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| ID | Type | Description | Link |
|---|---|---|---|
| 16.0023 |
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| Name | Class |
|---|---|
| Immunex Corporation | INDUSTRY |
This is an open label, multicenter study for extended treatment of patients who have participated in the Immunex clinical study 016.0012. The primary objective of this study is to evaluate the long term safety of etanercept (TNFR:Fc) in patients with early stage rheumatoid arthritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etanercept | Biological | Etanercept (TNFR:Fc) will be administered 50 mg per week as two 25 mg subcutaneous injections at separate sites, given either on the same day or 3 or 4 days apart. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Exposure to Etanercept With Gaps | Total participant exposure to etanercept (Enbrel) with gaps, calculated as the sum of the times on treatment for all participants. Gaps of up to 14 days from the last treatment in a previous Etanercept study were ignored in calculating time on treatment. | Up to 8 years |
| Total Exposure-Adjusted Rate of Malignancies | Exposure-adjusted rate of malignancies, excluding nonmelanoma skin cancers, occurring on study within 30 days of the last dose of etanercept | Up to 8 years |
| Total Exposure-Adjusted Rate of Deaths | Rate of deaths within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept | Up to 8 years |
| Total Exposure Adjusted Rate of Serious Infectious Events | Exposure-adjusted rate of serious infectious events (associated with hospitalization or IV antibiotics) occurring on study within 30 days of the last dose of etanercept | Up to 8 years |
| Total Exposure Adjusted Rate of Lymphomas | Rate of lymphomas occurring on study within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept | Up to 8 years |
| Malignancy | Occurrence of one or more malignancies within the participant on study within 30 days of the last dose of etanercept | Up to 8 years |
| Lymphoma |
| Measure | Description | Time Frame |
|---|---|---|
| ACR20 Response at Month 3 | American College of Rheumatology (ACR) 20, defined as a 20% improvement in both tender and swollen joints (78 joints) and a 20% improvement in 3 of 5 items (physician and patient global assessments, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein or erythrocyte sedimentation rate) | Baseline and month 3 |
Not provided
Inclusion Criteria: - Previous enrollment in Immunex protocol 016.0012.
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15996057 | Result | Genovese MC, Bathon JM, Fleischmann RM, Moreland LW, Martin RW, Whitmore JB, Tsuji WH, Leff JA. Longterm safety, efficacy, and radiographic outcome with etanercept treatment in patients with early rheumatoid arthritis. J Rheumatol. 2005 Jul;32(7):1232-42. | |
| 12115173 | Result | Genovese MC, Bathon JM, Martin RW, Fleischmann RM, Tesser JR, Schiff MH, Keystone EC, Wasko MC, Moreland LW, Weaver AL, Markenson J, Cannon GW, Spencer-Green G, Finck BK. Etanercept versus methotrexate in patients with early rheumatoid arthritis: two-year radiographic and clinical outcomes. Arthritis Rheum. 2002 Jun;46(6):1443-50. doi: 10.1002/art.10308. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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Participants were enrolled from 3 March 1999 through 17 Mar 2000
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| ID | Title | Description |
|---|---|---|
| FG000 | Etanercept (Enbrel) | Etanercept 50 mg subcutaneous dose weekly |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Etanercept (Enbrel) | Etanercept 50 mg subcutaneous dose weekly |
| 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 | Total Exposure to Etanercept With Gaps | Total participant exposure to etanercept (Enbrel) with gaps, calculated as the sum of the times on treatment for all participants. Gaps of up to 14 days from the last treatment in a previous Etanercept study were ignored in calculating time on treatment. | All enrolled participants who received at least one dose of etanercept | Posted | Number | Participant-years | Up to 8 years |
|
|
Up to 9.57 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 | Enbrel |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspepsia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic 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
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Occurrence of one or more lymphomas on study within 30 days of the last dose of etanercept
| Up to 8 years |
| Serious Infectious Event | Occurrence of one or more serious infectious events within the participant on study within 30 days of the last dose of study medication | Up to 8 years |
| Total Exposure Adjusted Rate of Serious Adverse Events | Rate of serious adverse events adjusted to total exposure to etanercept (events / exposure * 100) | Up to 8 years |
| Death | Death of the participant on study up to 30 days after the last dose of etanercept | Up to 8 years |
| Dosing Period | Duration of etanercept dosing | Up to 8 years |
| ACR20 Response at Month 12 | American College of Rheumatology (ACR) 20, defined as a 20% improvement in both tender and swollen joints (78 joints) and a 20% improvement in 3 of 5 items (including physician and patient global assessments), in adults | Baseline and month 12 |
| ACR50 Response at Month 12 | American College of Rheumatology (ACR) 50, defined as a 50% improvement in both tender and swollen joints (78 joints) and a 50% improvement in 3 of 5 items (including physician and patient global assessments), in adults | Baseline and month 12 |
