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) | |
* Shift tables were created for all patients with at least one neutrophil count available after day 0.