Study: NCT01061151

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 1547 at risk

Adverse event: Immune thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1547 at risk

Adverse event: Dermoid cyst
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1547 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1547 at risk

Adverse event: Abdominal mass
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1547 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 1547 at risk

Adverse event: Abdominal pain lower
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 1547 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1547 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1547 at risk

Adverse event: Peptic ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1547 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1547 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1547 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1547 at risk

Adverse event: Jaundice
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1547 at risk

Adverse event: Amniotic cavity infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1547 at risk

Adverse event: Anal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1547 at risk

Adverse event: Bartholin's abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 1547 at risk

Adverse event: Breast abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1547 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 1547 at risk

Adverse event: Giardiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1547 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1547 at risk

Adverse event: Malaria
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 1547 at risk

Adverse event: Meningitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1547 at risk

Adverse event: Meningitis cryptococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1547 at risk

Adverse event: Meningitis tuberculous
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1547 at risk

Adverse event: Neurosyphilis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1547 at risk

Adverse event: Pelvic infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1547 at risk

Adverse event: Plasmodium falciparum infection
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 1547 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1547 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1547 at risk

Adverse event: Postpartum sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1547 at risk

Adverse event: Pulmonary tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1547 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1547 at risk

Adverse event: Salmonella sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1547 at risk

Adverse event: Salpingitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1547 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 12 affected / 1547 at risk

Adverse event: Vulvovaginitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1547 at risk

Adverse event: Wound sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1547 at risk

Adverse event: Bladder injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1547 at risk

Adverse event: Forearm fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1547 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1547 at risk

Adverse event: Post procedural complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1547 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1547 at risk

Adverse event: Soft tissue injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1547 at risk

Adverse event: Uterine rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1547 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1547 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1547 at risk

Adverse event: Haemoglobin decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1547 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1547 at risk

Adverse event: Aphasia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1547 at risk

Adverse event: Facial paralysis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1547 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1547 at risk

Adverse event: Hemiparesis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1547 at risk

Adverse event: Abortion
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1547 at risk

Adverse event: Abortion complete
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1547 at risk

Adverse event: Abortion incomplete
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 1547 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 7 affected / 1547 at risk

Adverse event: Abortion threatened
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 1547 at risk

Adverse event: Ectopic pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 1547 at risk

Adverse event: False labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 1547 at risk

Adverse event: Foetal death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 25 affected / 1547 at risk

Adverse event: Foetal growth restriction
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 1547 at risk

Adverse event: Foetal hypokinesia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1547 at risk

Adverse event: Gestational hypertension
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 18 affected / 1547 at risk

Adverse event: Haemorrhage in pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 9 affected / 1547 at risk

Adverse event: Intrapartum haemorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1547 at risk

Adverse event: Labour pain
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1547 at risk

Adverse event: Oligohydramnios
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 1547 at risk

Adverse event: Peripartum cardiomyopathy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1547 at risk

Adverse event: Placenta praevia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1547 at risk

Adverse event: Postpartum haemorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 11 affected / 1547 at risk

Adverse event: Pre-eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 15 affected / 1547 at risk

Adverse event: Premature delivery
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 9 affected / 1547 at risk

Adverse event: Premature labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 16 affected / 1547 at risk

Adverse event: Premature rupture of membranes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 10 affected / 1547 at risk

Adverse event: Premature separation of placenta
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 6 affected / 1547 at risk

Adverse event: Preterm premature rupture of membranes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 7 affected / 1547 at risk

Adverse event: Prolonged pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1547 at risk

Adverse event: Retained placenta or membranes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 1547 at risk

Adverse event: Retained products of conception
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 6 affected / 1547 at risk

Adverse event: Stillbirth
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 1547 at risk

Adverse event: Threatened labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 1547 at risk

Adverse event: Umbilical cord around neck
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1547 at risk

Adverse event: Umbilical cord prolapse
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1547 at risk

Adverse event: Conversion disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1547 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1547 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1547 at risk

Adverse event: Cervix disorder
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1547 at risk

Adverse event: Ovarian cyst
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1547 at risk

Adverse event: Uterine atony
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1547 at risk

Adverse event: Vaginal haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1547 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1547 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1547 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1547 at risk

