. 2018 Jul 2;24(12):2494–2500. doi: 10.1093/ibd/izy160

Table 5:

Pregnancy Outcomes in Cases Identified in Noninterventional Safety Studies and Spontaneous AE Reporting

Cases of Exposure, No. (% of Identified Cases)	RA	Indication Not Reported	All
	n = 27 Maternal Cases	n = 15 Maternal Cases	n = 42 Maternal Cases
	n = 1 Paternal Case	n = 2 Paternal Cases	n = 3 Paternal Cases
Healthy newborn^a	5 (17.9)	2 (11.8)^b	7 (15.6)^b
Medical termination	1 (3.6)	0 (0.0)	1 (2.2)
Fetal death	0 (0.0)	0 (0.0)	0 (0.0)
Neonatal death	0 (0.0)	0 (0.0)	0 (0.0)
Congenital malformation	1 (3.6)	0 (0.0)	1 (2.2)
Spontaneous abortion	3 (10.7)	0 (0.0)	3 (6.7)
Pending or lost to follow-up	18 (64.3)^b	15 (88.2)^b	33 (73.3)^c

^aIncludes preterm births (n = 3).

^bCases of maternal exposure except for 1 paternal case.

^cCases of maternal exposure except for 2 paternal cases.