|
13 | 13 | Grade 2 6 (4.5%) 10 (7.5%) 7 (5.3%)
|
14 | 14 | Grade 3 18 (13.4%) 14 (10.4%) 16 (12.1%)
|
15 | 15 | Grade 4 15 (11.2%) 20 (14.9%) 18 (13.6%)
|
16 |
| - Grade 5 76 (56.7%) 70 (52.2%) 75 (56.8%) |
17 |
| - Missing 0 0 0 |
| 16 | + Grade 5 (fatal outcome) 76 (56.7%) 70 (52.2%) 75 (56.8%) |
18 | 17 | Total number of patients with study drug withdrawn due to AE 0 0 0
|
19 | 18 | Total number of patients with dose modified/interrupted due to AE 0 0 0
|
20 | 19 | Total number of patients with treatment received for AE 0 0 0
|
|
38 | 37 | Grade 2 6 (4.5%) 10 (7.5%) 7 (5.3%)
|
39 | 38 | Grade 3 18 (13.4%) 14 (10.4%) 16 (12.1%)
|
40 | 39 | Grade 4 15 (11.2%) 20 (14.9%) 18 (13.6%)
|
41 |
| - Grade 5 76 (56.7%) 70 (52.2%) 75 (56.8%) |
| 40 | + Grade 5 (fatal outcome) 76 (56.7%) 70 (52.2%) 75 (56.8%) |
42 | 41 | Total number of patients with all non-fatal AEs resolved 84 (62.7%) 92 (68.7%) 97 (73.5%)
|
43 | 42 | Total number of patients with at least one unresolved or ongoing non-fatal AE 102 (76.1%) 110 (82.1%) 107 (81.1%)
|
44 | 43 | Total number of patients with at least one related AE 105 (78.4%) 108 (80.6%) 109 (82.6%)
|
|
58 | 57 | Grade 2 6 (4.5%) 10 (7.5%) 7 (5.3%)
|
59 | 58 | Grade 3 18 (13.4%) 14 (10.4%) 16 (12.1%)
|
60 | 59 | Grade 4 15 (11.2%) 20 (14.9%) 18 (13.6%)
|
61 |
| - Grade 5 76 (56.7%) 70 (52.2%) 75 (56.8%) |
62 |
| - Missing 0 0 0 |
| 60 | + Grade 5 (fatal outcome) 76 (56.7%) 70 (52.2%) 75 (56.8%) |
63 | 61 | Total number of patients with study drug withdrawn due to AE 27 (20.1%) 26 (19.4%) 30 (22.7%)
|
64 | 62 | Total number of patients with dose modified/interrupted due to AE 66 (49.3%) 76 (56.7%) 74 (56.1%)
|
65 | 63 | Total number of patients with treatment received for AE 98 (73.1%) 102 (76.1%) 103 (78.0%)
|
|
83 | 81 | Grade 2 6 (4.5%) 10 (7.5%) 7 (5.3%)
|
84 | 82 | Grade 3 18 (13.4%) 14 (10.4%) 16 (12.1%)
|
85 | 83 | Grade 4 15 (11.2%) 20 (14.9%) 18 (13.6%)
|
86 |
| - Grade 5 76 (56.7%) 70 (52.2%) 75 (56.8%) |
87 |
| - Missing 0 0 0 |
| 84 | + Grade 5 (fatal outcome) 76 (56.7%) 70 (52.2%) 75 (56.8%) |
88 | 85 | Total number of patients with study drug withdrawn due to AE 27 (20.1%) 26 (19.4%) 30 (22.7%)
|
89 | 86 | Total number of patients with dose modified/interrupted due to AE 66 (49.3%) 76 (56.7%) 74 (56.1%)
|
90 | 87 | Total number of patients with treatment received for AE 98 (73.1%) 102 (76.1%) 103 (78.0%)
|
|
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