Adverse event: Abortion induced
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 1547 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 1547 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 1547 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1547 at risk

Adverse event: Iron deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 34 affected / 1547 at risk

Adverse event: Eye discharge
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 1547 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 167 affected / 1547 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 179 affected / 1547 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 72 affected / 1547 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 81 affected / 1547 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 118 affected / 1547 at risk

Adverse event: Body tinea
Serious: no
Organ System: Infections and infestations
Frequency: 81 affected / 1547 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 37 affected / 1547 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 111 affected / 1547 at risk

Adverse event: Malaria
Serious: no
Organ System: Infections and infestations
Frequency: 85 affected / 1547 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 1547 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 1547 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 88 affected / 1547 at risk

Adverse event: Plasmodium falciparum infection
Serious: no
Organ System: Infections and infestations
Frequency: 70 affected / 1547 at risk

Adverse event: Pneumonia bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 1547 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 177 affected / 1547 at risk

Adverse event: Vulvovaginal candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 229 affected / 1547 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 470 affected / 1547 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 68 affected / 1547 at risk

Adverse event: Blood albumin decreased
Serious: no
Organ System: Investigations
Frequency: 61 affected / 1547 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 764 affected / 1547 at risk

Adverse event: Hormone level abnormal
Serious: no
Organ System: Investigations
Frequency: 25 affected / 1547 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 668 affected / 1547 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 151 affected / 1547 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 112 affected / 1547 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 66 affected / 1547 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 189 affected / 1547 at risk

Adverse event: Pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 272 affected / 1547 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 80 affected / 1547 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 116 affected / 1547 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 179 affected / 1547 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 1547 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 81 affected / 1547 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 64 affected / 1547 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 35 affected / 1547 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 119 affected / 1547 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 1545 at risk

Adverse event: Immune thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1545 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1545 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1545 at risk

Adverse event: Extrasystoles
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1545 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1545 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1545 at risk

Adverse event: Femoral hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1545 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1545 at risk

Adverse event: Haemorrhoids
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1545 at risk

Adverse event: Peptic ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1545 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1545 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1545 at risk

Adverse event: Autoimmune hepatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1545 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1545 at risk

Adverse event: Drug-induced liver injury
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 1545 at risk

Adverse event: Hepatic function abnormal
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1545 at risk

Adverse event: Hepatotoxicity
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 1545 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1545 at risk

Adverse event: Bacterial sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1545 at risk

Adverse event: Bartholin's abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1545 at risk

Adverse event: Breast abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1545 at risk

Adverse event: Cervicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1545 at risk

Adverse event: Disseminated tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1545 at risk

Adverse event: Dysentery
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1545 at risk

Adverse event: Enterobacter sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1545 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 1545 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1545 at risk

Adverse event: Malaria
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 1545 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1545 at risk

Adverse event: Plasmodium falciparum infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1545 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 1545 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 1545 at risk

Adverse event: Post procedural sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1545 at risk

Adverse event: Postoperative wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1545 at risk

Adverse event: Postpartum sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1545 at risk

Adverse event: Pulmonary tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1545 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1545 at risk

Adverse event: Sexually transmitted disease
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1545 at risk

Adverse event: Subcutaneous abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1545 at risk

Adverse event: Tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1545 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1545 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 1545 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1545 at risk

Adverse event: Vulvovaginitis trichomonal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1545 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1545 at risk

Adverse event: Wound sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1545 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1545 at risk

Adverse event: Penetrating abdominal trauma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1545 at risk

Adverse event: Postoperative wound complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1545 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1545 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1545 at risk

Adverse event: Uterine rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1545 at risk

Adverse event: Vulvovaginal injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1545 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1545 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 1545 at risk

Adverse event: Amniotic fluid volume decreased
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 1545 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1545 at risk

Adverse event: Foetal non-stress test abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1545 at risk

Adverse event: Haemoglobin decreased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 1545 at risk

Adverse event: Hepatic enzyme increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 1545 at risk

Adverse event: Liver function test increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1545 at risk

Adverse event: Transaminases increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 1545 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1545 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1545 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1545 at risk

Adverse event: Symphysiolysis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1545 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1545 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1545 at risk

