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The primary objective of this study is to examine the efficacy and safety (cardiovascular) of an investigational intravenous (IV) iron, ferric carboxymaltose (FCM), compared to IV iron sucrose (Venofer) in subjects who have iron deficiency anemia (IDA) and impaired renal function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ferric Carboxymaltose (FCM) | Experimental | 2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg |
|
| Iron Sucrose (Venofer) | Active Comparator | 5 doses of 200 mg for a total cumulative dose of 1000 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferric Carboxymaltose (FCM) | Drug | 2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline to the Highest Observed Hemoglobin Any Time From Baseline to End of Study. | Day 56 | |
| Proportion of Subjects Experiencing at Least One Event in the Primary Composite Safety Endpoint in the Randomized Population. | The primary composite safety endpoint was defined as death due to any cause, nonfatal myocardial infarction, nonfatal stroke, unstable angina requiring hospitalization or medical intervention, arrhythmias, protocol-defined hypersensitive events, and protocol-defined hyposensitive events. | Day 120 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Luitpold Pharmaceuticals, Inc. | Norristown | Pennsylvania | 19403 | United States |
14 subjects randomized to FCM and 9 subjects randomized to Venofer were discontinued prior to dosing due to subject request or selection criteria/study compliance reasons.
04-Sept-2009 through 15-Jun-2011; Hospitals and Medical Clinics
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| ID | Title | Description |
|---|---|---|
| FG000 | Ferric Carboxymaltose (FCM) | Ferric Carboxymaltose (FCM) : 2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg |
| FG001 | Iron Sucrose (Venofer) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Iron Sucrose (Venofer) | Drug | 5 doses of 200 mg for a total cumulative dose of 1000 mg |
|
Iron Sucrose (Venofer) : 5 doses of 200 mg for a total cumulative dose of 1000 mg
| COMPLETED |
|
| NOT COMPLETED |
|
14 subjects randomized to receive FCM and 9 subjects randomized to receive Venefor were randomized but discontinued prior to dosing due to subject request or selection criteria/study compliance reasons.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ferric Carboxymaltose (FCM) | Ferric Carboxymaltose (FCM) : 2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg |
| BG001 | Iron Sucrose (Venofer) | Iron Sucrose (Venofer) : 5 doses of 200 mg for a total cumulative dose of 1000 mg |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Mean Change From Baseline to the Highest Observed Hemoglobin Any Time From Baseline to End of Study. | Posted | Mean | Standard Deviation | g/dL | Day 56 |
|
|
| ||||||||||||||||||||||||||||||
| Primary | Proportion of Subjects Experiencing at Least One Event in the Primary Composite Safety Endpoint in the Randomized Population. | The primary composite safety endpoint was defined as death due to any cause, nonfatal myocardial infarction, nonfatal stroke, unstable angina requiring hospitalization or medical intervention, arrhythmias, protocol-defined hypersensitive events, and protocol-defined hyposensitive events. | Posted | Number | participants | Day 120 |
|
|
September 4, 2009 through June 15, 2011
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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 | Ferric Carboxymaltose (FCM) | Ferric Carboxymaltose (FCM) : 2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg | 202 | 1,276 | 305 | 1,276 | ||
| EG001 | Iron Sucrose (Venofer) | Iron Sucrose (Venofer) : 5 doses of 200 mg for a total cumulative dose of 1000 mg | 197 | 1,285 | 151 | 1,285 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (3.0) |
| ||
| Coagulopathy | Blood and lymphatic system disorders | CTCAE (3.0) |
| ||
| Normochromic normocytic anemia | Blood and lymphatic system disorders | CTCAE (3.0) |
| ||
| Pancytopenia | Blood and lymphatic system disorders | CTCAE (3.0) |
| ||
| Acute myocardial infarction | Cardiac disorders | CTCAE (3.0) |
| ||
| Angina pectoris | Cardiac disorders | CTCAE (3.0) |
| ||
| Angina unstable | Cardiac disorders | CTCAE (3.0) |
| ||
| Aortic valve stenosis | Cardiac disorders | CTCAE (3.0) |
| ||
| Arrhythmia | Cardiac disorders | CTCAE (3.0) |
| ||
| Arteriospasm coronary | Cardiac disorders | CTCAE (3.0) |
| ||
| Atrial fibrillation | Cardiac disorders | CTCAE (3.0) |
| ||
| Atrial flutter | Cardiac disorders | CTCAE (3.0) |
| ||
| Atrioventricular block second degree | Cardiac disorders | CTCAE (3.0) |
| ||
| Bifascicular block | Cardiac disorders | CTCAE (3.0) |
| ||
| Bradycardia | Cardiac disorders | CTCAE (3.0) |
| ||
| Cardiac arrest | Cardiac disorders | CTCAE (3.0) |
| ||
| Cardiac failure | Cardiac disorders | CTCAE (3.0) |
| ||
| Cardiac failure acute | Cardiac disorders | CTCAE (3.0) |
| ||
| Cardiac failure chronic | Cardiac disorders | CTCAE (3.0) |
| ||
| Cardiac failure congestive | Cardiac disorders | CTCAE (3.0) |
| ||
| Cardio-respiratory arrest | Cardiac disorders | CTCAE (3.0) |
| ||
| Cardiogenic shock | Cardiac disorders | CTCAE (3.0) |
| ||
| Coronary artery disease | Cardiac disorders | CTCAE (3.0) |
| ||
| Ischemic cardiomyopathy | Cardiac disorders | CTCAE (3.0) |
| ||
| Myocardial infarction | Cardiac disorders | CTCAE (3.0) |
| ||
| Myocardial ischemia | Cardiac disorders | CTCAE (3.0) |
| ||
| Nodal arrhythmia | Cardiac disorders | CTCAE (3.0) |
| ||
| Palpitations | Cardiac disorders | CTCAE (3.0) |
| ||
| Pericarditis | Cardiac disorders | CTCAE (3.0) |
| ||
| Right ventricular failure | Cardiac disorders | CTCAE (3.0) |
| ||
| Sick sinus syndrome | Cardiac disorders | CTCAE (3.0) |
| ||
| Sinus bradycardia | Cardiac disorders | CTCAE (3.0) |
| ||
| Superventricular tachycardia | Cardiac disorders | CTCAE (3.0) |
| ||
| Ventricular tachycardia | Cardiac disorders | CTCAE (3.0) |
| ||
| Vertigo | Ear and labyrinth disorders | CTCAE (3.0) |
| ||
| Retinal vein occlusion | Eye disorders | CTCAE (3.0) |
| ||
| Abdominal pain | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| Colitis | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| Constipation | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| Crohn's disease | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| Duodenal ulcer hemorrhage | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| Enterocolitis | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| Fecaloma | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| Gastric ulcer | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| Gastritis | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| Gastritis hemorrhagic | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| Gastrointestinal hemorrhage | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| Hematemesis | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| Hemorrhoids | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| Inguinal hernia, obstructive | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| Intestinal ischemia | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| Intestinal mass | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| Intra-abdominal hematoma | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| Pancreatic mass | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| Pancreatitis | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| Pancreatitis relapsing | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| Peritonitis | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| Small intestinal obstruction | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| Asthenia | General disorders | CTCAE (3.0) |
| ||
| Chest pain | General disorders | CTCAE (3.0) |
| ||
| Fatigue | General disorders | CTCAE (3.0) |
| ||
| Gait disturbance | General disorders | CTCAE (3.0) |
| ||
| Generalized edema | General disorders | CTCAE (3.0) |
| ||
| Hernia obstructive | General disorders | CTCAE (3.0) |
| ||
| Non-cardiac chest pain | General disorders | CTCAE (3.0) |
| ||
| Edema peripheral | General disorders | CTCAE (3.0) |
| ||
| Sudden cardiac death | General disorders | CTCAE (3.0) |
| ||
| Ulcer hemorrhage | General disorders | CTCAE (3.0) |
| ||
| Cholecystitis | Hepatobiliary disorders | CTCAE (3.0) |
| ||
| Cholelithiasis | Hepatobiliary disorders | CTCAE (3.0) |
| ||
| Hepatotoxicity | Hepatobiliary disorders | CTCAE (3.0) |
| ||
| Jaundice cholestatic | Hepatobiliary disorders | CTCAE (3.0) |
| ||
| Anaphylactic reaction | Immune system disorders | CTCAE (3.0) |
| ||
| Anaphylactoid reaction | Immune system disorders | CTCAE (3.0) |
| ||
| Hypersensitivity | Immune system disorders | CTCAE (3.0) |
| ||
| Pancreas transplant rejection | Immune system disorders | CTCAE (3.0) |
| ||
| Appendicitis | Infections and infestations | CTCAE (3.0) |
| ||
| Bacteremia | Infections and infestations | CTCAE (3.0) |
| ||
| Bacterial pyelonephritis | Infections and infestations | CTCAE (3.0) |
| ||
| Bronchitis | Infections and infestations | CTCAE (3.0) |
| ||
| Bronchopneumonia | Infections and infestations | CTCAE (3.0) |
| ||
| Cellulitis | Infections and infestations | CTCAE (3.0) |
| ||
| Cellulitis of male external genital organ | Infections and infestations | CTCAE (3.0) |
