Study: NCT02438423

Adverse event: Swelling/Induration (grade 1)
Serious: no
Organ System: General disorders
Frequency: 4 affected / 25 at risk

Adverse event: Redness/Erythema (grade 1)
Serious: no
Organ System: General disorders
Frequency: 9 affected / 25 at risk

Adverse event: Tenderness (grade 1)
Serious: no
Organ System: General disorders
Frequency: 13 affected / 25 at risk

Adverse event: Pain (grade 1)
Serious: no
Organ System: General disorders
Frequency: 5 affected / 25 at risk

Adverse event: Pruritis (itching) (grade 1)
Serious: no
Organ System: General disorders
Frequency: 16 affected / 25 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 12 affected / 25 at risk

Adverse event: Body ache (myalgia) (grade 1)
Serious: no
Organ System: General disorders
Frequency: 4 affected / 25 at risk

Adverse event: Shivering/shaking body movements (grade 1)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Sweating (grade 1)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 25 at risk

Adverse event: Malaise (grade 1)
Serious: no
Organ System: General disorders
Frequency: 4 affected / 25 at risk

Adverse event: Nausea (grade 1)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 25 at risk

Adverse event: Fever (grade 1)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Anemia (grade 1)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 25 at risk

Adverse event: Decreased absolute lymphocytes (grade 1)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Leukocytosis (grade 1)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Leukopenia (grade 1)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 25 at risk

Adverse event: Gastroenteritis (grade 1)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 25 at risk

Adverse event: URI (grade 1)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: Elevated ALT (grade 1)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 25 at risk

Adverse event: Left elbow tendonitis (grade 1)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: Neck pain (grade 1)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: Redness/Erythema (grade 2)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Tenderness (grade 2)
Serious: no
Organ System: General disorders
Frequency: 4 affected / 25 at risk

Adverse event: Pruritis (grade 2)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 25 at risk

Adverse event: Fatigue (grade 2)
Serious: no
Organ System: General disorders
Frequency: 12 affected / 25 at risk

Adverse event: Neutropenia (grade 2)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Thrombocytopenia (grade 2)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Headache (grade 2)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Pruritis (grade 3)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Swelling/Induration (grade 1)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Tenderness (grade 1)
Serious: no
Organ System: General disorders
Frequency: 9 affected / 25 at risk

Adverse event: Pain (grade 1)
Serious: no
Organ System: General disorders
Frequency: 8 affected / 25 at risk

Adverse event: Pruritis (itching) (grade 1)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 25 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 7 affected / 25 at risk

Adverse event: Body ache (myalgia) (grade 1)
Serious: no
Organ System: General disorders
Frequency: 6 affected / 25 at risk

Adverse event: Shivering/shaking body movements (grade 1)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Sweating (grade 1)
Serious: no
Organ System: General disorders
Frequency: 5 affected / 25 at risk

Adverse event: Malaise (grade 1)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 25 at risk

Adverse event: Nausea (grade 1)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 25 at risk

Adverse event: Joint pain (arthralgia) (grade 1)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Anemia (grade 1)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 25 at risk

Adverse event: Leukocytosis (grade 1)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Leukopenia (grade 1)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Thrombocytopenia (grade 1)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 25 at risk

Adverse event: URI (grade 1)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 25 at risk

Adverse event: Elevated CK (grade 1)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 25 at risk

Adverse event: Arthralgia (grade 1)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: Headache (grade 1)
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 25 at risk

Adverse event: Tenderness (grade 2)
Serious: no
Organ System: General disorders
Frequency: 6 affected / 25 at risk

Adverse event: Pruritis (grade 2)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Fatigue (grade 2)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 25 at risk

Adverse event: Pain (grade 2)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 25 at risk

Adverse event: Body ache (myalgia) (grade 2)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Shivering/shaking Body Movements (grade 2)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Malaise (grade 2)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 25 at risk

