TD139 | Placebo | Total | ||||||
0.15 mg | 1.5 mg | 3 mg | 10 mg | 20 mg | 50 mg | |||
TEAEs | 0 | 0 | 2 | 7 | 7 | 10 | 2 | 28 |
Subjects reporting ≥1 TEAE | ||||||||
TEAE | 0 | 0 | 2 (50.0) | 3 (75.0) | 4 (100.0) | 4 (100.0) | 2 (16.7) | 15 (41.7) |
Serious TEAE | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
TEAE leading to withdrawal | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Subjects with TEAE by severity | ||||||||
Mild | 0 | 0 | 2 (50.0) | 3 (75.0) | 4 (100.0) | 4 (100.0) | 2 (16.7) | 15 (41.7) |
Subjects with TEAE by relationship to study IMP | ||||||||
Almost definite | 0 | 0 | 1 (25.0) | 3 (75.0) | 4 (100.0) | 4 (100.0) | 2 (16.7) | 14 (38.9) |
Probable | 0 | 0 | 0 | 0 | 1 (25.0) | 0 | 0 | 1 (2.8) |
Possible | 0 | 0 | 0 | 2 (50.0) | 1 (25.0) | 3 (75.0) | 0 | 6 (16.7) |
Unlikely | 0 | 0 | 1 (25.0) | 0 | 0 | 0 | 0 | 1 (2.8) |
Data are presented as n or n (%). A subject with multiple occurrences of an adverse event is counted only once within each level of severity or relationship. IMP: investigational medicinal product.