Study: NCT03463577

Adverse event: Preeclampsia/eclampsia
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 874 affected / 16606 at risk

Adverse event: Intra-uterine infections
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 811 affected / 16606 at risk

Adverse event: Preterm delivery
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 1019 affected / 15767 at risk

Adverse event: Transfusion during delivery hospitalization
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 209 affected / 16335 at risk

Adverse event: Poor fetal growth
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 320 affected / 16606 at risk

Adverse event: Placental abruption
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 157 affected / 16606 at risk

Adverse event: Preterm pre-labor rupture of membranes
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 318 affected / 16022 at risk

Adverse event: Maternal deaths
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 2 affected / 16606 at risk

Adverse event: Stillbirths/fetal deaths without congenital anomalies
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 23 affected / 16368 at risk

Adverse event: Preeclampsia/eclampsia
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 588 affected / 16606 at risk

Adverse event: Intra-uterine infections
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 558 affected / 16606 at risk

Adverse event: Preterm delivery
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 1435 affected / 15551 at risk

Adverse event: Transfusion during delivery hospitalization
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 193 affected / 16062 at risk

Adverse event: Poor fetal growth
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 368 affected / 16606 at risk

Adverse event: Placental abruption
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 120 affected / 16606 at risk

Adverse event: Preterm pre-labor rupture of membranes
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 378 affected / 16022 at risk

Adverse event: Stillbirths/fetal deaths without congenital anomalies
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 39 affected / 16166 at risk

Adverse event: Preeclampsia/eclampsia
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 6 affected / 65 at risk

Adverse event: Intra-uterine infections
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 3 affected / 65 at risk

Adverse event: Preterm delivery
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 3 affected / 64 at risk

Adverse event: Transfusion during delivery hospitalization
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 1 affected / 64 at risk

Adverse event: Poor fetal growth
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 2 affected / 65 at risk

Adverse event: Preterm pre-labor rupture of membranes
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 2 affected / 65 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 1 affected / 65 at risk

Adverse event: Small for dates baby
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 1278 affected / 15892 at risk

Adverse event: Congenital anomalies of nervous system
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 46 affected / 16350 at risk

Adverse event: Congenital eye disorder
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 1142 affected / 16350 at risk

Adverse event: Congenital anomalies of ear, face or neck
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 266 affected / 16350 at risk

Adverse event: Congenital anomalies of cardiovascular system
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 399 affected / 16350 at risk

Adverse event: Respiratory tract malformation
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 225 affected / 16350 at risk

Adverse event: Clefts
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 32 affected / 16350 at risk

Adverse event: Congenital anomalies of upper gastrointestinal system
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 1109 affected / 16350 at risk

Adverse event: Congenital anomalies of lower gastrointestinal system
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 22 affected / 16350 at risk

Adverse event: Congenital genital malformation
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 355 affected / 16350 at risk

Adverse event: Congenital anomalies of renal system
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 128 affected / 16350 at risk

Adverse event: Congenital anomalies of musculoskeletal system
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 266 affected / 16350 at risk

Adverse event: Congenital anomalies of limb
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 116 affected / 16350 at risk

Adverse event: Congenital anomalies of integument
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 949 affected / 16350 at risk

Adverse event: Congenital anomaly
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 32 affected / 16350 at risk

Adverse event: Neonatal deaths
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 15 affected / 16350 at risk

Adverse event: Small for dates baby
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 1172 affected / 15626 at risk

Adverse event: Congenital anomalies of nervous system
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 38 affected / 16088 at risk

Adverse event: Congenital eye disorder
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 973 affected / 16088 at risk

Adverse event: Congenital anomalies of ear, face or neck
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 131 affected / 16088 at risk

Adverse event: Congenital anomalies of cardiovascular system
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 351 affected / 16088 at risk

Adverse event: Respiratory tract malformation
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 166 affected / 16088 at risk

Adverse event: Clefts
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 24 affected / 16088 at risk

Adverse event: Congenital anomalies of upper gastrointestinal system
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 609 affected / 16088 at risk

Adverse event: Congenital anomalies of lower gastrointestinal system
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 37 affected / 16088 at risk

Adverse event: Congenital genital malformation
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 297 affected / 16088 at risk

Adverse event: Congenital anomalies of renal system
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 95 affected / 16088 at risk

Adverse event: Congenital anomalies of musculoskeletal system
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 171 affected / 16088 at risk

Adverse event: Congenital anomalies of limb
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 111 affected / 16088 at risk

Adverse event: Congenital anomalies of integument
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 477 affected / 16088 at risk

Adverse event: Congenital anomaly
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 33 affected / 16088 at risk

Adverse event: Neonatal deaths
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 17 affected / 16088 at risk

Adverse event: Small for dates baby
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 7 affected / 60 at risk

Adverse event: Congenital eye disorder
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 6 affected / 68 at risk

Adverse event: Congenital anomalies of ear, face or neck
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 5 affected / 68 at risk

Adverse event: Congenital anomalies of cardiovascular system
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 1 affected / 68 at risk

Adverse event: Congenital anomalies of upper gastrointestinal system
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 1 affected / 68 at risk

Adverse event: Congenital genital malformation
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 3 affected / 68 at risk

Adverse event: Congenital anomalies of renal system
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 1 affected / 68 at risk

Adverse event: Congenital anomalies of musculoskeletal system
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 1 affected / 68 at risk

Adverse event: Congenital anomalies of integument
Serious: yes
Organ System: General disorders
Notes: No medical dictionary coding applied to this event
Frequency: 7 affected / 68 at risk