| ACR70 Response at Month 12 | American College of Rheumatology (ACR) 70, defined as a 70% improvement in both tender and swollen joints (78 joints) and a 70% improvement in 3 of 5 items (including physician and patient global assessments), in adults | Baseline and month 12 |
| Standardized Incidence Rate for All SEER Cancers | Standardized incidence rate for all cancers tracked by the National Cancer Institute's Surveillance Epidemiology and End Results (SEER) system, calculated as the ratio of the observed to expected age- and sex-adjusted incidence rates (per person-year) of cancer. Expected rates were based on 1998-2002 SEER data. | Up to 8 years |
| Percent Improvement in Physician Global Assessment of Disease Status From Baseline to Month 12 | Percent improvement in the Physician Global Assessment of disease status from baseline to month 12, assessed using a 0 - 10 Likert scale, where 0 = asymptomatic and 10 = severe symptoms | Baseline and month 12 |
| Percent Improvement in Participant Global Assessment of Disease Status From Baseline to Month 12 | Percent improvement in the Participant Global Assessment of disease status from baseline to month 12, assessed using a 0 - 10 Likert scale, where 0 = asymptomatic and 10 = severe symptoms | Baseline and Month 12 |
| Percent Improvement in Participant Pain Visual Analog Scale From Baseline to Month 12 | Percent improvement in the Participant Pain Visual Analog Scale (VAS) from baseline to month 12, using a 10 cm scale ranging from "no pain" (0 cm) to "severe pain" (10 cm). | Baseline and month 12 |
| Percent Improvement in Tender Joint Count From Baseline to Month 12 | Percent improvement in tender joint count (based on up to 71 joints) from baseline to month 12. Tender joints were assessed clinically, and the number of such joints was counted at each time point. | Baseline and month 12 |
| Percent Improvement in Swollen Joint Count From Baseline to Month 12 | Percent improvement in swollen joint count (based on up to 68 joints) from baseline to month 12. | Baseline and month 12 |
| Percent Improvement in HAQ DI From Baseline to Month 12 | Percent improvement in the Health Assessment Questionnaire Disability Index (HAQ DI) from baseline to month 12. | Baseline and month 12 |
| Percent Improvement in the Physical Component Summary Score for SF-36 From Baseline to Month 12 | Percent improvement in the Physical Component Summary Score for the Short Form 36 Health Survey (SF-36) from baseline to month 12. This score has a range of 0 to 100, with higher scores indicating better health. | Baseline and month 12 |
| Percent Improvement in Mental Component Summary Score of SF-36 From Baseline to Month 12 | Percent improvement in the Mental Component Summary Score of the Short Form 36 Health Survey (SF-36) from baseline to month 12. This score has a range of 0 to 100, with higher scores indicating better health. | Baseline and month 12 |
| Percent Improvement in C-Reactive Protein From Baseline to Month 12 | Percent improvement in C-reactive protein from baseline to month 12 | Baseline and month 12 |
| Percent Improvement in Duration of Morning Stiffness From Baseline to Month 12 | Percent improvement in the duration of morning stiffness from baseline to month 12 | Baseline and month 12 |
| Change From Baseline to Year 2 in Total Sharp Score | Change from baseline to year 2 in Total Sharp Score. This score has a range of 0 to 398, where 0 = no change and higher scores represent a worsening of joint erosions and joint space narrowing. | Baseline, Year 2 |
| Change From Baseline to Year 2 in Sharp Score Erosion Subscale | Change from baseline to year 2 in the joint erosion subscale of the Total Sharp Score. This subscale has a range of 0 to 230, where 0 = no change and higher values represent a worsening in joint erosions. | Baseline, Year 2 |
| Change From Baseline to Year 2 in Sharp Score Joint Space Narrowing Subscale | Change from baseline to year 2 in the joint space narrowing subscale of the Total Sharp Score. This subscale has a range of 0 to 168, where 0 = no change and higher values represent a worsening of joint space narrowing. | Baseline, Year 2 |
| 20957659 | Derived | Weinblatt ME, Bathon JM, Kremer JM, Fleischmann RM, Schiff MH, Martin RW, Baumgartner SW, Park GS, Mancini EL, Genovese MC. Safety and efficacy of etanercept beyond 10 years of therapy in North American patients with early and longstanding rheumatoid arthritis. Arthritis Care Res (Hoboken). 2011 Mar;63(3):373-82. doi: 10.1002/acr.20372. Epub 2010 Oct 18. |
| Physician Decision |
|
| Withdrawal by Subject |
|
| Completed month 12 only |
|
| Protocol issues |
|
| Response status |
|
| Other |
|
| Year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participant |
|
| Physician Global Assessment of Disease Status | Assessed using a 0 - 10 Likert scale, where 0 = asymptomatic and 10 = severe symptoms | Mean | Standard Deviation | Units on a scale |
|
| Participant Global Assessment of Disease Status | Assessed using a 0 - 10 Likert scale, where 0 = asymptomatic and 10 = severe symptoms | Mean | Standard Deviation | Units on a scale |
|
| Participant Pain Visual Analog Scale | Assessed using a 10 cm scale ranging from "no pain" (0 cm) to "severe pain" (10 cm). | Mean | Standard Deviation | Units on a scale |
|
| Tender Joint Count | Based on up to 71 joints | Mean | Standard Deviation | Joints |
|
| Swollen Joint Count | Based on up to 68 joints | Mean | Standard Deviation | Joints |
|
| Health Assessment Questionnaire Disability Index | This index is a weighted average of 24 items, each scored 0 (no difficulty) to 3 (unable to function). | Mean | Standard Deviation | Units on a scale |
|
| Physical Component Summary Score from SF-36 | Physical Component Summary Score from the Short Form-36 Health Survey. This score has a range of 0 to 100, with higher scores indicating better health. | Mean | Standard Deviation | Units on a scale |
