Study: NCT03032406

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 15 at risk

Adverse event: Discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 15 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 15 at risk

Adverse event: Liver function abnormalities (transaminitis)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 15 at risk

Adverse event: Anorexia/Weight loss
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 15 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 15 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 15 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 15 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Visual changes
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 15 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 15 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 15 at risk

Adverse event: Muscle weakness, limb
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 15 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 15 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: Laboratory Abnormalities
Frequency: 2 affected / 15 at risk

Adverse event: Elevated lipids
Serious: no
Organ System: Cardiac disorders
Notes: Laboratory Abnormalities
Frequency: 2 affected / 15 at risk

Adverse event: Elevated creatinine
Serious: no
Organ System: Renal and urinary disorders
Notes: Laboratory Abnormalities
Frequency: 4 affected / 15 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 6 affected / 15 at risk

Adverse event: SkinRash/Discomfort
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 15 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 15 at risk

Adverse event: Discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 15 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 15 at risk

Adverse event: Liver function abnormalities (transaminitis)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 15 at risk

Adverse event: Mucositis/oral pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 15 at risk

Adverse event: Anorexia/Weight loss
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 15 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 15 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 15 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 15 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 15 at risk

Adverse event: Visual changes
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 15 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 15 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 15 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 15 at risk

Adverse event: Electrolyte abnormalities
Serious: no
Organ System: Renal and urinary disorders
Notes: Laboratory Abnormalities
Frequency: 7 affected / 15 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: Laboratory Abnormalities
Frequency: 3 affected / 15 at risk

Adverse event: Elevated lipids
Serious: no
Organ System: Cardiac disorders
Notes: Laboratory Abnormalities
Frequency: 10 affected / 15 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 7 affected / 15 at risk

Adverse event: SkinRash/Discomfort
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 15 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 15 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 21 at risk

Adverse event: Parainfluenzae virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 21 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 21 at risk

Adverse event: Discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 21 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 21 at risk

Adverse event: Liver function abnormalities (transaminitis)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 21 at risk

Adverse event: Mucositis/oral pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 21 at risk

Adverse event: Anorexia/Weight loss
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 21 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 21 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 21 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 21 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 21 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 21 at risk

Adverse event: Visual changes
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 21 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 21 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 21 at risk

Adverse event: Muscle weakness, limb
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 21 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 21 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 21 at risk

Adverse event: Electrolyte abnormalities
Serious: no
Organ System: Renal and urinary disorders
Notes: Laboratory Abnormalities
Frequency: 11 affected / 21 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: Laboratory Abnormalities
Frequency: 3 affected / 21 at risk

Adverse event: Elevated lipids
Serious: no
Organ System: Cardiac disorders
Notes: Laboratory Abnormalities
Frequency: 13 affected / 21 at risk

Adverse event: Elevated creatinine
Serious: no
Organ System: Renal and urinary disorders
Notes: Laboratory Abnormalities
Frequency: 5 affected / 21 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 11 affected / 21 at risk

Adverse event: SkinRash/Discomfort
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 21 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 21 at risk