Study: NCT03048422

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 217 at risk

Adverse event: Ileus paralytic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 217 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 217 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 217 at risk

Adverse event: Postpartum sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 217 at risk

Adverse event: Pyometra
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 217 at risk

Adverse event: Wound sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 217 at risk

Adverse event: Uterine rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 217 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 217 at risk

Adverse event: Type 2 diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 217 at risk

Adverse event: Burkitt's lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 217 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 217 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 217 at risk

Adverse event: Eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 217 at risk

Adverse event: Failed trial of labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 217 at risk

Adverse event: Foetal death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 6 affected / 217 at risk

Adverse event: Foetal distress syndrome
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 217 at risk

Adverse event: Foetal hypokinesia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 217 at risk

Adverse event: Gestational hypertension
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 217 at risk

Adverse event: Haemorrhage in pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 217 at risk

Adverse event: Hyperemesis gravidarum
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 217 at risk

Adverse event: Large for dates baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 217 at risk

Adverse event: Postpartum haemorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 217 at risk

Adverse event: Pre-eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 217 at risk

Adverse event: Premature delivery
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 217 at risk

Adverse event: Premature rupture of membranes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 217 at risk

Adverse event: Preterm premature rupture of membranes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 217 at risk

Adverse event: Prolonged pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 217 at risk

Adverse event: Stillbirth
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 217 at risk

Adverse event: Umbilical cord around neck
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 217 at risk

Adverse event: Umbilical cord prolapse
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 217 at risk

Adverse event: Alcoholism
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 217 at risk

Adverse event: Essential hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 217 at risk

Adverse event: Anaemia of pregnancy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 217 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 217 at risk

Adverse event: Postpartum sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 217 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 217 at risk

Adverse event: Lower limb fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 217 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 217 at risk

Adverse event: Amylase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 217 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 217 at risk

Adverse event: Bilirubin conjugated increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 217 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 170 affected / 217 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 217 at risk

Adverse event: Creatinine renal clearance decreased
Serious: no
Organ System: Investigations
Frequency: 182 affected / 217 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 217 at risk

Adverse event: Hepatic enzyme increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 217 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 217 at risk

Adverse event: Foetal distress syndrome
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 217 at risk

Adverse event: Gestational hypertension
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 217 at risk

Adverse event: Premature delivery
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 217 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 217 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 217 at risk

Adverse event: Perinatal depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 217 at risk

Adverse event: Suicidal ideation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 217 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 217 at risk

Adverse event: Dermatitis allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 217 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 217 at risk

Adverse event: Urticaria papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 217 at risk

Adverse event: Abortion induced
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 217 at risk

Adverse event: Caesarean section
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 217 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 217 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 217 at risk

Adverse event: Anaemia of pregnancy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 215 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 215 at risk

Adverse event: Postoperative wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 215 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 215 at risk

Adverse event: Haemoglobin decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 215 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 215 at risk

Adverse event: Abortion threatened
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 215 at risk

Adverse event: Eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 215 at risk

Adverse event: False labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 215 at risk

Adverse event: Foetal death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 7 affected / 215 at risk

Adverse event: Foetal distress syndrome
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 215 at risk

Adverse event: Foetal growth restriction
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 215 at risk

Adverse event: Gestational diabetes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 215 at risk

Adverse event: Gestational hypertension
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 215 at risk

Adverse event: Haemorrhage in pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 215 at risk

Adverse event: Imminent abortion
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 215 at risk

Adverse event: Oligohydramnios
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 215 at risk

Adverse event: Pre-eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 215 at risk

Adverse event: Premature delivery
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 215 at risk

Adverse event: Premature rupture of membranes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 215 at risk

Adverse event: Premature separation of placenta
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 215 at risk

Adverse event: Preterm premature rupture of membranes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 215 at risk

Adverse event: Prolonged labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 215 at risk

Adverse event: Prolonged rupture of membranes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 215 at risk

Adverse event: Stillbirth
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 215 at risk

Adverse event: Threatened labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 215 at risk

Adverse event: Umbilical cord prolapse
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 215 at risk

Adverse event: Uterine atony
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 215 at risk

Adverse event: Physical assault
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 215 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 215 at risk

Adverse event: Anaemia of pregnancy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 215 at risk

Adverse event: Iron deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 215 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 215 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 215 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 215 at risk