Adverse event: Migraine
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1545 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1545 at risk

Adverse event: Abortion
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1545 at risk

Adverse event: Abortion complete
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1545 at risk

Adverse event: Abortion incomplete
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1545 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 1545 at risk

Adverse event: Abortion threatened
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1545 at risk

Adverse event: Eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 1545 at risk

Adverse event: False labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 1545 at risk

Adverse event: Foetal death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 37 affected / 1545 at risk

Adverse event: Foetal distress syndrome
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1545 at risk

Adverse event: Gestational diabetes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 1545 at risk

Adverse event: Gestational hypertension
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 9 affected / 1545 at risk

Adverse event: HELLP syndrome
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1545 at risk

Adverse event: Haemorrhage in pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 1545 at risk

Adverse event: Hyperemesis gravidarum
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1545 at risk

Adverse event: Oligohydramnios
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 1545 at risk

Adverse event: Placenta praevia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 1545 at risk

Adverse event: Placental insufficiency
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1545 at risk

Adverse event: Polyhydramnios
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1545 at risk

Adverse event: Postpartum haemorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 11 affected / 1545 at risk

Adverse event: Pre-eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 16 affected / 1545 at risk

Adverse event: Premature delivery
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 1545 at risk

Adverse event: Premature labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 15 affected / 1545 at risk

Adverse event: Premature rupture of membranes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 14 affected / 1545 at risk

Adverse event: Premature separation of placenta
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 1545 at risk

Adverse event: Preterm premature rupture of membranes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 1545 at risk

Adverse event: Retained placenta or membranes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1545 at risk

Adverse event: Retained products of conception
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 1545 at risk

Adverse event: Ruptured ectopic pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 1545 at risk

Adverse event: Stillbirth
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 9 affected / 1545 at risk

Adverse event: Threatened labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 1545 at risk

Adverse event: Brief psychotic disorder, with postpartum onset
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1545 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1545 at risk

Adverse event: Intentional self-injury
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 1545 at risk

Adverse event: Major depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1545 at risk

Adverse event: Mental disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1545 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 1545 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1545 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1545 at risk

Adverse event: Adnexa uteri mass
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1545 at risk

Adverse event: Ovarian cyst
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1545 at risk

Adverse event: Vaginal haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 1545 at risk

Adverse event: Vulval haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1545 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1545 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1545 at risk

Adverse event: Rash maculo-papular
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1545 at risk

Adverse event: Abortion induced
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1545 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1545 at risk

Adverse event: Psychosocial support
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1545 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 1545 at risk

Adverse event: Iron deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 33 affected / 1545 at risk

Adverse event: Eye discharge
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 1545 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 164 affected / 1545 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 202 affected / 1545 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 63 affected / 1545 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 90 affected / 1545 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 92 affected / 1545 at risk

Adverse event: Body tinea
Serious: no
Organ System: Infections and infestations
Frequency: 84 affected / 1545 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 30 affected / 1545 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 101 affected / 1545 at risk

Adverse event: Malaria
Serious: no
Organ System: Infections and infestations
Frequency: 79 affected / 1545 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 1545 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 1545 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 92 affected / 1545 at risk

Adverse event: Plasmodium falciparum infection
Serious: no
Organ System: Infections and infestations
Frequency: 75 affected / 1545 at risk

Adverse event: Pneumonia bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 1545 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 154 affected / 1545 at risk

Adverse event: Vulvovaginal candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 206 affected / 1545 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 493 affected / 1545 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 88 affected / 1545 at risk

Adverse event: Blood albumin decreased
Serious: no
Organ System: Investigations
Frequency: 85 affected / 1545 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 791 affected / 1545 at risk

Adverse event: Hormone level abnormal
Serious: no
Organ System: Investigations
Frequency: 30 affected / 1545 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 619 affected / 1545 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 144 affected / 1545 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 85 affected / 1545 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 54 affected / 1545 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 188 affected / 1545 at risk

Adverse event: Pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 271 affected / 1545 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 78 affected / 1545 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 136 affected / 1545 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 173 affected / 1545 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 1545 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 93 affected / 1545 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 69 affected / 1545 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 31 affected / 1545 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 120 affected / 1545 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 445 at risk