|
| Mental Component Summary Score from SF-36 | Mental Component Summary Score from the Short Form-36 Health Survey. This score has a range of 0 to 100, with higher scores indicating better health. | Mean | Standard Deviation | Units on a scale |
|
| C-Reactive Protein | Mean | Standard Deviation | mg/dL |
|
| Duration of Morning Stiffness | Mean | Standard Deviation | Minutes |
|
|
|
| Secondary | ACR20 Response at Month 3 | American College of Rheumatology (ACR) 20, defined as a 20% improvement in both tender and swollen joints (78 joints) and a 20% improvement in 3 of 5 items (physician and patient global assessments, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein or erythrocyte sedimentation rate) | All enrolled participants who received at least one dose of etanercept and had available data at month 3 | Posted | Number | Participants | Baseline and month 3 |
|
|
|
| Primary | Total Exposure-Adjusted Rate of Malignancies | Exposure-adjusted rate of malignancies, excluding nonmelanoma skin cancers, occurring on study within 30 days of the last dose of etanercept | All enrolled participants who received at least one dose of etanercept | Posted | Number | Malignancies per 100 participant-years | Up to 8 years |
|
|
|
| Primary | Total Exposure-Adjusted Rate of Deaths | Rate of deaths within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept | All enrolled participants who received at least one dose of etanercept | Posted | Number | Deaths per 100 participant-years | Up to 8 years |
|
|
|
| Primary | Total Exposure Adjusted Rate of Serious Infectious Events | Exposure-adjusted rate of serious infectious events (associated with hospitalization or IV antibiotics) occurring on study within 30 days of the last dose of etanercept | All enrolled participants who received at least one dose of etanercept | Posted | Number | Events per 100 participant-years | Up to 8 years |
|
|
|
| Primary | Total Exposure Adjusted Rate of Lymphomas | Rate of lymphomas occurring on study within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept | All enrolled participants who received at least one dose of etanercept | Posted | Number | Lymphomas per 100 participant-years | Up to 8 years |
|
|
|
| Primary | Malignancy | Occurrence of one or more malignancies within the participant on study within 30 days of the last dose of etanercept | All enrolled participants who received at least one dose of etanercept | Posted | Number | Participants | Up to 8 years |
|
|
|
| Primary | Lymphoma | Occurrence of one or more lymphomas on study within 30 days of the last dose of etanercept | All enrolled participants who received at least one dose of etanercept | Posted | Number | Participants | Up to 8 years |
|
|
|
| Primary | Serious Infectious Event | Occurrence of one or more serious infectious events within the participant on study within 30 days of the last dose of study medication | All enrolled participants who received at least one dose of etanercept | Posted | Number | Participants | Up to 8 years |
|
|
|
| Primary | Total Exposure Adjusted Rate of Serious Adverse Events | Rate of serious adverse events adjusted to total exposure to etanercept (events / exposure * 100) | All enrolled participants who received at least one dose of etanercept | Posted | Number | Events per 100 patient-years | Up to 8 years |
|
|
|
| Secondary | Dosing Period | Duration of etanercept dosing | All participants who received at least one dose of etanercept | Posted | Mean | Standard Deviation | Days | Up to 8 years |
|
|
|
| Secondary | ACR20 Response at Month 12 | American College of Rheumatology (ACR) 20, defined as a 20% improvement in both tender and swollen joints (78 joints) and a 20% improvement in 3 of 5 items (including physician and patient global assessments), in adults | All enrolled participants who received at least one dose of etanercept and had available data at month 12 | Posted | Number | Participants | Baseline and month 12 |
|
|
|
| Secondary | ACR50 Response at Month 12 | American College of Rheumatology (ACR) 50, defined as a 50% improvement in both tender and swollen joints (78 joints) and a 50% improvement in 3 of 5 items (including physician and patient global assessments), in adults | All enrolled participants who received at least one dose of etanercept and had available data at month 12 | Posted | Number | Participants | Baseline and month 12 |
|
|
|
| Secondary | ACR70 Response at Month 12 | American College of Rheumatology (ACR) 70, defined as a 70% improvement in both tender and swollen joints (78 joints) and a 70% improvement in 3 of 5 items (including physician and patient global assessments), in adults | All enrolled participants who received at least one dose of etanercept and had available data at month 12 | Posted | Number | Participants | Baseline and month 12 |
|
|
|
| Secondary | Standardized Incidence Rate for All SEER Cancers | Standardized incidence rate for all cancers tracked by the National Cancer Institute's Surveillance Epidemiology and End Results (SEER) system, calculated as the ratio of the observed to expected age- and sex-adjusted incidence rates (per person-year) of cancer. Expected rates were based on 1998-2002 SEER data. | All participants who received at least one dose of etanercept | Posted | Mean | 95% Confidence Interval | Standardized incidence rate | Up to 8 years |
|
|
|
| Secondary | Percent Improvement in Physician Global Assessment of Disease Status From Baseline to Month 12 | Percent improvement in the Physician Global Assessment of disease status from baseline to month 12, assessed using a 0 - 10 Likert scale, where 0 = asymptomatic and 10 = severe symptoms | All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12 | Posted | Mean | Standard Deviation | Percent change | Baseline and month 12 |
