Study: NCT02366091

Adverse event: Hospitalisation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Hospitalization for shoulder pain
Frequency: 2 affected / 24 at risk

Adverse event: Hopsitalization
Serious: yes
Organ System: Eye disorders
Notes: Hospitalization for transient bilateral vision loss.
Frequency: 1 affected / 24 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 24 at risk

Adverse event: Gastrointestinal disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 24 at risk

Adverse event: Joint/Muscle Soreness/Stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 24 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 24 at risk

Adverse event: Extremity swelling
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 24 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 24 at risk

Adverse event: Physical Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 24 at risk

Adverse event: Decreased White Blood Cell
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Decreased Hematocrit
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 24 at risk

Adverse event: Decreased Estimated GFR
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 24 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Cardiac disorders
Notes: Hospitalization for unstable angina/chest pain
Frequency: 1 affected / 23 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Hospitalization for pulmonary symptoms
Frequency: 1 affected / 23 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 23 at risk

Adverse event: Gastrointestinal disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 23 at risk

Adverse event: Joint/Muscle Soreness/Stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 23 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 23 at risk

Adverse event: Extremity swelling
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 23 at risk

Adverse event: Dental pain/infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 23 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 23 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 23 at risk

Adverse event: Physical Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 23 at risk

Adverse event: Mixed anxiety and depressive disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 23 at risk

Adverse event: Decreased White Blood Cell
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 23 at risk

Adverse event: Decreased Hematocrit
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 23 at risk

Adverse event: Decreased Estimated GFR
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 23 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 24 at risk

Adverse event: Gastrointestinal disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 24 at risk

Adverse event: Joint/Muscle Soreness/Stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 24 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 24 at risk

Adverse event: Dental pain/infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 24 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 24 at risk

Adverse event: Physical Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 24 at risk

Adverse event: Mixed anxiety and depressive disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 24 at risk

Adverse event: Increased Alanine Amino Trans
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 24 at risk

Adverse event: Decreased White Blood Cell
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Decreased Hematocrit
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 24 at risk

Adverse event: Decreased Estimated GFR
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 24 at risk

Adverse event: Increased Aspartate Amino Trans >3 x the normal range
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 24 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Cardiac disorders
Notes: Hospitalization for unstable angina/chest pain
Frequency: 1 affected / 23 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 23 at risk

Adverse event: Gastrointestinal disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 23 at risk

Adverse event: Joint/Muscle Soreness/Stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 23 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 23 at risk

Adverse event: Extremity swelling
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 23 at risk

Adverse event: Dental pain/infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 23 at risk

Adverse event: Physical Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 23 at risk

Adverse event: Decreased White Blood Cell
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 23 at risk

Adverse event: Decreased Hematocrit
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 23 at risk

Adverse event: Decreased Estimated GFR
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 23 at risk