Study: NCT00392678

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Hospitalization for Acute Cholecystitis, laparoscopic cholecystectomy performed.
Frequency: 1 affected / 27 at risk

Adverse event: Cardiorespiratory
Serious: no
Organ System: Cardiac disorders
Notes: Includes palpitations, chest pain or discomfort, and swelling of legs or feet
Frequency: 4 affected / 27 at risk

Adverse event: Neurologic
Serious: no
Organ System: Nervous system disorders
Notes: Includes blurry vision, dots or flashes in vision, tinnitus, and numbness or tingling.
Frequency: 7 affected / 27 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Notes: incudes heartburn, nausea, vomiting, diarrhea
Frequency: 11 affected / 27 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Includes stiffness, muscle or joint pain, arthritis, backache.
Frequency: 8 affected / 27 at risk

Adverse event: General
Serious: no
Organ System: General disorders
Notes: Includes fainting, dizziness, weakness or fatigue.
Frequency: 7 affected / 27 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 5 affected / 27 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: 1. Hospitalization for Cervical Disc Herniation.
Frequency: 1 affected / 27 at risk

Adverse event: Congestive Heart Failure with Diastolic Dysfunction
Serious: yes
Organ System: Cardiac disorders
Notes: Hospitalization for Congestive Heart Failure with Diastolic Dysfunction.
Frequency: 1 affected / 27 at risk

Adverse event: Cardiorespiratory
Serious: no
Organ System: Cardiac disorders
Notes: Includes palpitations, chest pain or discomfort, and swelling of legs or feet
Frequency: 1 affected / 27 at risk

Adverse event: Neurologic
Serious: no
Organ System: Nervous system disorders
Notes: Includes blurry vision, dots or flashes in vision, tinnitus, and numbness or tingling.
Frequency: 10 affected / 27 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Notes: incudes heartburn, nausea, vomiting, diarrhea
Frequency: 8 affected / 27 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Includes stiffness, muscle or joint pain, arthritis, backache.
Frequency: 5 affected / 27 at risk

Adverse event: General
Serious: no
Organ System: General disorders
Notes: Includes fainting, dizziness, weakness or fatigue.
Frequency: 4 affected / 27 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 6 affected / 27 at risk

Adverse event: Cardiorespiratory
Serious: no
Organ System: Cardiac disorders
Notes: Includes palpitations, chest pain or discomfort, and swelling of legs or feet
Frequency: 3 affected / 27 at risk

Adverse event: Neurologic
Serious: no
Organ System: Nervous system disorders
Notes: Includes blurry vision, dots or flashes in vision, tinnitus, and numbness or tingling.
Frequency: 8 affected / 27 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Notes: incudes heartburn, nausea, vomiting, diarrhea
Frequency: 8 affected / 27 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Includes stiffness, muscle or joint pain, arthritis, backache.
Frequency: 3 affected / 27 at risk

Adverse event: General
Serious: no
Organ System: General disorders
Notes: Includes fainting, dizziness, weakness or fatigue.
Frequency: 2 affected / 27 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 6 affected / 27 at risk

Adverse event: Spinal laminectomy
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Hospitalization for Lumbar laminectomy.
Frequency: 1 affected / 27 at risk

Adverse event: Cardiorespiratory
Serious: no
Organ System: Cardiac disorders
Notes: Includes palpitations, chest pain or discomfort, and swelling of legs or feet
Frequency: 3 affected / 27 at risk

Adverse event: Neurologic
Serious: no
Organ System: Nervous system disorders
Notes: Includes blurry vision, dots or flashes in vision, tinnitus, and numbness or tingling.
Frequency: 7 affected / 27 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Notes: incudes heartburn, nausea, vomiting, diarrhea
Frequency: 2 affected / 27 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Includes stiffness, muscle or joint pain, arthritis, backache.
Frequency: 7 affected / 27 at risk

Adverse event: General
Serious: no
Organ System: General disorders
Notes: Includes fainting, dizziness, weakness or fatigue.
Frequency: 4 affected / 27 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 27 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 27 at risk