|
|
|
| Secondary | Percent Improvement in Participant Global Assessment of Disease Status From Baseline to Month 12 | Percent improvement in the Participant Global Assessment of disease status from baseline to month 12, assessed using a 0 - 10 Likert scale, where 0 = asymptomatic and 10 = severe symptoms | All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12 | Posted | Mean | Standard Deviation | Percent change | Baseline and Month 12 |
|
|
|
| Secondary | Percent Improvement in Participant Pain Visual Analog Scale From Baseline to Month 12 | Percent improvement in the Participant Pain Visual Analog Scale (VAS) from baseline to month 12, using a 10 cm scale ranging from "no pain" (0 cm) to "severe pain" (10 cm). | All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12 | Posted | Mean | Standard Deviation | Percent change | Baseline and month 12 |
|
|
|
| Secondary | Percent Improvement in Tender Joint Count From Baseline to Month 12 | Percent improvement in tender joint count (based on up to 71 joints) from baseline to month 12. Tender joints were assessed clinically, and the number of such joints was counted at each time point. | All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12 | Posted | Mean | Standard Deviation | Percent change | Baseline and month 12 |
|
|
|
| Secondary | Percent Improvement in Swollen Joint Count From Baseline to Month 12 | Percent improvement in swollen joint count (based on up to 68 joints) from baseline to month 12. | All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12 | Posted | Mean | Standard Deviation | Percent change | Baseline and month 12 |
|
|
|
| Secondary | Percent Improvement in HAQ DI From Baseline to Month 12 | Percent improvement in the Health Assessment Questionnaire Disability Index (HAQ DI) from baseline to month 12. | All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12 | Posted | Mean | Standard Deviation | Percent change | Baseline and month 12 |
|
|
|
| Secondary | Percent Improvement in the Physical Component Summary Score for SF-36 From Baseline to Month 12 | Percent improvement in the Physical Component Summary Score for the Short Form 36 Health Survey (SF-36) from baseline to month 12. This score has a range of 0 to 100, with higher scores indicating better health. | All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12 | Posted | Mean | Standard Deviation | Percent change | Baseline and month 12 |
|
|
|
| Secondary | Percent Improvement in Mental Component Summary Score of SF-36 From Baseline to Month 12 | Percent improvement in the Mental Component Summary Score of the Short Form 36 Health Survey (SF-36) from baseline to month 12. This score has a range of 0 to 100, with higher scores indicating better health. | All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12 | Posted | Mean | Standard Deviation | Percent change | Baseline and month 12 |
|
|
|
| Secondary | Percent Improvement in C-Reactive Protein From Baseline to Month 12 | Percent improvement in C-reactive protein from baseline to month 12 | All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12 | Posted | Mean | Standard Deviation | Percent change | Baseline and month 12 |
|
|
|
| Secondary | Percent Improvement in Duration of Morning Stiffness From Baseline to Month 12 | Percent improvement in the duration of morning stiffness from baseline to month 12 | All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12 | Posted | Mean | Standard Deviation | Percent change | Baseline and month 12 |
|
|
|
| Primary | Death | Death of the participant on study up to 30 days after the last dose of etanercept | All enrolled participants who received at least one dose of etanercept | Posted | Number | Participants | Up to 8 years |
|
|
|
| Secondary | Change From Baseline to Year 2 in Total Sharp Score | Change from baseline to year 2 in Total Sharp Score. This score has a range of 0 to 398, where 0 = no change and higher scores represent a worsening of joint erosions and joint space narrowing. | All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and year 2 | Posted | Mean | Full Range | Units on a scale | Baseline, Year 2 |
|
|
|
| Secondary | Change From Baseline to Year 2 in Sharp Score Erosion Subscale | Change from baseline to year 2 in the joint erosion subscale of the Total Sharp Score. This subscale has a range of 0 to 230, where 0 = no change and higher values represent a worsening in joint erosions. | All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and year 2 | Posted | Mean | Full Range | Units on a scale | Baseline, Year 2 |
|
|
|
| Secondary | Change From Baseline to Year 2 in Sharp Score Joint Space Narrowing Subscale | Change from baseline to year 2 in the joint space narrowing subscale of the Total Sharp Score. This subscale has a range of 0 to 168, where 0 = no change and higher values represent a worsening of joint space narrowing. | All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and year 2 | Posted | Mean | Full Range | Units on a scale | Baseline, Year 2 |
|
|
|
| 169 |
| 468 |
| 320 |
| 468 |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Bradyarrhythmia | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Coronary artery occlusion | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Coronary artery stenosis | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pericarditis | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cleft palate | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
|
