Study: NCT01850030

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 11 affected / 518 at risk

Adverse event: abortion not specified as induced or spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 7 affected / 518 at risk

Adverse event: maternal complications of pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 8 affected / 518 at risk

Adverse event: labor onset and length abnormalities
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 7 affected / 518 at risk

Adverse event: Foetal complications NEC
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 518 at risk

Adverse event: Hypertension associated disorders of pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 518 at risk

Adverse event: Amniotic fluid and cavity disorders of pregnancy NEC
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 518 at risk

Adverse event: Gestational age and weight conditions
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 518 at risk

Adverse event: Haemorrhagic complications of pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 518 at risk

Adverse event: High risk pregnancies
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 518 at risk

Adverse event: Normal pregnancy, labour and delivery
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 518 at risk

Adverse event: Umbilical cord complications
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 518 at risk

Adverse event: Abortion related conditions and complications
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 518 at risk

Adverse event: Ovarian and fallopian tube disorders NEC
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 8 affected / 518 at risk

Adverse event: Cervix disorders
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 518 at risk

Adverse event: Ovarian and fallopian tube cysts and neoplasms
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 518 at risk

Adverse event: Induced abortions
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 518 at risk

Adverse event: Obstetric therapeutic procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 518 at risk

Adverse event: Autosomal chromosomal abnormalities
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 518 at risk

Adverse event: Sex chromosomal abnormalities
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 518 at risk

Adverse event: Gastrointestinal and abdominal pains (excl oral and throat)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 518 at risk

Adverse event: Peripheral embolism and thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 518 at risk

Adverse event: Vascular hypertensive disorders NEC
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 518 at risk

Adverse event: non-site specific injuries NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 518 at risk

Adverse event: Non-site specific procedural complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 518 at risk

Adverse event: Neurological signs and symptoms NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 518 at risk

Adverse event: Seizures and seizure disorders NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 518 at risk

Adverse event: Rate and rythm disorders NEC
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 518 at risk

Adverse event: Foetal and neonatal diagnostic procedures
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 518 at risk

Adverse event: Anaemias NEC
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 518 at risk

Adverse event: Thrombocytopenias
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 518 at risk

Adverse event: Potassium imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 518 at risk

Adverse event: Urinary abnormalities
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 518 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 61 affected / 518 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 38 affected / 518 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 44 affected / 518 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 518 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 27 affected / 518 at risk

Adverse event: Pregnancy of unknown location
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 19 affected / 518 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 16 affected / 511 at risk

Adverse event: abortion not specified as induced or spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 11 affected / 511 at risk

Adverse event: maternal complications of pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 7 affected / 511 at risk

Adverse event: labor onset and length abnormalities
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 511 at risk

Adverse event: Still birth and foetal death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 6 affected / 511 at risk

Adverse event: Foetal complications NEC
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 511 at risk

Adverse event: Hypertension associated disorders of pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 511 at risk

Adverse event: Amniotic fluid and cavity disorders of pregnancy NEC
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 511 at risk

Adverse event: Gestational age and weight conditions
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 511 at risk

Adverse event: Haemorrhagic complications of pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 511 at risk

Adverse event: High risk pregnancies
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 511 at risk

Adverse event: Normal pregnancy, labour and delivery
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 511 at risk

Adverse event: foetal growth complications
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 511 at risk

Adverse event: maternal complications of delivery NEC
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 511 at risk

Adverse event: Postpartum complications NEC
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 511 at risk

Adverse event: Ovarian and fallopian tube disorders NEC
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 6 affected / 511 at risk

Adverse event: Cervix disorders
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 511 at risk

Adverse event: Ovarian and fallopian tube cysts and neoplasms
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 511 at risk

Adverse event: Menstruation and uterine bleeding NEC
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 511 at risk

Adverse event: Reproductive tract disorders NEC (excl neoplasms)
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 511 at risk

Adverse event: Vulvovaginal disorders NEC
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 511 at risk

Adverse event: Induced abortions
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 4 affected / 511 at risk

Adverse event: Autosomal chromosomal abnormalities
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 3 affected / 511 at risk

Adverse event: Arterial disorders congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 511 at risk

Adverse event: Cardiac septal defects congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 511 at risk

Adverse event: Cardiac valve disorders congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 511 at risk

Adverse event: Central nervous system disorders congenital NEC
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 511 at risk

Adverse event: Cerebral disorders congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 511 at risk

Adverse event: Gastrointestinal and abdominal pains (excl oral and throat)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 511 at risk

Adverse event: Peripheral embolism and thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 511 at risk

Adverse event: Vascular hypertensive disorders NEC
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 511 at risk

Adverse event: haemorrhages NEC
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 511 at risk

Adverse event: Abdominal and gastrointestinal infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 511 at risk

Adverse event: cytomegaloviral infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 511 at risk

Adverse event: infections NEC
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 511 at risk

Adverse event: Urinary tract infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 511 at risk

Adverse event: Renal and urinary tract injuries NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 511 at risk

Adverse event: Autonomic nervous system disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 511 at risk

Adverse event: Rate and rythm disorders NEC
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 511 at risk

Adverse event: protein analyses NEC
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 511 at risk

Adverse event: Nasal disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 511 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 45 affected / 511 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 41 affected / 511 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 511 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 511 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 32 affected / 511 at risk

Adverse event: Pregnancy of unknown location
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 29 affected / 511 at risk