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This European study observes paediatric patients with Chronic Kidney Disease using Darbepoetin Alfa to assess the drug's long term safety and profile the patterns of its use within this population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Darbepoetin alfa | Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Serious Adverse Drug Reactions (SADR), Serious Adverse Events (SAEs) or Events of Medical Interest (EMIs) | An ADR was defined as an undesirable medical occurrence or worsening of a pre-existing medical condition that the investigator considered associated with the use of darbepoetin alfa. An AE is any untoward medical occurrence or worsening of a pre-existing condition whether or not considered to have a causal relationship with darbepoetin alfa. An SADR or SAE is any ADR or AE that is either: • Fatal • Life threatening • Requires or prolongs in-patient hospitalization • A persistent or significant disability/incapacity, or • A congenital anomaly/birth defect. An EMI is defined as one of the following pre-specified AEs: Thromboembolic Events (eg, venous thrombosis, embolism, vascular occlusion) • Seizures • Severe hypertension (Investigator discretion accompanied by recorded blood pressure) • Cardiovascular events (eg, cardiac arrhythmia, myocardial ischaemia/infarction, heart failure) • Pure red cell aplasia (PRCA) • Hypersensitivity reactions (eg, rash, urticaria, anaphylaxis). | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin Concentration by Three Monthly Intervals | Baseline, Months 3, 6, 9, 12, 15, 18, 21, and 24 | |
| Weight Adjusted Darbepoetin Alfa Monthly Dose by Monthly Intervals | Baseline dose = the daily dose equivalent x 30, where the daily dose equivalent = the last available dose prior to or at Day 1 / reported intended frequency. |
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Inclusion Criteria:
Exclusion Criteria:
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Specialist Centres
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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First participant was enrolled on 26 February 2008; last participant was enrolled on 24 February 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Darbepoetin Alfa | Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Full Analysis Set: all participants who received at least 1 dose of darbepoetin alfa during the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Darbepoetin Alfa | Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice. |
| 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 | Number of Participants With Serious Adverse Drug Reactions (SADR), Serious Adverse Events (SAEs) or Events of Medical Interest (EMIs) | An ADR was defined as an undesirable medical occurrence or worsening of a pre-existing medical condition that the investigator considered associated with the use of darbepoetin alfa. An AE is any untoward medical occurrence or worsening of a pre-existing condition whether or not considered to have a causal relationship with darbepoetin alfa. An SADR or SAE is any ADR or AE that is either: • Fatal • Life threatening • Requires or prolongs in-patient hospitalization • A persistent or significant disability/incapacity, or • A congenital anomaly/birth defect. An EMI is defined as one of the following pre-specified AEs: Thromboembolic Events (eg, venous thrombosis, embolism, vascular occlusion) • Seizures • Severe hypertension (Investigator discretion accompanied by recorded blood pressure) • Cardiovascular events (eg, cardiac arrhythmia, myocardial ischaemia/infarction, heart failure) • Pure red cell aplasia (PRCA) • Hypersensitivity reactions (eg, rash, urticaria, anaphylaxis). | Full Analysis Set | Posted | Number | participants | 2 years |
2 years
In this study only adverse drug reactions, serious adverse events and events of medical interest were collected. Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions and non-serious occurrences of events of medical interest that exceed the indicated frequency threshold.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Darbepoetin Alfa | Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | General disorders | MedDRA 15.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Baseline and Months 1 to 24 |
| Parathyroid Hormone Level by Three Monthly Intervals | Baseline, Months 3, 6, 9, 12, 15, 18, 21, and 24 |
| Number of Participants With Non-serious Adverse Drug Reactions (ADRs) | An ADR was defined as an undesirable medical occurrence or worsening of a pre-existing medical condition that the investigator considered associated with the use of darbepoetin alfa. A non-serious ADR was one in which none of the following applied:
| 2 years |
| Requirement for alternative therapy |
|
| Physician Decision |
|
| Lost to Follow-up |
|
| Death |
|
| Protocol-specified criteria |
|
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Darbepoetin Alfa | Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice. |
|
|
| Secondary | Hemoglobin Concentration by Three Monthly Intervals | Full analysis set | Posted | Mean | 95% Confidence Interval | g/dL | Baseline, Months 3, 6, 9, 12, 15, 18, 21, and 24 |
|
|
|
| Secondary | Weight Adjusted Darbepoetin Alfa Monthly Dose by Monthly Intervals | Baseline dose = the daily dose equivalent x 30, where the daily dose equivalent = the last available dose prior to or at Day 1 / reported intended frequency. | Full analysis set | Posted | Geometric Mean | 95% Confidence Interval | μg/kg/month | Baseline and Months 1 to 24 |
|
|
|
| Secondary | Parathyroid Hormone Level by Three Monthly Intervals | Full analysis set | Posted | Median | Inter-Quartile Range | pmol/L | Baseline, Months 3, 6, 9, 12, 15, 18, 21, and 24 |
|
|
|
| Secondary | Number of Participants With Non-serious Adverse Drug Reactions (ADRs) | An ADR was defined as an undesirable medical occurrence or worsening of a pre-existing medical condition that the investigator considered associated with the use of darbepoetin alfa. A non-serious ADR was one in which none of the following applied:
| Full analysis set | Posted | Number | participants | 2 years |
|
|
|
| 162 |
| 319 |
| 7 |
| 319 |
