Patients, n (%)
|
Randomized
|
216 (100)
|
276 (100)
|
39 (100)
|
66 (100)
|
37 (100)
|
56 (100)
|
Treated
|
215 (99.5)
|
275 (99.6)
|
39 (100)
|
66 (100)
|
37 (100)
|
56 (100)
|
Completeda
|
1 (0.5)
|
2 (0.7)
|
0
|
0
|
0
|
0
|
Withdrawn from treatment and/or studya
|
214 (99.5)
|
273 (99.3)
|
39 (100)
|
66 (100)
|
37 (100)
|
56 (100)
|
Primary reason for withdrawal from treatment (safety analysis population), n (%)
|
Unsatisfactory response-efficacy
|
3 (1.4)
|
6 (2.2)
|
1 (2.6)
|
1 (1.5)
|
2 (5.4)
|
2 (3.6)
|
Adverse event
|
16 (7.4)
|
11 (4.0)
|
2 (5.1)
|
5 (7.6)
|
2 (5.4)
|
6 (10.7)
|
Study termination
|
163 (75.8)
|
217 (78.9)
|
31 (79.5)
|
54 (81.8)
|
30 (81.1)
|
45 (80.4)
|
Subject request
|
19 (8.8)
|
25 (9.1)
|
1 (2.6)
|
4 (6.1)
|
3 (8.1)
|
3 (5.4)
|
Death
|
3 (1.4)
|
1 (0.4)
|
0
|
0
|
0
|
0
|
Recurrent episode of ARIA-E
|
1 (0.5)
|
0
|
0
|
0
|
0
|
0
|
All other reasonsb
|
9 (4.2)
|
13 (4.7)
|
4 (10.2)
|
2 (3.0)
|
0
|
0
|
Person-years of study drug exposurec
|
N
|
215
|
275
|
39
|
66
|
37
|
56
|
Mean (SD)
|
0.9 (0.58)
|
1.0 (0.58)
|
1.0 (0.53)
|
1.0 (0.61)
|
1.0 (5.4)
|
1.0 (5.4)
|
Median (range)
|
1 (0–3)
|
1 (0–3)
|
1 (0–2)
|
1 (0–3)
|
1 (0–2)
|
1 (0–2)
|