Study: NCT01013285

Adverse event: Acute dehydration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 70 at risk

Adverse event: Acute inferior wall MI
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 70 at risk

Adverse event: Altered mental status
Serious: yes
Organ System: Psychiatric disorders
Frequency: 6 affected / 70 at risk

Adverse event: Intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: Coma
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 70 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 70 at risk

Adverse event: Craniotomy wound w/cerebrospinal fluid leak
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 70 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 70 at risk

Adverse event: Falling episode/syncopal episode status post fall
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 70 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 70 at risk

Adverse event: Influenza like illness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 70 at risk

Adverse event: Fungal infection (Left lung)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 70 at risk

Adverse event: Gastroenteritis due to E. coli.
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: GI Bleeding
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 70 at risk

Adverse event: Hypertension
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 70 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 70 at risk

Adverse event: hypotention
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 70 at risk

Adverse event: Left retinal detachment
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 70 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 70 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 70 at risk

Adverse event: Nephritic proteinuria
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 70 at risk

Adverse event: Nephrotic syndrome
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 70 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 70 at risk

Adverse event: Urinary tract obstruction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 70 at risk

Adverse event: Perforated sigmoid diverticulum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 70 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 70 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 70 at risk

Adverse event: Steroid-induced psychosis
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 70 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 70 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 70 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 70 at risk

Adverse event: Upper Resp. tract Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 70 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 70 at risk

Adverse event: Ventriculoperitoneal shunt placement.
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 70 at risk

Adverse event: Wound dehisicence of frontal wound
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 70 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 70 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 12 affected / 70 at risk

Adverse event: Hypertension
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 70 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 70 at risk

Adverse event: Syncope
Serious: no
Organ System: General disorders
Frequency: 5 affected / 70 at risk