Table 3.
Treatment-emergent adverse events
Baminercept N=33 |
Placebo N=19 |
|||
---|---|---|---|---|
Subjects, N (%) | Events | Subjects, N (%) | Events | |
Total SAEs | 5 (15) | 5 | 1 (5) | 1 |
Total AEs | 33 (100) | 356 | 19 (100) | 204 |
Related to study drug | 29 (88) | 177 | 18 (95) | 100 |
Severity (total AEs)* | ||||
Grade 1 | 33 (100) | 275 | 18 (95) | 164 |
Grade 2 | 25 (76) | 70 | 13 (68) | 36 |
Grade 3 | 8 (24) | 10 | 3 (16) | 4 |
Grade 4 | 1 (3) | 1 | 0 (0) | 0 |
Grade 5 | 0 (0) | 0 | 0 (0) | 0 |
Abbreviations: SAE=serious adverse event; AE=adverse event;
graded using the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0