| ||
| Cystitis | Infections and infestations | CTCAE (3.0) |
| ||
| Diverticulitis | Infections and infestations | CTCAE (3.0) |
| ||
| Empyema | Infections and infestations | CTCAE (3.0) |
| ||
| Endocarditis | Infections and infestations | CTCAE (3.0) |
| ||
| Enterocolitis bacterial | Infections and infestations | CTCAE (3.0) |
| ||
| Gangrene | Infections and infestations | CTCAE (3.0) |
| ||
| Gastroenteritis | Infections and infestations | CTCAE (3.0) |
| ||
| Herpes zoster | Infections and infestations | CTCAE (3.0) |
| ||
| Herpes zoster ophthalmic | Infections and infestations | CTCAE (3.0) |
| ||
| Influenza | Infections and infestations | CTCAE (3.0) |
| ||
| Lobar pneumonia | Infections and infestations | CTCAE (3.0) |
| ||
| Osteomyelitis | Infections and infestations | CTCAE (3.0) |
| ||
| Pneumonia | Infections and infestations | CTCAE (3.0) |
| ||
| Pneumonia streptococcal | Infections and infestations | CTCAE (3.0) |
| ||
| Postoperative wound infection | Infections and infestations | CTCAE (3.0) |
| ||
| Pyelonephritis | Infections and infestations | CTCAE (3.0) |
| ||
| Pyelonephritis acute | Infections and infestations | CTCAE (3.0) |
| ||
| Renal cyst infection | Infections and infestations | CTCAE (3.0) |
| ||
| Sepsis | Infections and infestations | CTCAE (3.0) |
| ||
| Septic shock | Infections and infestations | CTCAE (3.0) |
| ||
| Sinusitis | Infections and infestations | CTCAE (3.0) |
| ||
| Staphylococcal bacteremia | Infections and infestations | CTCAE (3.0) |
| ||
| Staphy;ococcal infection | Infections and infestations | CTCAE (3.0) |
| ||
| Tracheobronchitis | Infections and infestations | CTCAE (3.0) |
| ||
| Urinary tract infection | Infections and infestations | CTCAE (3.0) |
| ||
| Urosepsis | Infections and infestations | CTCAE (3.0) |
| ||
| Wound infection | Infections and infestations | CTCAE (3.0) |
| ||
| Device lead damage | Injury, poisoning and procedural complications | CTCAE (3.0) |
| ||
| Drug toxicity | Injury, poisoning and procedural complications | CTCAE (3.0) |
| ||
| Face injury | Injury, poisoning and procedural complications | CTCAE (3.0) |
| ||
| Femoral neck fracture | Injury, poisoning and procedural complications | CTCAE (3.0) |
| ||
| Femur fracture | Injury, poisoning and procedural complications | CTCAE (3.0) |
| ||
| Fractured sacrum | Injury, poisoning and procedural complications | CTCAE (3.0) |
| ||
| Gastrointestinal stoma complication | Injury, poisoning and procedural complications | CTCAE (3.0) |
| ||
| Head injury | Injury, poisoning and procedural complications | CTCAE (3.0) |
| ||
| Hip fracture | Injury, poisoning and procedural complications | CTCAE (3.0) |
| ||
| Spinal compression fracture | Injury, poisoning and procedural complications | CTCAE (3.0) |
| ||
| Urostomy complication | Injury, poisoning and procedural complications | CTCAE (3.0) |
| ||
| Blood glucose decreased | Investigations | CTCAE (3.0) |
| ||
| International normalized ratio increased | Investigations | CTCAE (3.0) |
| ||
| Liver function abnormal | Investigations | CTCAE (3.0) |
| ||
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| Diabetes mellitus | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| Diabetic ketoacidosis | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| Electrolyte imbalance | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| Failure to thrive | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| Fluid overload | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| Gout | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| Hypovolemia | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| Metabolic acidosis | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| Costochondritis | Musculoskeletal and connective tissue disorders | CTCAE (3.0) |
| ||
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | CTCAE (3.0) |
| ||
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) |
| ||
| Osteoarthritis | Musculoskeletal and connective tissue disorders | CTCAE (3.0) |
| ||
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | CTCAE (3.0) |
| ||
| Scleroderma | Musculoskeletal and connective tissue disorders | CTCAE (3.0) |
| ||
| Angiomyolipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) |
| ||
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) |
| ||
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) |
| ||
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) |
| ||
| Metastatic renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) |
| ||
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) |
| ||
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) |
| ||
