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 | |
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 |
Crohn’s disease flare | |||||
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 |
Headache | Nasopharyngitis | ||||
15 | None | 15 | 1 | Nasopharyngitis | |
16 | 2 | Upper respiratory tract infection | 16 | 2 | Upper respiratory tract infection |
Pneumonia | Nasopharyngitis | ||||
SF† | 2 | Herpes zoster | N/A | ||
Galactostasis | |||||
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.