Adverse event: Joint pain (Arthralgia) (grade 2)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Nausea (grade 2)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Headache (grade 2)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Vomiting (grade 2)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Arthralgia (grade 2)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: Left hand bruise (grade 2)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: Fatigue (grade 3)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Elevated ALT (grade 3)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 25 at risk

Adverse event: Severe acute enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: severe acute enteritis (i.e. abdominal pain, nausea, and vomiting)
Frequency: 1 affected / 25 at risk

Adverse event: Swelling/Induration (grade 1)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Redness/Erythema (grade 1)
Serious: no
Organ System: General disorders
Frequency: 8 affected / 25 at risk

Adverse event: Tenderness (grade 1)
Serious: no
Organ System: General disorders
Frequency: 14 affected / 25 at risk

Adverse event: Pain (grade 1)
Serious: no
Organ System: General disorders
Frequency: 4 affected / 25 at risk

Adverse event: Pruritis (itching) (grade 1)
Serious: no
Organ System: General disorders
Frequency: 20 affected / 25 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 25 at risk

Adverse event: Body ache (myalgia) (grade 1)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Sweating (grade 1)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 25 at risk

Adverse event: Nausea (grade 1)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Fever (grade 1)
Serious: no
Organ System: General disorders
Frequency: 6 affected / 25 at risk

Adverse event: Joint pain (arthralgia) (grade 1)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 25 at risk

Adverse event: Anemia (grade 1)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Leukopenia (grade 1)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 25 at risk

Adverse event: URI (grade 1)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: Arthralgia (grade 1)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 25 at risk

Adverse event: Headache (grade 1)
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 25 at risk

Adverse event: Tooth infection (grade 1)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: Toe infection (grade 1)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: Conjunctivitis (grade 1)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: Presyncope (grade 1)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Hypertension (grade 1)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 25 at risk

Adverse event: Elevated ALT AST (grade 1)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 25 at risk

Adverse event: Redness/Erythema (grade 2)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 25 at risk

Adverse event: Tenderness (grade 2)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Pruritis (grade 2)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Fatigue (grade 2)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 25 at risk

Adverse event: Pain (grade 2)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Malaise (grade 2)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 25 at risk

Adverse event: Joint pain (Arthralgia) (grade 2)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Nausea (grade 2)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Swelling/Induration (grade 2)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Neutropenia (grade 2)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Hypertension (grade 2)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 25 at risk

Adverse event: Tenderness (grade 3)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Enteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Elevated AST (grade 4)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 25 at risk

Adverse event: Elevated CK (grade 4)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 25 at risk

Adverse event: Tenderness (grade 1)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 25 at risk

Adverse event: Pain (grade 1)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 25 at risk

Adverse event: Pruritis (itching) (grade 1)
Serious: no
Organ System: General disorders
Frequency: 4 affected / 25 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 25 at risk

Adverse event: Body ache (myalgia) (grade 1)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 25 at risk

Adverse event: Shivering/shaking body movements (grade 1)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Malaise (grade 1)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Nausea (grade 1)
Serious: no
Organ System: General disorders
Frequency: 6 affected / 25 at risk

Adverse event: Joint pain (arthralgia) (grade 1)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Anemia (grade 1)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 25 at risk

Adverse event: Leukopenia (grade 1)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 25 at risk

Adverse event: Thrombocytopenia (grade 1)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Epigastric pain (grade 1)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: URI (grade 1)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: Elevated ALT (grade 1)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 25 at risk

Adverse event: Transaminitis (grade 1)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 25 at risk

Adverse event: Arthralgia (grade 1)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: Leg pain (grade 1)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: Elevated ALT AST (grade 1)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 25 at risk

Adverse event: Tenderness (grade 2)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Body ache (myalgia) (grade 2)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Nausea (grade 2)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Neutropenia (grade 2)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 25 at risk

Adverse event: Headache (grade 2)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Vomiting (grade 2)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Headache (grade 3)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Hypertension (grade 3)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 25 at risk