Study: NCT02491437

Adverse event: abortions spontaneous (related to the mother)
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 12 affected / 518 at risk

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

Adverse event: labour onset and length abnormalities (related to the mother)
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 12 affected / 518 at risk

Adverse event: abortion not specified as induced or spontaneous (related to the mother)
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 13 affected / 518 at risk

Adverse event: gestational age and weight conditions (related to the mother)
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 7 affected / 518 at risk

Adverse event: still birth and foetal death (related to the mother)
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 518 at risk

Adverse event: Hypertension associated disorders of pregnancy (related to the mother)
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 518 at risk

Adverse event: placental abnormalities (excl neoplasms) (related to the mother)
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 518 at risk

Adverse event: haeomorrhagic complications of pregnancy (related to the mother)
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 518 at risk

Adverse event: abortion related conditions and complications (related to the mother)
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 518 at risk

Adverse event: pregnancy complicated by maternal disorders (related to the mother)
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 518 at risk

Adverse event: amniotic fluid and cavity disorders of pregnancy (related to the mother)
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 518 at risk

Adverse event: ovarium and fallopian tube disorders (related to the mother)
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 11 affected / 518 at risk

Adverse event: vulvovaginal disorders (related to the mother)
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 518 at risk

Adverse event: induced abortions (related to the mother)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 4 affected / 518 at risk

Adverse event: gastrointestinal and abdominal pains (excl oral and throat) (related to the mother)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 518 at risk

Adverse event: flatulence, bloating and distension (related to the mother)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 518 at risk

Adverse event: viral infections (related to the mother)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 518 at risk

Adverse event: central nervous system vascular disorders (related to the mother)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 518 at risk

Adverse event: renal obstructive disorders (related to the mother)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 518 at risk

Adverse event: urinary tract signs and symptoms (related to the mother)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 518 at risk

Adverse event: thyroid neoplasms malignant (related to the mother)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 518 at risk

Adverse event: peripheral embolism and thrombosis (related to the mother)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 518 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 50 affected / 518 at risk

Adverse event: abortions spontaneous (related to the mother)
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 14 affected / 512 at risk

Adverse event: maternal complications of pregnancy (related to the mother)
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 11 affected / 512 at risk

Adverse event: labour onset and length abnormalities (related to the mother)
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 6 affected / 512 at risk

Adverse event: abortion not specified as induced or spontaneous (related to the mother)
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 512 at risk

Adverse event: gestational age and weight conditions (related to the mother)
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 6 affected / 512 at risk

Adverse event: still birth and foetal death (related to the mother)
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 512 at risk

Adverse event: Hypertension associated disorders of pregnancy (related to the mother)
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 512 at risk

Adverse event: placental abnormalities (excl neoplasms) (related to the mother)
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 512 at risk

Adverse event: haeomorrhagic complications of pregnancy (related to the mother)
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 512 at risk

Adverse event: abortion related conditions and complications (related to the mother)
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 512 at risk

Adverse event: pregnancy complicated by maternal disorders (related to the mother)
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 512 at risk

Adverse event: maternal complications of delivery (related to the mother)
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 512 at risk

Adverse event: postpartum complications (related to the mother)
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 512 at risk

Adverse event: ovarium and fallopian tube disorders (related to the mother)
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 15 affected / 512 at risk

Adverse event: vulvovaginal disorders (related to the mother)
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 512 at risk

Adverse event: Uterine disorders (related to the mother)
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 512 at risk

Adverse event: induced abortions (related to the mother)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 512 at risk

Adverse event: obstetric therapeutic procedures (related to the mother)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 512 at risk

Adverse event: gastrointestinal and abdominal pains (excl oral and throat) (related to the mother)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 512 at risk

Adverse event: large intestinal stenosis and obstruction (related to the mother)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 512 at risk

Adverse event: upper respiratory tract infections (related to the mother)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 512 at risk

Adverse event: urinary tract infections (related to the mother)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 512 at risk

Adverse event: facial cranial nerve disorders (related to the mother)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 512 at risk

Adverse event: non-site specific injuries (related to the mother)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 512 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 35 affected / 512 at risk

