Study: NCT00315341

Adverse event: Death
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 727 at risk

Adverse event: life-threatening
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 727 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Investigations
Frequency: 38 affected / 727 at risk

Adverse event: Congenital anomaly
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 727 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 81 affected / 727 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 70 affected / 727 at risk

Adverse event: gamma glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 47 affected / 727 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 727 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 119 affected / 727 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 35 affected / 727 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 32 affected / 727 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 49 affected / 727 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 49 affected / 727 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 727 at risk

Adverse event: injury, poisoning, and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 134 affected / 727 at risk

Adverse event: nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 154 affected / 727 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 102 affected / 727 at risk

Adverse event: musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 135 affected / 727 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 50 affected / 727 at risk

Adverse event: psychiatric disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 114 affected / 727 at risk

Adverse event: general disorders and administration site conditions
Serious: no
Organ System: General disorders
Frequency: 79 affected / 727 at risk

Adverse event: skin and subcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 75 affected / 727 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 727 at risk

Adverse event: respiratory, thoracic, and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 82 affected / 727 at risk

Adverse event: investigations
Serious: no
Organ System: Investigations
Frequency: 215 affected / 727 at risk

Adverse event: infections and infestations
Serious: no
Organ System: Infections and infestations
Frequency: 281 affected / 727 at risk

Adverse event: gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 196 affected / 727 at risk

Adverse event: Death
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 520 at risk

Adverse event: life-threatening
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 520 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Investigations
Frequency: 45 affected / 520 at risk

Adverse event: Disability
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 520 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 70 affected / 520 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 63 affected / 520 at risk

Adverse event: gamma glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 57 affected / 520 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 26 affected / 520 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 117 affected / 520 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 34 affected / 520 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 520 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 55 affected / 520 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 47 affected / 520 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 520 at risk

Adverse event: injury, poisoning, and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 124 affected / 520 at risk

Adverse event: nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 106 affected / 520 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 54 affected / 520 at risk

Adverse event: musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 98 affected / 520 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 37 affected / 520 at risk

Adverse event: psychiatric disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 89 affected / 520 at risk

Adverse event: general disorders and administration site conditions
Serious: no
Organ System: General disorders
Frequency: 83 affected / 520 at risk

Adverse event: skin and subcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 75 affected / 520 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 38 affected / 520 at risk

Adverse event: respiratory, thoracic, and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 64 affected / 520 at risk

Adverse event: investigations
Serious: no
Organ System: Investigations
Frequency: 214 affected / 520 at risk

Adverse event: infections and infestations
Serious: no
Organ System: Infections and infestations
Frequency: 249 affected / 520 at risk

Adverse event: gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 174 affected / 520 at risk