Table 1.
Incidence of AEs observed in the CAMMS223 long-term follow-up cohort through Year 12
| Incidence, % | EAIR per 100 patient-yearsa | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Y1 (N = 60) | Y2 (N = 60) | Y3 (N = 60) | Y4 (N = 60) | Y5 (N = 60) | Y6 (N = 60) | Y7 (N = 60) | Y8 (N = 58) | Y9 (N = 58) | Y10 (N = 57) | Y11 (N = 57) | Y12 (N = 52) | Y0–12 (N = 60) | |
| Any AE | 98.3 | 91.7 | 75.0 | 46.7 | 41.7 | 55.0 | 65.0 | 62.1 | 63.8 | 70.2 | 54.4 | 38.5 | 2321.5 |
| Serious AEs | 8.3 | 8.3 | 13.3 | 3.3 | 5.0 | 8.3 | 10.0 | 3.4 | 10.3 | 8.8 | 1.8 | 3.8 | 5.9 |
| Infections | 53.3 | 33.3 | 35.0 | 20.0 | 25.0 | 26.7 | 36.7 | 27.6 | 36.2 | 29.8 | 26.3 | 26.9 | 26.1 |
| Serious infections | 3.3 | 0 | 1.7 | 1.7 | 0 | 0 | 0 | 0 | 1.7 | 0 | 0 | 0 | 0.8 |
| Autoimmune AEsb | |||||||||||||
| Thyroid AEs | 1.7 | 15.0 | 15.0 | 6.7 | 1.7 | 1.7 | 3.3 | 0 | 1.7 | 0 | 3.5 | 0 | 6.6 |
| Serious thyroid AEs | 0 | 1.7 | 0 | 0 | 0 | 1.7 | 1.7 | 1.7 | 1.7 | 0 | 0 | 1.9 | 0.9 |
| Immune thrombocytopenia | 0 | 0 | 0 | 1.7 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.1 |
| Nephropathies | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Malignancies | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3.5 | 0 | 0 | 0.3 |
| Deaths | 0 | 0 | 0 | 0 | 0 | 0 | 1.7 | 0 | 0 | 0 | 0 | 0 | 0.1 |
AE adverse event, EAIR exposure-adjusted incidence rate, Y year
aEAIR = (Number of patients with first AE in the time interval)/(Total follow-up duration [years] of all patients within the time interval, censoring at the time of AE for patients counted in the numerator) × 100
bFirst occurrence of AE for a patient