Study: NCT00237692

Adverse event: Circulatory
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 147 at risk

Adverse event: Coronary
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 147 at risk

Adverse event: Dermatologic
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 147 at risk

Adverse event: Endocrine
Serious: yes
Organ System: Endocrine disorders
Frequency: 4 affected / 147 at risk

Adverse event: Gastro-Intestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 147 at risk

Adverse event: General - ER visits
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 147 at risk

Adverse event: General - Med-Refill
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 147 at risk

Adverse event: General - Med Side Effect
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 147 at risk

Adverse event: Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 147 at risk

Adverse event: Injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 147 at risk

Adverse event: Neurologic
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 147 at risk

Adverse event: Optometry
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 147 at risk

Adverse event: Orthopedic Issues
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 147 at risk

Adverse event: Psychological
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 147 at risk

Adverse event: Pulmonary
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 147 at risk

Adverse event: Urology
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 147 at risk

Adverse event: Vascular
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 147 at risk

Adverse event: Coronary - Death
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 147 at risk

Adverse event: Coronary Safety Protocol
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 147 at risk

Adverse event: w/recurrent nosebleed
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 148 at risk

Adverse event: Cancer Tx
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 148 at risk

Adverse event: Circulatory
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 148 at risk

Adverse event: Coronary
Serious: yes
Organ System: Cardiac disorders
Frequency: 18 affected / 148 at risk

Adverse event: Dermatologic
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 148 at risk

Adverse event: Ear pain
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 148 at risk

Adverse event: Endocrine
Serious: yes
Organ System: Endocrine disorders
Frequency: 11 affected / 148 at risk

Adverse event: Gastro-Intestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 148 at risk

Adverse event: General - ER visits
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 148 at risk

Adverse event: General - Med-Refill
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 148 at risk

Adverse event: General - Med Side Effect
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 148 at risk

Adverse event: Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 148 at risk

Adverse event: Neurologic
Serious: yes
Organ System: Nervous system disorders
Frequency: 8 affected / 148 at risk

Adverse event: Optometry
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 148 at risk

Adverse event: Orthopedic Issues
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 148 at risk

Adverse event: Psychological
Serious: yes
Organ System: Psychiatric disorders
Frequency: 5 affected / 148 at risk

Adverse event: Pulmonary
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 148 at risk

Adverse event: Pulmonary-Death
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 148 at risk

Adverse event: Urology
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 148 at risk

Adverse event: Coronary - Death
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 148 at risk

Adverse event: Coronary Safety Protocol
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 148 at risk

Adverse event: Cancer Tx
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 149 at risk

Adverse event: Circulatory
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 149 at risk

Adverse event: Coronary
Serious: yes
Organ System: Cardiac disorders
Frequency: 20 affected / 149 at risk

Adverse event: Dermatologic
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 149 at risk

Adverse event: Ear pain
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 149 at risk

Adverse event: Endocrine
Serious: yes
Organ System: Endocrine disorders
Frequency: 7 affected / 149 at risk

Adverse event: Eye
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 149 at risk

Adverse event: Gastro-Intestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 149 at risk

Adverse event: General - ER visits
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 149 at risk

Adverse event: General - Med-Refill
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 149 at risk

Adverse event: General - Med Side Effect
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 149 at risk

Adverse event: Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 12 affected / 149 at risk

Adverse event: Injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 149 at risk

Adverse event: Neurologic
Serious: yes
Organ System: Nervous system disorders
Frequency: 10 affected / 149 at risk

Adverse event: Optometry
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 149 at risk

Adverse event: Orthopedic Issues
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 18 affected / 149 at risk

Adverse event: Psychological
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 149 at risk

Adverse event: Pulmonary
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 149 at risk

Adverse event: Renal
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 149 at risk

Adverse event: Urology
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 149 at risk

Adverse event: Coronary - Death
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 149 at risk

Adverse event: Coronary Safety Protocol
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 149 at risk

Adverse event: Cancer Tx
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 147 at risk

Adverse event: Circulatory
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 147 at risk

Adverse event: Coronary
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 147 at risk

Adverse event: Dermatologic
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 147 at risk

Adverse event: Ear pain
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 147 at risk

Adverse event: Endocrine
Serious: yes
Organ System: Endocrine disorders
Frequency: 7 affected / 147 at risk

Adverse event: Gastro-Intestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 147 at risk

Adverse event: General - ER visits
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 147 at risk

Adverse event: General - Med-Refill
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 147 at risk

Adverse event: General - Med Side Effect
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 147 at risk

Adverse event: Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 147 at risk

Adverse event: Injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 147 at risk

Adverse event: Neurologic
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 147 at risk

Adverse event: Optometry
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 147 at risk

Adverse event: Orthopedic Issues
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 21 affected / 147 at risk

Adverse event: Psychological
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 147 at risk

Adverse event: Pulmonary
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 147 at risk

Adverse event: Pulmonary-Death
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 147 at risk

Adverse event: Urology
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 147 at risk

Adverse event: Coronary - Death
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 147 at risk

Adverse event: Coronary Safety Protocol
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 147 at risk