Study: NCT01149369

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Endocrine disorders
Notes: The patient was determined to be diabetic and had delayed retention. Hospitalization due to nausea and vomiting.
Frequency: 1 affected / 63 at risk

Adverse event: Nausea, vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 63 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 63 at risk

Adverse event: Contusion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 63 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 63 at risk

Adverse event: Gastrointestinal - Other (abdominal pain)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 63 at risk

Adverse event: Nausea, abdominal pain, diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 63 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 63 at risk

Adverse event: Diarrhea, syncope
Serious: no
Organ System: General disorders
Notes: Reaction to different medication; not study-related
Frequency: 1 affected / 63 at risk

Adverse event: Musculoskeletal - Other (neck and right hand pain)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 63 at risk

Adverse event: Diarrhea, loss of appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 63 at risk

Adverse event: Gastrointestinal - Other (fainting sensation)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 63 at risk

Adverse event: Renal/Genitourinary - Other (Bleeding)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 63 at risk

Adverse event: Fibromyalgia cystitis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 63 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 63 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 63 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 63 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 63 at risk

Adverse event: Gastrointestinal - Other (Nausea, malaise)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 63 at risk

Adverse event: Musculoskeletal - Other (Limb pain)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 63 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 63 at risk

Adverse event: Nausea, vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 63 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 63 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 63 at risk

Adverse event: Flashing lights/floaters
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 63 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 63 at risk

Adverse event: Gastrointestinal - Other (abdominal pain)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 63 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 63 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 63 at risk

Adverse event: Contusion
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 63 at risk

Adverse event: Asthmatic crisis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: High blood pressure, shortness of breath, dizziness, palpitations
Frequency: 1 affected / 63 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: Withdrawal from depression medication caused dizziness, vertigo, and light sensitivity
Frequency: 1 affected / 63 at risk

Adverse event: Neurology - other
Serious: no
Organ System: Nervous system disorders
Notes: Migraines, pain, stiffness, chest pain, heart palpitations, lower left quad pain, chills, fever, burping
Frequency: 1 affected / 63 at risk