Study: NCT01265563

Adverse event: Road traffic accident
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Heart burn, nausea, diarrhea, abd pain, anorexia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 16 at risk

Adverse event: Congestion, Sore throat, Myalgias
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Infection - soft tissue, UTI
Serious: no
Organ System: General disorders
Frequency: 2 affected / 16 at risk

Adverse event: Vertigo
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 16 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 12 at risk

Adverse event: Heart burn, nausea, diarrhea, abd pain, anorexia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 12 at risk

Adverse event: AKI, hyperkalemia, Edema
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 12 at risk

Adverse event: Flushing
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Wheezing
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Heart burn, nausea, diarrhea, abd pain, anorexia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 16 at risk

Adverse event: Congestion, Sore throat, Myalgias
Serious: no
Organ System: General disorders
Frequency: 3 affected / 16 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 16 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Heart burn, nausea, diarrhea, abd pain, anorexia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 16 at risk

Adverse event: Congestion, Sore throat, Myalgias
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: AKI, hyperkalemia, Edema
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 16 at risk

Adverse event: Fracture, sprain, stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 14 at risk

Adverse event: Heart burn, nausea, diarrhea, abd pain, anorexia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 14 at risk

Adverse event: Congestion, Sore throat, Myalgias
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Infection - soft tissue, UTI
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 14 at risk

Adverse event: AKI, hyperkalemia, Edema
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 14 at risk