
|
|
|
| Secondary | Euroqol-5D (EQ-5D) Visual Analog Scale (VAS) | The EQ-5D visual analog scale (VAS) is a 100 mm scale with 100 representing 'best imaginable health state' and 0 representing 'worst imaginable health state'. Participants were asked to indicate on this scale how good or bad their health was today. | Participants who received at least one registry dose of etanercept, excluding participants who were enrolled at sites that were closed for cause, and with available data at each time point (indicated by n). | Posted | Mean | Standard Error | units on a scale | Baseline, Year 3 and Year 5 |
|
|
|
| Secondary | Healthcare Resource Use | This self-administered questionnaire is designed to measure the amount of healthcare resource utilization by the participant in the past 4 weeks. The average answers to the following questions are reported:
| Participants who received at least one registry dose of etanercept, excluding participants who were enrolled at sites that were closed for cause, and with available data at each time point (indicated by n). | Posted | Mean | Standard Error | times | Baseline, Year 3 and Year 5 |
|
|
|
| Secondary | Work Productivity and Activity Impairment (WPAI) | The WPAI questionnaire has six questions to assess whether the participant was currently employed (Q1); how many hours from work were missed due to problems associated with psoriasis (Q2) or any other reason (Q3); hours actually worked (Q4); degree that psoriasis affected productivity while working (Q5); and degree that psoriasis affected regular activities (Q6) over the past 7 days. Four separate overall scores were calculated, including absenteeism (work time missed due to health), presenteeism (impairment at work due to health), work productivity loss (overall work impairment due to health), and activity impairment due to health. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity (ie, worse outcomes). | Participants who received at least one registry dose of etanercept, excluding participants who were enrolled at sites that were closed for cause, and with available data at each time point (indicated by n), and who were employed (for the first 3 scores). | Posted | Mean | Standard Error | units on a scale | Baseline, Year 3 and Year 5 |
|
|
|
| Secondary | Percentage of Body Surface Area Affected by Psoriasis | Body Surface Area (BSA) is a numerical score used to measure the physician's assessment of the percentage of the participant's total BSA involved with psoriasis. | Participants who received at least one registry dose of etanercept, excluding participants who were enrolled at sites that were closed for cause, and with available data at each time point (indicated by n). | Posted | Mean | Standard Error | percentage of body surface area | Baseline, Year 3 and Year 5 |
|
|
|
| 418 |
| 2,510 |
| 0 |
| 2,510 |
| Haemorrhagic Anaemia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Acute Coronary Syndrome | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| Acute Myocardial Infarction | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| Angina Pectoris | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| Angina Unstable | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| Aortic Valve Disease | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| Arteriosclerosis Coronary Artery | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| Cardiac Arrest | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| Cardiac Failure | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| Cardiac Failure Congestive | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| Cardiomyopathy | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| Coronary Artery Disease | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| Coronary Artery Insufficiency | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| Coronary Artery Occlusion | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| Coronary Artery Stenosis | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| Extrasystoles | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| Heart Valve Incompetence | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| Mitral Valve Incompetence | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| Mitral Valve Prolapse | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| Adrenoleukodystrophy | Congenital, familial and genetic disorders | MedDRA 15.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 15.0 | Systematic Assessment |
|
| Autoimmune Thyroiditis | Endocrine disorders | MedDRA 15.0 | Systematic Assessment |
|
| Hyperparathyroidism | Endocrine disorders | MedDRA 15.0 | Systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | MedDRA 15.0 | Systematic Assessment |
|
| Ophthalmoplegia | Eye disorders | MedDRA 15.0 | Systematic Assessment |
|
| Visual Acuity Reduced | Eye disorders | MedDRA 15.0 | Systematic Assessment |
|
| Abdominal Adhesions | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Abdominal Hernia | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Abdominal Strangulated Hernia | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Alcoholic Pancreatitis | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Anal Fissure | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Crohn's Disease | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Diverticulum Gastric | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Faeces Discoloured | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Gastric Volvulus | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Gastrointestinal Necrosis | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Hiatus Hernia | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Intestinal Haemorrhage | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Large Intestine Perforation | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Oesophageal Stenosis | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Pancreatitis Acute | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Umbilical Hernia | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Umbilical Hernia, Obstructive | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Upper Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Chest Discomfort | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Cyst | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Death | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Device Malfunction | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Generalised Oedema | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Injection Site Urticaria | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Medical Device Complication | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Multi-Organ Failure | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Non-Cardiac Chest Pain | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Biliary Dyskinesia | Hepatobiliary disorders | MedDRA 15.0 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 15.0 | Systematic Assessment |
|
| Cholecystitis Acute | Hepatobiliary disorders | MedDRA 15.0 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 15.0 | Systematic Assessment |
|
| Chronic Hepatic Failure | Hepatobiliary disorders | MedDRA 15.0 | Systematic Assessment |
|
| Cirrhosis Alcoholic | Hepatobiliary disorders | MedDRA 15.0 | Systematic Assessment |
|
| Hepatic Cirrhosis | Hepatobiliary disorders | MedDRA 15.0 | Systematic Assessment |
|
| Hepatic Function Abnormal | Hepatobiliary disorders | MedDRA 15.0 | Systematic Assessment |
|
| Hepatitis | Hepatobiliary disorders | MedDRA 15.0 | Systematic Assessment |
|
| Hepatitis Alcoholic | Hepatobiliary disorders | MedDRA 15.0 | Systematic Assessment |
|
