Table 2.
Number of AEs and participants with one or more on-treatment adverse events, by physiologic system
| 1 mg/day (n = 28) | 5 mg/day (n = 36) | 15 mg/day (n = 14) | Placebo (n = 36) | P value* (5 mg/day vs Placebo) | P value* (any effect) | |
|---|---|---|---|---|---|---|
| Cardiovascular | 9 (5) | 5 (5) | 2 (1) | 3 (2) | 0.73 | 0.10 |
| Dermatologic | 12 (7) | 19 (11) | 18 (5) | 12 (10) | 0.55 | 0.018 |
| Endocrine/metabolic | 3 (2) | 3 (3) | 1 (1) | 0 | 0.25 | 0.27 |
| Gastrointestinal | 5 (3) | 9 (8) | 3 (2) | 15 (7) | 0.065 | 0.09 |
| Genital/urinary | 1 (1) | 5 (4) | 2 (1) | 0 | 0.065 | 0.12 |
| Hematologic/lymphatic | 1 (1) | 2 (1) | 0 | 1(1) | 0.99 | 0.99 |
| Hepatic/biliary | 0 | 0 | 1 (1) | 0 | -- | 0.16 |
| Musculoskeletal | 4 (4) | 21 (15) | 10 (5) | 13 (9) | 0.37 | 0.033 |
| Neurologic | 3 (2) | 1 (1) | 1 (1) | 4 (4) | 0.18 | 0.37 |
| Psychiatric | 1 (1) | 1 (1) | 0 | 0 | 0.99 | 0.82 |
| Respiratory | 3 (2) | 4 (3) | 1 (1) | 5 (3) | 0.52 | 0.77 |
| Infectious disease | 15 (6) | 8 (7) | 1 (1) | 7 (5) | 0.90 | 0.004 |
| Other | 8 (5) | 17(10) | 7 (5) | 18 (13) | 0.40 | 0.37 |
| One or more SAEa | 1b | -- | 1c | 1d | -- | -- |
Abbreviation: SAE, serious adverse event.
*Chi-square or Fisher’s exact tests for the difference between number of events across all 4 groups and comparison between placebo and 5 mg/day dose.
a There was 1 SAE (myocardial infarction) reported from the 1 mg/day dose group; however, it occurred before drug administration, hence it is not counted in this table.
b Coronary Artery Bypass Grafting (hospitalization).
c Renal cancer.
d Lung and liver cancer.