Study: NCT01891357

Adverse event: Death
Serious: yes
Organ System: Psychiatric disorders
Notes: suicide
Frequency: 1 affected / 61 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Notes: Anxiety
Frequency: 1 affected / 61 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Cholecystitis
Frequency: 1 affected / 61 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Decreased appetite
Frequency: 1 affected / 61 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Renal and urinary disorders
Notes: Dehydration
Frequency: 1 affected / 61 at risk

Adverse event: Device related thrombosis
Serious: yes
Organ System: Vascular disorders
Notes: Device related thrombosis
Frequency: 1 affected / 61 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: diarrhoea
Frequency: 3 affected / 61 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Notes: Fatigue
Frequency: 1 affected / 61 at risk

Adverse event: hypokaleamia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: hypokaleamia
Frequency: 1 affected / 61 at risk

Adverse event: Impaired healing
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: impaired healing
Frequency: 1 affected / 61 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Leukopenia
Frequency: 1 affected / 61 at risk

Adverse event: Mucosal inflammation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Mucosal Inflammation
Frequency: 1 affected / 61 at risk

Adverse event: Ophthalmic herpes simplex
Serious: yes
Organ System: Eye disorders
Notes: Ophthalmic herpes simplex
Frequency: 1 affected / 61 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Pneumonia
Frequency: 1 affected / 61 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Notes: septic shock
Frequency: 1 affected / 61 at risk

Adverse event: Subcutaneous abscess
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Subcutaneous abscess
Frequency: 1 affected / 61 at risk

Adverse event: Syncope
Serious: yes
Organ System: Cardiac disorders
Notes: Syncope
Frequency: 1 affected / 61 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Notes: Urinary tract infection
Frequency: 1 affected / 61 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Renal and urinary disorders
Notes: Urosepsis
Frequency: 1 affected / 61 at risk

Adverse event: Blood and lymphatic system disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Blood and lymphatic system disorders
Frequency: 21 affected / 61 at risk

Adverse event: Cardiac disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 61 at risk

Adverse event: Ear and labyrinth disorders
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Ear and labyrinth disorders
Frequency: 3 affected / 61 at risk

Adverse event: Eye disorders
Serious: no
Organ System: Eye disorders
Notes: Eye disorders
Frequency: 5 affected / 61 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Notes: Gastrointestinal disorders
Frequency: 59 affected / 61 at risk

Adverse event: General disorders and administration site conditions
Serious: no
Organ System: General disorders
Notes: General disorders and administration site conditions
Frequency: 53 affected / 61 at risk

Adverse event: Hepatobiliary disorders
Serious: no
Organ System: Hepatobiliary disorders
Notes: Hepatobiliary disorders
Frequency: 2 affected / 61 at risk

Adverse event: Immune system disorders
Serious: no
Organ System: Immune system disorders
Notes: Immune system disorders
Frequency: 5 affected / 61 at risk

Adverse event: Infections and infestations
Serious: no
Organ System: Infections and infestations
Notes: Infections and infestations
Frequency: 30 affected / 61 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Injury, poisoning and procedural complications
Frequency: 4 affected / 61 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Notes: Investigations
Frequency: 28 affected / 61 at risk

Adverse event: Metabolism and nMetabolism and nutrition disordersutrition disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Metabolism and nutrition disorders
Frequency: 10 affected / 61 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 61 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Notes: Nervous system disorders
Frequency: 59 affected / 61 at risk

Adverse event: Psychiatric disorders
Serious: no
Organ System: Psychiatric disorders
Notes: Psychiatric disorders
Frequency: 15 affected / 61 at risk

Adverse event: Renal and urinary disorders
Serious: no
Organ System: Renal and urinary disorders
Notes: Renal and urinary disorders
Frequency: 2 affected / 61 at risk

Adverse event: Reproductive system and breast disorders
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Reproductive system and breast disorders
Frequency: 1 affected / 61 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory, thoracic and mediastinal disorders
Frequency: 31 affected / 61 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Skin and subcutaneous tissue disorders
Frequency: 59 affected / 61 at risk

Adverse event: Vascular disorders
Serious: no
Organ System: Vascular disorders
Notes: Vascular disorders
Frequency: 14 affected / 61 at risk