Table 5 Incidence of ADAs at weeks 12 and 24, AEs, and TEAEs between treatment groups
Test (n = 112) | Reference (n = 56) | |
|---|---|---|
Immunogenicity assessment | ||
Incidence of ADAs at week 12, n (%) | 53 (61.63) | 23 (60.53) |
PD (95% CI) | 1.1 (−17.5, 19.7) | |
p value | 1.000 | |
Incidence of ADAs at week 24, n (%) | 51 (61.45) | 24 (63.16) |
PD (95% CI) | −1.7 (−20.3, 16.9) | |
p value | 1.000 | |
Safety assessments | ||
Patients with at least one AE, n (%) | 34 (30.4) | 20 (35.7) |
p value | 0.4889 | |
Number of TEAEs, n (%) | 60 (53.6) | 28 (50.0) |
p value | 0.7436 | |