Study: NCT00486863

Adverse event: Amoebiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 184 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 184 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 184 at risk

Adverse event: Foetal death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 184 at risk

Adverse event: Multiple injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 184 at risk

Adverse event: Postpartum haemorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 184 at risk

Adverse event: Pre-eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 184 at risk

Adverse event: Premature labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 184 at risk

Adverse event: Preterm premature rupture of membranes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 184 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 184 at risk

Adverse event: 17-hydroxyprogesterone increased
Serious: yes
Organ System: Investigations
Notes: Reported in infant born to participant
Frequency: 1 affected / 184 at risk

Adverse event: Abdominal distension
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Reported in infant born to participant
Frequency: 1 affected / 184 at risk

Adverse event: Chemical burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Reported in infant born to participant
Frequency: 1 affected / 184 at risk

Adverse event: Hyperbilirubinaemia
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Reported in infant born to participant
Frequency: 1 affected / 184 at risk

Adverse event: Interstitial lung disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Reported in infant born to participant
Frequency: 1 affected / 184 at risk

Adverse event: Jaundice
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Reported in infant born to participant
Frequency: 2 affected / 184 at risk

Adverse event: Low birth weight baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Reported in infant born to participant
Frequency: 1 affected / 184 at risk

Adverse event: Microtia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: Reported in infant born to participant
Frequency: 1 affected / 184 at risk

Adverse event: Neonatal asphyxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Reported in infant born to participant
Frequency: 1 affected / 184 at risk

Adverse event: Neonatal pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Reported in infant born to participant
Frequency: 2 affected / 184 at risk

Adverse event: Omphalitis
Serious: yes
Organ System: Infections and infestations
Notes: Reported in infant born to participant
Frequency: 1 affected / 184 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Reported in infant born to participant
Frequency: 1 affected / 184 at risk

Adverse event: Premature baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Reported in infant born to participant
Frequency: 3 affected / 184 at risk

Adverse event: Small for dates baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Reported in infant born to participant
Frequency: 1 affected / 184 at risk

Adverse event: Staphylococcal skin infection
Serious: yes
Organ System: Infections and infestations
Notes: Reported in infant born to participant
Frequency: 1 affected / 184 at risk

Adverse event: Talipes
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: Reported in infant born to participant
Frequency: 1 affected / 184 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 51 affected / 184 at risk

Adverse event: Abdominal pain lower
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 184 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 13 affected / 184 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 184 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 184 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 184 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 16 affected / 184 at risk

Adverse event: White blood cells urine positive
Serious: no
Organ System: Investigations
Frequency: 10 affected / 184 at risk

Adverse event: Uterine contractions during pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 15 affected / 184 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 184 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 37 affected / 184 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: This symptom was solicited as the oral temperature taken by the subject daily for 14 days. Oral temperatures were graded during statistical analyses to define pyrexia as an oral temperature of 37.5 degrees Celsius or greater on any of the 14 days.
Frequency: 47 affected / 184 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 82 affected / 184 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 68 affected / 184 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 63 affected / 184 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 68 affected / 184 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 53 affected / 184 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Dyspnoea was solicited as 'shortness of breath'.
Frequency: 11 affected / 184 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 50 affected / 184 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 184 at risk

Adverse event: Abortion spontaneous incomplete
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 186 at risk

Adverse event: Abortion threatened
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 186 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 186 at risk

Adverse event: Eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 186 at risk

Adverse event: Foetal death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 186 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 186 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 186 at risk

Adverse event: Postpartum haemorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 186 at risk

Adverse event: Pre-eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 186 at risk

Adverse event: Premature delivery
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 186 at risk

Adverse event: Premature labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 186 at risk

Adverse event: Stillbirth
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 186 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 186 at risk

Adverse event: Abdominal distension
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Reported in infant born to participant
Frequency: 1 affected / 186 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Notes: Reported in infant born to participant
Frequency: 1 affected / 186 at risk

Adverse event: Cleft lip and palate
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: Reported in infant born to participant
Frequency: 2 affected / 186 at risk

Adverse event: Dacryocystitis
Serious: yes
Organ System: Infections and infestations
Notes: Reported in infant born to participant
Frequency: 1 affected / 186 at risk

Adverse event: Foetal growth restriction
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Reported in infant born to participant
Frequency: 1 affected / 186 at risk

Adverse event: Glucose-6-phosphate dehydrogenase deficiency
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: Reported in infant born to participant
Frequency: 4 affected / 186 at risk

Adverse event: Hyperbilirubinaemia
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Reported in infant born to participant
Frequency: 1 affected / 186 at risk

Adverse event: Hyperbilirubinaemia neonatal
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Reported in infant born to participant
Frequency: 1 affected / 186 at risk

Adverse event: Jaundice
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Reported in infant born to participant
Frequency: 1 affected / 186 at risk

Adverse event: Low birth weight baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Reported in infant born to participant
Frequency: 1 affected / 186 at risk

Adverse event: Neonatal asphyxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Reported in infant born to participant
Frequency: 1 affected / 186 at risk

Adverse event: Neonatal aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Reported in infant born to participant
Frequency: 1 affected / 186 at risk

Adverse event: Neonatal pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Reported in infant born to participant
Frequency: 5 affected / 186 at risk

Adverse event: Neonatal respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Reported in infant born to participant
Frequency: 1 affected / 186 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Reported in infant born to participant
Frequency: 1 affected / 186 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Reported in infant born to participant
Frequency: 1 affected / 186 at risk

Adverse event: Premature baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Reported in infant born to participant
Frequency: 2 affected / 186 at risk

Adverse event: Small for dates baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Reported in infant born to participant
Frequency: 1 affected / 186 at risk

Adverse event: Talipes
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: Reported in infant born to participant
Frequency: 1 affected / 186 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: Reported in infant born to participant
Frequency: 1 affected / 186 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 47 affected / 186 at risk

Adverse event: Abdominal pain lower
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 186 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 16 affected / 186 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 186 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 186 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 186 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 186 at risk

Adverse event: White blood cells urine positive
Serious: no
Organ System: Investigations
Frequency: 4 affected / 186 at risk

Adverse event: Uterine contractions during pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 10 affected / 186 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 15 affected / 186 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 37 affected / 186 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: This symptom was solicited as the oral temperature taken by the subject daily for 14 days. Oral temperatures were graded during statistical analyses to define pyrexia as an oral temperature of 37.5 degrees Celsius or greater on any of the 14 days.
Frequency: 39 affected / 186 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 99 affected / 186 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 81 affected / 186 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 76 affected / 186 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 94 affected / 186 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 77 affected / 186 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Dyspnoea was solicited as 'shortness of breath'.
Frequency: 14 affected / 186 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 100 affected / 186 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 20 affected / 186 at risk