Study: NCT02292771

Adverse event: Preterm premature rupture of membranes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 47 at risk

Adverse event: Pre-eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 47 at risk

Adverse event: Premature separation of placenta
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 47 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 47 at risk

Adverse event: Haematoma infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 47 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 47 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 47 at risk

Adverse event: Retroperitoneal haematoma
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 47 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 47 at risk

Adverse event: Abdominal wound dehiscence
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 47 at risk

Adverse event: Foetal monitoring abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 47 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 47 at risk

Adverse event: Foetal hypokinesia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 47 at risk

Adverse event: Postpartum haemorrhage
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 47 at risk

Adverse event: Gestational hypertension
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 47 at risk

Adverse event: Polyhydramnios
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 47 at risk

Adverse event: Premature labour
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 47 at risk

Adverse event: Preterm premature rupture of membranes
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 47 at risk

Adverse event: Hepatic steatosis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 47 at risk

Adverse event: Neonatal respiratory distress syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 47 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 47 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 47 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 47 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 47 at risk

Adverse event: Gingival bleeding
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 47 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 47 at risk

Adverse event: Bacterial vaginosis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 47 at risk

Adverse event: Cervicitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 47 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 47 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 47 at risk

Adverse event: Vaginitis gardnerella
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 47 at risk

Adverse event: Escherichia urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 47 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 47 at risk

Adverse event: Pulpitis dental
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 47 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 47 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 47 at risk

Adverse event: Uterine atony
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 47 at risk

Adverse event: Vulval oedema
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 47 at risk

Adverse event: Vulvovaginal pruritus
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 47 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 47 at risk

Adverse event: Anaemia of pregnancy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 47 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Suprapubic pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 47 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 47 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 47 at risk

Adverse event: Escherichia test positive
Serious: no
Organ System: Investigations
Frequency: 2 affected / 47 at risk

Adverse event: Candida test positive
Serious: no
Organ System: Investigations
Frequency: 1 affected / 47 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 47 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 47 at risk

Adverse event: Flank pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 47 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 47 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 47 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 47 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 47 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 47 at risk

Adverse event: Abdominal wound dehiscence
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 47 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 47 at risk

Adverse event: Macule
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 47 at risk

Adverse event: Postpartum haemorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 50 at risk

Adverse event: Preterm premature rupture of membranes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 50 at risk

Adverse event: Normal labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 50 at risk

Adverse event: Premature labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 50 at risk

Adverse event: Amniotic cavity infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Postoperative wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Visual impairment
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 50 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 50 at risk

Adverse event: Postpartum haemorrhage
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 50 at risk

Adverse event: Gestational hypertension
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 50 at risk

Adverse event: Neonatal respiratory distress syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 50 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Abdominal rigidity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Dental caries
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 50 at risk

Adverse event: Bacterial vaginosis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 50 at risk

Adverse event: Cervicitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 50 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 50 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 50 at risk

Adverse event: Asymptomatic bacteriuria
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 50 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Vaginitis gardnerella
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Genital candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Pyuria
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Skin candida
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Ureaplasma infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 50 at risk

Adverse event: Breast engorgement
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 50 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 50 at risk

Adverse event: Anaemia of pregnancy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 50 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 50 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 50 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 50 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 50 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 50 at risk

Adverse event: Peripheral swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 50 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 50 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 50 at risk

Adverse event: Burning sensation
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 50 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 50 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 50 at risk

Adverse event: Psychiatric evaluation abnormal
Serious: no
Organ System: Investigations
Frequency: 2 affected / 50 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 50 at risk

Adverse event: Klebsiella test positive
Serious: no
Organ System: Investigations
Frequency: 1 affected / 50 at risk

Adverse event: White blood cell count increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 50 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 50 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 50 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 50 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 50 at risk

Adverse event: Mood swings
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 50 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 50 at risk

Adverse event: Iron deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 50 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 50 at risk

Adverse event: Renal pain
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 50 at risk

Adverse event: Oligohydramnios
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 47 at risk

Adverse event: Hydrops foetalis
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 47 at risk

Adverse event: Foetal heart rate disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 47 at risk

Adverse event: Foetal heart rate deceleration abnormality
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 47 at risk

Adverse event: Foetal heart rate deceleration abnormality
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 47 at risk

Adverse event: Bradycardia foetal
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 47 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 47 at risk

Adverse event: Tachycardia foetal
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 47 at risk

Adverse event: Foetal hypokinesia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 47 at risk

Adverse event: Foetal heart rate disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 50 at risk

Adverse event: Congenital hydronephrosis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 50 at risk

Adverse event: Foetal heart rate disorder
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 50 at risk

Adverse event: Foetal hypokinesia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 50 at risk

Adverse event: Oligohydramnios
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 50 at risk

Adverse event: Jaundice neonatal
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 46 at risk

Adverse event: Bacterial disease carrier
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 46 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 46 at risk

Adverse event: Gastric perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Hyperbilirubinaemia neonatal
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 46 at risk

Adverse event: Cataract congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 46 at risk

Adverse event: Pyloric stenosis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 46 at risk

Adverse event: Ventricular septal defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 46 at risk

Adverse event: Neonatal respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 46 at risk

Adverse event: Jaundice neonatal
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 46 at risk

Adverse event: Cephalhaematoma
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 46 at risk

Adverse event: Hyperbilirubinaemia neonatal
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 10 affected / 46 at risk

Adverse event: Jaundice
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 46 at risk

Adverse event: Transient tachypnoea of the newborn
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Choking
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Respiratory acidosis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Tachypnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Infantile colic
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Scrotal oedema
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 46 at risk

Adverse event: Testicular retraction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 46 at risk

Adverse event: Polycythaemia neonatorum
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 46 at risk

Adverse event: Eyelid oedema
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 46 at risk

Adverse event: Generalised oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 46 at risk

Adverse event: Cerebral haemorrhage
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 46 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 46 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 46 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 46 at risk

Adverse event: Congenital hydronephrosis
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 46 at risk

Adverse event: Jaundice neonatal
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 50 at risk

Adverse event: Hyperbilirubinaemia neonatal
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 50 at risk

Adverse event: Blood bilirubin increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 50 at risk

Adverse event: Tethered oral tissue
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 50 at risk

Adverse event: Atrial septal defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 50 at risk

Adverse event: Neonatal respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Choking
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Meconium aspiration syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Sudden infant death syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 50 at risk

Adverse event: Milk allergy
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 50 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 50 at risk

Adverse event: Jaundice neonatal
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 50 at risk

Adverse event: Hyperbilirubinaemia neonatal
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 8 affected / 50 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 50 at risk

Adverse event: Transient tachypnoea of the newborn
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Apnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Respiratory disorder neonatal
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Use of accessory respiratory muscles
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Infantile colic
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Inguinal hernia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Regurgitation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Umbilical hernia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 50 at risk

Adverse event: Auditory disorder
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 50 at risk

Adverse event: Eyelid haemangioma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 50 at risk

Adverse event: Metabolic acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 50 at risk

Adverse event: Acne infantile
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 50 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 50 at risk

Adverse event: Hydrocele
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 50 at risk