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) |
| ||
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) |
| ||
| Renal cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) |
| ||
| Renal cell carcinoma recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) |
| ||
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) |
| ||
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) |
| ||
| Cerebrovascular accident | Nervous system disorders | CTCAE (3.0) |
| ||
| Convulsion | Nervous system disorders | CTCAE (3.0) |
| ||
| Dizziness | Nervous system disorders | CTCAE (3.0) |
| ||
| Embolic stroke | Nervous system disorders | CTCAE (3.0) |
| ||
| Encephalopathy | Nervous system disorders | CTCAE (3.0) |
| ||
| Hypoglycemic coma | Nervous system disorders | CTCAE (3.0) |
| ||
| Normal pressure hydrocephalus | Nervous system disorders | CTCAE (3.0) |
| ||
| Sedation | Nervous system disorders | CTCAE (3.0) |
| ||
| Subarachnoid hemorrhage | Nervous system disorders | CTCAE (3.0) |
| ||
| Syncope | Nervous system disorders | CTCAE (3.0) |
| ||
| Syncope vasovagal | Nervous system disorders | CTCAE (3.0) |
| ||
| Transient ischemic attack | Nervous system disorders | CTCAE (3.0) |
| ||
| Delirium | Psychiatric disorders | CTCAE (3.0) |
| ||
| Mental disorder | Psychiatric disorders | CTCAE (3.0) |
| ||
| Mental status change | Psychiatric disorders | CTCAE (3.0) |
| ||
| Azotemia | Renal and urinary disorders | CTCAE (3.0) |
| ||
| Hematuria | Renal and urinary disorders | CTCAE (3.0) |
| ||
| Nephritis | Renal and urinary disorders | CTCAE (3.0) |
| ||
| Nephrotic syndrome | Renal and urinary disorders | CTCAE (3.0) |
| ||
| Obstructive uropathy | Renal and urinary disorders | CTCAE (3.0) |
| ||
| Renal artery occlusion | Renal and urinary disorders | CTCAE (3.0) |
| ||
| Renal failure | Renal and urinary disorders | CTCAE (3.0) |
| ||
| Renal failure acute | Renal and urinary disorders | CTCAE (3.0) |
| ||
| Renal failure chronic | Renal and urinary disorders | CTCAE (3.0) |
| ||
| Renal impairment | Renal and urinary disorders | CTCAE (3.0) |
| ||
| Urinary retention | Renal and urinary disorders | CTCAE (3.0) |
| ||
| Benign prostatic hyperplasia | Reproductive system and breast disorders | CTCAE (3.0) |
| ||
| Epididymitis | Reproductive system and breast disorders | CTCAE (3.0) |
| ||
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
| ||
| Asthma | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
| ||
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
| ||
| Dyspnea paroxysmal nocturnal | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
| ||
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
| ||
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
| ||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
| ||
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
| ||
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
| ||
| Angiedema | Skin and subcutaneous tissue disorders | CTCAE (3.0) |
| ||
| Dermatitis allergic | Skin and subcutaneous tissue disorders | CTCAE (3.0) |
| ||
| Drug eruption | Skin and subcutaneous tissue disorders | CTCAE (3.0) |
| ||
| Rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) |
| ||
| Skin ulcer | Skin and subcutaneous tissue disorders | CTCAE (3.0) |
| ||
| Aortic dissection | Vascular disorders | CTCAE (3.0) |
| ||
| Aortic stenosis | Vascular disorders | CTCAE (3.0) |
| ||
| Arterial stenosis | Vascular disorders | CTCAE (3.0) |
| ||
| Arterial thrombosis | Vascular disorders | CTCAE (3.0) |
| ||
| Deep vein thrombosis | Vascular disorders | CTCAE (3.0) |
| ||
| Hypertension | Vascular disorders | CTCAE (3.0) |
| ||
| Hypertensive crisis | Vascular disorders | CTCAE (3.0) |
| ||
| Hypertensive emergency | Vascular disorders | CTCAE (3.0) |
| ||
| Hypotension | Vascular disorders | CTCAE (3.0) |
| ||
| Malignant hypertension | Vascular disorders | CTCAE (3.0) |
| ||
| Peripheral ischemia | Vascular disorders | CTCAE (3.0) |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | CTCAE (3.0) |
| ||
| Nausea | Gastrointestinal disorders | CTCAE (3.0) |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark A. Falone, MD | Luitpold Pharmaceuticals, Inc. | 610-650-4200 | mfalone@luitpold.com |
| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000090463 | Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C522335 | ferric carboxymaltose |
| D000077605 | Ferric Oxide, Saccharated |
| ID | Term |
|---|---|
| D005290 | Ferric Compounds |
| D058085 | Iron Compounds |
| D007287 | Inorganic Chemicals |
| D005937 | Glucaric Acid |
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
Not provided
Not provided
| >=65 years |
|
| Male |
|
|