Study: NCT00474045

Adverse event: Aborption spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: SAE for Mother, Safety-Pregnant
Frequency: 8 affected / 152 at risk

Adverse event: Pre-eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: SAE for Mother, Safety-Pregnant
Frequency: 8 affected / 152 at risk

Adverse event: Threatened labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: SAE for Mother, Safety-Pregnant
Frequency: 3 affected / 152 at risk

Adverse event: Failed induction of labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: SAE for Mother, Safety-Pregnant
Frequency: 3 affected / 152 at risk

Adverse event: Abortion missed
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: SAE for Mother, Safety-Pregnant
Frequency: 1 affected / 152 at risk

Adverse event: Abortion threatened
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: SAE for Mother, Safety-Pregnant
Frequency: 3 affected / 152 at risk

Adverse event: Hyperemesis gravidarum
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: SAE for Mother, Safety-Pregnant
Frequency: 1 affected / 152 at risk

Adverse event: Ectopic pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: SAE for Mother, Safety-Pregnant
Frequency: 1 affected / 152 at risk

Adverse event: Gestational hypertension
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: SAE for Mother, Safety-Pregnant
Frequency: 1 affected / 152 at risk

Adverse event: Foetal death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: SAE for Mother, Safety-Pregnant
Frequency: 1 affected / 152 at risk

Adverse event: Premature labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: SAE for Mother, Safety-Pregnant
Frequency: 2 affected / 152 at risk

Adverse event: Aborption incomplete
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: SAE for Mother, Safety-Pregnant
Frequency: 1 affected / 152 at risk

Adverse event: Breech presentation
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: SAE for Mother, Safety-Pregnant
Frequency: 1 affected / 152 at risk

Adverse event: Cephalo-pelvic disproportion
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: SAE for Mother, Safety-Pregnant
Frequency: 1 affected / 152 at risk

Adverse event: Imminent abortion
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: SAE for Mother, Safety-Pregnant
Frequency: 1 affected / 152 at risk

Adverse event: Labour complication
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: SAE for Mother, Safety-Pregnant
Frequency: 1 affected / 152 at risk

Adverse event: Stillbirth
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: SAE for Mother, Safety-Pregnant
Frequency: 1 affected / 152 at risk

Adverse event: Uterine contractions abnormal
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: SAE for Mother, Safety-Pregnant
Frequency: 1 affected / 152 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: SAE for Mother, Safety-Pregnant
Frequency: 5 affected / 152 at risk

Adverse event: Hypoglycaemic unconsciousness
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: SAE for Mother, Safety-Pregnant
Frequency: 2 affected / 152 at risk

Adverse event: Diabetes mellitus inadequate control
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: SAE for Mother, Safety-Pregnant
Frequency: 5 affected / 152 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: SAE for Mother, Safety-Pregnant
Frequency: 3 affected / 152 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: SAE for Mother, Safety-Pregnant
Frequency: 2 affected / 152 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: SAE for Mother, Safety-Pregnant
Frequency: 5 affected / 152 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: SAE for Mother, Safety-Pregnant
Frequency: 2 affected / 152 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: SAE for Mother, Safety-Pregnant
Frequency: 1 affected / 152 at risk

Adverse event: Impaired gastric emptying
Serious: yes
Organ System: Gastrointestinal disorders
Notes: SAE for Mother, Safety-Pregnant
Frequency: 1 affected / 152 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Notes: SAE for Mother, Safety-Pregnant
Frequency: 4 affected / 152 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Notes: SAE for Mother, Safety-Pregnant
Frequency: 1 affected / 152 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: SAE for Mother, Safety-Pregnant
Frequency: 1 affected / 152 at risk

Adverse event: Urogenital infection bacterial
Serious: yes
Organ System: Infections and infestations
Notes: SAE for Mother, Safety-Pregnant
Frequency: 1 affected / 152 at risk

Adverse event: Uterine haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: SAE for Mother, Safety-Pregnant
Frequency: 1 affected / 152 at risk

Adverse event: Intermenstrual bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: SAE for Mother, Safety-Pregnant
Frequency: 1 affected / 152 at risk

Adverse event: Genital haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: SAE for Mother, Safety-Pregnant
Frequency: 1 affected / 152 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Notes: SAE for Mother, Safety-Pregnant
Frequency: 3 affected / 152 at risk

Adverse event: Migraine
Serious: yes
Organ System: Nervous system disorders
Notes: SAE for Mother, Safety-Pregnant
Frequency: 1 affected / 152 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Notes: SAE for Mother, Safety-Pregnant
Frequency: 2 affected / 152 at risk

