Study: NCT03297216

Adverse event: Abdominal pain
Serious: yes
Organ System: General disorders
Notes: Pain in the abdomen not necessarily associated with a specific diagnosis or etiology
Frequency: 6 affected / 399 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Low hemoglobin
Frequency: 2 affected / 399 at risk

Adverse event: Oedema
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Swelling in lower legs
Frequency: 1 affected / 399 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 399 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Antepartum or postpartum
Frequency: 5 affected / 399 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Pregnancy induced and postpartum hypertension
Frequency: 2 affected / 399 at risk

Adverse event: Nose Bleed / Laceration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 399 at risk

Adverse event: Premature rupture of membranes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Preterm or Term
Frequency: 2 affected / 399 at risk

Adverse event: Pre-eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 399 at risk

Adverse event: Presumed Psychosis
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 399 at risk

Adverse event: Premature labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 399 at risk

Adverse event: Postpartum sepsis
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 399 at risk

Adverse event: Stillbirth
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 10 affected / 399 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 399 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 8 affected / 399 at risk

Adverse event: Intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 399 at risk

Adverse event: Left Side Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 399 at risk

Adverse event: Cesarean Scar Tenderness
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 399 at risk

Adverse event: Abdominal Trauma
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 399 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 399 at risk

Adverse event: Neonatal Hypoglecemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 399 at risk

Adverse event: Placental Abruption
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 399 at risk

Adverse event: Kidney infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 399 at risk

Adverse event: Headache
Serious: no
Organ System: Product Issues
Frequency: 25 affected / 399 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Product Issues
Frequency: 18 affected / 399 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: General disorders
Notes: Pain in the abdomen not necessarily associated with a specific diagnosis or etiology
Frequency: 7 affected / 401 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Low hemoglobin
Frequency: 3 affected / 401 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 401 at risk

Adverse event: Eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 401 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Antepartum or postpartum
Frequency: 4 affected / 401 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Pregnancy induced and postpartum hypertension
Frequency: 2 affected / 401 at risk

Adverse event: Malaria
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 401 at risk

Adverse event: Nose Bleed / Laceration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 401 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 401 at risk

Adverse event: Premature rupture of membranes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Preterm or Term
Frequency: 2 affected / 401 at risk

Adverse event: Pre-eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 401 at risk

Adverse event: Premature labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 401 at risk

Adverse event: Stillbirth
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 9 affected / 401 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 401 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 401 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 11 affected / 401 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 401 at risk

Adverse event: Malaise
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 401 at risk

Adverse event: Pulmonary tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 401 at risk

Adverse event: Bladder injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 401 at risk

Adverse event: Headache
Serious: no
Organ System: Product Issues
Frequency: 17 affected / 401 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Product Issues
Frequency: 10 affected / 401 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Low hemoglobin
Frequency: 1 affected / 399 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 399 at risk

Adverse event: Neonatal Hypothermia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 399 at risk

Adverse event: Jaundice neonatal
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 399 at risk

Adverse event: Neonatal Death of Unknown Cause
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 399 at risk

Adverse event: Presumed Neonatal Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 399 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 399 at risk

Adverse event: Neonatal Encephelopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 399 at risk

Adverse event: Neonatal respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 399 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Low hemoglobin
Frequency: 1 affected / 401 at risk

Adverse event: Neonatal Hypothermia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 401 at risk

Adverse event: Neonatal intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 401 at risk

Adverse event: Neonatal Death of Unknown Cause
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 401 at risk

Adverse event: Presumed Neonatal Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 401 at risk

Adverse event: Neonatal Encephelopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 401 at risk

Adverse event: Neonatal respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 401 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 401 at risk

Adverse event: Neonatal Dehydration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 401 at risk

Adverse event: Premature baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 401 at risk