Study: NCT00148941

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1053 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1053 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1053 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1053 at risk

Adverse event: Pneumonia necrotising
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1053 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 162 affected / 1053 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 391 affected / 1053 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 620 affected / 1053 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 227 affected / 1053 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 194 affected / 1053 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 295 affected / 1053 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 54 affected / 1053 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 1051 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Burkitt's lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1051 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1051 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Hypernatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Optic atrophy
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Subcutaneous abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1051 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 160 affected / 1051 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 400 affected / 1051 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 583 affected / 1051 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 228 affected / 1051 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 217 affected / 1051 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 266 affected / 1051 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 57 affected / 1051 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1052 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1052 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 162 affected / 1052 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 412 affected / 1052 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 642 affected / 1052 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 234 affected / 1052 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 185 affected / 1052 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 292 affected / 1052 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 71 affected / 1052 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1053 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1053 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1053 at risk

Adverse event: Appendicitis perforated
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1053 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1053 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 166 affected / 1053 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 424 affected / 1053 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 601 affected / 1053 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 233 affected / 1053 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 181 affected / 1053 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 298 affected / 1053 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 60 affected / 1053 at risk