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| ID | Type | Description | Link |
|---|---|---|---|
| 16.0018 |
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| Name | Class |
|---|---|
| Immunex Corporation | INDUSTRY |
This study was designed to provide all adult and pediatric arthritis patients (placebo and etanercept(TNFR:Fc) treated) who have participated in clinical trials with etanercept (TNFR:Fc) the opportunity to receive continued treatment with etanercept (TNFR:Fc). The primary objective of this study is to examine safety parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etanercept | Biological | Adult Rheumatoid Arthritis (RA) patients on etanercept (TNFR:Fc) with well controlled arthritic symptoms will continue on the etanercept (TNFR:Fc) dose administered in their original protocol of enrollment. All other adults will receive 50 mg per week as two 25 mg subcutaneous (SC) injections at separate sites, either on the same day or 3 or 4 days apart. Pediatric patients ages 4 to 17 years will receive a 0.8 mg/kg per week dose (up to a maximum of 50 mg per week). |
| Measure | Description | Time Frame |
|---|---|---|
| Total Exposure to Etanercept With Gaps | Total participant exposure to etanercept (Enbrel) with gaps | Up to 10 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 10 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 10 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 10 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 10 years |
| Malignancy | Occurrence of one or more malignancies on study within 30 days of the last dose of etanercept | Up to 10 years |
| Lymphoma | Occurrence of one or more lymphomas on study within 30 days of the last dose of etanercept | Up to 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Dosing Period | Duration of etanercept dosing | Up to 10 years |
| Tender Joint Count | Number of tender joints, as assessed by the investigator using criteria based on pressure and joint manipulation |
Not provided
Inclusion Criteria:
Not provided
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Not provided
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12672185 | Background | Fleischmann RM, Baumgartner SW, Tindall EA, Weaver AL, Moreland LW, Schiff MH, Martin RW, Spencer-Green GT. Response to etanercept (Enbrel) in elderly patients with rheumatoid arthritis: a retrospective analysis of clinical trial results. J Rheumatol. 2003 Apr;30(4):691-6. | |
| 12794815 | Background | Kremer JM, Weinblatt ME, Bankhurst AD, Bulpitt KJ, Fleischmann RM, Jackson CG, Atkins KM, Feng A, Burge DJ. Etanercept added to background methotrexate therapy in patients with rheumatoid arthritis: continued observations. Arthritis Rheum. 2003 Jun;48(6):1493-9. doi: 10.1002/art.11142. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
Not provided
Not provided
Participants were enrolled from 31 July 1997 through 12 Oct 1999
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Adult Participants | Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly |
| FG001 | Pediatric Participants | Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pediatric Participants | Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly |
| BG001 | Adult Participants |
| 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 | All participants who received at least one dose of etanercept | Posted | Number | Participant-years | Up to 10 years |
|
Up to 11.29 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 | Total Adults |
| 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 |
|---|---|---|---|---|---|
| Abdominal pain | 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
Not provided
Not provided
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Not provided
|
| 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. A serious infectious event is a serious adverse event that is infectious. | Up to 10 years |
| Death | Occurrence of death on study within 30 days of the last dose of etanercept | Up to 10 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 10 years |
| Month 12 |
| Swollen Joint Count | Number of swollen joints | Month 12 |
| Health Assessment Questionnaire Disability Index | Health Assessment Questionnaire Disability Index (HAQ DI). This index is a weighted average of 24 items, each scored 0 (no difficulty) to 3 (unable to function). | Month 12 |
| Childhood Health Assessment Questionnaire | Childhood Health Assessment Questionnaire (CHAQ) disability index, having a range of 0 (no difficulty) to 3 (unable to do). | Month 12 |
| C-Reactive Protein | C-reactive protein at month 12 | Month 12 |
| ACR20 at Month 3 in Adults | 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 3 |
| JRA DOI 30 at Month 3 in Juveniles | Juvenile Rheumatoid Arthritis Definition of Improvement 30 (JRA DOI 30), defined as a 30% improvement from baseline in 3 of 6 items (including Childhood Health Assessment Questionnaire, disease severity, overall well-being, and erythrocyte sedimentation rate) and a worsening of >30% in at most one of the remaining items. | Baseline and month 3 |
| 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. | up to 10 years |
| 12528122 | Background | Lovell DJ, Giannini EH, Reiff A, Jones OY, Schneider R, Olson JC, Stein LD, Gedalia A, Ilowite NT, Wallace CA, Lange M, Finck BK, Burge DJ; Pediatric Rheumatology Collaborative Study Group. Long-term efficacy and safety of etanercept in children with polyarticular-course juvenile rheumatoid arthritis: interim results from an ongoing multicenter, open-label, extended-treatment trial. Arthritis Rheum. 2003 Jan;48(1):218-26. doi: 10.1002/art.10710. |
| 18438876 | Background | Lovell DJ, Reiff A, Ilowite NT, Wallace CA, Chon Y, Lin SL, Baumgartner SW, Giannini EH; Pediatric Rheumatology Collaborative Study Group. Safety and efficacy of up to eight years of continuous etanercept therapy in patients with juvenile rheumatoid arthritis. Arthritis Rheum. 2008 May;58(5):1496-504. doi: 10.1002/art.23427. |
| 16732547 | Background | Lovell DJ, Reiff A, Jones OY, Schneider R, Nocton J, Stein LD, Gedalia A, Ilowite NT, Wallace CA, Whitmore JB, White B, Giannini EH; Pediatric Rheumatology Collaborative Study Group. Long-term safety and efficacy of etanercept in children with polyarticular-course juvenile rheumatoid arthritis. Arthritis Rheum. 2006 Jun;54(6):1987-94. doi: 10.1002/art.21885. |
| 11987981 | Background | Moreland LW, Bucy RP, Weinblatt ME, Mohler KM, Spencer-Green GT, Chatham WW. Immune function in patients with rheumatoid arthritis treated with etanercept. Clin Immunol. 2002 Apr;103(1):13-21. doi: 10.1006/clim.2001.5183. |
| 11409115 | Background | Moreland LW, Cohen SB, Baumgartner SW, Tindall EA, Bulpitt K, Martin R, Weinblatt M, Taborn J, Weaver A, Burge DJ, Schiff MH. Long-term safety and efficacy of etanercept in patients with rheumatoid arthritis. J Rheumatol. 2001 Jun;28(6):1238-44. |
| 16541481 | Background | Moreland LW, Weinblatt ME, Keystone EC, Kremer JM, Martin RW, Schiff MH, Whitmore JB, White BW. Etanercept treatment in adults with established rheumatoid arthritis: 7 years of clinical experience. J Rheumatol. 2006 May;33(5):854-61. Epub 2006 Mar 15. |
| 11352248 | Background | Stone JH, Uhlfelder ML, Hellmann DB, Crook S, Bedocs NM, Hoffman GS. Etanercept combined with conventional treatment in Wegener's granulomatosis: a six-month open-label trial to evaluate safety. Arthritis Rheum. 2001 May;44(5):1149-54. doi: 10.1002/1529-0131(200105)44:53.0.CO;2-F. |
| 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. |
| Lost to Follow-up |
|
| Physician Decision |
|
| Withdrawal by Subject |
|
| Completed month 12 only |
|
| Protocol issues |
|
| Response status |
|
| Other |
|
Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participant |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Dosing Period | Duration of etanercept dosing | All participants who received at least one dose of etanercept | Posted | Mean | Standard Deviation | Days | Up to 10 years |
|
|
|
| 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 participants who received at least one dose of etanercept | Posted | Number | Malignancies per 100 participant-years | Up to 10 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 participants who received at least one dose of etanercept | Posted | Number | Deaths per 100 participant-years | Up to 10 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 participants who received at least one dose of etanercept | Posted | Number | Events per 100 participant-years | Up to 10 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 participants who received at least one dose of etanercept | Posted | Number | Lymphomas per 100 participant-years | Up to 10 years |
|
|
|
| Primary | Malignancy | Occurrence of one or more malignancies on study within 30 days of the last dose of etanercept | All participants who received at least one dose of etanercept | Posted | Number | Participants | Up to 10 years |
|
|
|
| Primary | Lymphoma | Occurrence of one or more lymphomas on study within 30 days of the last dose of etanercept | All participants who received at least one dose of etanercept | Posted | Number | Participants | Up to 10 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. A serious infectious event is a serious adverse event that is infectious. | All participants who received at least one dose of etanercept | Posted | Number | Participants | Up to 10 years |
|
|
|
| Primary | Death | Occurrence of death on study within 30 days of the last dose of etanercept | All participants who received at least one dose of etanercept | Posted | Number | Participants | Up to 10 years |
|
|
|
| Secondary | Tender Joint Count | Number of tender joints, as assessed by the investigator using criteria based on pressure and joint manipulation | All participants who received at least one dose of etanercept and had available data | Posted | Mean | Standard Deviation | Joints | Month 12 |
|
|
|
| Secondary | Swollen Joint Count | Number of swollen joints | All participants who received at least one dose of etanercept and had available data | Posted | Mean | Standard Deviation | Joints | Month 12 |
|
|
|
| Secondary | Health Assessment Questionnaire Disability Index | Health Assessment Questionnaire Disability Index (HAQ DI). This index is a weighted average of 24 items, each scored 0 (no difficulty) to 3 (unable to function). | All participants who received at least one dose of etanercept and had available data | Posted | Mean | Standard Deviation | Units on a scale | Month 12 |
|
|
|
| Secondary | Childhood Health Assessment Questionnaire | Childhood Health Assessment Questionnaire (CHAQ) disability index, having a range of 0 (no difficulty) to 3 (unable to do). | All participants who received at least one dose of etanercept and had available data | Posted | Mean | Standard Deviation | Units on a scale | Month 12 |
|
|
|
| Secondary | C-Reactive Protein | C-reactive protein at month 12 | All participants who received at least one dose of etanercept and had available data | Posted | Mean | Standard Deviation | mg/dL | Month 12 |
|
|
|
| Secondary | ACR20 at Month 3 in Adults | 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 participants who received at least one dose of etanercept and had available data at both baseline and month 3 | Posted | Number | Participants | Baseline and month 3 |
|
|
|
| Secondary | JRA DOI 30 at Month 3 in Juveniles | Juvenile Rheumatoid Arthritis Definition of Improvement 30 (JRA DOI 30), defined as a 30% improvement from baseline in 3 of 6 items (including Childhood Health Assessment Questionnaire, disease severity, overall well-being, and erythrocyte sedimentation rate) and a worsening of >30% in at most one of the remaining items. | All participants who received at least one dose of etanercept and were evaluable for this endpoint at 3 months | Posted | Number | Participants | Baseline and month 3 |
|
|
|
| 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. | All participants who received at least one dose of etanercept | Posted | Number | Observed count / expected count | up to 10 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 participants who received at least one dose of etanercept | Posted | Number | Events per 100 participant-years | Up to 10 years |
|
|
|
| 293 |
| 581 |
| 484 |
| 581 |
| EG001 | Pediatric Subjects | 16 | 58 | 49 | 58 |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Splenic infarction | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Thrombocytopenia | 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 |
|
| Arrhythmia | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Arrhythmia supraventricular | 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 |
|
| Bradycardia | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cardio-respiratory arrest | 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 |
|
