Study: NCT00119379

Adverse event: Hypoglycemia Gr. 3
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 26 at risk

Adverse event: Abnormal phos. Gr. 3
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Renal calculus Gr. 3
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Elevated CK Gr. 3 & 4
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 26 at risk

Adverse event: Hypercholesterolem Gr. 3
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 26 at risk

Adverse event: Diarrhea Gr. 3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Hypertrigliceridemia Gr. 3 & 4
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 26 at risk

Adverse event: Abnormal AST Gr. 3
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Incisional hematoma Gr. 1 & 2
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 26 at risk

Adverse event: Incisional seroma Gr. 1 & 2
Serious: no
Organ System: General disorders
Frequency: 2 affected / 26 at risk

Adverse event: Hyperglycemia Gr. 1 & 2
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 26 at risk

Adverse event: Hypoglycemia Gr. 1 & 2
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 26 at risk

Adverse event: Hypophosphatemia Gr. 2
Serious: no
Organ System: General disorders
Frequency: 4 affected / 26 at risk

Adverse event: Sinusitis Gr. 1
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Thrombocytopenia Gr. 2
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 26 at risk

Adverse event: Elevated triglycerides Gr. 2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: URI Gr. 2
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Elevated AST Gr. 2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Diarhhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 26 at risk

Adverse event: Neurtropenia Gr. 2
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Rash/Bactrim allergy Gr. 1
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Elevated CK Gr. 2
Serious: no
Organ System: General disorders
Frequency: 2 affected / 26 at risk

Adverse event: Abnormal LDL Chol Gr. 2
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 26 at risk

Adverse event: Incisional neuritis Gr. 2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Gross hematuria Gr. 2
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Abnormal cholesterol Gr. 2
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 26 at risk

Adverse event: Abnormal Glucose Gr. 1 & 2
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 26 at risk

Adverse event: Abnormal BMD/T score Gr. 2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Abnormal creatine Gr. 2
Serious: no
Organ System: General disorders
Frequency: 2 affected / 26 at risk

Adverse event: Abnormal FBS Gr. 2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Chalazion left eye - Gr. 2
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 26 at risk

Adverse event: Abnormal phos. Gr. 3
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Elevated CK Gr. 3 & 4
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 24 at risk

Adverse event: Pancreatitis Gr. 3
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 24 at risk

Adverse event: Vertigo Gr. 3
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 24 at risk

Adverse event: Dysuria Gr. 3
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 24 at risk

Adverse event: Incisional hematoma Gr. 1 & 2
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 24 at risk

Adverse event: Infected Incisional hematoma Gr. 2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Incisional seroma Gr. 1 & 2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Hypoglycemia Gr. 1 & 2
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 24 at risk

Adverse event: Hypophosphatemia Gr. 2
Serious: no
Organ System: General disorders
Frequency: 4 affected / 24 at risk

Adverse event: Tachycardia Gr. 2
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 24 at risk

Adverse event: Elevated triglycerides Gr. 2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Elevated AST Gr. 2
Serious: no
Organ System: General disorders
Frequency: 2 affected / 24 at risk

Adverse event: Otitis Gr. 2
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 24 at risk

Adverse event: Prob. Herpes simplex Gr. 2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Prob. Renal calculus Gr. 2
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 24 at risk

Adverse event: Elevated CK Gr. 2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Herpes zoster Gr. 2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Abnormal Glucose Gr. 1 & 2
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 24 at risk

Adverse event: Abnormal ALT Gr. 2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Elevated LFTs Gr. 2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk