Study: NCT00972725

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 13 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Notes: 1 subject in the GSK732461+Nivaquine group reported gastroenteritis 1 day before vaccination
Frequency: 1 affected / 13 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 13 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 9 affected / 13 at risk

Adverse event: Gastro-intestinal symptoms
Serious: no
Organ System: General disorders
Frequency: 6 affected / 13 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 9 affected / 13 at risk

Adverse event: Temperature (Orally)
Serious: no
Organ System: General disorders
Frequency: 8 affected / 13 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 13 affected / 13 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 3 affected / 13 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 3 affected / 13 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 6 affected / 15 at risk

Adverse event: Hangover
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 15 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Notes: 1 subject in the GSK732461+Nivaquine group reported gastroenteritis 1 day before vaccination
Frequency: 1 affected / 15 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 15 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 15 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 15 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 14 affected / 15 at risk

Adverse event: Gastro-intestinal symptoms
Serious: no
Organ System: General disorders
Frequency: 5 affected / 15 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 13 affected / 15 at risk

Adverse event: Temperature (Orally)
Serious: no
Organ System: General disorders
Frequency: 10 affected / 15 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 14 affected / 15 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 6 affected / 15 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 5 affected / 15 at risk