Adverse event: Vulvovaginal candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 215 at risk

Adverse event: Vulvovaginitis trichomonal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 215 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 215 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 215 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 215 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 179 affected / 215 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 215 at risk

Adverse event: Creatinine renal clearance decreased
Serious: no
Organ System: Investigations
Frequency: 193 affected / 215 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 20 affected / 215 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 215 at risk

Adverse event: Foetal distress syndrome
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 215 at risk

Adverse event: Oligohydramnios
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 215 at risk

Adverse event: Pre-eclampsia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 215 at risk

Adverse event: Premature rupture of membranes
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 215 at risk

Adverse event: Prolonged pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 215 at risk

Adverse event: Adjustment disorder with depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 215 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 215 at risk

Adverse event: Major depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 215 at risk

Adverse event: Cervical dysplasia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 215 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 215 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 215 at risk

Adverse event: Pulmonary hypertension
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 215 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 215 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 215 at risk

Adverse event: Rash papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 215 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 215 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 215 at risk

Adverse event: Varicose vein
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 215 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 211 at risk

Adverse event: Amniotic cavity infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 211 at risk

Adverse event: Dengue fever
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 211 at risk

Adverse event: Disseminated tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 211 at risk

Adverse event: Malaria
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 211 at risk

Adverse event: Pelvic inflammatory disease
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 211 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 211 at risk

Adverse event: Postpartum sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 211 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 211 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 211 at risk

Adverse event: Haemoglobin decreased
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 211 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 211 at risk

Adverse event: Cervix dystocia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 211 at risk

Adverse event: Failed induction of labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 211 at risk

Adverse event: Foetal death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 211 at risk

Adverse event: Foetal distress syndrome
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 211 at risk

Adverse event: Gestational hypertension
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 7 affected / 211 at risk

Adverse event: Haemorrhage in pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 211 at risk

Adverse event: Hydrops foetalis
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 211 at risk

Adverse event: Oligohydramnios
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 211 at risk

Adverse event: Placenta praevia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 211 at risk

Adverse event: Postpartum haemorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 211 at risk

Adverse event: Premature delivery
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 211 at risk

Adverse event: Premature rupture of membranes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 211 at risk

Adverse event: Preterm premature rupture of membranes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 211 at risk

Adverse event: Prolonged labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 211 at risk

Adverse event: Stillbirth
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 211 at risk

Adverse event: Pyoderma gangrenosum
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 211 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 211 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 211 at risk

Adverse event: Anaemia of chronic disease
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 211 at risk

Adverse event: Iron deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 211 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 211 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 211 at risk

Adverse event: Immune reconstitution inflammatory syndrome
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 211 at risk

Adverse event: Amniotic cavity infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 211 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 211 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 211 at risk

Adverse event: Furuncle
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 211 at risk

Adverse event: Genital herpes simplex
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 211 at risk

Adverse event: Herpes simplex
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 211 at risk

Adverse event: Perihepatitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 211 at risk

Adverse event: Postoperative wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 211 at risk

Adverse event: Skin bacterial infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 211 at risk

Adverse event: Tracheobronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 211 at risk

Adverse event: Tuberculous pleurisy
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 211 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 211 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 211 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 76 affected / 211 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 211 at risk

Adverse event: Blood sodium decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 211 at risk

Adverse event: Creatinine renal clearance decreased
Serious: no
Organ System: Investigations
Frequency: 132 affected / 211 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 14 affected / 211 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 211 at risk

Adverse event: Neutrophil count increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 211 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 211 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 211 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 211 at risk

Adverse event: Gestational diabetes
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 211 at risk

Adverse event: Gestational hypertension
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 211 at risk

Adverse event: Meconium in amniotic fluid
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 211 at risk

Adverse event: Morning sickness
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 211 at risk

Adverse event: Oligohydramnios
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 211 at risk

Adverse event: Pre-eclampsia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 211 at risk

Adverse event: Premature delivery
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 211 at risk

Adverse event: Premature labour
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 211 at risk

Adverse event: Preterm premature rupture of membranes
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 211 at risk

Adverse event: Abnormal behaviour
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 211 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 211 at risk

Adverse event: Hallucination, visual
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 211 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 211 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 211 at risk

Adverse event: Suicidal ideation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 211 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 211 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 211 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 211 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 208 at risk

