Study: NCT01030341

Adverse event: Severe hypoglycemic events, screening/run-in phase
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 45 at risk

Adverse event: Severe hypoglycemic events, treatment phase
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 42 at risk

Adverse event: Severe hyperglycemic events, treatment phase
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 42 at risk

Adverse event: Severe gastroparesis exacerbation, screening/run-in phase
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Severe gastroparesis exacerbation, treatment phase
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 42 at risk

Adverse event: Pain, numbness, paresthesia in hands, screening/run-in phase
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 45 at risk

Adverse event: Retinal detachment, screening/run-in phase
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 45 at risk

Adverse event: Death of unknown cause, screening/run-in phase
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 45 at risk

Adverse event: Heart attack, screening/run-in phase
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 45 at risk

Adverse event: Abdominal pain, nausea, vomiting, screening/run-in phase
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Abdominal pain, nausea, vomiting, treatment phase
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Also included anxiety in one case
Frequency: 3 affected / 42 at risk

Adverse event: Non-severe gastroparesis exacerbation, screening/run-in phase
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 45 at risk

Adverse event: Non-severe gastroparesis exacerbation, treatment phase
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 42 at risk

Adverse event: Non-severe hyperglycemia, screening/run-in phase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 45 at risk

Adverse event: Cholecystectomy, screening/run-in phase
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 45 at risk

Adverse event: Bilateral otitis externa, treatment phase
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Also included vomiting and diarrhea in one case
Frequency: 1 affected / 42 at risk

Adverse event: Pruritis/itching rash under CGMS site, screening/run-in phase
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 45 at risk

Adverse event: Rash generalized over upper body at CGMS site, treatment phase
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 42 at risk

Adverse event: Abdominal pain, nausea, vomiting, screening/run-in phase
Serious: no
Organ System: Gastrointestinal disorders
Notes: Also included fever, cough, nasal congestion, and/or sore throat in some cases
Frequency: 2 affected / 45 at risk

Adverse event: Abdominal pain, nausea, vomiting, treatment phase
Serious: no
Organ System: Gastrointestinal disorders
Notes: Also included dizziness, fainting, and/or diarrhea in some cases
Frequency: 2 affected / 42 at risk

Adverse event: Tingling, disorientation, dizziness, screening/run-in phase
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 45 at risk