Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| HALT Prostate Cancer |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will evaluate AMG 162 in the treatment of bone loss in subjects undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMG 162 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 162 | Drug | 60 mg (1.0mL) administered subcutaneously at Day 1, Months 6, 12, 18, 24, 30 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24 | Lumbar Spine Bone Mineral Density Percent Chnage From Baseline at Month 24 Assessed by Dual Energy X-Ray Absorptiometry. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24 | Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24 Assessed by Dual Energy X-Ray Absorptiometry. | 24 months |
| Total Hip Bone Mineral Density Percent Change From Baseline at Month 24 |
Not provided
Other criteria also apply
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22641239 | Background | Egerdie RB, Saad F, Smith MR, Tammela TL, Heracek J, Sieber P, Ke C, Leder B, Dansey R, Goessl C. Responder analysis of the effects of denosumab on bone mineral density in men receiving androgen deprivation therapy for prostate cancer. Prostate Cancer Prostatic Dis. 2012 Sep;15(3):308-12. doi: 10.1038/pcan.2012.18. | |
| Background | Lippuner k, Wolff JM, Hadji P, Braun A, Ke C, Steinle T, Eisen C. Risk reduction for vertebral fractures in patients with normal to osteopenic bone mineral density receiving denosumab: A subgroup analysis of the HALT Prostate Cancer Trial. Osteologie 2014;23(2):117-122. [published in German only] | ||
| 19671656 |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
Not provided
Not provided
First Subject Enrolled: 15-Apr-2004 Last Subject Enrolled: 29-Apr-2005
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo administered subcutaneous every 6 months for 3 years |
| FG001 | Denosumab 60 mg Q6M | Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo administered subcutaneous every 6 months for 3 years |
| BG001 | Denosumab 60 mg Q6M | Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24 | Lumbar Spine Bone Mineral Density Percent Chnage From Baseline at Month 24 Assessed by Dual Energy X-Ray Absorptiometry. | Randomized subjects who had a nonmissing baseline and >= 1 nonmissing postbaseline data before or at month 24. LOCF used as imputation method. | Posted | Least Squares Mean | 95% Confidence Interval | Percent Change from Baseline | 24 months |
|
36 months
Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
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 | Placebo | Placebo administered subcutaneous every 6 months for 3 years |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069448 | Denosumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
60 mg (1.0mL) administered subcutaneously at Day 1, Months 6, 12, 18, 24, 30 |
|
Total Hip Bone Mineral Density Percent Change From Baseline at Month 24 Assessed by Dual Energy X-Ray Absorptiometry. |
| 24 months |
| Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 36 | Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 36 Assessed by Dual Energy X-Ray Absorptiometry. | 36 months |
| Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 36 | Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 36 Assessed by Dual Energy X-Ray Absorptiometry. | 36 months |
| Total Hip Bone Mineral Density Percent Change From Baseline at Month 36 | Total Hip Bone Mineral Density Percent Change From Baseline at Month 36 Assessed by Dual Energy X-Ray Absorptiometry. | 36 months |
| Number of Participants With Any Fracture Through Month 36 | Any fracture includes osteroporotic fractures at any site excluding skull, facial, mandible, metacarpals, finger phalanges, and toe phalanges. | 36 months |
| Number of Participants With a New Vertebral Fracture Through Month 36 | New Vertebral Fracture Assessed by Lateral Spine X-ray using Genant Semiquantitative Scoring Method excluding any symptomatic new vertebral fracture associated with high trauma severity or a pathologic fracture. | 36 months |
| Time to First Clinical Fracture Through Month 36 | A clinical fracture was defined as any nonvertebral fracture or clinically evident fracture at the cervical vertebrae, thoracic vertebrae, and lumbar vertebrae that was associated with signs and/or symptoms indicative of a fracture. Fractures associated with high trauma severity and pathologic (ie, metastatic) fractures were excluded. Since the median time was not reached, time to first clinical fracture is represented by the Kaplan-Meier estimate of the percentage of participants with a clinical fracture. | 36 months |
| Number of Participants With Any Fracture Through Month 24 | Any fracture includes osteroporotic fractures at any site excluding skull, facial, mandible, metacarpals, finger phalanges, and toe phalanges. | 24 months |
| Background |
| Smith MR, Egerdie B, Hernandez Toriz N, Feldman R, Tammela TL, Saad F, Heracek J, Szwedowski M, Ke C, Kupic A, Leder BZ, Goessl C; Denosumab HALT Prostate Cancer Study Group. Denosumab in men receiving androgen-deprivation therapy for prostate cancer. N Engl J Med. 2009 Aug 20;361(8):745-55. doi: 10.1056/NEJMoa0809003. Epub 2009 Aug 11. |
| 21898590 | Background | Smith MR, Saad F, Egerdie B, Sieber P, Tammela TLj, Leder BZ, Ke C, Goessl C. Denosumab and changes in bone turnover markers during androgen deprivation therapy for prostate cancer. J Bone Miner Res. 2011 Dec;26(12):2827-33. doi: 10.1002/jbmr.492. |
| 19836774 | Background | Smith MR, Saad F, Egerdie B, Szwedowski M, Tammela TL, Ke C, Leder BZ, Goessl C. Effects of denosumab on bone mineral density in men receiving androgen deprivation therapy for prostate cancer. J Urol. 2009 Dec;182(6):2670-5. doi: 10.1016/j.juro.2009.08.048. |
| 21555773 | Derived | Kuchler U, Luvizuto ER, Tangl S, Watzek G, Gruber R. Short-term teriparatide delivery and osseointegration: a clinical feasibility study. J Dent Res. 2011 Aug;90(8):1001-6. doi: 10.1177/0022034511407920. Epub 2011 May 9. |
| Withdrawal by Subject |
|
| Death |
|
| Disease progression |
|
| Ineligibility determined |
|
| Lost to Follow-up |
|
| Noncompliance |
|
| Other |
|
| Requirement for alternative therapy |
|
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
|
|
|
| Secondary | Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24 | Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24 Assessed by Dual Energy X-Ray Absorptiometry. | Randomized subjects who had a nonmissing baseline and >= 1 nonmissing postbaseline data before or at month 24. LOCF used as imputation method. | Posted | Least Squares Mean | 95% Confidence Interval | Percent Change from Baseline | 24 months |
|
|
|
|
| Secondary | Total Hip Bone Mineral Density Percent Change From Baseline at Month 24 | Total Hip Bone Mineral Density Percent Change From Baseline at Month 24 Assessed by Dual Energy X-Ray Absorptiometry. | Randomized subjects who had a nonmissing baseline and >= 1 nonmissing postbaseline data before or at month 24. LOCF used as imputation method. | Posted | Least Squares Mean | 95% Confidence Interval | Percent Change from Baseline | 24 months |
|
|
|
|
| Secondary | Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 36 | Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 36 Assessed by Dual Energy X-Ray Absorptiometry. | Randomized subjects who had a nonmissing baseline and >= 1 nonmissing postbaseline data before or at month 36. LOCF used as imputation method. | Posted | Least Squares Mean | 95% Confidence Interval | Percent Change from Baseline | 36 months |
|
|
|
|
| Secondary | Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 36 | Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 36 Assessed by Dual Energy X-Ray Absorptiometry. | Randomized subjects who had a nonmissing baseline and >= 1 nonmissing postbaseline data before or at month 36. LOCF used as imputation method. | Posted | Least Squares Mean | 95% Confidence Interval | Percent Change from Baseline | 36 months |
|
|
|
|