Adverse event: Anaemia neonatal
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 208 at risk

Adverse event: Accessory auricle
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 208 at risk

Adverse event: Anomalous pulmonary venous connection
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 208 at risk

Adverse event: Atrial septal defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 3 affected / 208 at risk

Adverse event: Congenital skin dimples
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 208 at risk

Adverse event: Congenital syphilis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 208 at risk

Adverse event: Haemangioma congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 208 at risk

Adverse event: Naevus flammeus
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 208 at risk

Adverse event: Patent ductus arteriosus
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 208 at risk

Adverse event: Talipes
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 208 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 208 at risk

Adverse event: Fever neonatal
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 208 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 208 at risk

Adverse event: Abscess limb
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 208 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 208 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 208 at risk

Adverse event: Meningitis pneumococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 208 at risk

Adverse event: Neonatal pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 208 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 208 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 208 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 208 at risk

Adverse event: Sepsis neonatal
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 208 at risk

Adverse event: Staphylococcal scalded skin syndrome
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 208 at risk

Adverse event: Tracheobronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 208 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 208 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 208 at risk

Adverse event: Blood bilirubin increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 208 at risk

Adverse event: Cardiac murmur
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 208 at risk

Adverse event: Haemoglobin decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 208 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 208 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 208 at risk

Adverse event: Hypoxic-ischaemic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 208 at risk

Adverse event: Neonatal seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 208 at risk

Adverse event: Status epilepticus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 208 at risk

Adverse event: Jaundice neonatal
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 208 at risk

Adverse event: Low birth weight baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 208 at risk

Adverse event: Premature baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 208 at risk

Adverse event: Umbilical cord cyst
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 208 at risk

Adverse event: Meconium aspiration syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 208 at risk

Adverse event: Neonatal asphyxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 208 at risk

Adverse event: Neonatal respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 208 at risk

Adverse event: Transient tachypnoea of the newborn
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 208 at risk

Adverse event: Rash neonatal
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 208 at risk

Adverse event: Iron deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 208 at risk

Adverse event: Congenital toxoplasmosis
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 208 at risk

Adverse event: Congenital umbilical hernia
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 208 at risk

Adverse event: Acarodermatitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 208 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 208 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 208 at risk

Adverse event: Blood glucose decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 208 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 208 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 208 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 208 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 208 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 208 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 208 at risk

Adverse event: Poor feeding infant
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 208 at risk

Adverse event: Poor sucking reflex
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 208 at risk

Adverse event: Jaundice neonatal
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 208 at risk

Adverse event: Low birth weight baby
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 208 at risk

Adverse event: Small for dates baby
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 208 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 208 at risk

Adverse event: Transient tachypnoea of the newborn
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 208 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 208 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 208 at risk

Adverse event: Neutropenia neonatal
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 202 at risk

Adverse event: Thrombocytopenia neonatal
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 202 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 202 at risk

Adverse event: Arachnodactyly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 202 at risk

Adverse event: Congenital foot malformation
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 202 at risk

Adverse event: Congenital mitral valve incompetence
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 202 at risk

Adverse event: Congenital syphilis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 202 at risk

Adverse event: Congenital tricuspid valve incompetence
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 202 at risk

Adverse event: Congenital ureteric anomaly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 202 at risk

Adverse event: Macrocephaly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 202 at risk

Adverse event: Multiple congenital abnormalities
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 202 at risk

Adverse event: Sickle cell anaemia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 202 at risk

Adverse event: Sickle cell disease
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 202 at risk

Adverse event: Talipes
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 202 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 202 at risk

Adverse event: Infantile vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 202 at risk

Adverse event: Death neonatal
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 202 at risk

Adverse event: Hyperbilirubinaemia neonatal
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 202 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 202 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 202 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 202 at risk

Adverse event: Conjunctivitis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 202 at risk

Adverse event: Neonatal pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 202 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 202 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 202 at risk

Adverse event: Sepsis neonatal
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 202 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 202 at risk

Adverse event: Urinary tract infection neonatal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 202 at risk

Adverse event: Blood glucose decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 202 at risk

Adverse event: Cardiac murmur
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 202 at risk

Adverse event: Haemoglobin decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 202 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 202 at risk

Adverse event: Hypoglycaemia neonatal
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 202 at risk

Adverse event: Infant irritability
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 202 at risk

