Study: NCT00997035

Adverse event: Endophthalmitis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 121 at risk

Adverse event: Ulcer not healing after 6 weeks of therapy
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 121 at risk

Adverse event: Increase in hypopyon (increase>2mm)
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 121 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 8 affected / 121 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 121 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 2 affected / 121 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 121 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 121 at risk

Adverse event: Lethargy
Serious: no
Organ System: General disorders
Frequency: 1 affected / 121 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 121 at risk

Adverse event: Local allergic reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 121 at risk

Adverse event: Endophthalmitis
Serious: yes
Organ System: Eye disorders
Frequency: 3 affected / 119 at risk

Adverse event: Evisceration
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 119 at risk

Adverse event: Myocardial infarction or stroke
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 119 at risk

Adverse event: AST or ALT elevated to five times the upper limit of normal
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 119 at risk

Adverse event: Ulcer not healing after 6 weeks of therapy
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 119 at risk

Adverse event: Increase in hypopyon (increase>2mm)
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 119 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 7 affected / 119 at risk

Adverse event: AST or ALT elevated to twice upper limit of normal
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 8 affected / 119 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 5 affected / 119 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 4 affected / 119 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 119 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 119 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 119 at risk

Adverse event: Lethargy
Serious: no
Organ System: General disorders
Frequency: 2 affected / 119 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 2 affected / 119 at risk

Adverse event: Local allergic reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 119 at risk

Adverse event: Other systemic event thought to be related to study drug
Serious: no
Organ System: General disorders
Frequency: 1 affected / 119 at risk

Adverse event: Dermatologic reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 119 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 119 at risk