Table 4.
Comparison of safety outcomes between ET-101 and the control group.
|
|
ET-101 (n=49), n (%) | Control (n=50), n (%) | P value | ||
| Serious adverse events | .47 | ||||
|
|
Yes | 2 (4.1) | 0 (0) |
|
|
|
|
No | 4 (8.2) | 4 (8) |
|
|
| Relevance to digital therapeutics | N/Aa | ||||
|
|
Definitely related | 0 (0) | 0 (0) |
|
|
|
|
Probably related | 0 (0) | 0 (0) |
|
|
|
|
Possibly related | 0 (0) | 0 (0) |
|
|
|
|
Probably not related | 0 (0) | 0 (0) |
|
|
|
|
Definitely not related | 6 (12.2) | 4 (8) |
|
|
|
|
Unknown | 0 (0) | 0 (0) |
|
|
| Total | 6 (12.2) | 4(8) | .52 | ||
aN/A: not applicable.