Month of onset of AE | 0-1 | >1-2 | >2-3 | >3-6 | >6-9 | >9-12 | >12 |
---|---|---|---|---|---|---|---|
Subjects at each time point, n | Â | Â | Â | Â | Â | Â | Â |
PBO/RIS | 48 | 45 | 44 | 43 | 22 | 0 | 0 |
RIS/RIS | 292 | 266 | 254 | 242 | 136 | 67 | 42 |
Direct-enroll | 50 | 44 | 41 | 40 | 19 | 0 | 0 |
Any AE, n (%) | Â | Â | Â | Â | Â | Â | Â |
PBO/RIS | 39 (81) | 11 (24) | 9 (20) | 21 (49) | 3 (14) | – | – |
RIS/RIS | 197 (67) | 82 (31) | 80 (31) | 117 (48) | 51 (38) | 33 (49) | 8 (19) |
Direct-enroll | 40 (80) | 21 (48) | 18 (44) | 23 (58) | 3 (16) | – | – |
Somnolence, n (%) | Â | Â | Â | Â | Â | Â | Â |
PBO/RIS | 15 (31) | 1 (2) | 2 (5) | 1 (2) | 0 | – | – |
RIS/RIS | 55 (19) | 4 (2) | 8 (3) | 9 (4) | 2 (1) | 3 (4) | 0 |
Direct-enroll | 16 (32) | 4 (9) | 2 (5) | 2 (5) | 0 | – | – |
Tremor, n (%) | Â | Â | Â | Â | Â | Â | Â |
PBO/RIS | 6 (13) | 0 | 0 | 0 | 0 | – | – |
RIS/RIS | 23 (8) | 2 (1) | 3 (1) | 5 (2) | 2 (1) | 0 | 0 |
Direct-enroll | 3 (6) | 1 (2) | 0 | 0 | 0 | – | – |
Insomnia, n (%) | Â | Â | Â | Â | Â | Â | Â |
PBO/RIS | 5 (10) | 1 (2) | 0 | 1 (2) | 0 | – | – |
RIS/RIS | 24 (8) | 4 (2) | 5 (2) | 8 (3) | 4 (3) | 2 (3) | 1 (2) |
Direct-enroll | 3 (6) | 1 (2) | 1 (2) | 1 (3) | 0 | – | – |
Hypertonia, n (%) | Â | Â | Â | Â | Â | Â | Â |
PBO/RIS | 6 (13) | 0 | 0 | 0 | 2 (9) | – | – |
RIS/RIS | 27 (9) | 1 (<1) | 6 (2) | 7 (3) | 0 | 0 | 0 |
Direct-enroll | 6 (12) | 1 (2) | 0 | 2 (5) | 0 | – | – |
Weight increase, n (%) | Â | Â | Â | Â | Â | Â | Â |
PBO/RIS | 1 (2) | 1 (2) | 0 | 5 (12) | 0 | – | – |
RIS/RIS | 15 (5) | 6 (2) | 5 (2) | 10 (4) | 4 (3) | 2 (3) | 0 |
Direct-enroll | 11 (22) | 2 (5) | 1 (2) | 3 (8) | 0 | – | – |