Study: NCT02409680

Adverse event: Maternal death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 9 affected / 5943 at risk

Adverse event: Fetal loss
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 142 affected / 5943 at risk

Adverse event: Neonatal death up to 28 days
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 163 affected / 5943 at risk

Adverse event: Miscarriage, abortion, or medical termination of pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 51 affected / 5943 at risk

Adverse event: Preterm labour or preterm birth evaluation before delivery
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 45 affected / 5943 at risk

Adverse event: Haemorrhage in pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 35 affected / 5943 at risk

Adverse event: Post-partum harmorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 50 affected / 5943 at risk

Adverse event: Vaginal spotting, bleeding, or leaking
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 10 affected / 5943 at risk

Adverse event: Congenital anomaly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 32 affected / 5943 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 24 affected / 5943 at risk

Adverse event: Fever or infection
Serious: yes
Organ System: Infections and infestations
Frequency: 54 affected / 5943 at risk

Adverse event: Other
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 57 affected / 5943 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 5943 at risk

Adverse event: Pre-eclampsia or eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 150 affected / 5943 at risk

Adverse event: Hypertension admission or medical visit before delivery
Serious: yes
Organ System: Cardiac disorders
Frequency: 120 affected / 5943 at risk

Adverse event: Maternal death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 12 affected / 5936 at risk

Adverse event: Fetal loss
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 162 affected / 5936 at risk

Adverse event: Neonatal death up to 28 days
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 190 affected / 5936 at risk

Adverse event: Miscarriage, abortion, or medical termination of pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 54 affected / 5936 at risk

Adverse event: Preterm labour or preterm birth evaluation before delivery
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 56 affected / 5936 at risk

Adverse event: Haemorrhage in pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 33 affected / 5936 at risk

Adverse event: Post-partum harmorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 43 affected / 5936 at risk

Adverse event: Vaginal spotting, bleeding, or leaking
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 10 affected / 5936 at risk

Adverse event: Congenital anomaly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 36 affected / 5936 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 23 affected / 5936 at risk

Adverse event: Fever or infection
Serious: yes
Organ System: Infections and infestations
Frequency: 46 affected / 5936 at risk

Adverse event: Other
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 57 affected / 5936 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5936 at risk

Adverse event: Pre-eclampsia or eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 141 affected / 5936 at risk

Adverse event: Hypertension admission or medical visit before delivery
Serious: yes
Organ System: Cardiac disorders
Frequency: 106 affected / 5936 at risk