Study: NCT01829295

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 107 at risk

Adverse event: SGOT and SGPT
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: ≥5 times the upper limit of normal of the reference range
Frequency: 3 affected / 107 at risk

Adverse event: Disability or permanent damage
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 107 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 107 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 107 at risk

Adverse event: Other serious/systemic event
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 107 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 107 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 107 at risk

Adverse event: Suspected/confirmed glaucoma diagnosis
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 107 at risk

Adverse event: Ocular hypertension
Serious: no
Organ System: Eye disorders
Frequency: 10 affected / 107 at risk

Adverse event: Peripheral and/or central vitreous hemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 107 at risk

Adverse event: Other ocular event
Serious: no
Organ System: Eye disorders
Frequency: 27 affected / 107 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: General disorders
Notes: ≥1.5 to \<2 mg/dL
Frequency: 1 affected / 107 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: General disorders
Notes: \>6.4 to \<10 g/dL
Frequency: 2 affected / 107 at risk

Adverse event: Leukocytes
Serious: no
Organ System: General disorders
Notes: \>1000 and \<2500 µL lasting less than 1 month or absolute neutrophil count (ANC) \<1000 but \>500
Frequency: 3 affected / 107 at risk

Adverse event: SGOT or SGPT
Serious: no
Organ System: General disorders
Notes: 2 to 5 times the upper limit of normal
Frequency: 14 affected / 107 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: General disorders
Frequency: 14 affected / 107 at risk

Adverse event: Mild congestive heart failure or arrhythmia
Serious: no
Organ System: Cardiac disorders
Notes: Not requiring therapy
Frequency: 4 affected / 107 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Renal and urinary disorders
Frequency: 25 affected / 107 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: General disorders
Frequency: 21 affected / 107 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 62 affected / 107 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: \<103 degrees for 12 hours
Frequency: 11 affected / 107 at risk

Adverse event: Alopecia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 107 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 55 affected / 107 at risk

Adverse event: Non-serious systemic infection
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 107 at risk

Adverse event: Mood changes
Serious: no
Organ System: Psychiatric disorders
Notes: Not requiring therapy
Frequency: 33 affected / 107 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: No decrease in function
Frequency: 32 affected / 107 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 42 affected / 107 at risk

Adverse event: Numbness/tingling
Serious: no
Organ System: Nervous system disorders
Frequency: 25 affected / 107 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 26 affected / 107 at risk

Adverse event: Other systemic (no treatment required)
Serious: no
Organ System: General disorders
Frequency: 65 affected / 107 at risk

Adverse event: Decrease in vision/defective vision
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 107 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 107 at risk

Adverse event: Glaucoma
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 109 at risk

Adverse event: SGOT and SGPT
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: ≥5 times the upper limit of normal of the reference range
Frequency: 2 affected / 109 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 109 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 109 at risk

Adverse event: Serious systemic infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 109 at risk

Adverse event: Other serious/systemic event
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 109 at risk

Adverse event: Suspected/confirmed glaucoma diagnosis
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 109 at risk

Adverse event: Hypotony
Serious: no
Organ System: Eye disorders
Notes: Intraocular pressure \<5 mmHg without structural damage
Frequency: 1 affected / 109 at risk

Adverse event: Ocular hypertension
Serious: no
Organ System: Eye disorders
Frequency: 13 affected / 109 at risk

Adverse event: Peripheral and/or central vitreous hemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 109 at risk

Adverse event: Other ocular event
Serious: no
Organ System: Eye disorders
Frequency: 26 affected / 109 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: General disorders
Notes: \>6.4 to \<10 g/dL
Frequency: 3 affected / 109 at risk

Adverse event: Leukocytes
Serious: no
Organ System: General disorders
Notes: \>1000 and \<2500 µL lasting less than 1 month or absolute neutrophil count (ANC) \<1000 but \>500
Frequency: 1 affected / 109 at risk

Adverse event: SGOT or SGPT
Serious: no
Organ System: General disorders
Notes: 2 to 5 times the upper limit of normal
Frequency: 8 affected / 109 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: General disorders
Frequency: 11 affected / 109 at risk

Adverse event: Mild congestive heart failure or arrhythmia
Serious: no
Organ System: Cardiac disorders
Notes: Not requiring therapy
Frequency: 2 affected / 109 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Renal and urinary disorders
Frequency: 24 affected / 109 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: General disorders
Frequency: 22 affected / 109 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 59 affected / 109 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: \<103 degrees for 12 hours
Frequency: 18 affected / 109 at risk

Adverse event: Alopecia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 109 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 45 affected / 109 at risk

Adverse event: Non-serious systemic infection
Serious: no
Organ System: Infections and infestations
Frequency: 27 affected / 109 at risk

Adverse event: Mood changes
Serious: no
Organ System: Psychiatric disorders
Notes: Not requiring therapy
Frequency: 26 affected / 109 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: No decrease in function
Frequency: 26 affected / 109 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 30 affected / 109 at risk

Adverse event: Numbness/tingling
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 109 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 24 affected / 109 at risk

Adverse event: Other systemic (no treatment required)
Serious: no
Organ System: General disorders
Frequency: 63 affected / 109 at risk

Adverse event: Decrease in vision/defective vision
Serious: no
Organ System: Eye disorders
Frequency: 19 affected / 109 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 109 at risk