| Myxoedema | Endocrine disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Diverticulum | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Peptic ulcer | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Retroperitoneal haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Adverse drug reaction | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Condition aggravated | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Death | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Impaired healing | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Anaphylactic shock | Immune system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal abscess | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Abscess | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Anorectal infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Appendicitis perforated | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Arthritis bacterial | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Bronchitis bacterial | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Bursitis infective | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Cholecystitis infective | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Diarrhoea infectious | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Empyema | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Haemophilus sepsis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Localised infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Lung infection pseudomonal | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Orchitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pelvic abscess | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Perirectal abscess | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Peritonsillar abscess | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pneumonia escherichia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pneumonia klebsiella | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pneumonia staphylococcal | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Post procedural infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pseudomembranous colitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pseudomonas infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Staphylococcal sepsis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Streptococcal infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Fracture displacement | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Pseudomeningocele | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Biopsy prostate | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Colonoscopy | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Obesity | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Bone disorder | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cervical spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| B-cell small lymphocytic lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Benign colonic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Benign neoplasm of thyroid gland | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Breast cancer in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Breast cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Chronic lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Lung squamous cell carcinoma stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Lymphocytic lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Metastases to spine | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Metastatic malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Neuroendocrine carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Non-Hodgkin's lymphoma stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Non-small cell lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| T-cell chronic lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Intracranial aneurysm | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Multiple sclerosis | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Myelopathy | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ruptured cerebral aneurysm | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Adjustment disorder | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Conversion disorder | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| IgA nephropathy | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Renal mass | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Endometriosis | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Prostatic disorder | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Uterine haemorrhage | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Stasis dermatitis | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cholecystectomy | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
|
| Cystopexy | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
|
| Incisional hernia repair | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
|
| Knee arthroplasty | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
|
| Shoulder arthroplasty | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
|
| Spinal laminectomy | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
|
| Surgery | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
|
| Aortic aneurysm | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Arterial thrombosis | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Lymphoedema | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Peripheral ischaemia | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. 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 multi-center studies, the investigator agrees not to publish any results before the first multi-center publication.
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System 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 |