Study: NCT02017704

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 1 affected / 4 at risk

Adverse event: Proctitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 1 affected / 4 at risk

Adverse event: sacral decubitis ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 3
Frequency: 1 affected / 4 at risk

Adverse event: ANC elevated
Serious: no
Organ System: Investigations
Notes: Grade not specified
Frequency: 1 affected / 4 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1
Frequency: 1 affected / 4 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Notes: Grade 1
Frequency: 1 affected / 4 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 2 affected / 4 at risk

Adverse event: Blood creatinine decreased
Serious: no
Organ System: Investigations
Notes: Grade 1
Frequency: 1 affected / 4 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Notes: Grade 1
Frequency: 1 affected / 4 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1
Frequency: 1 affected / 4 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 2 affected / 4 at risk

Adverse event: Dyspareunia
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Grade 1
Frequency: 1 affected / 4 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 1 affected / 4 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 1
Frequency: 1 affected / 4 at risk

Adverse event: Anal incontinence
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 1 affected / 4 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 1 affected / 4 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Grade 1
Frequency: 1 affected / 4 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 2 affected / 4 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1
Frequency: 2 affected / 4 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1
Frequency: 1 affected / 4 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1
Frequency: 1 affected / 4 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Notes: Grade 1
Frequency: 2 affected / 4 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 3 affected / 4 at risk

Adverse event: Nocturia
Serious: no
Organ System: Renal and urinary disorders
Notes: Grade 1
Frequency: 2 affected / 4 at risk

Adverse event: pain (NOS)
Serious: no
Organ System: General disorders
Notes: Grade 1
Frequency: 2 affected / 4 at risk

Adverse event: Proctitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 2 affected / 4 at risk

Adverse event: Proctalgia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 2 affected / 4 at risk

Adverse event: urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Notes: Grade 1
Frequency: 2 affected / 4 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Notes: Grade 1
Frequency: 2 affected / 4 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: Grade 1
Frequency: 1 affected / 4 at risk

Adverse event: Dyspareunia
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Grade 2
Frequency: 1 affected / 4 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Grade 2
Frequency: 2 affected / 4 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 2
Frequency: 1 affected / 4 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 2 affected / 4 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 2
Frequency: 1 affected / 4 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 2
Frequency: 1 affected / 4 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Notes: Grade 2
Frequency: 1 affected / 4 at risk

Adverse event: Nocturia
Serious: no
Organ System: Renal and urinary disorders
Notes: Grade 2
Frequency: 1 affected / 4 at risk

Adverse event: pain (NOS)
Serious: no
Organ System: General disorders
Notes: Grade 2
Frequency: 1 affected / 4 at risk

Adverse event: Proctalgia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 1 affected / 4 at risk

Adverse event: urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Notes: Grade 2
Frequency: 1 affected / 4 at risk

Adverse event: Vulvovaginal dryness
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Grade 2
Frequency: 1 affected / 4 at risk

Adverse event: Vulvovaginal pain
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Grade 2
Frequency: 1 affected / 4 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: Grade 2
Frequency: 1 affected / 4 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Notes: Grade 3
Frequency: 1 affected / 5 at risk

Adverse event: pain (NOS)
Serious: yes
Organ System: General disorders
Notes: Grade 3
Frequency: 1 affected / 5 at risk

Adverse event: Female genital tract fistula
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Grade 3
Frequency: 1 affected / 5 at risk

Adverse event: alanine amino transferase increased
Serious: no
Organ System: Investigations
Notes: Grade 1
Frequency: 2 affected / 5 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1
Frequency: 3 affected / 5 at risk

Adverse event: aspartate amino transferase increased
Serious: no
Organ System: Investigations
Notes: Grade 1
Frequency: 1 affected / 5 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 3 affected / 5 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1
Frequency: 1 affected / 5 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 3 affected / 5 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 1 affected / 5 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 1
Frequency: 3 affected / 5 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 4 affected / 5 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 1 affected / 5 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1
Frequency: 3 affected / 5 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 4 affected / 5 at risk

Adverse event: Nocturia
Serious: no
Organ System: Renal and urinary disorders
Notes: Grade 1
Frequency: 4 affected / 5 at risk

Adverse event: pain (NOS)
Serious: no
Organ System: General disorders
Notes: Grade 1
Frequency: 2 affected / 5 at risk

Adverse event: Proctitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 1 affected / 5 at risk

Adverse event: Proctalgia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 3 affected / 5 at risk

Adverse event: urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Notes: Grade 1
Frequency: 2 affected / 5 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: Grade 1
Frequency: 1 affected / 5 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Investigations
Notes: Grade 2
Frequency: 1 affected / 5 at risk

Adverse event: Atrial flutter
Serious: no
Organ System: Cardiac disorders
Notes: Grade 2
Frequency: 1 affected / 5 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 1 affected / 5 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 1 affected / 5 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Grade 2
Frequency: 1 affected / 5 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 1 affected / 5 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 2
Frequency: 1 affected / 5 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 1 affected / 5 at risk

Adverse event: pain (NOS)
Serious: no
Organ System: General disorders
Notes: Grade 2
Frequency: 1 affected / 5 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Notes: Grade 2
Frequency: 1 affected / 5 at risk

Adverse event: Proctitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 2 affected / 5 at risk

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 1 affected / 5 at risk

Adverse event: Proctalgia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 1 affected / 5 at risk

Adverse event: Rectal stenosis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 1 affected / 5 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Grade 2
Frequency: 1 affected / 5 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 1 affected / 5 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Notes: Grade 2
Frequency: 1 affected / 5 at risk