Adverse event: Peptic ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 445 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 445 at risk

Adverse event: Hepatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 445 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 445 at risk

Adverse event: Malaria
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 445 at risk

Adverse event: Pelvic abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 445 at risk

Adverse event: Pelvic inflammatory disease
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 445 at risk

Adverse event: Plasmodium falciparum infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 445 at risk

Adverse event: Plasmodium malariae infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 445 at risk

Adverse event: Postoperative wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 445 at risk

Adverse event: Postpartum sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 445 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 445 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 445 at risk

Adverse event: Vaginal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 445 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 445 at risk

Adverse event: Abdominal wound dehiscence
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 445 at risk

Adverse event: Traumatic fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 445 at risk

Adverse event: Uterine dehiscence
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 445 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 445 at risk

Adverse event: Abortion threatened
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 445 at risk

Adverse event: Eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 445 at risk

Adverse event: Foetal death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 7 affected / 445 at risk

Adverse event: Gestational hypertension
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 6 affected / 445 at risk

Adverse event: Haemorrhage in pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 445 at risk

Adverse event: Hyperemesis gravidarum
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 445 at risk

Adverse event: Obstructed labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 445 at risk

Adverse event: Oligohydramnios
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 445 at risk

Adverse event: Placenta accreta
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 445 at risk

Adverse event: Postpartum haemorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 445 at risk

Adverse event: Pre-eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 445 at risk

Adverse event: Premature delivery
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 445 at risk

Adverse event: Premature labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 8 affected / 445 at risk

Adverse event: Premature rupture of membranes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 445 at risk

Adverse event: Premature separation of placenta
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 445 at risk

Adverse event: Preterm premature rupture of membranes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 445 at risk

Adverse event: Prolonged labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 445 at risk

Adverse event: Prolonged pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 445 at risk

Adverse event: Retained products of conception
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 445 at risk

Adverse event: Stillbirth
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 445 at risk

Adverse event: Morning sickness
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 445 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 445 at risk

Adverse event: Iron deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 445 at risk

Adverse event: Eye discharge
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 445 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 445 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 41 affected / 445 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 445 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 445 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 26 affected / 445 at risk

Adverse event: Body tinea
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 445 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 445 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 445 at risk

Adverse event: Malaria
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 445 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 445 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 445 at risk

Adverse event: Plasmodium falciparum infection
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 445 at risk

Adverse event: Pneumonia bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 445 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 52 affected / 445 at risk

Adverse event: Vulvovaginal candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 68 affected / 445 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 116 affected / 445 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 29 affected / 445 at risk

Adverse event: Blood albumin decreased
Serious: no
Organ System: Investigations
Frequency: 50 affected / 445 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 191 affected / 445 at risk

Adverse event: Hormone level abnormal
Serious: no
Organ System: Investigations
Frequency: 11 affected / 445 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 161 affected / 445 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 41 affected / 445 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 21 affected / 445 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 15 affected / 445 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 23 affected / 445 at risk

Adverse event: Pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 52 affected / 445 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 9 affected / 445 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 21 affected / 445 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 445 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 445 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 445 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 445 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 445 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 27 affected / 445 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 204 at risk

Adverse event: Iron deficiency anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 204 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 204 at risk

Adverse event: Hepatic enzyme increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 204 at risk

Adverse event: Transaminases increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 204 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 204 at risk

Adverse event: Abortion missed
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 204 at risk

Adverse event: Foetal death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 204 at risk

Adverse event: Stillbirth
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 204 at risk

Adverse event: Iron deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 204 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 204 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 204 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 204 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 204 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 204 at risk

Adverse event: Body tinea
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 204 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 204 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 204 at risk

Adverse event: Malaria
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 204 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 204 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 204 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 204 at risk

Adverse event: Plasmodium falciparum infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 204 at risk

Adverse event: Pneumonia bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 204 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 204 at risk

Adverse event: Vulvovaginal candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 204 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 36 affected / 204 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 12 affected / 204 at risk

Adverse event: Blood albumin decreased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 204 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 103 affected / 204 at risk

