Study: NCT00041938

Adverse event: ALLERGY/IMMUNOLOGY: Other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1163 at risk

Adverse event: Laryngeal edema/Allergic reaction/Anaphylaxis/Angioedema/Rash
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 1163 at risk

Adverse event: Blood disorder
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 1163 at risk

Adverse event: BLOOD/BONE MARROW: Other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1163 at risk

Adverse event: Thrombocytopenia/Anemia/Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1163 at risk

Adverse event: Atrial fibrillation/Atrial flutter/Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 56 affected / 1163 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 1163 at risk

Adverse event: CARDIAC ARRHYTHMIA: Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 1163 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 1163 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 24 affected / 1163 at risk

Adverse event: Acute cardiac failure/CHF/Pulmonary edema
Serious: yes
Organ System: Cardiac disorders
Frequency: 209 affected / 1163 at risk

Adverse event: AICD firing/discharge
Serious: yes
Organ System: Cardiac disorders
Frequency: 16 affected / 1163 at risk

Adverse event: Angina/Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 70 affected / 1163 at risk

Adverse event: CARDIAC GENERAL: Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 16 affected / 1163 at risk

Adverse event: Malignant hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1163 at risk

Adverse event: Myocardial infarction/Acute Coronary Syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 48 affected / 1163 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 1163 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS: Other
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 1163 at risk

Adverse event: DERMATOLOGY/SKIN: Other
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1163 at risk

Adverse event: Grade 4 dermatologic manifestations
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1163 at risk

Adverse event: Diabetes mellitus and its complications
Serious: yes
Organ System: Endocrine disorders
Frequency: 26 affected / 1163 at risk

Adverse event: ENDOCRINE: Other
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 1163 at risk

Adverse event: Gastrointestinal disturbance/Diarrhea/Jaundice/Nausea/Stomach pain/Etc.
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 54 affected / 1163 at risk

Adverse event: GASTROINTESTINAL: Other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 1163 at risk

Adverse event: Acute hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 1163 at risk

Adverse event: HEPATOBILIARY/PANCREAS: Other
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 1163 at risk

Adverse event: Infection/Sepsis/Fever
Serious: yes
Organ System: Infections and infestations
Frequency: 66 affected / 1163 at risk

Adverse event: LYMPHATICS: Other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1163 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 1163 at risk

Adverse event: MALIGNANCY: Other
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 22 affected / 1163 at risk

Adverse event: Metabolic disturbance/Gout
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 1163 at risk

Adverse event: METABOLIC/LABORATORY: Other
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 1163 at risk

Adverse event: MUSCULOSKELETAL/SOFT TISSUE: Other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 39 affected / 1163 at risk

Adverse event: Convulsions/Seizures
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 1163 at risk

Adverse event: NEUROLOGY: Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 8 affected / 1163 at risk

Adverse event: Stroke or TIA
Serious: yes
Organ System: Nervous system disorders
Frequency: 13 affected / 1163 at risk

Adverse event: Syncope/Pre-syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 41 affected / 1163 at risk

Adverse event: OCULAR/VISUAL: Other
Serious: yes
Organ System: Eye disorders
Frequency: 5 affected / 1163 at risk

Adverse event: Drug abuse
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 1163 at risk

Adverse event: OTHER: Other
Serious: yes
Organ System: General disorders
Frequency: 19 affected / 1163 at risk

Adverse event: Suicide attempt/Psychiatric disorder
Serious: yes
Organ System: General disorders
Frequency: 16 affected / 1163 at risk

Adverse event: PAIN: Other
Serious: yes
Organ System: General disorders
Frequency: 14 affected / 1163 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 1163 at risk

Adverse event: Pulmonary disease/Pneumonia/Bronchitis/Asthma/Breathing difficulties
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 87 affected / 1163 at risk

Adverse event: PULMONARY/UPPER RESPIRATORY: Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 1163 at risk

Adverse event: Acute renal failure/Proteinuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 28 affected / 1163 at risk

Adverse event: RENAL/GENITOURINARY: Other
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 7 affected / 1163 at risk

Adverse event: SEXUAL/REPRODUCTIVE FUNCTION: Other
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 1163 at risk

Adverse event: "Cardiac device implantation (pacemaker, defibrillator, etc.)"
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 123 affected / 1163 at risk

Adverse event: "Cardiac procedure (stent, catheterization, EP study, ablation, etc.)"
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 62 affected / 1163 at risk

Adverse event: Cardiac surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 28 affected / 1163 at risk

Adverse event: Non-cardiac surgery/Diagnostic surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 75 affected / 1163 at risk

Adverse event: SURGERY/INTRA-OPERATIVE INJURY: Other
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 4 affected / 1163 at risk

Adverse event: Embolism arterial
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 1163 at risk

Adverse event: VASCULAR: Other
Serious: yes
Organ System: Vascular disorders
Frequency: 16 affected / 1163 at risk

Adverse event: All non-serious adverse events
Serious: no
Organ System: General disorders
Frequency: 749 affected / 1163 at risk

Adverse event: ALLERGY/IMMUNOLOGY: Other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1142 at risk

Adverse event: Laryngeal edema/Allergic reaction/Anaphylaxis/Angioedema/Rash
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1142 at risk

Adverse event: Blood disorder
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 1142 at risk

Adverse event: BLOOD/BONE MARROW: Other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 1142 at risk

Adverse event: Thrombocytopenia/Anemia/Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 1142 at risk

Adverse event: Atrial fibrillation/Atrial flutter/Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 35 affected / 1142 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 1142 at risk

Adverse event: CARDIAC ARRHYTHMIA: Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1142 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 15 affected / 1142 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 39 affected / 1142 at risk

Adverse event: Acute cardiac failure/CHF/Pulmonary edema
Serious: yes
Organ System: Cardiac disorders
Frequency: 243 affected / 1142 at risk

Adverse event: AICD firing/discharge
Serious: yes
Organ System: Cardiac disorders
Frequency: 20 affected / 1142 at risk

Adverse event: Angina/Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 88 affected / 1142 at risk

Adverse event: CARDIAC GENERAL: Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 16 affected / 1142 at risk

Adverse event: Malignant hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 1142 at risk

Adverse event: Myocardial infarction/Acute Coronary Syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 50 affected / 1142 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 1142 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS: Other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1142 at risk

Adverse event: Grade 4 dermatologic manifestations
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1142 at risk

Adverse event: Diabetes mellitus and its complications
Serious: yes
Organ System: Endocrine disorders
Frequency: 22 affected / 1142 at risk

Adverse event: ENDOCRINE: Other
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 1142 at risk

Adverse event: Gastrointestinal disturbance/Diarrhea/Jaundice/Nausea/Stomach pain/Etc.
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 66 affected / 1142 at risk

Adverse event: GASTROINTESTINAL: Other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 1142 at risk

Adverse event: Hemorrhage/Bleeding
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1142 at risk

Adverse event: Acute hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 1142 at risk

Adverse event: HEPATOBILIARY/PANCREAS: Other
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 1142 at risk

Adverse event: Infection/Sepsis/Fever
Serious: yes
Organ System: Infections and infestations
Frequency: 79 affected / 1142 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 1142 at risk

Adverse event: MALIGNANCY: Other
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 20 affected / 1142 at risk

Adverse event: Metabolic disturbance/Gout
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 1142 at risk

Adverse event: METABOLIC/LABORATORY: Other
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 1142 at risk

Adverse event: MUSCULOSKELETAL/SOFT TISSUE: Other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 29 affected / 1142 at risk

Adverse event: Visceral necrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 1142 at risk

Adverse event: Convulsions/Seizures
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 1142 at risk

Adverse event: NEUROLOGY: Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 1142 at risk

Adverse event: Stroke or TIA
Serious: yes
Organ System: Nervous system disorders
Frequency: 15 affected / 1142 at risk

Adverse event: Syncope/Pre-syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 68 affected / 1142 at risk

Adverse event: OCULAR/VISUAL: Other
Serious: yes
Organ System: Eye disorders
Frequency: 3 affected / 1142 at risk

Adverse event: Drug abuse
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1142 at risk

Adverse event: OTHER: Other
Serious: yes
Organ System: General disorders
Frequency: 32 affected / 1142 at risk

Adverse event: Pregnancy
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1142 at risk

Adverse event: Suicide attempt/Psychiatric disorder
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 1142 at risk

Adverse event: PAIN: Other
Serious: yes
Organ System: General disorders
Frequency: 13 affected / 1142 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 1142 at risk

Adverse event: Pulmonary disease/Pneumonia/Bronchitis/Asthma/Breathing difficulties
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 79 affected / 1142 at risk

Adverse event: PULMONARY/UPPER RESPIRATORY: Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1142 at risk

Adverse event: Acute renal failure/Proteinuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 33 affected / 1142 at risk

Adverse event: RENAL/GENITOURINARY: Other
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 7 affected / 1142 at risk

Adverse event: SEXUAL/REPRODUCTIVE FUNCTION: Other
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 6 affected / 1142 at risk

Adverse event: "Cardiac device implantation (pacemaker, defibrillator, etc.)"
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 109 affected / 1142 at risk

Adverse event: "Cardiac procedure (stent, catheterization, EP study, ablation, etc.)"
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 66 affected / 1142 at risk

Adverse event: Cardiac surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 23 affected / 1142 at risk

Adverse event: Non-cardiac surgery/Diagnostic surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 57 affected / 1142 at risk

Adverse event: SURGERY/INTRA-OPERATIVE INJURY: Other
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 8 affected / 1142 at risk

Adverse event: Embolism arterial
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 1142 at risk

Adverse event: VASCULAR: Other
Serious: yes
Organ System: Vascular disorders
Frequency: 13 affected / 1142 at risk

Adverse event: All non-serious adverse events
Serious: no
Organ System: General disorders
Frequency: 799 affected / 1142 at risk