Table 4.
Comparison of AE rates across different groups
| Number of subjects | Number of subjects with any AE (%) | Number of subjects with any GI AE (%) | |
|---|---|---|---|
| Gender | |||
| Males | 5 | 5 (100) | 2 (40) |
| Females | 10 | 9 (90) | 6 (60) |
| P-value* | 1.00 | 0.61 | |
| Age | |||
| ≤70 years | 8 | 7 (87.5) | 3 (37.5) |
| >70 years | 7 | 7 (100) | 5 (71.4) |
| P-value* | 1.00 | 0.31 | |
| ALA dose level | |||
| 600 mg | 15 | 11 (73.3) | 3 (20) |
| 800 mg | 15 | 10 (66.7) | 5 (33.3) |
| 1,200 mg | 14 | 10 (71.4) | 6 (42.9) |
| P-value* | 1.00 | 0.44 | |
Note:
*
P-value was calculated using Fisher’s exact test.
Abbreviations: AE, adverse event; ALA, alpha lipoic acid; GI, gastrointestinal.