Study: NCT01691430

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Frequency: 33 affected / 92 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 17 affected / 92 at risk

Adverse event: Abnormal blood glucose
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 92 at risk

Adverse event: Chest pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 92 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 92 at risk

Adverse event: Altered mental status
Serious: no
Organ System: Psychiatric disorders
Frequency: 53 affected / 92 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 92 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Frequency: 11 affected / 92 at risk

Adverse event: Blood pressure alteration
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 92 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 47 affected / 92 at risk

Adverse event: Dehydration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 92 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 92 at risk

Adverse event: ear problem
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 6 affected / 92 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 17 affected / 92 at risk

Adverse event: exposure to influenza
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 92 at risk

Adverse event: Eye infection
Serious: no
Organ System: Eye disorders
Frequency: 18 affected / 92 at risk

Adverse event: Fall
Serious: no
Organ System: General disorders
Frequency: 48 affected / 92 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 18 affected / 92 at risk

Adverse event: GI disturbance
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 53 affected / 92 at risk

Adverse event: Generalized malaise
Serious: no
Organ System: General disorders
Frequency: 29 affected / 92 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 10 affected / 92 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 92 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 36 affected / 92 at risk

Adverse event: lab abnormality
Serious: no
Organ System: General disorders
Frequency: 42 affected / 92 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 92 at risk

Adverse event: oral cavity disturbance
Serious: no
Organ System: General disorders
Frequency: 34 affected / 92 at risk

Adverse event: respiratory difficulty
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 55 affected / 92 at risk

Adverse event: skin/soft tissue event
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 71 affected / 92 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 33 affected / 92 at risk

Adverse event: Weight increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 42 affected / 92 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 62 affected / 92 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Frequency: 50 affected / 93 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 16 affected / 93 at risk

Adverse event: Abnormal blood glucose
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 93 at risk

Adverse event: Chest pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 93 at risk

Adverse event: Altered mental status
Serious: no
Organ System: Psychiatric disorders
Frequency: 61 affected / 93 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 93 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Frequency: 17 affected / 93 at risk

Adverse event: Blood pressure alteration
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 93 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 51 affected / 93 at risk

Adverse event: Dehydration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 93 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 93 at risk

Adverse event: ear problem
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 11 affected / 93 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 21 affected / 93 at risk

Adverse event: exposure to influenza
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 93 at risk

Adverse event: Eye infection
Serious: no
Organ System: Eye disorders
Frequency: 17 affected / 93 at risk

Adverse event: Fall
Serious: no
Organ System: General disorders
Frequency: 55 affected / 93 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 21 affected / 93 at risk

Adverse event: GI disturbance
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 53 affected / 93 at risk

Adverse event: Generalized malaise
Serious: no
Organ System: General disorders
Frequency: 27 affected / 93 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 19 affected / 93 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 10 affected / 93 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 31 affected / 93 at risk

Adverse event: lab abnormality
Serious: no
Organ System: General disorders
Frequency: 43 affected / 93 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 93 at risk

Adverse event: oral cavity disturbance
Serious: no
Organ System: General disorders
Frequency: 25 affected / 93 at risk

Adverse event: respiratory difficulty
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 59 affected / 93 at risk

Adverse event: skin/soft tissue event
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 83 affected / 93 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 44 affected / 93 at risk

Adverse event: Weight increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 48 affected / 93 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 74 affected / 93 at risk