Skip to main content

Table 3 Safety summary for patients who participated in the vaccination substudy and for those who did not

From: Maintenance of antibody response to diphtheria/tetanus vaccine in patients aged 2–5 years with polyarticular-course juvenile idiopathic arthritis receiving subcutaneous abatacept

EventParticipated
n = 29
Did not participate
n = 17
Total cohort 2a
n = 46
Deaths000
SAEs4 (13.8)b1 (5.9)5 (10.9)
Related SAEsc2 (6.9)02 (4.3)
Discontinued due to SAEs000
AEs29 (100.0)15 (88.2)44 (95.7)
Related AEs23 (79.3)7 (41.2)30 (65.2)
Discontinued due to AEs01 (5.9)1 (2.2)
  1. Data are number (%) of patients. Cohort 2 included all patients aged 2–5 years
  2. aIncludes all patients who did or did not participate in the vaccination substudy
  3. bSAEs included febrile convulsions, tendon disorder, limb abscess, cellulitis and an overdose of mild intensity (administration of a higher abatacept dose due to misclassification by weight tier)
  4. cTreatment-related SAEs included a limb abscess that was severe in intensity and an overdose of mild intensity (administration of a higher abatacept dose due to misclassification by weight tier)
  5. AE adverse event, SAE serious adverse event
\