Table 6.
Summary of volunteers with TEAEs and DRAEs following a multiple dosing schedule with BI 1358894 in study 1402-0002
| + Midazolam (Days 1 and 14)a | − Midazolam (Days 2–13)b | Total BI 1358894 [N = 40] |
Total receiving treatment [N = 50] | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Placebo | BI 1358894 | Placebo | BI 1358894 | |||||||||||||
| [n = 10] | 10 mg [n = 8] |
25 mg [n = 8] |
50 mg [n = 8] |
100 mg [n = 8] |
200 mg [n = 8] |
[n = 10] | 10 mg [n = 8] |
25 mg [n = 8] |
50 mg [n = 8] |
100 mg [n = 8] |
200 mg [n = 8] |
|||||
| Any TEAE [n (%)] | 1 (10.0) | 4 (50.0) | 4 (50.0) | 3 (37.5) | 4 (50.0) | 5 (62.5) | 7 (70.0) | 3 (37.5) | 6 (75.0) | 1 (12.5) | 4 (50.0) | 5 (62.5) | 26 (65.0) | 34 (68.0) | ||
| DRAEs [n (%)] | 1 (10.0) | 4 (50.0) | 4 (50.0) | 3 (37.5) | 4 (50.0) | 5 (62.5) | 6 (60.0) | 2 (25.0) | 5 (62.5) | 1 (12.5) | 4 (50.0) | 5 (62.5) | 26 (65.0) | 32 (64.0) | ||
| Nervous system disorders | 1 (10.0) | 4 (50.0) | 4 (50.0) | 3 (37.5) | 4 (50.0) | 5 (62.5) | 6 (60.0) | 1 (12.5) | 5 (62.5) | 1 (12.5) | 2 (25.0) | 5 (62.5) | 24 (60.0) | 30 (60.0) | ||
| Headachec | 1 (10.0) | 3 (37.5) | 3 (37.5) | 2 (25.0) | 2 (25.0) | 3 (37.5) | 4 (40.0) | 0 (0) | 5 (62.5) | 1 (12.5) | 1 (12.5) | 5 (62.5) | 17 (42.5) | 21 (42.0) | ||
| Orthostatic intolerancec | 1 (10.0) | 1 (12.5) | 1 (12.5) | 1 (12.5) | 0 (0) | 1 (12.5) | 4 (40.0) | 1 (12.5) | 0 (0) | 0 (0) | 1 (12.5) | 1 (12.5) | 6 (15.0) | 11 (22.0) | ||
| Dizzinessc | 0 (0) | 1 (12.5) | 0 (0) | 1 (12.5) | 1 (12.5) | 1 (12.5) | 1 (10.0) | 0 (0) | 0 (0) | 1 (12.5) | 0 (0) | 0 (0) | 5 (12.5) | 6 (12.0) | ||
The AE data reported here are for the 50 volunteers, split by AEs during and after midazolam dosing
a Includes all AEs that occurred between the intake of placebo/BI 1358894 + midazolam until 24 h thereafter
bIncludes all AEs that occurred during the intake of placebo/BI 1358894 plus the 14-day residual effect period, excluding the 24 h after the intake of BI 1358894 + midazolam
cMost frequently reported DRAEs
AE adverse event, DRAEs drug-related adverse events, TEAEs treatment-emergent adverse events