Adverse event: cardiac septal defects congenital (fetus/newborn)
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 5 affected / 221 at risk

Adverse event: cardiac disorders congenital NEC (fetus/newborn)
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 221 at risk

Adverse event: persistant foetal circulation disorders (fetus/newborn)
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 221 at risk

Adverse event: muskuloskeletal and connective tissue disorders of limbs congenital (fetus/newborn)
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 221 at risk

Adverse event: renal disorders congenital (fetus/newborn)
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 221 at risk

Adverse event: central nervous system disorder congenital NEC (fetus/newborn)
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 221 at risk

Adverse event: intestinal disorders congenital (fetus/newborn)
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 221 at risk

Adverse event: lymphatic system disorders congenital (fetus/newborn)
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 221 at risk

Adverse event: Non-site specific muscle disorders congenital (fetus/newborn)
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 221 at risk

Adverse event: sex chromosomal abnormalities (fetus/newborn)
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 221 at risk

Adverse event: lower respiratory tract and lung infections (fetus/newborn)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 221 at risk

Adverse event: sepsis, bacteraemia, viraemia and fungaemia NEC (fetus/newborn)
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 221 at risk

Adverse event: gestational age and weight conditions (fetus/newborn)
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 6 affected / 221 at risk

Adverse event: foetal complications NEC (fetus/newborn)
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 221 at risk

Adverse event: neonatal hypoxic conditions (fetus/newborn)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 221 at risk

Adverse event: pulmonary oedemas (fetus/newborn)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 221 at risk

Adverse event: breathing abnormalities (fetus/newborn)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 221 at risk

Adverse event: rate and rythm disorders NEC (fetus/newborn)
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 221 at risk

Adverse event: ischaemic coronary artery disorders (fetus/newborn)
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 221 at risk

Adverse event: encephalopathies NEC (fetus/newborn)
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 221 at risk

Adverse event: hydrocephalic conditions (fetus/newborn)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 221 at risk

Adverse event: foetal and neonatal diagnostic procedures (fetus/newborn)
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 221 at risk

Adverse event: coagulopathies (fetus/newborn)
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: The number of fetus/newborn was 221 in the dydrogesterone group and 201 in the micronized progesterone group. Frequencies in the Adverse Event table are provided based on the safety sample.
Frequency: 1 affected / 221 at risk

Adverse event: cardiac septal defects congenital (fetus/newborn)
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 7 affected / 201 at risk

Adverse event: cardiac disorders congenital NEC (fetus/newborn)
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 4 affected / 201 at risk

Adverse event: persistant foetal circulation disorders (fetus/newborn)
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 4 affected / 201 at risk

Adverse event: great vessel disorders congenital (fetus/newborn)
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 201 at risk

Adverse event: lower respiratory tract and lung infections (fetus/newborn)
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 201 at risk

Adverse event: sepsis, bacteraemia, viraemia and fungaemia NEC (fetus/newborn)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 201 at risk

Adverse event: infections NEC (fetus/newborn)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 201 at risk

Adverse event: respiratory syncytial viral infections (fetus/newborn)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 201 at risk

Adverse event: gestational age and weight conditions (fetus/newborn)
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 201 at risk

Adverse event: foetal complications NEC (fetus/newborn)
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 201 at risk

Adverse event: foetal growth complications (fetus/newborn)
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 201 at risk

Adverse event: neonatal hypoxic conditions (fetus/newborn)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 201 at risk

Adverse event: pulmonary oedemas (fetus/newborn)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 201 at risk

Adverse event: respiratory failures (excl neonatal) (fetus/newborn)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 201 at risk

Adverse event: rate and rythm disorders NEC (fetus/newborn)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 201 at risk

Adverse event: structural brain disorders NEC (fetus/newborn)
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 201 at risk

Adverse event: foetal and neonatal diagnostic procedures (fetus/newborn)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 201 at risk

Adverse event: colitis (excl infective) (fetus/newborn)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 201 at risk

Adverse event: intestinal ulcers and perforation NEC (fetus/newborn)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 201 at risk