Adverse event: Muscle contractions involuntary
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 202 at risk

Adverse event: Hypothermia neonatal
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 202 at risk

Adverse event: Jaundice neonatal
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 202 at risk

Adverse event: Low birth weight baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 202 at risk

Adverse event: Neonatal disorder
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 202 at risk

Adverse event: Premature baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 202 at risk

Adverse event: Pyelocaliectasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 202 at risk

Adverse event: Grunting
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 202 at risk

Adverse event: Meconium aspiration syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 202 at risk

Adverse event: Neonatal asphyxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 202 at risk

Adverse event: Neonatal respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 202 at risk

Adverse event: Neonatal respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 202 at risk

Adverse event: Iron deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 202 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 202 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 202 at risk

Adverse event: Congenital joint malformation
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 202 at risk

Adverse event: Polydactyly
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 202 at risk

Adverse event: Developmental delay
Serious: no
Organ System: General disorders
Frequency: 1 affected / 202 at risk

Adverse event: Macrosomia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 202 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 202 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 202 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 202 at risk

Adverse event: Pneumonia bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 202 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 202 at risk

Adverse event: Blood glucose decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 202 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 202 at risk

Adverse event: Head lag
Serious: no
Organ System: Investigations
Frequency: 1 affected / 202 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 202 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 202 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 202 at risk

Adverse event: Malnutrition
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 202 at risk

Adverse event: Underweight
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 202 at risk

Adverse event: Acrochordon
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 202 at risk

Adverse event: Neonatal seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 202 at risk

Adverse event: Jaundice neonatal
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 202 at risk

Adverse event: Low birth weight baby
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 202 at risk

Adverse event: Premature baby
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 202 at risk

Adverse event: Neonatal respiratory distress
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 202 at risk

Adverse event: Neonatal tachypnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 202 at risk

Adverse event: Tethered oral tissue
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 207 at risk

Adverse event: Congenital inguinal hernia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 207 at risk

Adverse event: Congenital joint malformation
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 207 at risk

Adverse event: Congenital syphilis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 207 at risk

Adverse event: Duodenal atresia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 207 at risk

Adverse event: Hydrocele
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 207 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 207 at risk

Adverse event: Ileal stenosis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 207 at risk

Adverse event: Infantile vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 207 at risk

Adverse event: Death neonatal
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 207 at risk

Adverse event: Bacterial sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 207 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 207 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 207 at risk

Adverse event: Neonatal pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 207 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 207 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 207 at risk

Adverse event: Sepsis neonatal
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 207 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 207 at risk

Adverse event: Staphylococcal scalded skin syndrome
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 207 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 207 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 207 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 207 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 207 at risk

Adverse event: Blood potassium increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 207 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 207 at risk

Adverse event: Fontanelle bulging
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 207 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 207 at risk

Adverse event: Hypoxic-ischaemic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 207 at risk

Adverse event: Intraventricular haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 207 at risk

Adverse event: Birth trauma
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 207 at risk

Adverse event: Meconium in amniotic fluid
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 207 at risk

Adverse event: Premature baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 207 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 207 at risk

Adverse event: Meconium aspiration syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 207 at risk

Adverse event: Neonatal asphyxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 207 at risk

Adverse event: Neonatal respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 207 at risk

Adverse event: Neonatal tachypnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 207 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 207 at risk

Adverse event: Transient tachypnoea of the newborn
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 207 at risk

Adverse event: Use of accessory respiratory muscles
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 207 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 207 at risk

Adverse event: Iron deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 207 at risk

Adverse event: Congenital umbilical hernia
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 207 at risk

Adverse event: Polydactyly
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 207 at risk

Adverse event: Trisomy 21
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 207 at risk

Adverse event: Diarrhoea infectious
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 207 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 207 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 207 at risk

Adverse event: Sepsis neonatal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 207 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 207 at risk

Adverse event: Blood glucose decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 207 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 207 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 14 affected / 207 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 207 at risk

Adverse event: Jaundice neonatal
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 207 at risk

Adverse event: Low birth weight baby
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 207 at risk

Adverse event: Premature baby
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 207 at risk

Adverse event: Neonatal asphyxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 207 at risk

Adverse event: Neonatal respiratory distress syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 207 at risk

Adverse event: Respiratory distress
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 207 at risk

Adverse event: Skin mass
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 207 at risk