| Cyanosis | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Diastolic dysfunction | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Left ventricular dysfunction | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Myocarditis | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pericarditis | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Sick sinus syndrome | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ventricular fibrillation | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gastrointestinal arteriovenous malformation | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
|
| Adrenal insufficiency | Endocrine disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal hernia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal hernia obstructive | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Diverticular perforation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Diverticulum oesophageal | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gastroduodenitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hiatus hernia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Large intestine perforation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Oesophageal rupture | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Oesophageal stenosis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Oesophageal ulcer | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rectal prolapse | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Retroperitoneal haematoma | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Adverse event | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Chest discomfort | 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 |
|
| Fatigue | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Impaired healing | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Necrosis | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Sudden death | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Autoimmune hepatitis | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hepatitis alcoholic | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Perforation bile duct | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Allergy to arthropod sting | Immune system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Anaphylactic reaction | Immune system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Sarcoidosis | Immune system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Abscess | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Abscess intestinal | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Abscess limb | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Arthritis bacterial | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Arthritis infective | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Atypical mycobacterial infection | 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 |
|
| Bronchopneumonia | 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 |
|
| Cellulitis staphylococcal | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Cellulitis streptococcal | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Clostridium difficile colitis | 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 |
|
| Enterocolitis infectious | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Escherichia bacteraemia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Escherichia urinary tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Fungal sepsis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Gastrointestinal infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Graft infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Hepatitis B | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Incisional hernia gangrenous | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Kidney infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Localised infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Meningitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Meningitis aseptic | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Meningococcal sepsis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Osteomyelitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Peritonitis bacterial | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pneumococcal sepsis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Post procedural infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Post procedural pneumonia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Proteus infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pseudomembranous colitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Sepsis syndrome | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Shigella infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Soft tissue infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Staphylococcal skin infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Streptococcal infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Toxic shock syndrome streptococcal | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Urinary tract infection enterococcal | 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 |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Caustic injury | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Chest injury | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Compression fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Device malfunction | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Dislocation of joint prosthesis | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Extradural haematoma | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Eye injury | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Facial bones 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 |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Foot fracture | 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 |
|
| Injury | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Jaw fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Joint dislocation postoperative | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Medical device complication | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Open fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Arteriogram coronary | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Blood pressure abnormal | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Bone density decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Cardiac ventriculogram left | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Catheterisation cardiac | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Heart rate abnormal | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Oxygen saturation decreased | 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 |
