Study: NCT01501513

Adverse event: Worsening of re-current diabetic left ankle ulceration
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 184 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 184 at risk

Adverse event: Hospitalization from severe anemia due to vaginal bleed
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 184 at risk

Adverse event: Hospitalization for chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 184 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 184 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 84 affected / 184 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 71 affected / 184 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 81 affected / 184 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 184 at risk

Adverse event: Discomfort
Serious: no
Organ System: General disorders
Frequency: 108 affected / 184 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 184 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 184 at risk

Adverse event: Bilateral silicone breast implant rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 180 at risk

Adverse event: Lower anterior resection of the rectum
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 180 at risk

Adverse event: Acute renal failure (post-operative)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 180 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 180 at risk

Adverse event: Bilateral breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 180 at risk

Adverse event: Bilateral mastectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 180 at risk

Adverse event: Left breast tissue expander removal
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 180 at risk

Adverse event: Sigmoid colon resection
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 180 at risk

Adverse event: Laparoscopic assisted anterior rectosigmoid colon resection
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 180 at risk

Adverse event: Septic shock secondary to cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 180 at risk

Adverse event: Haematemesis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 180 at risk

Adverse event: Melaena
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 180 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 180 at risk

Adverse event: Cirrhosis - Liver transplant
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 180 at risk

Adverse event: Surgery for sigmoid colectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 180 at risk

Adverse event: Colon resection
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 180 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 180 at risk

Adverse event: Attenuated familial adenomatous polyposis
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 180 at risk

Adverse event: Stage II breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 180 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 89 affected / 180 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 65 affected / 180 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 61 affected / 180 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 180 at risk

Adverse event: Discomfort
Serious: no
Organ System: General disorders
Frequency: 100 affected / 180 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 180 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 180 at risk

Adverse event: Worsening of vague upper abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 177 at risk

Adverse event: Splenic injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 177 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 177 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 94 affected / 177 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 55 affected / 177 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 56 affected / 177 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 177 at risk

Adverse event: Discomfort
Serious: no
Organ System: General disorders
Frequency: 95 affected / 177 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 177 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 177 at risk