Adverse event: Retinopathy
Serious: yes
Organ System: Eye disorders
Notes: SAE for Mother, Safety-Pregnant
Frequency: 1 affected / 152 at risk

Adverse event: Visual impairment
Serious: yes
Organ System: Eye disorders
Notes: SAE for Mother, Safety-Pregnant
Frequency: 1 affected / 152 at risk

Adverse event: Device failure
Serious: yes
Organ System: General disorders
Notes: SAE for Mother, Safety-Pregnant
Frequency: 1 affected / 152 at risk

Adverse event: Malaise
Serious: yes
Organ System: General disorders
Notes: SAE for Mother, Safety-Pregnant
Frequency: 1 affected / 152 at risk

Adverse event: Cholestasis of pregnancy
Serious: yes
Organ System: Hepatobiliary disorders
Notes: SAE for Mother, Safety-Pregnant
Frequency: 1 affected / 152 at risk

Adverse event: Hepatic cytolysis
Serious: yes
Organ System: Hepatobiliary disorders
Notes: SAE for Mother, Safety-Pregnant
Frequency: 1 affected / 152 at risk

Adverse event: Inadequate diet
Serious: yes
Organ System: Social circumstances
Notes: SAE for Mother, Safety-Pregnant
Frequency: 1 affected / 152 at risk

Adverse event: Amniotic fluid volume decreased
Serious: yes
Organ System: Investigations
Notes: SAE for Mother, Safety-Pregnant
Frequency: 1 affected / 152 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: AE for Mother, Safety-Pregnant
Frequency: 45 affected / 152 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: AE for Mother, Safety-Pregnant
Frequency: 17 affected / 152 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Notes: AE for Mother, Safety-Pregnant
Frequency: 13 affected / 152 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: AE for Mother, Safety-Pregnant
Frequency: 9 affected / 152 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Notes: AE for Mother, Safety-Pregnant
Frequency: 9 affected / 152 at risk

Adverse event: Pre-eclampsia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: AE for Mother, Safety-Pregnant
Frequency: 8 affected / 152 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: AE for Mother, Safety-Pregnant
Frequency: 43 affected / 152 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: AE for Mother, Safety-Pregnant
Frequency: 21 affected / 152 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: AE for Mother, Safety-Pregnant
Frequency: 11 affected / 152 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: AE for Mother, Safety-Pregnant
Frequency: 12 affected / 152 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Notes: AE for Mother, Safety-Pregnant
Frequency: 7 affected / 152 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: AE for Mother, Safety-Pregnant
Frequency: 4 affected / 152 at risk

Adverse event: Diabetic retinopathy
Serious: no
Organ System: Eye disorders
Notes: AE for Mother, Safety-Pregnant
Frequency: 6 affected / 152 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: AE for Mother, Safety-Pregnant
Frequency: 11 affected / 152 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: AE for Mother, Safety-Pregnant
Frequency: 22 affected / 152 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: AE for Mother, Safety-Pregnant
Frequency: 5 affected / 152 at risk

Adverse event: Aborption spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: SAE for Mother, Safety-Pregnant
Frequency: 4 affected / 158 at risk

Adverse event: Pre-eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: SAE for Mother, Safety-Pregnant
Frequency: 1 affected / 158 at risk

Adverse event: Threatened labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: SAE for Mother, Safety-Pregnant
Frequency: 4 affected / 158 at risk

Adverse event: Failed induction of labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: SAE for Mother, Safety-Pregnant
Frequency: 3 affected / 158 at risk

Adverse event: Abortion missed
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: SAE for Mother, Safety-Pregnant
Frequency: 2 affected / 158 at risk

Adverse event: Hyperemesis gravidarum
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: SAE for Mother, Safety-Pregnant
Frequency: 2 affected / 158 at risk

Adverse event: Ectopic pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: SAE for Mother, Safety-Pregnant
Frequency: 1 affected / 158 at risk

Adverse event: Gestational hypertension
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: SAE for Mother, Safety-Pregnant
Frequency: 1 affected / 158 at risk

Adverse event: Foetal death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: SAE for Mother, Safety-Pregnant
Frequency: 1 affected / 158 at risk

Adverse event: Placenta praevia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: SAE for Mother, Safety-Pregnant
Frequency: 2 affected / 158 at risk

Adverse event: Placenta praevia haemorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: SAE for Mother, Safety-Pregnant
Frequency: 1 affected / 158 at risk

Adverse event: Premature separation of placenta
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: SAE for Mother, Safety-Pregnant
Frequency: 2 affected / 158 at risk

Adverse event: Haemorrhage in pregnancy
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: SAE for Mother, Safety-Pregnant
Frequency: 1 affected / 158 at risk

