Study: NCT00454909

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 587 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 587 at risk

Adverse event: Lower limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 587 at risk

Adverse event: Post procedural diarrhoea
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 587 at risk

Adverse event: Procedural nausea
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 587 at risk

Adverse event: Procedural vomiting
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 587 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 587 at risk

Adverse event: Swelling
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 587 at risk

Adverse event: Type 1 diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 587 at risk

Adverse event: Pain (Days 0-3)
Serious: no
Organ System: General disorders
Frequency: 317 affected / 579 at risk

Adverse event: Redness (Days 0-3)
Serious: no
Organ System: General disorders
Frequency: 77 affected / 579 at risk

Adverse event: Swelling (Days 0-3)
Serious: no
Organ System: General disorders
Frequency: 62 affected / 579 at risk

Adverse event: Pain (Days 0-7)
Serious: no
Organ System: General disorders
Frequency: 318 affected / 579 at risk

Adverse event: Redness (Days 0-7)
Serious: no
Organ System: General disorders
Frequency: 77 affected / 579 at risk

Adverse event: Swelling (Days 0-7)
Serious: no
Organ System: General disorders
Frequency: 63 affected / 579 at risk

Adverse event: Fatigue (Days 0-3)
Serious: no
Organ System: General disorders
Frequency: 156 affected / 579 at risk

Adverse event: Fever/Orally (Days 0-3)
Serious: no
Organ System: General disorders
Frequency: 34 affected / 579 at risk

Adverse event: Gastrointestinal (Days 0-3)
Serious: no
Organ System: General disorders
Frequency: 87 affected / 579 at risk

Adverse event: Headache (Days 0-3)
Serious: no
Organ System: General disorders
Frequency: 161 affected / 579 at risk

Adverse event: Fatigue (Days 0-7)
Serious: no
Organ System: General disorders
Frequency: 172 affected / 579 at risk

Adverse event: Fever/Orally (Days 0-7)
Serious: no
Organ System: General disorders
Frequency: 41 affected / 579 at risk

Adverse event: Gastrointestinal (Days 0-7)
Serious: no
Organ System: General disorders
Frequency: 109 affected / 579 at risk

Adverse event: Headache (Days 0-7)
Serious: no
Organ System: General disorders
Frequency: 191 affected / 579 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 197 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 197 at risk

Adverse event: Pain (Days 0-3)
Serious: no
Organ System: General disorders
Frequency: 105 affected / 194 at risk

Adverse event: Redness (Days 0-3)
Serious: no
Organ System: General disorders
Frequency: 21 affected / 194 at risk

Adverse event: Swelling (Days 0-3)
Serious: no
Organ System: General disorders
Frequency: 13 affected / 194 at risk

Adverse event: Pain (Days 0-7)
Serious: no
Organ System: General disorders
Frequency: 105 affected / 194 at risk

Adverse event: Redness (Days 0-7)
Serious: no
Organ System: General disorders
Frequency: 21 affected / 194 at risk

Adverse event: Swelling (Days 0-7)
Serious: no
Organ System: General disorders
Frequency: 13 affected / 194 at risk

Adverse event: Fatigue (Days 0-3)
Serious: no
Organ System: General disorders
Frequency: 55 affected / 194 at risk

Adverse event: Fever/Orally (Days 0-3)
Serious: no
Organ System: General disorders
Frequency: 11 affected / 194 at risk

Adverse event: Gastrointestinal (Days 0-3)
Serious: no
Organ System: General disorders
Frequency: 26 affected / 194 at risk

Adverse event: Headache (Days 0-3)
Serious: no
Organ System: General disorders
Frequency: 60 affected / 194 at risk

Adverse event: Fatigue (Days 0-7)
Serious: no
Organ System: General disorders
Frequency: 62 affected / 194 at risk

Adverse event: Fever/Orally (Days 0-7)
Serious: no
Organ System: General disorders
Frequency: 16 affected / 194 at risk

Adverse event: Gastrointestinal (Days 0-7)
Serious: no
Organ System: General disorders
Frequency: 32 affected / 194 at risk

Adverse event: Headache (Days 0-7)
Serious: no
Organ System: General disorders
Frequency: 72 affected / 194 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 88 at risk

Adverse event: Pain (Days 0-3)
Serious: no
Organ System: General disorders
Frequency: 48 affected / 86 at risk

Adverse event: Redness (Days 0-3)
Serious: no
Organ System: General disorders
Frequency: 15 affected / 86 at risk

Adverse event: Swelling (Days 0-3)
Serious: no
Organ System: General disorders
Frequency: 18 affected / 86 at risk

Adverse event: Pain (Days 0-7)
Serious: no
Organ System: General disorders
Frequency: 48 affected / 86 at risk

Adverse event: Redness (Days 0-7)
Serious: no
Organ System: General disorders
Frequency: 15 affected / 86 at risk

Adverse event: Swelling (Days 0-7)
Serious: no
Organ System: General disorders
Frequency: 18 affected / 86 at risk

Adverse event: Fatigue (Days 0-3)
Serious: no
Organ System: General disorders
Frequency: 24 affected / 86 at risk

Adverse event: Fever/Orally (Days 0-3)
Serious: no
Organ System: General disorders
Frequency: 6 affected / 86 at risk

Adverse event: Gastrointestinal (Days 0-3)
Serious: no
Organ System: General disorders
Frequency: 11 affected / 86 at risk

Adverse event: Headache (Days 0-3)
Serious: no
Organ System: General disorders
Frequency: 27 affected / 86 at risk

Adverse event: Fatigue (Days 0-7)
Serious: no
Organ System: General disorders
Frequency: 27 affected / 86 at risk

Adverse event: Fever/Orally (Days 0-7)
Serious: no
Organ System: General disorders
Frequency: 7 affected / 86 at risk

Adverse event: Gastrointestinal (Days 0-7)
Serious: no
Organ System: General disorders
Frequency: 15 affected / 86 at risk

Adverse event: Headache (Days 0-7)
Serious: no
Organ System: General disorders
Frequency: 30 affected / 86 at risk