Table 5 Neutropaenia day 0 severity grade compared to maximum severity grade at follow up, safety population
Study-T | ASAQ | AL | |
|---|---|---|---|
(>5 years) | N = 482* | N = 490* | |
Neutropenia grade at day 0 | Maximum Neutropenia grade after day 0 | Patients N (%) | |
0 | 0 | 332 (68.9) | 325 (66.3) |
1 | 0 | 33 (6.8) | 25 (5.1) |
2 | 0 | 2 (0.4) | 2 (0.4) |
missing | 0 | 3 (0.6) | 3 (0.6) |
0 | 1 | 59 (12.2) | 73 (14.9) |
1 | 1 | 28 (5.8) | 31 (6.3) |
2 | 1 | 3 (0.6) | 7 (1.4) |
3 | 1 | 0 (0.0) | 2 (0.4) |
missing | 1 | 4 (0.8) | 3 (0.6) |
0 | 2 | 6 (1.2) | 7 (1.4) |
1 | 2 | 6 (1.2) | 5 (1.0) |
2 | 2 | 6 (1.2) | 2 (0.4) |
3 | 2 | 0 (0.0) | 1 (0.2) |
1 | 3 | 2 (0.4) | 1 (0.2) |
3 | 3 | 1 (0.2) | 0 (0.0) |
Any worsening after baseline | 73 (15.1) | 86 (17.6) | |
Study-E | ASAQ | AL | |
(6-59 months) | N = 142* | N = 143* | |
Neutropenia grade at day 0 | Maximum Neutropenia grade after day 0 | Patients N (%) | |
0 | 0 | 121 (85.2) | 125 (87.4) |
1 | 0 | 3 (2.1) | 3 (2.1) |
missing | 0 | 9 (6.3) | 7 (4.9) |
0 | 1 | 6 (4.2) | 6 (4.2) |
1 | 1 | 3 (2.1) | 2 (1.4) |
Any worsening after baseline | 6 (4.2) | 6 (4.2) | |