Table 3. Safety analysis at Week 73 in the Safety population.
| 9BLMZ (N = 126) |
9BCLLfxZ (N = 122) |
9BDLLfxZ (N = 127) |
9DCLLfxZ (N = 124) |
9DCMZ (N = 120) |
Control (N = 126) |
Total (N = 745) |
|
|---|---|---|---|---|---|---|---|
| Participants with any adverse event – no. (%) | 126 (100.0%) | 122 (100.0%) | 127 (100.0%) | 124 (100.0%) | 120 (100.0%) | 125 (99.2%) | 744 (99.9%) |
| Grade 3 or higher adverse events |
|||||||
| Participants with ≥1 event– no. (%) | 69 (54.8%) | 68 (55.7%) | 78 (61.4%) | 75 (60.5%) | 72 (60.0%) | 79 (62.7%) | 441 (59.2%) |
| No. of events | 136 | 166 | 144 | 148 | 148 | 163 | 901 |
| No. of events related to study drug(s) (% of all events)^ | 49 (36.3%) | 57 (34.3%) | 56 (38.9%) | 58 (40.2%) | 37 (25.0%) | 56 (34.4%) | 313 (34.7%) |
| Serious adverse events | |||||||
| Participants with ≥1 event– no. (%) | 18 (14.3%) | 16 (13.1%) | 20 (15.8%) | 18 (14.5%) | 20 (16.7%) | 21 (16.7%) | 113 (15.2%) |
| No. of events | 26 | 29 | 30 | 26 | 31 | 32 | 174 |
| No. of events related to study drug(s) (% of all events)^ |
7 (26.9%) | 11 (37.9%) | 11 (36.7%) | 11 (42.3%) | 6 (19.4%) | 8 (25.0%) | 54 (31.0%) |
| Death from any cause – no. (%) | 3 (2.4%) | 1 (0.8%) | 3 (2.4%) | 4 (3.2%) | 2 (1.7%) | 2 (1.6%) | 15 (2.0%) |
| Adverse event of special interest | |||||||
| Participants with ≥1 event– no. (%) |
35 (27.8%) | 33 (27.1%) | 25 (19.7%) | 33 (26.6%) | 26 (21.7%) | 26 (20.6%) | 178 (23.9%) |
| Participants with any Grade 3-4 increase in ALT or AST– no. (%) | 23 (18.3%) | 17 (13.9%) | 8 (6.3%) | 18 (14.5%) | 12 (10.0%) | 9 (7.1%) | 87 (11.7%) |
| Participants with any Grade 3-4 leukopenia, anemia, or thrombocytopenia – no. (%) |
11 (8.7%) | 9 (7.4%) | 10 (7.9%) | 13 (10.5%) | 9 (7.5%) | 13 (10.3%) | 65 (8.7%) |
| Participants with any Grade 3-4 peripheral neuropathy – no. (%) |
4 (3.2%) | 5 (4.1%) | 9 (7.1%) | 3 (2.4%) | 3 (2.5%) | 6 (4.8%) | 30 (4.0%) |
| Participants with any Grade 3-4 optic neuritis – no. (%) | 0 (0.0%) | 1 (0.8%) | 0 (0.0%) | 1 (0.8%) | 0 (0.0%) | 2 (1.6%) | 4 (0.5%) |
| Participants with any Grade 3-4 QT corrected* interval prolonged – no. (%) |
0 (0.0%) | 4 (3.3%) | 0 (0.0%) | 0 (0.0%) | 5 (4.2%) | 0 (0.0%) | 9 (1.2%) |
| Participants with permanent discontinuation of any drug due to adverse event – no. (%) |
26 (20.6%) | 32 (26.2%) | 35 (27.6%) | 29 (23.4%) | 19 (15.8%) | 51 (40.5%) | 192 (25.8%) |
Safety population is all randomized participants who had received at least one dose of study treatment.
^
related is defined as at least a reasonable possibility to be caused by one or more drugs in the regimen;
*
QT interval corrected according to the Fridericia formula. ALT denotes alanine transaminase, AST aspartate aminotransferase