Study: NCT03871491

Adverse event: Maternal death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: This event applies to mothers only and not neonates (stillbirth or live birth).
Frequency: 3 affected / 14589 at risk

Adverse event: Vomited within 15 minutes after study drug administration
Serious: no
Organ System: Gastrointestinal disorders
Notes: This event applies to mothers only and not neonates (stillbirth or live birth).
Frequency: 311 affected / 14589 at risk

Adverse event: Feeling faint or dizzy
Serious: no
Organ System: Cardiac disorders
Notes: This event applies to mothers only and not neonates (stillbirth or live birth).
Frequency: 241 affected / 14589 at risk

Adverse event: Nausea/vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: This event applies to mothers only and not neonates (stillbirth or live birth).
Frequency: 45 affected / 14589 at risk

Adverse event: Diarrhea/loose stools
Serious: no
Organ System: Gastrointestinal disorders
Notes: This event applies to mothers only and not neonates (stillbirth or live birth).
Frequency: 76 affected / 14589 at risk

Adverse event: Severe abdominal or uterine pain
Serious: no
Organ System: General disorders
Notes: This event applies to mothers only and not neonates (stillbirth or live birth).
Frequency: 170 affected / 14589 at risk

Adverse event: Foul-smelling vaginal discharge
Serious: no
Organ System: General disorders
Notes: This event applies to mothers only and not neonates (stillbirth or live birth).
Frequency: 37 affected / 14589 at risk

Adverse event: Severe vaginal pain
Serious: no
Organ System: General disorders
Notes: This event applies to mothers only and not neonates (stillbirth or live birth).
Frequency: 309 affected / 14589 at risk

Adverse event: GI symptoms and other reported side effects
Serious: no
Organ System: Gastrointestinal disorders
Notes: This event applies to mothers only and not neonates (stillbirth or live birth).
Frequency: 119 affected / 14589 at risk

Adverse event: Stillbirth
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: This event applies to neonates only (stillbirth or live birth) and not mothers.
Frequency: 1 affected / 14686 at risk

Adverse event: Neonatal death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: This event applies to neonates only (stillbirth or live birth) and not mothers.
Frequency: 9 affected / 14627 at risk

Adverse event: Other neonatal serious adverse event
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: This event applies to neonates only (stillbirth or live birth) and not mothers.
Frequency: 1 affected / 14627 at risk

Adverse event: Pyloric stenosis
Serious: no
Organ System: Gastrointestinal disorders
Notes: This event applies to neonates (stillbirth or live birth) and not mothers.
Frequency: 8 affected / 14627 at risk

Adverse event: Maternal death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: This event applies to mothers only and not neonates (stillbirth or live birth).
Frequency: 1 affected / 14687 at risk

Adverse event: Other maternal serious adverse event
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: This event applies to mothers only and not neonates (stillbirth or live birth).
Frequency: 2 affected / 14687 at risk

Adverse event: Vomited within 15 minutes after study drug administration
Serious: no
Organ System: Gastrointestinal disorders
Notes: This event applies to mothers only and not neonates (stillbirth or live birth).
Frequency: 279 affected / 14687 at risk

Adverse event: Feeling faint or dizzy
Serious: no
Organ System: Cardiac disorders
Notes: This event applies to mothers only and not neonates (stillbirth or live birth).
Frequency: 309 affected / 14687 at risk

Adverse event: Nausea/vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: This event applies to mothers only and not neonates (stillbirth or live birth).
Frequency: 48 affected / 14687 at risk

Adverse event: Diarrhea/loose stools
Serious: no
Organ System: Gastrointestinal disorders
Notes: This event applies to mothers only and not neonates (stillbirth or live birth).
Frequency: 66 affected / 14687 at risk

Adverse event: Severe abdominal or uterine pain
Serious: no
Organ System: General disorders
Notes: This event applies to mothers only and not neonates (stillbirth or live birth).
Frequency: 208 affected / 14687 at risk

Adverse event: Foul-smelling vaginal discharge
Serious: no
Organ System: General disorders
Notes: This event applies to mothers only and not neonates (stillbirth or live birth).
Frequency: 83 affected / 14687 at risk

Adverse event: Severe vaginal pain
Serious: no
Organ System: General disorders
Notes: This event applies to mothers only and not neonates (stillbirth or live birth).
Frequency: 329 affected / 14687 at risk

Adverse event: GI symptoms and other reported side effects
Serious: no
Organ System: Gastrointestinal disorders
Notes: This event applies to mothers only and not neonates (stillbirth or live birth).
Frequency: 110 affected / 14687 at risk

Adverse event: Stillbirth
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: This event applies to neonates only (stillbirth or live birth) and not mothers.
Frequency: 1 affected / 14781 at risk

Adverse event: Neonatal death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: This event applies to neonates only (stillbirth or live birth) and not mothers.
Frequency: 5 affected / 14725 at risk

Adverse event: Other neonatal serious adverse event
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: This event applies to neonates only (stillbirth or live birth) and not mothers.
Frequency: 2 affected / 14725 at risk

Adverse event: Pyloric stenosis
Serious: no
Organ System: Gastrointestinal disorders
Notes: This event applies to neonates (stillbirth or live birth) and not mothers.
Frequency: 3 affected / 14726 at risk