Table 3.
Safety summary for patients who participated in the vaccination substudy and for those who did not
| Event | Participated n = 29 |
Did not participate n = 17 |
Total cohort 2a n = 46 |
|---|---|---|---|
| Deaths | 0 | 0 | 0 |
| SAEs | 4 (13.8)b | 1 (5.9) | 5 (10.9) |
| Related SAEsc | 2 (6.9) | 0 | 2 (4.3) |
| Discontinued due to SAEs | 0 | 0 | 0 |
| AEs | 29 (100.0) | 15 (88.2) | 44 (95.7) |
| Related AEs | 23 (79.3) | 7 (41.2) | 30 (65.2) |
| Discontinued due to AEs | 0 | 1 (5.9) | 1 (2.2) |
Data are number (%) of patients. Cohort 2 included all patients aged 2–5 years
aIncludes all patients who did or did not participate in the vaccination substudy
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)
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)
AE adverse event, SAE serious adverse event