Table 4.
Summary of adverse events during treatment (number of participants, % of participants, and event count).
| Safety population | ||||
|---|---|---|---|---|
| Adverse event type | DTxP (n=12) | Sham placebo (n=17) | Standard care (n=11) | Total (N=40) |
| Participant N, (%), Event N | Participant N, (%), Event N | Participant N, (%), Event N | Participant N, (%), Event N | |
| Posttreatment | ||||
| All AEs | 12 (100) 50 | 14 (82.4) 60 | 7 (63.6) 30 | 33 (82.5) 140 |
| Mild AEs | 4 (33.3) 17 | 6 (35.3) 17 | 2 (18.2) 7 | 12 (30.0) 41 |
| Moderate AEs | 10 (83.3) 25 | 11 (64.7) 36 | 6 (54.5) 16 | 27 (67.5) 77 |
| Severe AEs | 6 (50.0) 8 | 5 (29.4) 7 | 4 (36.4) 7 | 15 (37.5) 22 |
| Treatment-related AEs | 3 (25.0) 25 | 6 (35.3) 29 | 2 (18.2) 4 | 11 (27.5) 58 |
| Serious AEs | 0 (0) 0 | 0 (0) 0 | 0 (0) 0 | 0 (0) 0 |
| Follow-up | ||||
| All AEs | 7 (58.3) 18 | 9 (52.9) 23 | 3 (27.3) 3 | 19 (47.5) 44 |
| Mild AEs | 3 (25.0) 5 | 5 (29.4) 6 | 1 (9.1) 1 | 9 (22.5) 12 |
| Moderate AEs | 5 (41.7) 6 | 5 (29.4) 11 | 1 (9.1) 1 | 11 (27.5) 18 |
| Severe AEs | 4 (33.3) 7 | 5 (29.4) 6 | 1 (9.1) 1 | 10 (25.0) 14 |
| Serious AEs | 1 (5.9) 1 | 1 (2.5) 1 |
DTxP, digital treatment for pain; AEs, adverse events.