Adverse event: Hormone level abnormal
Serious: no
Organ System: Investigations
Frequency: 15 affected / 204 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 67 affected / 204 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 18 affected / 204 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 204 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 12 affected / 204 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 204 at risk

Adverse event: Pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 26 affected / 204 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 204 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 5 affected / 204 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 204 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 204 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 204 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 204 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 18 affected / 204 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 1500 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 1500 at risk

Adverse event: Pulmonary valve stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1500 at risk

Adverse event: Atrial septal defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1500 at risk

Adverse event: Congenital inguinal hernia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1500 at risk

Adverse event: Congenital malaria
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1500 at risk

Adverse event: Congenital megacolon
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 1500 at risk

Adverse event: Congenital musculoskeletal disorder
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1500 at risk

Adverse event: Congenital pneumonia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 1500 at risk

Adverse event: Congenital syphilis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1500 at risk

Adverse event: Craniosynostosis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1500 at risk

Adverse event: Genitalia external ambiguous
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1500 at risk

Adverse event: Heart disease congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1500 at risk

Adverse event: Holoprosencephaly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1500 at risk

Adverse event: Hypospadias
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1500 at risk

Adverse event: Micrognathia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1500 at risk

Adverse event: Intestinal atresia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1500 at risk

Adverse event: Patent ductus arteriosus
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1500 at risk

Adverse event: Sickle cell anaemia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1500 at risk

Adverse event: Talipes
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 1500 at risk

Adverse event: Trisomy 21
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1500 at risk

Adverse event: Conjunctival haemorrhage
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1500 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1500 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1500 at risk

Adverse event: Ileus paralytic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1500 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1500 at risk

Adverse event: Necrotising colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 1500 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1500 at risk

Adverse event: Umbilical hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1500 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 1500 at risk

Adverse event: Infusion site extravasation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1500 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 1500 at risk

Adverse event: Sudden infant death syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1500 at risk

Adverse event: Jaundice cholestatic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1500 at risk

Adverse event: Abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1500 at risk

Adverse event: Abscess neck
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1500 at risk

Adverse event: Arthritis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1500 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1500 at risk

Adverse event: Bacterial sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1500 at risk

Adverse event: Brain abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1500 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 1500 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1500 at risk

Adverse event: Encephalitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1500 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 29 affected / 1500 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 1500 at risk

Adverse event: Malaria
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 1500 at risk

Adverse event: Meningitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1500 at risk

Adverse event: Meningitis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1500 at risk

Adverse event: Neonatal pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1500 at risk

Adverse event: Ophthalmia neonatorum
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1500 at risk

Adverse event: Plasmodium falciparum infection
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 1500 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 34 affected / 1500 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 23 affected / 1500 at risk

Adverse event: Pulmonary tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1500 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1500 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 1500 at risk

Adverse event: Sepsis neonatal
Serious: yes
Organ System: Infections and infestations
Frequency: 47 affected / 1500 at risk

Adverse event: Staphylococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1500 at risk

Adverse event: Subcutaneous abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1500 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1500 at risk

Adverse event: Burns first degree
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1500 at risk

Adverse event: Clavicle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1500 at risk

Adverse event: Herbal toxicity
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1500 at risk

Adverse event: Lower limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1500 at risk

Adverse event: Multiple injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1500 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1500 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1500 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1500 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 1500 at risk

Adverse event: Malnutrition
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 22 affected / 1500 at risk

Adverse event: Poor feeding infant
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1500 at risk

Adverse event: Neonatal seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1500 at risk

Adverse event: Encephalopathy neonatal
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1500 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1500 at risk

Adverse event: Generalised tonic-clonic seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1500 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1500 at risk

Adverse event: Hypoxic-ischaemic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1500 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1500 at risk

Adverse event: Jaundice neonatal
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 6 affected / 1500 at risk

Adverse event: Low birth weight baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 1500 at risk

Adverse event: Meconium in amniotic fluid
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1500 at risk

Adverse event: Premature baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 25 affected / 1500 at risk

Adverse event: Allergic respiratory disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1500 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1500 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1500 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1500 at risk

Adverse event: Meconium aspiration syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 1500 at risk

Adverse event: Neonatal asphyxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 1500 at risk

Adverse event: Neonatal respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 1500 at risk