| Haemolysis | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cardiomegaly | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cardiomyopathy | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Congestive cardiomyopathy | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Congenital mitochondrial cytopathy | Congenital, familial and genetic disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cryptorchism | Congenital, familial and genetic disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hydrocele | Congenital, familial and genetic disorders | MedDRA 15.1 | Systematic Assessment |
|
| Autoimmune thyroiditis | Endocrine disorders | MedDRA 15.1 | Systematic Assessment |
|
| Goitre | Endocrine disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hyperparathyroidism | Endocrine disorders | MedDRA 15.1 | Systematic Assessment |
|
| Blindness | Eye disorders | MedDRA 15.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Crohn's disease | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Gastrointestinal necrosis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Umbilical hernia | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Catheter site haematoma | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Catheter site haemorrhage | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Device malfunction | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hyperthermia | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Medical device complication | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Thrombosis in device | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Acute hepatic failure | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Kidney transplant rejection | Immune system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Arteriovenous fistula site infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Atypical pneumonia | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Bronchitis viral | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Catheter site infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Device related sepsis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Febrile infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Fungal peritonitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Gastroenteritis norovirus | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Gastroenteritis rotavirus | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Keratitis herpetic | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Leishmaniasis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Peritonitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Peritonitis bacterial | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Pseudomonal sepsis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Respiratory tract infection viral | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Staphylococcal sepsis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Varicella | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Arteriovenous fistula site complication | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Arteriovenous fistula site haemorrhage | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Arteriovenous fistula thrombosis | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Complications of transplanted kidney | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Foreign body | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Shunt thrombosis | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Transplant failure | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Vascular graft thrombosis | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Cardiac output increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| HLA marker study positive | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| International normalised ratio increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Fluid overload | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Fluid retention | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypervolaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Osteitis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Post transplant lymphoproliferative disorder | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Aphasia | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypertensive encephalopathy | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Migraine with aura | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Neuritis | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Partial seizures | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Posterior reversible encephalopathy syndrome | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Abnormal behaviour | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Anuria | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Bladder dysfunction | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Oliguria | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Renal failure chronic | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Urinary bladder haemorrhage | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Urinary tract disorder | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Vesicoureteric reflux | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Priapism | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
|
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Asthmatic crisis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Inadequate diet | Social circumstances | MedDRA 15.1 | Systematic Assessment |
|
| Accelerated hypertension | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Embolism | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypertensive emergency | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Thrombophlebitis | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Venous thrombosis limb | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results aftercompletion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
|
| Month 9 (n=245) |
|
| Month 12 (n=214) |
|
| Month 15 (n=199) |
|
| Month 18 (n=167) |
|
| Month 21 (n=154) |
|
| Month 24 (n=151) |
|
| Title | Measurements |
|---|---|
|
| Month 3 (n=297) |
|
| Month 4 (n=287) |
|
| Month 5 (n=277) |
|
| Month 6 (n=269) |
|
| Month 7 (n=256) |
|
| Month 8 (n=245) |
|
| Month 9 (n=233) |
|
| Month 10 (n=227) |
|
| Month 11 (n=216) |
|
| Month 12 (n=211) |
|
| Month 13 (n=206) |
|
| Month 14 (n=200) |
|
| Month 15 (n=193) |
|
| Month 16 (n=186) |
|
| Month 17 (n=180) |
|
| Month 18 (n=170) |
|
| Month 19 (n=164) |
|
| Month 20 (n=162) |
|
| Month 21 (n=157) |
|
| Month 22 (n=155) |
|
| Month 23 (n=154) |
|
| Month 24 (n=146) |
|
|
| Month 9 (n=225) |
|
| Month 12 (n=194) |
|
| Month 15 (n=184) |
|
| Month 18 (n=150) |
|
| Month 21 (n=142) |
|
| Month 24 (n=137) |
|