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| Name | Class |
|---|---|
| Wyeth is now a wholly owned subsidiary of Pfizer | INDUSTRY |
The overall objective of the study was to describe the long-term effectiveness and safety of etanercept in patients with psoriatic arthritis in a Canadian clinical practice setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Etanercept | Other | Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etanercept | Drug | Administered according to the product monograph by subcutaneous (SC) injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Improvement of ≥ 0.50 Units From Baseline to Month 24 in the HAQ DI | The HAQ DI is a questionnaire which measures functional status in patients with psoriatic arthritis. The questionnaire addresses health-related quality of life issues related to psoriatic arthritis such as dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. | Baseline and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Month 24 in the Health and Labour Questionnaire (HLQ) Absence From Work Module | The HLQ collects quantitative data on the relation between illness and treatment and work performance. The instrument is divided into 4 modules to collect data about absence from work, reduced productivity at paid work, unpaid labor production and impediments to paid and unpaid labor. The absence from work module asks participants to indicate how many days in the past 2 weeks they missed work due to health problems. Change from Baseline was calculated as the Baseline value - Month 24 value. A positive change from Baseline value indicates improvement. |
Not provided
Inclusion Criteria:
Presence of psoriasis or previous evidence of psoriasis documented by a dermatologist as part of usual care
At least one of the following forms of psoriatic arthritis (PsA):
Active psoriatic arthritis at the time of the study enrollment
Patients must demonstrate greater than 3 swollen joints and greater than 3 tender/painful joints
Greater than 18 years of age at the time of consent
Able to start etanercept therapy per the approved product monograph
Informed consent must be provided before any study specific procedures are performed
Exclusion Criteria:
Active infections at time of initiating Enbrel® therapy
Evidence of skin conditions (e.g., eczema) other than psoriasis that would interfere with evaluations of the study medication
A malignancy, other than basal cell carcinoma of the skin or, in situ carcinoma of the cervix, within the past 5 years
Known hypersensitivity to etanercept or any of its components
Patients receiving, or who have received:
Patients receiving or who have received etanercept
Treatment with any investigational therapy in the 30 days prior to enrollment or during the study
Active guttate, erythrodermic or pustular psoriasis at the time of screening
Presence of any significant and uncontrolled medical condition, which in the Investigator's opinion, precludes the use of etanercept as outlined in the product monograph
Sepsis or at risk of septic syndrome
Patients not available for follow-up assessment
Concerns for subject's compliance with the protocol procedures
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21572156 | Background | Gladman DD, Bombardier C, Thorne C, Haraoui B, Khraishi M, Rahman P, Bensen W, Syrotuik J, Poulin-Costello M. Effectiveness and safety of etanercept in patients with psoriatic arthritis in a Canadian clinical practice setting: the REPArE trial. J Rheumatol. 2011 Jul;38(7):1355-62. doi: 10.3899/jrheum.100698. Epub 2011 May 15. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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Not provided
Participants were enrolled from 5 August 2005 through 2 February 2007
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Enbrel | Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Enbrel | Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Improvement of ≥ 0.50 Units From Baseline to Month 24 in the HAQ DI | The HAQ DI is a questionnaire which measures functional status in patients with psoriatic arthritis. The questionnaire addresses health-related quality of life issues related to psoriatic arthritis such as dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. | Full Analysis Set, composed of all participants who received at least one dose of study medication and had at least one baseline and at least one post-baseline measurement for the endpoint of interest. Imputation by last observation carried forward (LOCF) was applied. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and 24 months |
|
Up to 25 months
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 | Enbrel | Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 8.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068800 | Etanercept |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
Not provided
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Not provided
Not provided
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| Baseline and 24 months |
