Table 2.
Summary of adverse events
| Number (%) of participants with AEs | Placebo n = 31 (100%) |
BAY1128688 | Total N = 121 (100%) |
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|---|---|---|---|---|---|---|---|
| 3 mg OD n = 11 (100%) |
10 mg OD n = 31 (100%) |
30 mg OD n = 10 (100%) |
30 mg BID n = 11 (100%) |
60 mg BID n = 27 (100%) |
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| Any AE | 24 (77.4) | 8 (72.7) | 16 (51.6) | 9 (90.0) | 7 (63.6) | 23 (85.2) | 87 (71.9) |
| Any TEAE | 20 (64.5) | 5 (45.5) | 10 (32.3) | 9 (90.0) | 6 (54.5) | 21 (77.8) | 71 (58.7) |
| Study-drug-related TEAE | 9 (29.0) | 4 (36.4) | 3 (9.7) | 4 (40.0) | 2 (18.2) | 14 (51.9) | 36 (29.8) |
| Procedure-related TEAE | 0 | 0 | 0 | 0 | 0 | 2 (7.4) | 2 (1.7) |
| Any SAE | 1 (3.2) | 1 (9.1) | 0 | 2 (20.0) | 0 | 1 (3.7) | 5 (4.1) |
| Any TESAE | 1 (3.2) | 1 (9.1) | 0 | 2 (20.0) | 0 | 1 (3.7) | 5 (4.1) |
| Study-drug-related SAE | 1 (3.2) | 0 | 0 | 1 (10.0) | 0 | 1 (3.7) | 3 (2.5) |
| SAE related to procedure | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Discontinuation due to TEAE | 1 (3.2) | 0 | 1 (3.2) | 0 | 2 (18.2) | 3 (11.1) | 7 (5.8) |
| Discontinuation due to TESAE | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
AE adverse event, BID twice daily, OD once daily, SAE serious adverse event, TEAE treatment-emergent adverse event, TESAE treatment-emergent serious adverse event