Study: NCT02646566

Adverse event: Post procedural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 237 at risk

Adverse event: Abscess Presacral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 237 at risk

Adverse event: Fatty tissue prolapse at the tempral lobe
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 237 at risk

Adverse event: Numbness in the leg
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 237 at risk

Adverse event: Postoperative rise in creatinine
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 237 at risk

Adverse event: Post cholecystectomy bile leak
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 237 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 237 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 237 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 237 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 237 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 237 at risk

Adverse event: Infusion site pain
Serious: no
Organ System: General disorders
Frequency: 8 affected / 237 at risk

Adverse event: Pruritus
Serious: no
Organ System: General disorders
Frequency: 7 affected / 237 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 230 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 230 at risk

Adverse event: Postoperative ileus
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 230 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 230 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 230 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 230 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 230 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 230 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 230 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 230 at risk

Adverse event: Infusion site pain
Serious: no
Organ System: General disorders
Frequency: 12 affected / 230 at risk

Adverse event: Pruritus
Serious: no
Organ System: General disorders
Frequency: 10 affected / 230 at risk

Adverse event: Anastomosis Insufficiency
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 235 at risk

Adverse event: Leukocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 235 at risk

Adverse event: Non-infectious gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 235 at risk

Adverse event: Unspecified Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 235 at risk

Adverse event: Intra-abdominal haematoma
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 235 at risk

Adverse event: Intractable vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 235 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 235 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 235 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 235 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 235 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 235 at risk

Adverse event: Infusion site pain
Serious: no
Organ System: General disorders
Frequency: 10 affected / 235 at risk

Adverse event: Pruritus
Serious: no
Organ System: General disorders
Frequency: 13 affected / 235 at risk