Table 4

Adverse events (AEs) occurring in mother-infant pairs

MothersInfants
Mother (n=18)*No. of AEs in mother (n)AEInfant (n=17)*No. of AEs in infant (n)AE
1None12Lichen striatus
Upper respiratory tract infection
21Breast abscess‡ 2None
3None31Gastro-oesophageal reflux disease
51Rash51Nasopharyngitis
71Upper respiratory tract infection71Upper respiratory tract infection
82Candida infection81Candida infection
Crohn’s disease flare
101Viral upper respiratory tract infection10None
111Headache11None
131Psoriatic arthritis flare13None
142Nipple disorder142Vomiting
HeadacheNasopharyngitis
15None151Nasopharyngitis
162Upper respiratory tract infection162Upper respiratory tract infection
PneumoniaNasopharyngitis
SF†2Herpes zosterN/A
Galactostasis
Total number of mothers experiencing any AE10Total number of infants experiencing any AE8
Total number of AEs14Total number of AEs11
  • 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.