Study: NCT00366301

Adverse event: Hyperglycemia Requiring Hospitalization
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 124 at risk

Adverse event: Cellulitis Hospitalization
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 124 at risk

Adverse event: Sepsis Hospitazation
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 124 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: Subjects were queried at each study visit.
Frequency: 1 affected / 124 at risk

Adverse event: Hyperglycemia: Confirmed Fasting Glucose >= 250 mg/dl
Serious: no
Organ System: Endocrine disorders
Frequency: 10 affected / 124 at risk

Adverse event: Hyperglycemia: Any Self-Monitor Blood Glucose >= 400 mg/dl
Serious: no
Organ System: Endocrine disorders
Frequency: 3 affected / 124 at risk

Adverse event: Weight Gain >= 5% of Baseline
Serious: no
Organ System: Endocrine disorders
Frequency: 3 affected / 124 at risk

Adverse event: Gastrointestinal Adverse Event (e.g. diarrhea not requiring hospitalization)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 124 at risk

Adverse event: Severe Diarrhea Requiring Hospitalization
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 126 at risk

Adverse event: Supraventricular Tachycardia Requiring Hospitalization
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 126 at risk

Adverse event: Gastroenteritis Hospitalization
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 126 at risk

Adverse event: Chest Pain Hospitalization
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 126 at risk

Adverse event: Traumatic Injury/Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 126 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 126 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: Subjects were queried at each study visit.
Frequency: 3 affected / 126 at risk

Adverse event: Hyperglycemia: Confirmed Fasting Glucose >= 250 mg/dl
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 126 at risk

Adverse event: Weight Gain >= 5% of Baseline
Serious: no
Organ System: Endocrine disorders
Frequency: 4 affected / 126 at risk

Adverse event: Gastrointestinal Adverse Event (e.g. diarrhea not requiring hospitalization)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 126 at risk

Adverse event: Chest Pain Hospitalization
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 126 at risk

Adverse event: Nephrolithiasis Requiring Hospitalization
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 126 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: Subjects were queried at each study visit.
Frequency: 3 affected / 126 at risk

Adverse event: Hyperglycemia: Confirmed Fasting Glucose >= 250 mg/dl
Serious: no
Organ System: Endocrine disorders
Frequency: 4 affected / 126 at risk

Adverse event: Hyperglycemia: Any Self-Monitor Blood Glucose >= 400 mg/dl
Serious: no
Organ System: Endocrine disorders
Frequency: 3 affected / 126 at risk

Adverse event: Weight Gain >= 5% of Baseline
Serious: no
Organ System: Endocrine disorders
Frequency: 14 affected / 126 at risk

Adverse event: Gastrointestinal Adverse Event (e.g. diarrhea not requiring hospitalization)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 126 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: Subjects were queried at each study visit.
Frequency: 6 affected / 124 at risk

Adverse event: Hyperglycemia: Confirmed Fasting Glucose >= 250 mg/dl
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 124 at risk

Adverse event: Hyperglycemia: Any Self-Monitor Blood Glucose >= 400 mg/dl
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 124 at risk

Adverse event: Weight Gain >= 5% of Baseline
Serious: no
Organ System: Endocrine disorders
Frequency: 8 affected / 124 at risk

Adverse event: Gastrointestinal Adverse Event (e.g. diarrhea not requiring hospitalization)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 124 at risk