| Change From Baseline to Month 24 in the HLQ Reduced Productivity at Paid Work Module | The HLQ collects quantitative data on the relation between illness and treatment and work performance. The instrument is divided into 4 modules to collect data about absence from work, reduced productivity at paid work, unpaid labor production and impediments to paid and unpaid labor. In the reduced productivity at work module participants were asked to estimate the number of additional hours required to compensate for production losses due to illness on working days over the past 2 weeks. Change from Baseline was calculated as the Baseline value - Month 24 value. A positive change from Baseline value indicates improvement. | Baseline and Month 24 |
| Change From Baseline to Month 24 in the HLQ Unpaid Labour Production Module | The HLQ collects quantitative data on the relation between illness and treatment and work performance. The instrument is divided into 4 modules to collect data about absence from work, reduced productivity at paid work, unpaid labor production and impediments to paid and unpaid labor. The Unpaid Labour Production Module assesses the amount of hours of unpaid work (including household work, shopping, caring for children and odd jobs around the house), normally performed by the participant, that were taken over by other members of the household, family or friends (unpaid help), and/or by paid workers due to health problems of the participant. Change from Baseline was calculated as the Baseline value - Month 24 value. A positive change from Baseline value indicates improvement. | Baseline and month 24 |
| Change From Baseline to Month 24 in the HLQ Impediments to Paid and Unpaid Labour Module | In the HLQ impediments to paid and unpaid labor module participants were asked "Were you hindered by health problems at your paid work over the past two weeks?" and answered according to the following: 'no not at all = 0', 'yes, a little = 1', 'yes, very = 2'. Participants were also asked whether they had performed 4 unpaid activities (household work, shopping, odd jobs / chores, and childcare), and answered according to the following: Did do, hindered = 1; Did do, not hindered = 0; Did not do, due to health problems = 2; Did not do, due to other reasons = 0. The aggregated score ranges from 0 (no impediments) to 8 (unable to do any of the surveyed activities). Change from Baseline was calculated as the Baseline value - Month 24 value. A positive change from Baseline value indicates improvement. | Baseline and month 24 |
| Change From Baseline to Month 24 in the Physician Global Assessment | The physician global assessment of disease activity asks the physician to assess how the participant is doing since their last visit on a scale from 1 (very good, asymptomatic, no limitations in normal activities) to 5 (very poor, severe symptoms that are intolerable, inability to carry out all normal activites). Change from Baseline was calculated as Baseline value - Month 24 value. A positive change from Baseline indicates improvement. | Baseline and month 24 |
| Percent Change From Baseline to Month 24 in Physician Global Assessment | The physician global assessment of disease activity asks the physician to assess how the participant is doing since their last visit on a scale from 1 (very good, asymptomatic, no limitations in normal activities) to 5 (very poor, severe symptoms that are intolerable, inability to carry out all normal activites). Percent change from Baseline was calculated as (Baseline value - Month 24 value) / Baseline value * 100. A positive change from Baseline indicates improvement. | Baseline and Month 24 |
| Change From Baseline to Month 24 in Patient Global Assessment | The patient global assessment of disease activity is a 5-point scale that asks how the participant is doing since their last visit with regard to their rheumatoid arthritis. Participants answer on a scale from 1 (very good, asymptomatic, no limitation in normal activites) to 5 (very poor, very severe symptoms that are intolerable, inability to perform all normal activites). Change from Baseline was calculated as Baseline value - Month 24 value. A positive change from Baseline indicates improvement. | Baseline and Month 24 |
| Percent Change From Baseline to Month 24 in Patient Global Assessment | The patient global assessment of disease activity is a 5-point scale that asks how the participant is doing since their last visit with regard to their rheumatoid arthritis. Participants answer on a scale from 1 (very good, asymptomatic, no limitation in normal activites) to 5 (very poor, very severe symptoms that are intolerable, inability to perform all normal activites). Percent change from Baseline was calculated as (Baseline value - Month 24 value) / Baseline value * 100. A positive change from Baseline indicates improvement. | Baseline and month 24 |
| Percentage of Participants With Improvement of ≥ 75 Percent From Baseline to Month 24 in the Psoriasis Activity and Severity Index (PASI) | The PASI was is a method for quantifying the intensity of psoriasis, and for evaluating its improvement with treatment. This index is based on the quantitative assessment of three typical signs of psoriatic lesions: erythema, infiltration, and desquamation, combined with the skin surface area involvement. The index has a range from 0.0 to 72.0, with higher scores indicating worse psoriasis. | Baseline and Month 24 |
| Percentage of Participants With a Psoriatic Arthritis Response Criteria (PsARC) Response at Month 24 | Psoriatic Arthritis Response Criteria response is defined as improvement from Baseline in at least 2 of 4 criteria, one of which must be joint pain /tenderness or swelling and no worsening in any of the 4 following criteria: • Joint Pain/Tenderness score: Physician assessment of 78 joints for pain/tenderness on a scale from 0 (none) to 3 (severe) with a total score ranging from 0 to 234, with higher scores indicating more severe disability; • Joint Swelling score: Physician assessment of 78 joints for swelling on a scale from 0 (none) to 3 (severe) with a total score ranging from 0 to 234 with higher scores indicating more severe disability; • Patient global assessment of disease activity: Measured on a 5-point scale from 1 (very good) to 5 (very poor); • Physician global assessment of disease activity: Measured on a 5-point scale from 1 (very good) to 5 (very poor). | Baseline and Month 24 |
| Lack of Efficacy |
|
| Noncompliance |
|
| Protocol Violation |
|
| Other |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Health and Labour Questionnaire (HLQ) Absence from Work Module | The HLQ collects quantitative data on the relation between illness and treatment and work performance. The instrument is divided into 4 modules to collect data about absence from work, reduced productivity at paid work, unpaid labor production and impediments to paid and unpaid labor. The absence from work module asks participants to indicate how many days in the past 2 weeks they missed work due to health problems. | Mean | Standard Deviation | days |
|
| HLQ Reduced Productivity at Paid Work Module | The reduced productivity at work module of the HLQ asks participants to estimate the number of additional hours required to compensate for production losses due to illness on working days over the past 2 weeks. | Mean | Standard Deviation | Hours |
|
| HLQ Unpaid Work Module: Help Received with Unpaid Work | The Unpaid Labour Production Module of the HLQ assesses the amount of hours of unpaid work (including household work, shopping, caring for children and odd jobs around the house), normally performed by the participant, that were taken over by other members of the household, family or friends (unpaid help), and/or by paid workers due to health problems of the participant. Analysis only includes participants who received unpaid help (103 participants) or paid help (51 participants). | Mean | Standard Deviation | Hours |
|
| HLQ Impediments to Work Module | The HLQ impediments to paid and unpaid labor module asks participants how much they were indered by health problems at work over the past 2 weeks on a scale from not at all (0), a little (1) to very (2). Participants were also asked whether they had performed unpaid activities (household work, shopping, odd jobs/chores, childcare) according to the following: Did do, hindered (1); Did do, not hindered (0); Did not do, due to health problems (2); Did not do, due to other reasons (0). The aggregated score ranges from 0 (no impediments) to 8 (unable to do any of the surveyed activities). | Mean | Standard Deviation | Units on a scale |
|
| Physician Global Assessment | The physician global assessment of disease activity asks the physician to assess how the participant is doing since their last visit on a scale from 1 (very good, asymptomatic, no limitations in normal activities) to 5 (very poor, severe symptoms that are intolerable, inability to carry out all normal activites). | Mean | Standard Deviation | Units on a scale |
|
| Patient Global Assessment | The patient global assessment of disease activity is a 5-point scale concerning disease activity that asks how the participant is doing since their last visit with regard to their rheumatoid arthritis. Participants answer on a scale from 1 (very good, asymptomatic, no limitation in normal activites) to 5 (very poor, very severe symptoms that are intolerable, inability to perform all normal activites). | Mean | Standard Deviation | Units on a scale |
|
| Title |
|---|
| Description |
|---|
| OG000 | Enbrel | Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months. |
|
|
| Secondary | Change From Baseline to Month 24 in the Health and Labour Questionnaire (HLQ) Absence From Work Module | The HLQ collects quantitative data on the relation between illness and treatment and work performance. The instrument is divided into 4 modules to collect data about absence from work, reduced productivity at paid work, unpaid labor production and impediments to paid and unpaid labor. The absence from work module asks participants to indicate how many days in the past 2 weeks they missed work due to health problems. Change from Baseline was calculated as the Baseline value - Month 24 value. A positive change from Baseline value indicates improvement. | Full Analysis Set participants who completed the HLQ at Baseline and Month 24, and were employed. | Posted | Mean | Standard Deviation | days | Baseline and 24 months |
|
|
|
| Secondary | Change From Baseline to Month 24 in the HLQ Reduced Productivity at Paid Work Module | The HLQ collects quantitative data on the relation between illness and treatment and work performance. The instrument is divided into 4 modules to collect data about absence from work, reduced productivity at paid work, unpaid labor production and impediments to paid and unpaid labor. In the reduced productivity at work module participants were asked to estimate the number of additional hours required to compensate for production losses due to illness on working days over the past 2 weeks. Change from Baseline was calculated as the Baseline value - Month 24 value. A positive change from Baseline value indicates improvement. | Full Analysis Set participants who completed the HLQ at Baseline and Month 24, were employed, and indicated they had some production losses due to health problems at work (participants with no production losses were not included). | Posted | Mean | Standard Deviation | Hours | Baseline and Month 24 |
|
|
|
| Secondary | Change From Baseline to Month 24 in the HLQ Unpaid Labour Production Module | The HLQ collects quantitative data on the relation between illness and treatment and work performance. The instrument is divided into 4 modules to collect data about absence from work, reduced productivity at paid work, unpaid labor production and impediments to paid and unpaid labor. The Unpaid Labour Production Module assesses the amount of hours of unpaid work (including household work, shopping, caring for children and odd jobs around the house), normally performed by the participant, that were taken over by other members of the household, family or friends (unpaid help), and/or by paid workers due to health problems of the participant. Change from Baseline was calculated as the Baseline value - Month 24 value. A positive change from Baseline value indicates improvement. | Full Analysis Set participants who completed the HLQ at Baseline and Month 24 and who performed any unpaid work at both time points (71 participants). "n" indicates the number of participants who had unpaid or paid help with their unpaid work. | Posted | Mean | Standard Deviation | Hours | Baseline and month 24 |
|
|
|
| Secondary | Change From Baseline to Month 24 in the HLQ Impediments to Paid and Unpaid Labour Module | In the HLQ impediments to paid and unpaid labor module participants were asked "Were you hindered by health problems at your paid work over the past two weeks?" and answered according to the following: 'no not at all = 0', 'yes, a little = 1', 'yes, very = 2'. Participants were also asked whether they had performed 4 unpaid activities (household work, shopping, odd jobs / chores, and childcare), and answered according to the following: Did do, hindered = 1; Did do, not hindered = 0; Did not do, due to health problems = 2; Did not do, due to other reasons = 0. The aggregated score ranges from 0 (no impediments) to 8 (unable to do any of the surveyed activities). Change from Baseline was calculated as the Baseline value - Month 24 value. A positive change from Baseline value indicates improvement. | Full Analysis Set participants who completed the HLQ at Baseline and Month 24 and who performed any unpaid work at both time points. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and month 24 |
|
|
|
| Secondary | Change From Baseline to Month 24 in the Physician Global Assessment | The physician global assessment of disease activity asks the physician to assess how the participant is doing since their last visit on a scale from 1 (very good, asymptomatic, no limitations in normal activities) to 5 (very poor, severe symptoms that are intolerable, inability to carry out all normal activites). Change from Baseline was calculated as Baseline value - Month 24 value. A positive change from Baseline indicates improvement. | Full Analysis Set, composed of all participants who received at least one dose of study medication and had at least one baseline and at least one post-baseline measurement for the endpoint of interest. Imputation by last observation carried forward (LOCF) was applied. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and month 24 |
|
|
|
| Secondary | Percent Change From Baseline to Month 24 in Physician Global Assessment | The physician global assessment of disease activity asks the physician to assess how the participant is doing since their last visit on a scale from 1 (very good, asymptomatic, no limitations in normal activities) to 5 (very poor, severe symptoms that are intolerable, inability to carry out all normal activites). Percent change from Baseline was calculated as (Baseline value - Month 24 value) / Baseline value * 100. A positive change from Baseline indicates improvement. | Full Analysis Set, composed of all participants who received at least one dose of study medication and had at least one baseline and at least one post-baseline measurement for the endpoint of interest. Imputation by last observation carried forward (LOCF) was applied. | Posted | Mean | Full Range | Percentage change | Baseline and Month 24 |
|
|
|