Adverse event: Respiratory depression
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1500 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 1500 at risk

Adverse event: Transient tachypnoea of the newborn
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 1500 at risk

Adverse event: Upper airway obstruction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1500 at risk

Adverse event: Blister
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1500 at risk

Adverse event: Umbilical haemorrhage
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1500 at risk

Adverse event: Acrochordon excision
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1500 at risk

Adverse event: Infection prophylaxis
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1500 at risk

Adverse event: Subgaleal haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1500 at risk

Adverse event: Iron deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 96 affected / 1500 at risk

Adverse event: Congenital umbilical hernia
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 93 affected / 1500 at risk

Adverse event: Eye discharge
Serious: no
Organ System: Eye disorders
Frequency: 99 affected / 1500 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 1500 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 307 affected / 1500 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1500 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 107 affected / 1500 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 260 affected / 1500 at risk

Adverse event: Body tinea
Serious: no
Organ System: Infections and infestations
Frequency: 80 affected / 1500 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 99 affected / 1500 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 227 affected / 1500 at risk

Adverse event: Malaria
Serious: no
Organ System: Infections and infestations
Frequency: 103 affected / 1500 at risk

Adverse event: Ophthalmia neonatorum
Serious: no
Organ System: Infections and infestations
Frequency: 61 affected / 1500 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 124 affected / 1500 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 74 affected / 1500 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 37 affected / 1500 at risk

Adverse event: Plasmodium falciparum infection
Serious: no
Organ System: Infections and infestations
Frequency: 103 affected / 1500 at risk

Adverse event: Pneumonia bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 94 affected / 1500 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 1500 at risk

Adverse event: Vulvovaginal candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 1500 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 106 affected / 1500 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 1500 at risk

Adverse event: Blood albumin decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 1500 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 1226 affected / 1500 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 859 affected / 1500 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 94 affected / 1500 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 29 affected / 1500 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 12 affected / 1500 at risk

Adverse event: Failure to thrive
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 53 affected / 1500 at risk

Adverse event: Growth failure
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 63 affected / 1500 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 1500 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 274 affected / 1500 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 78 affected / 1500 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 144 affected / 1500 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 139 affected / 1500 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 73 affected / 1500 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 1478 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 1478 at risk

Adverse event: Tethered oral tissue
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1478 at risk

Adverse event: Atrial septal defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1478 at risk

Adverse event: Congenital anaemia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1478 at risk

Adverse event: Congenital anomaly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1478 at risk

Adverse event: Congenital genital malformation male
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1478 at risk

Adverse event: Congenital pneumonia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 3 affected / 1478 at risk

Adverse event: Congenital syphilis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 1478 at risk

Adverse event: Congenital umbilical hernia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1478 at risk

Adverse event: Exomphalos
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1478 at risk

Adverse event: Gastroschisis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1478 at risk

Adverse event: Heart disease congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1478 at risk

Adverse event: Hypospadias
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 1478 at risk

Adverse event: Laryngomalacia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1478 at risk

Adverse event: Meningomyelocele
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 1478 at risk

Adverse event: Multiple congenital abnormalities
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1478 at risk

Adverse event: Patent ductus arteriosus
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 1478 at risk

Adverse event: Persistent foetal circulation
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1478 at risk

Adverse event: Talipes
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1478 at risk

Adverse event: Trisomy 21
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1478 at risk

Adverse event: Ventricular septal defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1478 at risk

Adverse event: Strabismus
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1478 at risk

Adverse event: Abdominal distension
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1478 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1478 at risk

Adverse event: Necrotising colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1478 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1478 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 1478 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 1478 at risk

Adverse event: Hepatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1478 at risk

Adverse event: Hepatotoxicity
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1478 at risk

Adverse event: Hyperbilirubinaemia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1478 at risk

Adverse event: Bacterial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1478 at risk

Adverse event: Bacterial sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1478 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 1478 at risk

Adverse event: Bullous impetigo
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1478 at risk

Adverse event: Conjunctivitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1478 at risk

Adverse event: Dysentery
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1478 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 26 affected / 1478 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1478 at risk

Adverse event: Malaria
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 1478 at risk

Adverse event: Measles
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1478 at risk

