Study: NCT02624180

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 41 at risk

Adverse event: Gastrointestinal disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 41 at risk

Adverse event: Joint/Muscle Soreness/Stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 41 at risk

Adverse event: Fatigue
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 41 at risk

Adverse event: Vision
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 41 at risk

Adverse event: Physical Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 41 at risk

Adverse event: Increased Aspartate Amino Trans
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 7 affected / 41 at risk

Adverse event: Increased Alanine Amino Trans
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 7 affected / 41 at risk

Adverse event: Decreased White Blood Cell
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 41 at risk

Adverse event: Decreased Hematocrit
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 41 at risk

Adverse event: Decreased Estimated GFR
Serious: no
Organ System: Renal and urinary disorders
Frequency: 10 affected / 41 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Renal and urinary disorders
Notes: Urinary tract infection requiring hospitalization
Frequency: 1 affected / 38 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Surgical and medical procedures
Notes: Participant underwent elective carotid endarterectomy during study
Frequency: 1 affected / 38 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 38 at risk

Adverse event: Gastrointestinal disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 38 at risk

Adverse event: Joint/Muscle Soreness/Stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 38 at risk

Adverse event: Fatigue
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Extremity swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Dental pain/infection
Serious: no
Organ System: General disorders
Frequency: 3 affected / 38 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 38 at risk

Adverse event: Physical Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 38 at risk

Adverse event: Increased Aspartate Amino Trans
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 6 affected / 38 at risk

Adverse event: Increased Alanine Amino Trans
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 38 at risk

Adverse event: Decreased White Blood Cell
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 38 at risk

Adverse event: Decreased Hematocrit
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 38 at risk

Adverse event: Decreased Estimated GFR
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 38 at risk