|
| Diabetic foot | 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 |
|
| Type 1 diabetes mellitus | 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 |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Fracture delayed union | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hand deformity | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Juvenile arthritis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Low turnover osteopathy | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Muscle haemorrhage | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Muscle necrosis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Osteolysis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pelvic deformity | 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 |
|
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Acute myeloid leukaemia | 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 |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Bile duct cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Bladder transitional cell carcinoma | 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 female | 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 |
|
| Bronchial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Cervix carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Cervix carcinoma stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Colon adenoma | 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 |
|
| Colon cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Follicle centre lymphoma diffuse small cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Gastrointestinal tract adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Gliosarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Histiocytosis haematophagic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Hodgkin's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Laryngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Laryngeal cancer stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Lentigo maligna stage unspecified | 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 |
|
| Lymphocytic leukaemia | 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 |
|
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Meningioma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Metastases to ovary | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Metastases to small intestine | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Myelodysplastic syndrome | 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-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Non-small cell lung cancer stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Ovarian cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Ovarian epithelial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Prolymphocytic leukaemia | 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 cell carcinoma | 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 |
|
| Thyroid neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Brain stem infarction | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cerebral thrombosis | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hemiparesis | 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 |
|
| Lumbar radiculopathy | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Multiple sclerosis | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Radiculopathy | 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 |
|
| Bipolar disorder | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Mental disorder | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Calculus ureteric | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Renal tubular necrosis | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Uterine polyp | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vaginal erythema | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal 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 |
|
| Diffuse alveolar damage | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Haemoptysis | 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 |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pulmonary sarcoidosis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Henoch-Schonlein purpura | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Panniculitis | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Joint prosthesis user | Social circumstances | MedDRA 12.0 | Systematic Assessment |
|
| Cardiac ablation | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
|
| Cholecystectomy | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
|
| Fracture treatment | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
|
| Hip arthroplasty | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
|
| Joint arthroplasty | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
|
| Knee arthroplasty | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
|
| Leg amputation | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
|
| Shoulder arthroplasty | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
|
| Shoulder operation | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
|
| Angiopathy | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Aortic aneurysm rupture | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Circulatory collapse | 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 |
|
| Infarction | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Peripheral embolism | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Peripheral ischaemia | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Peripheral vascular disorder | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Shock | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vomiting | 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 pain | 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 |
|
| Pyrexia | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Conjunctivitis infective | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal 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 |
| 1.30 |
| 95 |
| 0.97 |
| 1.71 |
| Superiority or Other |