Adverse event: Meningitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1478 at risk

Adverse event: Meningitis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1478 at risk

Adverse event: Meningitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1478 at risk

Adverse event: Neonatal pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1478 at risk

Adverse event: Ophthalmia neonatorum
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1478 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1478 at risk

Adverse event: Pertussis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1478 at risk

Adverse event: Plasmodium falciparum infection
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 1478 at risk

Adverse event: Plasmodium malariae infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1478 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 33 affected / 1478 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 15 affected / 1478 at risk

Adverse event: Pulmonary tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1478 at risk

Adverse event: Rhinitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1478 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1478 at risk

Adverse event: Sepsis neonatal
Serious: yes
Organ System: Infections and infestations
Frequency: 33 affected / 1478 at risk

Adverse event: Staphylococcal scalded skin syndrome
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1478 at risk

Adverse event: Staphylococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1478 at risk

Adverse event: Staphylococcal skin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1478 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1478 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1478 at risk

Adverse event: Burns first degree
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1478 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1478 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1478 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1478 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1478 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1478 at risk

Adverse event: Hypoglycaemia neonatal
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1478 at risk

Adverse event: Malnutrition
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 20 affected / 1478 at risk

Adverse event: Joint hyperextension
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1478 at risk

Adverse event: Encephalopathy neonatal
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1478 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1478 at risk

Adverse event: Hemiparesis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1478 at risk

Adverse event: Hypoxic-ischaemic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1478 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1478 at risk

Adverse event: Jaundice neonatal
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 1478 at risk

Adverse event: Low birth weight baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 6 affected / 1478 at risk

Adverse event: Premature baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 42 affected / 1478 at risk

Adverse event: Small for dates baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 1478 at risk

Adverse event: Anuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1478 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1478 at risk

Adverse event: Apnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1478 at risk

Adverse event: Asphyxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1478 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1478 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1478 at risk

Adverse event: Meconium aspiration syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1478 at risk

Adverse event: Neonatal asphyxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 1478 at risk

Adverse event: Neonatal respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 1478 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1478 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1478 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 1478 at risk

Adverse event: Transient tachypnoea of the newborn
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 1478 at risk

Adverse event: Angioedema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 1478 at risk

Adverse event: Skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1478 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1478 at risk

Adverse event: Iron deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 81 affected / 1478 at risk

Adverse event: Congenital umbilical hernia
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 89 affected / 1478 at risk

Adverse event: Eye discharge
Serious: no
Organ System: Eye disorders
Frequency: 94 affected / 1478 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 1478 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 317 affected / 1478 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1478 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 106 affected / 1478 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 240 affected / 1478 at risk

Adverse event: Body tinea
Serious: no
Organ System: Infections and infestations
Frequency: 74 affected / 1478 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 75 affected / 1478 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 205 affected / 1478 at risk

Adverse event: Malaria
Serious: no
Organ System: Infections and infestations
Frequency: 95 affected / 1478 at risk

Adverse event: Ophthalmia neonatorum
Serious: no
Organ System: Infections and infestations
Frequency: 71 affected / 1478 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 112 affected / 1478 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 62 affected / 1478 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 35 affected / 1478 at risk

Adverse event: Plasmodium falciparum infection
Serious: no
Organ System: Infections and infestations
Frequency: 95 affected / 1478 at risk

Adverse event: Pneumonia bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 84 affected / 1478 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 1478 at risk

Adverse event: Vulvovaginal candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 1478 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 66 affected / 1478 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 1478 at risk

Adverse event: Blood albumin decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 1478 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 1230 affected / 1478 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 848 affected / 1478 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 94 affected / 1478 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 20 affected / 1478 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 1478 at risk

Adverse event: Failure to thrive
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 40 affected / 1478 at risk

Adverse event: Growth failure
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 72 affected / 1478 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1478 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1478 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 253 affected / 1478 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 80 affected / 1478 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 138 affected / 1478 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 130 affected / 1478 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 74 affected / 1478 at risk

Adverse event: Cleft palate
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 429 at risk

Adverse event: Congenital anomaly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 429 at risk

Adverse event: Congenital rubella infection
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 429 at risk

Adverse event: Dermoid cyst
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 429 at risk

