Study: NCT00493220

Adverse event: Infusion site anaesthesia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 30 at risk

Adverse event: Infusion site bruising
Serious: no
Organ System: General disorders
Frequency: 2 affected / 30 at risk

Adverse event: Infusion site erythema
Serious: no
Organ System: General disorders
Frequency: 18 affected / 30 at risk

Adverse event: Infusion site induration
Serious: no
Organ System: General disorders
Frequency: 2 affected / 30 at risk

Adverse event: Infusion site pain
Serious: no
Organ System: General disorders
Frequency: 30 affected / 30 at risk

Adverse event: Infusion site pruritus
Serious: no
Organ System: General disorders
Frequency: 2 affected / 30 at risk

Adverse event: Infusion site reaction
Serious: no
Organ System: General disorders
Notes: Reported term = "muscle twitching"
Frequency: 6 affected / 30 at risk

Adverse event: Infusion site swelling
Serious: no
Organ System: General disorders
Frequency: 5 affected / 30 at risk

Adverse event: Vessel puncture site bruise
Serious: no
Organ System: General disorders
Notes: Refers to site of placement of catheter for PK plasma sample collection, not study drug administration site
Frequency: 1 affected / 30 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 30 at risk

Adverse event: Infusion site anaesthesia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Infusion site bruising
Serious: no
Organ System: General disorders
Frequency: 4 affected / 30 at risk

Adverse event: Infusion site erythema
Serious: no
Organ System: General disorders
Frequency: 15 affected / 30 at risk

Adverse event: Infusion site induration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Infusion site pain
Serious: no
Organ System: General disorders
Frequency: 30 affected / 30 at risk

Adverse event: Infusion site swelling
Serious: no
Organ System: General disorders
Frequency: 28 affected / 30 at risk

Adverse event: Vessel puncture site bruise
Serious: no
Organ System: General disorders
Notes: Refers to site of placement of catheter for PK plasma sample collection, not study drug administration site
Frequency: 2 affected / 30 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 30 at risk

Adverse event: Infusion site bruising
Serious: no
Organ System: General disorders
Frequency: 6 affected / 29 at risk

Adverse event: Infusion site erythema
Serious: no
Organ System: General disorders
Frequency: 4 affected / 29 at risk

Adverse event: Infusion site pain
Serious: no
Organ System: General disorders
Frequency: 9 affected / 29 at risk

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

Adverse event: Infusion site swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: Vessel puncture site bruise
Serious: no
Organ System: General disorders
Notes: Refers to site of placement of catheter for PK plasma sample collection, not study drug administration site
Frequency: 2 affected / 29 at risk