Study: NCT01447914

Adverse event: Bacteremia Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 16 at risk

Adverse event: Neutropenia (Neutrophil count decreased)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 16 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 16 at risk

Adverse event: Multiple pulmonary emboli
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Syncope
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 16 at risk

Adverse event: Anorectal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 16 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 16 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 16 at risk

Adverse event: Anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 16 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 16 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 16 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 16 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 16 at risk

Adverse event: Depression
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 16 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 16 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 16 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 16 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 16 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 10 affected / 16 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 16 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Gait distrubance
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Diverticulitis flare
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Muscle discomfort
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 16 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 16 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 16 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 16 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 16 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 16 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 16 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Endocrine disorders
Notes: Note: Baseline collection.
Frequency: 1 affected / 16 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Cardiac disorders
Notes: Note: Baseline collection.
Frequency: 1 affected / 16 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 16 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 16 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 16 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 7 affected / 16 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Peripheral motor neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 16 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 16 at risk

Adverse event: Dermatitis acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Nocturia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 16 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 16 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 16 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 16 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 16 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 16 at risk

Adverse event: Urinary tract pain
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 16 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 16 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Upper-airway cough syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 16 at risk