Study: NCT02793622

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 375 at risk

Adverse event: Congenital anomaly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: Birthed infant with congenital anomaly
Frequency: 2 affected / 375 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 375 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 375 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 273 affected / 375 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 254 affected / 375 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 256 affected / 375 at risk

Adverse event: Pyuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 51 affected / 375 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 50 affected / 375 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 48 affected / 375 at risk

Adverse event: Vomitting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 34 affected / 375 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 26 affected / 375 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 373 at risk

Adverse event: Congenital anomaly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: Birthed infant with congenital anomaly
Frequency: 10 affected / 373 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 373 at risk

Adverse event: Elevated Alanine Aminotransferase
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 373 at risk

Adverse event: Altered mental status
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 373 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 373 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 373 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 282 affected / 373 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 268 affected / 373 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 237 affected / 373 at risk

Adverse event: Pyuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 59 affected / 373 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 49 affected / 373 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 44 affected / 373 at risk

Adverse event: Vomitting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 35 affected / 373 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 24 affected / 373 at risk