| Secondary | Total Hip Bone Mineral Density Percent Change From Baseline at Month 36 | Total Hip Bone Mineral Density Percent Change From Baseline at Month 36 Assessed by Dual Energy X-Ray Absorptiometry. | Randomized subjects who had a nonmissing baseline and >= 1 nonmissing postbaseline data before or at month 36. LOCF used as imputation method. | Posted | Least Squares Mean | 95% Confidence Interval | Percent Change from Baseline | 36 months |
|
|
|
|
| Secondary | Number of Participants With Any Fracture Through Month 36 | Any fracture includes osteroporotic fractures at any site excluding skull, facial, mandible, metacarpals, finger phalanges, and toe phalanges. | Full analysis set | Posted | Number | Participants | 36 months |
|
|
|
|
| Secondary | Number of Participants With a New Vertebral Fracture Through Month 36 | New Vertebral Fracture Assessed by Lateral Spine X-ray using Genant Semiquantitative Scoring Method excluding any symptomatic new vertebral fracture associated with high trauma severity or a pathologic fracture. | All randomized subjects who have a baseline and >= 1 postbaseline evaluation of vertebral fracture at or before 3 years. | Posted | Number | Participants | 36 months |
|
|
|
|
| Secondary | Time to First Clinical Fracture Through Month 36 | A clinical fracture was defined as any nonvertebral fracture or clinically evident fracture at the cervical vertebrae, thoracic vertebrae, and lumbar vertebrae that was associated with signs and/or symptoms indicative of a fracture. Fractures associated with high trauma severity and pathologic (ie, metastatic) fractures were excluded. Since the median time was not reached, time to first clinical fracture is represented by the Kaplan-Meier estimate of the percentage of participants with a clinical fracture. | Full analysis set | Posted | Number | Percentage of participants | 36 months |
|
|
|
|
| Secondary | Number of Participants With Any Fracture Through Month 24 | Any fracture includes osteroporotic fractures at any site excluding skull, facial, mandible, metacarpals, finger phalanges, and toe phalanges. | Full analysis set | Posted | Number | Participants | 24 months |
|
|
|
|
| 222 |
| 725 |
| 364 |
| 725 |
| EG001 | Denosumab 60 mg Q6M | Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years | 253 | 731 | 390 | 731 |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Acute coronary syndrome | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Aortic valve disease | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Aortic valve incompetence | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Aortic valve stenosis | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Atrial tachycardia | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Atrioventricular block | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Atrioventricular block complete | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Cardiac disorder | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Cardiac flutter | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Cardiogenic shock | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Cardiomyopathy | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Cardiovascular disorder | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Coronary artery stenosis | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Coronary artery thrombosis | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Mitral valve incompetence | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Myocardial fibrosis | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Sick sinus syndrome | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Sinus arrhythmia | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Trifascicular block | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Ventricular fibrillation | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Atrial septal defect | Congenital, familial and genetic disorders | MedDRA 11.0 | Systematic Assessment |
|
| Coarctation of the aorta | Congenital, familial and genetic disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hydrocele | Congenital, familial and genetic disorders | MedDRA 11.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 11.0 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 11.0 | Systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA 11.0 | Systematic Assessment |
|
| Retinal detachment | Eye disorders | MedDRA 11.0 | Systematic Assessment |
|
| Retinal vascular thrombosis | Eye disorders | MedDRA 11.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Colonic polyp | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Diverticulum | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Diverticulum intestinal haemorrhagic | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Enterovesical fistula | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Faecal incontinence | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Gastrointestinal ulcer haemorrhage | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hiatus hernia | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Intestinal infarction | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Intestinal perforation | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Leukoplakia oral | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Lumbar hernia | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pancreatitis haemorrhagic | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Peritoneal disorder | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Stomach discomfort | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Subileus | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Umbilical hernia | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Umbilical hernia, obstructive | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Condition aggravated | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Death | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Generalised oedema | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hypothermia | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Impaired healing | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pelvic mass | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Sudden death | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Biliary dyskinesia | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hepatitis | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hepatitis alcoholic | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Abdominal abscess | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Arthritis bacterial | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Arthritis infective | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Bursitis infective staphylococcal | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Clostridium difficile colitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Endocarditis bacterial | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Gangrene | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Gastroenteritis salmonella | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Gastrointestinal gangrene | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Infected skin ulcer | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Labyrinthitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Lobar pneumonia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Localised infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Osteomyelitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Pneumococcal sepsis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Pneumonia staphylococcal | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Postoperative abscess | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Prostate infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Pseudomembranous colitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Pseudomonas infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Pyothorax | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Staphylococcal osteomyelitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Device failure | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Failure