Study: NCT03057808

Adverse event: Preterm labor/delivery
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 7 affected / 144 at risk

Adverse event: Caesarean section
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 6 affected / 144 at risk

Adverse event: Pre-eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 144 at risk

Adverse event: Kidney infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 144 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 144 at risk

Adverse event: NICU admission
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 144 at risk

Adverse event: Low white blood count
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 144 at risk

Adverse event: Heart rate issues
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 144 at risk

Adverse event: Cholecystectomy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 144 at risk

Adverse event: Hospitalization due to viral illness
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 144 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 144 at risk

Adverse event: Uterine haemorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 144 at risk

Adverse event: Elevated blood pressure with amniotic fluid leak
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 144 at risk

Adverse event: Chest pains, shortness of breath, syncope
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 144 at risk

Adverse event: Placenta praevia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 144 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 144 at risk

Adverse event: Depressive symptoms
Serious: no
Organ System: Psychiatric disorders
Frequency: 12 affected / 144 at risk

Adverse event: Gestational diabetes
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 11 affected / 144 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 144 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 144 at risk

Adverse event: Appendicectomy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 142 at risk

Adverse event: Female sterilisation
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 142 at risk

Adverse event: Preterm labor/delivery
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 142 at risk

Adverse event: Caesarean section
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 142 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 142 at risk

Adverse event: Pre-eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 142 at risk

Adverse event: Kidney infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 142 at risk

Adverse event: Placenta praevia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 142 at risk

Adverse event: Epileptic event
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 142 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 142 at risk

Adverse event: Neonatal death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 142 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 142 at risk

Adverse event: Cellulitis infection
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 142 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 142 at risk

Adverse event: Depressive symptoms
Serious: no
Organ System: Psychiatric disorders
Frequency: 14 affected / 142 at risk

Adverse event: Gestational diabetes
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 6 affected / 142 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 142 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 142 at risk

Adverse event: Appendicectomy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 144 at risk

Adverse event: Female sterilisation
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 144 at risk

Adverse event: Preterm labor/delivery
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 144 at risk

Adverse event: Caesarean section
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 144 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 144 at risk

Adverse event: Pre-eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 144 at risk

Adverse event: NICU admission
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 144 at risk

Adverse event: Ruptured rectum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 144 at risk

Adverse event: Epileptic event
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 144 at risk

Adverse event: Retained placenta or membranes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 144 at risk

Adverse event: Car accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 144 at risk

Adverse event: Mastitis
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 144 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 144 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 144 at risk

Adverse event: Dermoid cyst
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 144 at risk

Adverse event: Fetal termination due to anomalies
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 144 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 144 at risk

Adverse event: Depressive symptoms
Serious: no
Organ System: Psychiatric disorders
Frequency: 17 affected / 144 at risk

Adverse event: Gestational diabetes
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 13 affected / 144 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 144 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 144 at risk