Subjects with ≥ 1 TEAE, n (%)
|
169 (52.2)
|
184 (56.8)
|
Study drug-related
|
88 (27.2)
|
99 (30.6)
|
TEAEs reported in ≥ 5% of subjects in either treatment group
|
ISR
|
16 (4.9)
|
22 (6.8)
|
Nasopharyngitis
|
17 (5.2)
|
20 (6.2)
|
Upper respiratory tract infection
|
17 (5.2)
|
20 (6.2)
|
Neutropenia
|
14 (4.3)
|
17 (5.2)
|
Subjects with ≥ 1 TESAE, n (%)
|
10 (3.1)
|
16 (4.9)
|
Subjects with ≥ 1 TEAE leading to study drug discontinuation, n (%)
|
5 (1.5)
|
8 (2.5)
|
Subjects with ≥ 1 TEAE classified as hypersensitivity/allergic reactions, n (%)
|
2 (0.6)
|
4 (1.2)
|
Subjects with ≥ 1 TEAE classified as ISR, n (%)
|
16 (4.9)
|
22 (6.8)
|
Subjects with ≥ 1 TEAE classified as infection, n (%)
|
97 (29.9)
|
103 (31.8)
|
Subjects with ≥ 1 TEAE classified as malignancy, n (%)
|
1 (0.3)a
|
0
|
Total number of TEAEs leading to death
|
0
|
0
|