Study: NCT01135914

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 73 at risk

Adverse event: Colitis ischaemic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 73 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 73 at risk

Adverse event: Hypothermia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 73 at risk

Adverse event: Sarcoidosis
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 73 at risk

Adverse event: Diabetic foot infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 73 at risk

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 73 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 73 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 73 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 73 at risk

Adverse event: Tendonitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 73 at risk

Adverse event: Conjunctival haemorrhage (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 73 at risk

Adverse event: Eye irritation (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 73 at risk

Adverse event: Vision blurred (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 73 at risk

Adverse event: Vitreous haemorrhage (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 73 at risk

Adverse event: Vitreous haemorrhage (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 73 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 73 at risk

Adverse event: Intraocular pressure increased (Fellow eye)
Serious: no
Organ System: Investigations
Frequency: 4 affected / 73 at risk

Adverse event: Intraocular pressure increased (Study eye)
Serious: no
Organ System: Investigations
Frequency: 8 affected / 73 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 73 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 73 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 73 at risk

Adverse event: Hyperthyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 75 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Impaired gastric emptying
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 75 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 75 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 75 at risk

Adverse event: Endometrial cancer stage II
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 75 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 75 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 75 at risk

Adverse event: Neurogenic bladder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 75 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Lung disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Cataract (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 75 at risk

Adverse event: Cataract (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 75 at risk

Adverse event: Conjunctival haemorrhage (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 75 at risk

Adverse event: Vitreous haemorrhage (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 75 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 75 at risk

Adverse event: Intraocular pressure increased (Fellow eye)
Serious: no
Organ System: Investigations
Frequency: 4 affected / 75 at risk

Adverse event: Intraocular pressure increased (Study eye)
Serious: no
Organ System: Investigations
Frequency: 10 affected / 75 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 75 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 75 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 75 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 75 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 74 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 74 at risk

Adverse event: Vitreous haemorrhage (Fellow eye)
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 74 at risk

Adverse event: Vitreous haemorrhage (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 74 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 74 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 74 at risk

Adverse event: Cataract (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 74 at risk

Adverse event: Conjunctival haemorrhage (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 74 at risk

Adverse event: Vitreous haemorrhage (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 74 at risk

Adverse event: Vitreous haemorrhage (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 74 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 74 at risk

Adverse event: Intraocular pressure increased (Fellow eye)
Serious: no
Organ System: Investigations
Frequency: 3 affected / 74 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 74 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 74 at risk