Study: NCT02126553

Adverse event: Cellulitis Hand
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 29 at risk

Adverse event: elevated transaminases
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 29 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: Cellulitis Foot
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 29 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 29 at risk

Adverse event: Dysarthria
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 29 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 29 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 29 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 29 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: AST, SGOT (serum glutamic oxaloacetic transaminase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 29 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 29 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 29 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 29 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 29 at risk

Adverse event: Dry mouth/salivary gland (xerostomia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 29 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 29 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Edema: limb
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 29 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 6 affected / 29 at risk

Adverse event: Heartburn/dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 29 at risk

Adverse event: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10^
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 29 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: Myalgia Back and Neck
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: Myositis (inflammation/damage of muscle)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 29 at risk

Adverse event: Neuropathy: motor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 29 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 29 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 29 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: Platelets Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 29 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 29 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 29 at risk

Adverse event: Taste alteration (dysgeusia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Vision-photophobia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 29 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 29 at risk