Table 2.
Safety summary
| Number of patients (%) | |||
|---|---|---|---|
| Summary | Non-responder (N = 52) | Responder (N = 272) | Robust responder (N = 213) |
| Discontinued due to: | 24 (46.2) | 28 (10.3) | 20 (9.4) |
| Administrative | 4 (7.7) | 9 (3.3) | 7 (3.3) |
| Adverse event | 12 (23.1) | 10 (3.7) | 9 (4.2) |
| Lack of efficacy | 1 (1.9) | 1 (0.4) | 1 (0.5) |
| Protocol violation | 1 (1.9) | 1 (0.4) | 1 (0.5) |
| Withdrew consent | 6 (11.5) | 7 (2.6) | 2 (0.9) |
| Any adverse event (AE) | 47 (90.4) | 251 (92.3) | 194 (91.1) |
| Any severe AE | 20 (38.5) | 76 (27.9) | 57 (26.8) |
| Any serious AE | 23 (44.2) | 82 (30.1) | 64 (30.0) |
| AEs occurring in ≥10% patients in any patient group | |||
| Complication of device insertiona | 20 (38.5) | 93 (34.2) | 70 (32.9) |
| Abdominal pain | 15 (28.8) | 86 (31.6) | 64 (30.0) |
| Procedural pain | 10 (19.2) | 57 (21.0) | 49 (23.0) |
| Nausea | 10 (19.2) | 44 (16.2) | 35 (16.4) |
| Incision site erythema | 10 (19.2) | 32 (11.8) | 27 (12.7) |
| Vomiting | 8 (15.4) | 20 (7.4) | 15 (7.0) |
| Procedural site reaction | 7 (13.5) | 25 (9.2) | 18 (8.5) |
| Sleep attacks | 6 (11.5) | 15 (5.5) | 12 (5.6) |
| Pneumoperitoneum | 6 (11.5) | 13 (4.8) | 11 (5.2) |
| Hallucination | 6 (11.5) | 10 (3.7) | 6 (2.8) |
| Postoperative wound infection | 5 (9.6) | 45 (16.5) | 33 (15.5) |
| Constipation | 5 (9.6) | 42 (15.4) | 31 (14.6) |
| Dyskinesia | 5 (9.6) | 26 (9.6) | 23 (10.8) |
| Fall | 4 (7.7) | 45 (16.5) | 35 (16.4) |
| Insomnia | 4 (7.7) | 40 (14.7) | 30 (14.1) |
| Urinary tract infection | 4 (7.7) | 33 (12.1) | 25 (11.7) |
| Upper respiratory tract infection | 4 (7.7) | 4 (1.5) | 3 (1.4) |
| Excessive granulation tissue | 2 (3.8) | 50 (18.4) | 38 (17.8) |
| Weight decreased | 1 (1.9) | 30 (11.0) | 22 (10.3) |
aEvents with this term were most often additionally coded to abdominal pain, abdominal discomfort, abdominal distension, flatulence, and pneumoperitoneum