Table 3 Safety summary of treatment-emergent adverse events over the 24-week treatment period and corresponding incidence rate ratios (Safety population)
Pts with ≥1 event; % (n) | M3.0 (N=58) | IRR[M3.0] | M4.5 (N=185) | IRR[M4.5] | tM6.0 (N=186) | IRR[tM6.0] | Pooled PBO (N=280) |
|---|---|---|---|---|---|---|---|
a AE (any grade) | 91.4% (53) | 1.2 | 87.0% (161) | 1.1 | 86.0% (160) | 1.1 | 77.5% (217) |
AE leading to death | 0 | 0 | 0.5% (1) | 1.3 | 0.5% (1) | 1.3 | 0.4% (1) |
Serious AE (non-fatal) | 10.3% (6) | 1.9 | 13.0% (24) | 2.4 | 13.4% (25) | 2.5 | 5.4% (15) |
Severe AE (grades 3 or 4) | 15.5% (9) | 0.8 | 26.5% (49) | 1.4 | 25.3% (47) | 1.3 | 19.3% (54) |
TEAE leading to permanent discontinuation | 24.1% (14) | 4.8 | 15.7% (29) | 3.1 | 24.2% (45) | 4.8 | 5.0% (14) |
TRAE leading to permanent discontinuation | 12.1% (7) | 3.1 | 12.4% (23) | 3.2 | 21.5% (40) | 5.5 | 3.9% (11) |
b Mild / Moderate | 5.2% (3) | 7.0% (13) | 14.0% (26) | 3.9% (11) | |||
bSevere | 6.9% (4) | 4.7% (9) | 6.5% (12) | 0 |