| Secondary | Change From Baseline to Month 24 in Patient Global Assessment | The patient global assessment of disease activity is a 5-point scale that asks how the participant is doing since their last visit with regard to their rheumatoid arthritis. Participants answer on a scale from 1 (very good, asymptomatic, no limitation in normal activites) to 5 (very poor, very severe symptoms that are intolerable, inability to perform all normal activites). Change from Baseline was calculated as Baseline value - Month 24 value. A positive change from Baseline indicates improvement. | Full Analysis Set, composed of all participants who received at least one dose of study medication and had at least one baseline and at least one post-baseline measurement for the endpoint of interest. Imputation by last observation carried forward (LOCF) was applied. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Month 24 |
|
|
|
| Secondary | Percent Change From Baseline to Month 24 in Patient Global Assessment | The patient global assessment of disease activity is a 5-point scale that asks how the participant is doing since their last visit with regard to their rheumatoid arthritis. Participants answer on a scale from 1 (very good, asymptomatic, no limitation in normal activites) to 5 (very poor, very severe symptoms that are intolerable, inability to perform all normal activites). Percent change from Baseline was calculated as (Baseline value - Month 24 value) / Baseline value * 100. A positive change from Baseline indicates improvement. | Full Analysis Set, composed of all participants who received at least one dose of study medication and had at least one baseline and at least one post-baseline measurement for the endpoint of interest. Imputation by last observation carried forward (LOCF) was applied. Change was based on paired data. | Posted | Mean | Full Range | Percentage change | Baseline and month 24 |
|
|
|
| Secondary | Percentage of Participants With Improvement of ≥ 75 Percent From Baseline to Month 24 in the Psoriasis Activity and Severity Index (PASI) | The PASI was is a method for quantifying the intensity of psoriasis, and for evaluating its improvement with treatment. This index is based on the quantitative assessment of three typical signs of psoriatic lesions: erythema, infiltration, and desquamation, combined with the skin surface area involvement. The index has a range from 0.0 to 72.0, with higher scores indicating worse psoriasis. | Full Analysis Set, composed of all participants who received at least one dose of study medication and had at least one baseline and at least one post-baseline measurement for the endpoint of interest. Imputation by last observation carried forward (LOCF) was applied. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Month 24 |
|
|
|
| Secondary | Percentage of Participants With a Psoriatic Arthritis Response Criteria (PsARC) Response at Month 24 | Psoriatic Arthritis Response Criteria response is defined as improvement from Baseline in at least 2 of 4 criteria, one of which must be joint pain /tenderness or swelling and no worsening in any of the 4 following criteria: • Joint Pain/Tenderness score: Physician assessment of 78 joints for pain/tenderness on a scale from 0 (none) to 3 (severe) with a total score ranging from 0 to 234, with higher scores indicating more severe disability; • Joint Swelling score: Physician assessment of 78 joints for swelling on a scale from 0 (none) to 3 (severe) with a total score ranging from 0 to 234 with higher scores indicating more severe disability; • Patient global assessment of disease activity: Measured on a 5-point scale from 1 (very good) to 5 (very poor); • Physician global assessment of disease activity: Measured on a 5-point scale from 1 (very good) to 5 (very poor). | Full Analysis Set, composed of all participants who received at least one dose of study medication and had at least one baseline and at least one post-baseline measurement for the endpoint of interest. Imputation by last observation carried forward (LOCF) was applied. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Month 24 |
|
|
|
| 14 |
| 110 |
| 67 |
| 110 |
| Cardiac arrest | Cardiac disorders | MedDRA 8.1 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 8.1 | Systematic Assessment |
|
| Appendicitis perforated | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Umbilical hernia | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Abdominal abscess | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
|
| Pneumonia viral | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
|
| Streptococcal infection | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
|
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA 8.1 | Systematic Assessment |
|
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 8.1 | Systematic Assessment |
|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 8.1 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
|
| Scleroderma | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.1 | Systematic Assessment |
|
| Malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.1 | Systematic Assessment |
|
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.1 | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 8.1 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 8.1 | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 8.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 8.1 | Systematic Assessment |
|
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.
| 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 |
| 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 |