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