| Drug Hypersensitivity | Immune system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Abdominal Abscess | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Abscess Intestinal | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Abscess Limb | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Arteriovenous Graft Site Infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Beta Haemolytic Streptococcal Infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Chest Wall Abscess | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Cholecystitis Infective | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Clostridial Infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Clostridium Difficile Colitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Clostridium Difficile Sepsis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Dural Abscess | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Escherichia Infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Escherichia Sepsis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Escherichia Urinary Tract Infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Hepatitis C | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Herpes Zoster | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Infectious Mononucleosis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Infective Exacerbation Of Chronic Obstructive Airways Disease | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Injection Site Cellulitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Kidney Infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Klebsiella Bacteraemia | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Latent Tuberculosis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Liver Abscess | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Localised Infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Mastitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Meningitis Aseptic | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Meningitis Listeria | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Meningitis Streptococcal | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Necrotising Fasciitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Osteomyelitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Pelvic Inflammatory Disease | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Perirectal Abscess | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Peritonitis Bacterial | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Pneumonia Bacterial | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Pneumonia Staphylococcal | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Post Procedural Infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Septic Shock | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Staphylococcal Abscess | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Staphylococcal Bacteraemia | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Staphylococcal Infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Subcutaneous Abscess | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Tooth Abscess | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Toxic Shock Syndrome | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Tuberculosis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Viral Infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Wound Infection Staphylococcal | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Anaemia Postoperative | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Craniocerebral Injury | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Crushing Injury Of Trunk | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Femur Fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Foot Fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Fractured Sacrum | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Gastrointestinal Anastomotic Leak | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Hand Fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Head Injury | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Hip Fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Intentional Overdose | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Joint Injury | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Ligament Rupture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Lumbar Vertebral Fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Meniscus Lesion | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Muscle Strain | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Nail Injury | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Patella Fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Pelvic Fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Post Procedural Haemorrhage | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Pubis Fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Rib Fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Road Traffic Accident | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Spinal Compression Fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Spinal Fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Subdural Haematoma | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Tendon Rupture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Thoracic Vertebral Fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Toxicity To Various Agents | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Traumatic Renal Injury | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Upper Limb Fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Ureteric Injury | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Wrist Fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Anticonvulsant Drug Level Increased | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| Antinuclear Antibody Positive | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| Blood Creatinine Increased | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| Lipase Increased | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| Tuberculin Test Positive | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| White Blood Cell Count Increased | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
|
| Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
|
| Electrolyte Imbalance | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
|
| Failure To Thrive | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
|
| Obesity | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Intervertebral Disc Degeneration | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Kyphoscoliosis | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Lumbar Spinal Stenosis | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Pseudarthrosis | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Psoriatic Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Rotator Cuff Syndrome | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Spinal Column Stenosis | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Spinal Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| Adenosquamous Cell Lung Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| Anal Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| Astrocytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| B Precursor Type Acute Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| B-Cell Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| Benign Hepatic Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| Benign Uterine Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| Bladder Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| Brain Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| Colon Adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| Colon Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| Colon Cancer Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| Colorectal Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| Gastrointestinal Stromal Tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| Glioblastoma Multiforme | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| Hepatic Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| Large Cell Carcinoma Of The Respiratory Tract Stage Unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| Lip And/Or Oral Cavity Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| Liposarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| Lung Cancer Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| Lung Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| Lung Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| Malignant Melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| Metastases To Liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| Metastatic Renal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| Multiple Myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| Mycosis Fungoides | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| Myelodysplastic Syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| Oesophageal Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| Oesophageal Carcinoma Stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| Ovarian Adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| Ovarian Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| Pancreatic Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| Precursor B-Lymphoblastic Lymphoma Recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| Rectal Cancer Stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| Renal Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| Renal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| Salivary Gland Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| Small Cell Lung Cancer Stage Unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| Thyroid Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| Thyroid Cancer Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| Thyroid Cancer Stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| Ureteric Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| Uterine Leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| Vulval Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| Arachnoid Cyst | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Arachnoiditis | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Balance Disorder | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Benign Intracranial Hypertension | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Carotid Artery Occlusion | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Carotid Artery Stenosis | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Cerebrovascular Accident | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Dementia | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Diabetic Neuropathy | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Hepatic Encephalopathy | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Intracranial Aneurysm | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Intracranial Pressure Increased | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Ischaemic Stroke | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Loss Of Consciousness | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Multiple Sclerosis | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Neuropathy Peripheral | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Parkinson's Disease | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Peripheral Sensorimotor Neuropathy | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Radicular Syndrome | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Radiculopathy | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Thoracic Outlet Syndrome | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Transient Ischaemic Attack | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Abortion Spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 15.0 | Systematic Assessment |
|
| Complication Of Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 15.0 | Systematic Assessment |
|
| Pre-Eclampsia | Pregnancy, puerperium and perinatal conditions | MedDRA 15.0 | Systematic Assessment |
|
| Adjustment Disorder With Mixed Disturbance Of Emotion And Conduct | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
|
| Aggression | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
|
| Bipolar Disorder | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
|
| Completed Suicide | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
|
| Major Depression | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
|
| Mental Status Changes | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
|
| Psychotic Disorder | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
|
| Suicidal Ideation | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
|
| Suicide Attempt | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
|
| Calculus Ureteric | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
|
| Glomerulonephritis Membranous | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
|
| Renal Aneurysm | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
|
| Renal Failure | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
|
| Renal Failure Acute | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
|
| Renal Failure Chronic | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
|
| Endometrial Hyperplasia | Reproductive system and breast disorders | MedDRA 15.0 | Systematic Assessment |
|
| Menometrorrhagia | Reproductive system and breast disorders | MedDRA 15.0 | Systematic Assessment |
|
| Ovarian Cyst | Reproductive system and breast disorders | MedDRA 15.0 | Systematic Assessment |
|
| Ovarian Mass | Reproductive system and breast disorders | MedDRA 15.0 | Systematic Assessment |
|
| Polycystic Ovaries | Reproductive system and breast disorders | MedDRA 15.0 | Systematic Assessment |
|
| Prostatitis | Reproductive system and breast disorders | MedDRA 15.0 | Systematic Assessment |
|
| Uterine Polyp | Reproductive system and breast disorders | MedDRA 15.0 | Systematic Assessment |
|
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Idiopathic Pulmonary Fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Pickwickian Syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Pulmonary Fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Pulmonary Hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Sleep Apnoea Syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Dermatitis Exfoliative | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Skin Ulcer | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Caesarean Section | Surgical and medical procedures | MedDRA 15.0 | Systematic Assessment |
|
| Aortic Aneurysm | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
|
| Aortic Dissection | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
|
| Arteriosclerosis | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
|
| Deep Vein Thrombosis | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
|
| Intermittent Claudication | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
|
| Peripheral Arterial Occlusive Disease | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
|
| Peripheral Vascular Disorder | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
|
| Superior Vena Cava Syndrome | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
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| Thrombosis | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
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The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results aftercompletion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| 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 |
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| CNS demyelinating disorder |
|
| Tuberculosis |
|
| Lupus disease |
|
| Opportunistic infection |
|
| Coccidioidomycosis |
|
| Histoplasmosis |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|
| Baseline: Paid help with chores (n=2414) |
|
| Baseline: Friend or family provided care (n=2415) |
|
| Year 3: Physician/urgent care visits (n=1458) |
|
| Year 3: Nurse practitioner, etc visits (n=1451) |
|
| Year 3: Home care visits from a HP (n=1451) |
|
| Year 3: Paid help with chores (n=1451) |
|
| Year 3: Friend or family provided care (n=1453) |
|
| Year 5: Physician/urgent care visits (n=1317) |
|
| Year 5: Nurse practitioner, etc visits (n=1318) |
|
| Year 5: Home care visits from a HP (n=1317) |
|
| Year 5: Paid help with chores (n=1318) |
|
| Year 5: Friend or family provided care (n=1318) |
|
| Title | Measurements |
|---|---|
|
| Presenteeism - Baseline (n=1832) |
|
| Presenteeism - Year 3 (n=1009) |
|
| Presenteeism - Year 5 (n=866) |
|
| Work Productivity Loss - Baseline (n=1702) |
|
| Work Productivity Loss - Year 3 (n=944) |
|
| Work Productivity Loss - Year 5 (n=805) |
|
| Activity Impairment - Baseline (n=2440) |
|
| Activity Impairment - Year 3 (n=1460) |
|
| Activity Impairment - Year 5 (n=1322) |
|
| Title | Measurements |
|---|---|
|