Table II.

Primary outcome and secondary outcomes of participants in this trial.

	rhG-CSF	Placebo	Relative risk	P value
	no./total		no. (%) (95% CI)
Primary outcome
Live birth after 20 weeks of gestation	45/76 (59.2)	48/74 (64.9)	0.9 (0.7, 1.2)	0.48
Secondary outcomes
Pregnancy outcomes
Clinical pregnancy at 6 weeks	67/76 (88.2)	69/74 (93.2)	0.9 (0.9, 1.0)	0.28
Ongoing pregnancy at 8 weeks	51/76 (67.1)	59/74 (79.7)	0.8 (0.7, 1.0)	0.09
Ongoing pregnancy at 12 weeks	45/76 (59.2)	51/74 (68.9)	0.9 (0.7, 1.1)	0.22
Live birth after 24 weeks of gestation	45/76 (59.2)	48/74 (64.9)	0.9 (0.7, 1.2)	0.48
Live birth after 34 weeks of gestation	45/76 (59.2)	42/74 (56.8)	1.0 (0.8, 1.4)	0.76
Ectopic pregnancy	1/76 (1.3)	0/74 (0.0)	NA	NA
Miscarriagea	28/76 (36.8)	25/74 (33.8)	1.1 (0.7, 1.7)	0.70
Stillbirth	0/76 (0.0)	0/76 (0.0)	NA	NA
Preterm birth (before 37 weeks 0 days of gestation)	5/45 (11.1)	8/48 (16.7)	0.7 (0.3, 2.0)	0.54
Infant birth weight (g)
Median	3420.0	3300.0	NA	NA
Range	3005–3920	2690–3610	NA	NA
Neonatal outcomesb
Infants discharged alive from hospital	46/46 (100.0)	49/49 (100.0)	NA	NA
Any congenital anomaly	1/46 (2.2)	1/49 (2.0)	0.9 (0.1, 13.4)	0.93
Adverse eventsc	n/N (%)	n/N(%)
Maternal adverse events	52/76 (68.4)	43/74 (58.1)	1.2 (0.9, 1.5)	0.20
Serious adverse events	4/76 (5.2)	2/74 (2.7)	1.9 (0.3, 10.3)	0.43
Incidence of anti-drug antibody formation	0/76 (0.0)	NA	NA	NA

^aMiscarriage was defined as spontaneous loss of a pregnancy less than 24 weeks of gestation; the median gestational age at miscarriage was 6.0 weeks (interquartile range, 6–7) in the rhG-CSF and 6.5 weeks (interquartile range, 6–9) in the placebo group. There were three pregnancies of unknown location in the rhG-CSF group.

^bThe end point is listed per neonate.

^cPlease see Supplementary Table SI for details.