Study: NCT02792959

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Blood and lymphatic system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Large intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Blood and lymphatic system disorders
Frequency: 3 affected / 11 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: Cardiac disorders
Frequency: 1 affected / 11 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Notes: Gastrointestinal disorders
Frequency: 2 affected / 11 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Notes: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Gastrointestinal disorders
Frequency: 2 affected / 11 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Gastrointestinal disorders
Frequency: 2 affected / 11 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Gastrointestinal disorders
Frequency: 2 affected / 11 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: General disorders and administration site conditions
Frequency: 2 affected / 11 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: General disorders and administration site conditions
Frequency: 2 affected / 11 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Notes: Immune system disorders
Frequency: 2 affected / 11 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: Infections and infestations
Frequency: 2 affected / 11 at risk

Adverse event: Enterocolitis infectious
Serious: no
Organ System: Infections and infestations
Notes: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Peritonitis
Serious: no
Organ System: Infections and infestations
Notes: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: Infections and infestations
Frequency: 2 affected / 11 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Notes: Investigations
Frequency: 1 affected / 11 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Notes: Investigations
Frequency: 1 affected / 11 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Notes: Investigations
Frequency: 1 affected / 11 at risk

Adverse event: Musculoskeletal and connective tissue disorder - Other, specify
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Notes: Nervous system disorders
Frequency: 2 affected / 11 at risk

Adverse event: Cystitis noninfective
Serious: no
Organ System: Renal and urinary disorders
Notes: Renal and urinary disorders
Frequency: 1 affected / 11 at risk

Adverse event: Renal and urinary disorders - Other, specify
Serious: no
Organ System: Renal and urinary disorders
Notes: Renal and urinary disorders
Frequency: 2 affected / 11 at risk

Adverse event: Reproductive system and breast disorders - Other, specify
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Reproductive system and breast disorders
Frequency: 1 affected / 11 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Reproductive system and breast disorders
Frequency: 1 affected / 11 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 11 at risk

Adverse event: Nail discolouration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: Vascular disorders
Frequency: 2 affected / 11 at risk

Adverse event: Embolism
Serious: no
Organ System: Vascular disorders
Notes: Vascular disorders
Frequency: 1 affected / 11 at risk