Table 4.

Maternal serious adverse events^*

Treatment	Adverse event	Investigator assessment of drug relatedness	Comments
Retosiban	Post-partum haemorrhage	No	The event occurred >30 days post-discontinuation of retosiban
Retosiban	Musculoskeletal pain	No	The event was secondary to a motor vehicle accident and occurred >26 days post-discontinuation of retosiban
Placebo	Amniotic fluid volume decreased	No	AFI decreased to 5.8 cm 2 days after completion of placebo infusion. Event resolved as AFI subsequently increased to 6.6 cm and 7.1 cm
Placebo	Hypertension	No	Elevated systolic and diastolic blood pressure at 3-week post-partum visit, approximately 5 weeks after completion of placebo infusion. Admitted to hospital and blood pressure normalized with antihypertensives

AFI, amniotic fluid index.

^*A serious adverse event is any untoward medical occurrence that results in death, is life threatening, results in hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, drug-induced liver injury, or any other event deemed medically important.