Study: NCT02163447

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 106 at risk

Adverse event: Congenital anomaly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 106 at risk

Adverse event: Stillbirth
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 106 at risk

Adverse event: Abortion threatened
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 106 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 74 affected / 106 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 55 affected / 106 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 56 affected / 106 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 20 affected / 106 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 106 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 15 affected / 106 at risk

Adverse event: Dysphagia
Serious: no
Organ System: General disorders
Frequency: 9 affected / 106 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 106 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 106 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 106 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 2 affected / 106 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 106 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 106 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 94 at risk

Adverse event: Congenital anomaly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 4 affected / 94 at risk

Adverse event: Stillbirth
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 94 at risk

Adverse event: Retained products of conception
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 94 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 94 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 94 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 58 affected / 94 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 48 affected / 94 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 45 affected / 94 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 13 affected / 94 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 94 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 9 affected / 94 at risk

Adverse event: Dysphagia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 94 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 94 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 94 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 94 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 94 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 100 at risk

Adverse event: Stillbirth
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 100 at risk

Adverse event: Pre-eclampsia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 100 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 73 affected / 100 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 57 affected / 100 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 55 affected / 100 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 11 affected / 100 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 100 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 6 affected / 100 at risk

Adverse event: Dysphagia
Serious: no
Organ System: General disorders
Frequency: 13 affected / 100 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 100 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 100 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 100 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 4 affected / 100 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 100 at risk

Adverse event: Hypotension
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 100 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 100 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 100 at risk

Adverse event: Elevated temperature
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 100 at risk

Adverse event: Elevated Alanine Aminotransferase
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 100 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 100 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 100 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 100 at risk

Adverse event: Malnutrition
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 100 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 100 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 94 affected / 100 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 87 affected / 100 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 10 affected / 100 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 58 affected / 100 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 16 affected / 100 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 29 affected / 100 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 27 affected / 100 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 191 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 191 at risk

Adverse event: Elevated temperature
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 191 at risk

Adverse event: Elevated Alanine Aminotransferase
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 191 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 191 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 191 at risk

Adverse event: Altered Mental State
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 191 at risk

Adverse event: Burns
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 191 at risk

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 191 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 183 affected / 191 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 168 affected / 191 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 25 affected / 191 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 117 affected / 191 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 43 affected / 191 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 56 affected / 191 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 49 affected / 191 at risk