Table 4

Adverse events (AEs) occurring in mother-infant pairs

Mothers			Infants
Mother (n=18)^*	No. of AEs in mother (n)	AE	Infant (n=17)*	No. of AEs in infant (n)	AE
1	None		1	2	Lichen striatus
1	None		1	2	Upper respiratory tract infection
2	1	Breast abscess‡	2	None
3	None		3	1	Gastro-oesophageal reflux disease
5	1	Rash	5	1	Nasopharyngitis
7	1	Upper respiratory tract infection	7	1	Upper respiratory tract infection
8	2	Candida infection	8	1	Candida infection
8	2	Crohn’s disease flare	8	1	Candida infection
10	1	Viral upper respiratory tract infection	10	None
11	1	Headache	11	None
13	1	Psoriatic arthritis flare	13	None
14	2	Nipple disorder	14	2	Vomiting
14	2	Headache	14	2	Nasopharyngitis
15	None		15	1	Nasopharyngitis
16	2	Upper respiratory tract infection	16	2	Upper respiratory tract infection
16	2	Pneumonia	16	2	Nasopharyngitis
SF†	2	Herpes zoster	N/A
SF†	2	Galactostasis	N/A
Total number of mothers experiencing any AE		10	Total number of infants experiencing any AE		8
Total number of AEs		14	Total number of AEs		11

The safety analysis included all mothers who received at least one dose of CZP and the infants of all mothers who participated in the study. The safety follow-up period extended up to 5 weeks (±5 days) after the final sample was collected. AEs in mother-infant pairs were not necessarily associated temporally.
Bold text indicates serious adverse event (SAE).
*Mother-infant pairs are numbered as per table 2.
†SF, screen failure: mother discontinued from study due to AE of herpes zoster during screening period.
‡Breast abscess during screening period, which resolved prior to sampling.
CZP, certolizumab pegol; N/A, not applicable as the mother did not enter the sampling period.