of implant | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Fractured ischium | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Gastroenteritis radiation | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Multiple injuries | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Nerve root injury cervical | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Pacemaker complication | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Patella fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Periorbital haematoma | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Procedural hypertension | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Scapula fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Skull fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Stenosis of vesicourethral anastomosis | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Therapeutic agent toxicity | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Traumatic intracranial haemorrhage | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Wound evisceration | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| Diabetic foot | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Joint lock | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Adenocarcinoma pancreas | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Adenoma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Breast cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Chondrosarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Colon cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Intestinal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Lung adenocarcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Malignant glioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Metastases to abdominal cavity | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Metastases to lymph nodes | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Metastases to pleura | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Metastases to spine | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Metastatic malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Metastatic renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Neuroendocrine carcinoma of the skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Oncocytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Prostate cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Rectal cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Seborrhoeic keratosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Small intestine carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Altered state of consciousness | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Ataxia | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Brain injury | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Carotid artery occlusion | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Carotid artery stenosis | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Cerebral ischaemia | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Cerebrovascular disorder | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Cerebrovascular spasm | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dementia | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Depressed level of consciousness | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Encephalopathy | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Facial paresis | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Haemorrhage intracranial | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Haemorrhagic stroke | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hypoxic encephalopathy | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Parkinson's disease | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Parkinsonism | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Senile dementia | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Syncope vasovagal | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Thalamus haemorrhage | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Cephalhaematoma | Pregnancy, puerperium and perinatal conditions | MedDRA 11.0 | Systematic Assessment |
|
| Alcoholism | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hallucination | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
|
| Major depression | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
|
| Anuria | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Bladder neck obstruction | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Bladder obstruction | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Calculus bladder | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Calculus ureteric | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Contracted bladder | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Polyuria | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Renal colic | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Renal cyst | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Renal failure chronic | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Ureteric obstruction | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Ureteric perforation | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Urethral obstruction | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Urinary bladder haemorrhage | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Urinary tract disorder | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Urinary tract obstruction | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 11.0 | Systematic Assessment |
|
| Prostatic obstruction | Reproductive system and breast disorders | MedDRA 11.0 | Systematic Assessment |
|
| Prostatomegaly | Reproductive system and breast disorders | MedDRA 11.0 | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Respiratory acidosis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Skin necrosis | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Cardiac pacemaker replacement | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
|
| Cholecystectomy | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
|
| Coronary arterial stent insertion | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
|
| Hernia repair | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
|
| Hip arthroplasty | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
|
| Implantable defibrillator replacement | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
|
| Kidney ablation | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
|
| Knee arthroplasty | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
|
| Spinal operation | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
|
| Aortic aneurysm | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Aortic dissection | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Aortic stenosis | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Arterial occlusive disease | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Arterial thrombosis limb | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Cardiovascular insufficiency | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Circulatory collapse | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Femoral artery aneurysm | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hypovolaemic shock | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Iliac artery occlusion | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Ischaemia | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Lymphoedema | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Peripheral artery aneurysm | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Peripheral vascular disorder | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Thrombophlebitis | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Venous occlusion | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Venous thrombosis limb | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results aftercompletion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |