Study: NCT00088374

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

Adverse event: ALLERGY/IMMUNOLOGY:: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 9 at risk

Adverse event: BLOOD/BONE MARROW:: Hemoglobin
Serious: no
Organ System: Investigations
Frequency: 1 affected / 9 at risk

Adverse event: BLOOD/BONE MARROW:: Leukocytes (total WBC)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 9 at risk

Adverse event: BLOOD/BONE MARROW:: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 9 at risk

Adverse event: CARDIAC ARRHYTHMIA:: Conduction abnormality/atrioventricular heart block:: AV Block-First degree
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 9 at risk

Adverse event: CARDIAC ARRHYTHMIA:: Conduction abnormality/atrioventricular heart block:: AV Block-Second degree Mo
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 9 at risk

Adverse event: CARDIAC ARRHYTHMIA:: Palpitations
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 9 at risk

Adverse event: CARDIAC ARRHYTHMIA:: Supraventricular and nodal arrhythmia:: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 9 at risk

Adverse event: CARDIAC ARRHYTHMIA:: Supraventricular and nodal arrhythmia:: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 9 at risk

Adverse event: CARDIAC ARRHYTHMIA:: Ventricular arrhythmia:: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 9 at risk

Adverse event: CARDIAC GENERAL:: Left ventricular diastolic dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 9 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS:: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 5 affected / 9 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS:: Insomnia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 9 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS:: Odor (patient odor)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS:: Weight gain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS:: Weight loss
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: DERMATOLOGY/SKIN:: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: DERMATOLOGY/SKIN:: Rash: acne/acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: GASTROINTESTINAL:: Anorexia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: GASTROINTESTINAL:: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: GASTROINTESTINAL:: Diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 9 at risk

Adverse event: GASTROINTESTINAL:: Dysphagia (difficulty swallowing)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: GASTROINTESTINAL:: Heartburn/dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: GASTROINTESTINAL:: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 9 at risk

Adverse event: GASTROINTESTINAL:: Salivary gland changes/saliva
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: GASTROINTESTINAL:: Taste alteration (dysgeusia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 9 at risk

Adverse event: GASTROINTESTINAL:: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 9 at risk

Adverse event: HEMORRHAGE/BLEEDING:: Hemorrhage, GI:: Oral cavity
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 9 at risk

Adverse event: HEMORRHAGE/BLEEDING:: Hemorrhage, pulmonary/upper respiratory:: Nose
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 9 at risk

Adverse event: METABOLIC/LABORATORY:: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 9 at risk

Adverse event: METABOLIC/LABORATORY:: AST, SGOT(serum glutamic oxaloacetic transaminase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 9 at risk

Adverse event: METABOLIC/LABORATORY:: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 9 at risk

Adverse event: METABOLIC/LABORATORY:: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 9 at risk

Adverse event: METABOLIC/LABORATORY:: CPK (creatine phosphokinase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 9 at risk

Adverse event: METABOLIC/LABORATORY:: Calcium, serum-high (hypercalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 9 at risk

Adverse event: METABOLIC/LABORATORY:: Calcium, serum-low (hypocalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 9 at risk

Adverse event: METABOLIC/LABORATORY:: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 9 at risk

Adverse event: METABOLIC/LABORATORY:: Glucose, serum-low (hypoglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 9 at risk

Adverse event: METABOLIC/LABORATORY:: Magnesium, serum-high (hypermagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 9 at risk

Adverse event: METABOLIC/LABORATORY:: Metabolic/Laboratory - Other (Specify, __)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: High LDH
Frequency: 1 affected / 9 at risk

Adverse event: METABOLIC/LABORATORY:: Phosphate, serum-low (hypophosphatemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 9 at risk

Adverse event: METABOLIC/LABORATORY:: Potassium, serum-high (hyperkalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 9 at risk

Adverse event: METABOLIC/LABORATORY:: Potassium, serum-low (hypokalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 9 at risk

Adverse event: METABOLIC/LABORATORY:: Sodium, serum-low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 9 at risk

Adverse event: METABOLIC/LABORATORY:: Uric acid, serum-high (hyperuricemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 9 at risk

Adverse event: MUSCULOSKELETAL/SOFT TISSUE:: Extremity-upper (function)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: NEUROLOGY:: Ataxia (incoordination)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

Adverse event: NEUROLOGY:: Cognitive disturbance
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

Adverse event: NEUROLOGY:: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 9 at risk

Adverse event: NEUROLOGY:: Neurology - Other (Specify, __)
Serious: no
Organ System: Nervous system disorders
Notes: Dizziness
Frequency: 1 affected / 9 at risk

Adverse event: PAIN:: Pain:: Abdomen NOS
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 9 at risk

Adverse event: PAIN:: Pain:: Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: PAIN:: Pain:: Bone
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: PAIN:: Pain:: Chest wall
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: PAIN:: Pain:: Extremity-limb
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: PAIN:: Pain:: Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 9 at risk

Adverse event: PAIN:: Pain:: Muscle
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 9 at risk

Adverse event: PAIN:: Pain:: Neck
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: PAIN:: Pain:: Pain NOS
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

Adverse event: PAIN:: Pain:: Pelvis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: PULMONARY/UPPER RESPIRATORY:: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 9 at risk

Adverse event: PULMONARY/UPPER RESPIRATORY:: Fistula, pulmonary/upper respiratory:: Lung
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: PULMONARY/UPPER RESPIRATORY:: Pulmonary/Upper Respiratory - Other (Specify, __)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: nasal drying
Frequency: 1 affected / 9 at risk