Adverse event: Developmental hip dysplasia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 429 at risk

Adverse event: Macrocephaly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 429 at risk

Adverse event: Meningomyelocele
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 429 at risk

Adverse event: Talipes
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 429 at risk

Adverse event: Ventricular septal defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 429 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 429 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 429 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 429 at risk

Adverse event: Bacterial sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 429 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 429 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 429 at risk

Adverse event: Malaria
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 429 at risk

Adverse event: Ophthalmia neonatorum
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 429 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 429 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 429 at risk

Adverse event: Pulmonary tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 429 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 429 at risk

Adverse event: Sepsis neonatal
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 429 at risk

Adverse event: Staphylococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 429 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 429 at risk

Adverse event: Burns second degree
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 429 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 429 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 429 at risk

Adverse event: Malnutrition
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 429 at risk

Adverse event: Vitamin K deficiency
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 429 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 429 at risk

Adverse event: Hypoxic-ischaemic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 429 at risk

Adverse event: Jaundice neonatal
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 429 at risk

Adverse event: Low birth weight baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 429 at risk

Adverse event: Premature baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 19 affected / 429 at risk

Adverse event: Prolonged rupture of membranes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 429 at risk

Adverse event: Umbilical granuloma
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 429 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 429 at risk

Adverse event: Meconium aspiration syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 429 at risk

Adverse event: Neonatal asphyxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 429 at risk

Adverse event: Neonatal respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 429 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 429 at risk

Adverse event: Tachypnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 429 at risk

Adverse event: Transient tachypnoea of the newborn
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 429 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 429 at risk

Adverse event: Iron deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 429 at risk

Adverse event: Congenital umbilical hernia
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 34 affected / 429 at risk

Adverse event: Eye discharge
Serious: no
Organ System: Eye disorders
Frequency: 11 affected / 429 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 429 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 52 affected / 429 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 429 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 48 affected / 429 at risk

Adverse event: Body tinea
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 429 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 429 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 58 affected / 429 at risk

Adverse event: Malaria
Serious: no
Organ System: Infections and infestations
Frequency: 29 affected / 429 at risk

Adverse event: Ophthalmia neonatorum
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 429 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 44 affected / 429 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 30 affected / 429 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 429 at risk

Adverse event: Plasmodium falciparum infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 429 at risk

Adverse event: Pneumonia bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 429 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 429 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 12 affected / 429 at risk

Adverse event: Blood albumin decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 429 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 356 affected / 429 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 255 affected / 429 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 40 affected / 429 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 16 affected / 429 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 429 at risk

Adverse event: Failure to thrive
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 429 at risk

Adverse event: Growth failure
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 38 affected / 429 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 429 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 35 affected / 429 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 30 affected / 429 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 23 affected / 429 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 20 affected / 429 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 429 at risk

Adverse event: Heart disease congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 204 at risk

Adverse event: Patent ductus arteriosus
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 204 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 204 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 204 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 204 at risk

Adverse event: Malaria
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 204 at risk

Adverse event: Meningitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 204 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 204 at risk

Adverse event: Sepsis neonatal
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 204 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 204 at risk

Adverse event: Malnutrition
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 204 at risk

Adverse event: Marasmus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 204 at risk

Adverse event: Iron deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 18 affected / 204 at risk

Adverse event: Congenital umbilical hernia
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 4 affected / 204 at risk

Adverse event: Eye discharge
Serious: no
Organ System: Eye disorders
Frequency: 13 affected / 204 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 204 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 204 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 204 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 204 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 18 affected / 204 at risk

Adverse event: Body tinea
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 204 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 204 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 38 affected / 204 at risk

Adverse event: Malaria
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 204 at risk

Adverse event: Ophthalmia neonatorum
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 204 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 204 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 204 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 204 at risk

Adverse event: Plasmodium falciparum infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 204 at risk

Adverse event: Pneumonia bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 204 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 14 affected / 204 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 204 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 124 affected / 204 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 115 affected / 204 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 204 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 204 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 204 at risk

Adverse event: Failure to thrive
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 204 at risk

Adverse event: Growth failure
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 204 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 204 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 204 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 204 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 204 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 204 at risk