Study: NCT02023164

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Drowsiness
Frequency: 1 affected / 16 at risk

Adverse event: Rash pruritic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Red plaques, skin redness, pruritis urticaria, rash,
Frequency: 3 affected / 16 at risk

Adverse event: Burning sensation
Serious: no
Organ System: General disorders
Notes: Burning sensation
Frequency: 1 affected / 16 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Urticaria
Frequency: 2 affected / 16 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pruritis
Frequency: 3 affected / 16 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Headache
Frequency: 1 affected / 16 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Notes: Upset stomach
Frequency: 1 affected / 16 at risk

Adverse event: Lip swelling
Serious: no
Organ System: Gastrointestinal disorders
Notes: Lip swelling
Frequency: 1 affected / 16 at risk

Adverse event: Peripheral swelling
Serious: no
Organ System: General disorders
Notes: Swollen lips and legs; General disorders and administration site conditions
Frequency: 1 affected / 16 at risk

Adverse event: Injection site pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Burning at IV site
Frequency: 1 affected / 16 at risk

Adverse event: Tachypnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Tachypnea
Frequency: 1 affected / 16 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Rash
Frequency: 4 affected / 16 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Rigors; General disorders and administration site conditions
Frequency: 1 affected / 16 at risk

Adverse event: Eye swelling
Serious: no
Organ System: Eye disorders
Notes: Swollen eyes
Frequency: 1 affected / 16 at risk

Adverse event: Respiration abnormal
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 17 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Drowsiness
Frequency: 1 affected / 17 at risk

Adverse event: Rash pruritic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Red plaques, skin redness, pruritis urticaria, rash,
Frequency: 3 affected / 17 at risk

Adverse event: Burning sensation
Serious: no
Organ System: General disorders
Notes: Burning sensation
Frequency: 1 affected / 17 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Constipation
Frequency: 1 affected / 17 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Urticaria
Frequency: 2 affected / 17 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pruritis
Frequency: 1 affected / 17 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Notes: Sedation
Frequency: 1 affected / 17 at risk

Adverse event: Peripheral swelling
Serious: no
Organ System: General disorders
Notes: Swollen lips and legs; General disorders and administration site conditions
Frequency: 1 affected / 17 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: Tachycardia
Frequency: 1 affected / 17 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Rash
Frequency: 2 affected / 17 at risk

Adverse event: Adverse event
Serious: no
Organ System: General disorders
Frequency: 1 affected / 17 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Redness
Frequency: 1 affected / 17 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Back pain
Frequency: 1 affected / 17 at risk

Adverse event: Swelling face
Serious: no
Organ System: General disorders
Notes: Swelling on face; General disorders and administration site conditions
Frequency: 1 affected / 17 at risk