Adverse event: Anembryonic gestation
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: SAE for Mother, Safety-Pregnant
Frequency: 1 affected / 158 at risk

Adverse event: Cervical incompetence
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: SAE for Mother, Safety-Pregnant
Frequency: 1 affected / 158 at risk

Adverse event: Placental insufficiency
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: SAE for Mother, Safety-Pregnant
Frequency: 1 affected / 158 at risk

Adverse event: Polyhydramnios
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: SAE for Mother, Safety-Pregnant
Frequency: 1 affected / 158 at risk

Adverse event: Premature rupture of membranes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: SAE for Mother, Safety-Pregnant
Frequency: 1 affected / 158 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: SAE for Mother, Safety-Pregnant
Frequency: 5 affected / 158 at risk

Adverse event: Hypoglycaemic unconsciousness
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: SAE for Mother, Safety-Pregnant
Frequency: 7 affected / 158 at risk

Adverse event: Diabetes mellitus inadequate control
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: SAE for Mother, Safety-Pregnant
Frequency: 1 affected / 158 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: SAE for Mother, Safety-Pregnant
Frequency: 2 affected / 158 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: SAE for Mother, Safety-Pregnant
Frequency: 2 affected / 158 at risk

Adverse event: Abdominal pain, upper
Serious: yes
Organ System: Gastrointestinal disorders
Notes: SAE for Mother, Safety-Pregnant
Frequency: 1 affected / 158 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: SAE for Mother, Safety-Pregnant
Frequency: 1 affected / 158 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: SAE for Mother, Safety-Pregnant
Frequency: 1 affected / 158 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Notes: SAE for Mother, Safety-Pregnant
Frequency: 1 affected / 158 at risk

Adverse event: Beta haemolytic streptococcal infection
Serious: yes
Organ System: Infections and infestations
Notes: SAE for Mother, Safety-Pregnant
Frequency: 1 affected / 158 at risk

Adverse event: Uterine haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: SAE for Mother, Safety-Pregnant
Frequency: 2 affected / 158 at risk

Adverse event: Intermenstrual bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: SAE for Mother, Safety-Pregnant
Frequency: 1 affected / 158 at risk

Adverse event: Pelvic pain
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: SAE for Mother, Safety-Pregnant
Frequency: 1 affected / 158 at risk

Adverse event: Vaginal haematoma
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: SAE for Mother, Safety-Pregnant
Frequency: 1 affected / 158 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Notes: SAE for Mother, Safety-Pregnant
Frequency: 2 affected / 158 at risk

Adverse event: Incorrect dose administered
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE for Mother, Safety-Pregnant
Frequency: 2 affected / 158 at risk

Adverse event: Wrong product administered
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE for Mother, Safety-Pregnant
Frequency: 1 affected / 158 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Notes: SAE for Mother, Safety-Pregnant
Frequency: 1 affected / 158 at risk

Adverse event: Social stay hospitalisation
Serious: yes
Organ System: Social circumstances
Notes: SAE for Mother, Safety-Pregnant
Frequency: 1 affected / 158 at risk

Adverse event: Polymorphic eruption of pregnancy
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: SAE for Mother, Safety-Pregnant
Frequency: 1 affected / 158 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: AE for Mother, Safety-Pregnant
Frequency: 47 affected / 158 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: AE for Mother, Safety-Pregnant
Frequency: 12 affected / 158 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Notes: AE for Mother, Safety-Pregnant
Frequency: 9 affected / 158 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: AE for Mother, Safety-Pregnant
Frequency: 13 affected / 158 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Notes: AE for Mother, Safety-Pregnant
Frequency: 16 affected / 158 at risk

Adverse event: Pre-eclampsia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: AE for Mother, Safety-Pregnant
Frequency: 10 affected / 158 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: AE for Mother, Safety-Pregnant
Frequency: 35 affected / 158 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: AE for Mother, Safety-Pregnant
Frequency: 11 affected / 158 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: AE for Mother, Safety-Pregnant
Frequency: 12 affected / 158 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: AE for Mother, Safety-Pregnant
Frequency: 5 affected / 158 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Notes: AE for Mother, Safety-Pregnant
Frequency: 9 affected / 158 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: AE for Mother, Safety-Pregnant
Frequency: 11 affected / 158 at risk

Adverse event: Diabetic retinopathy
Serious: no
Organ System: Eye disorders
Notes: AE for Mother, Safety-Pregnant
Frequency: 10 affected / 158 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: AE for Mother, Safety-Pregnant
Frequency: 13 affected / 158 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: AE for Mother, Safety-Pregnant
Frequency: 23 affected / 158 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: AE for Mother, Safety-Pregnant
Frequency: 8 affected / 158 at risk