Table 3.
Cumulative adverse events related to device, procedure, or therapy through 18 months.
| Adverse event | vBloc | Sham control | ||||
|---|---|---|---|---|---|---|
| (n = 162) | (n = 77) | |||||
| Number (%) of patients | Number of events | % events mild/moderate severity | Number (%) of patients | Number of events | % events mild/moderate severity | |
| Pain, neuroregulator site | 61 (38) | 76 | 96% | 32 (42) | 36 | 100% |
| Heartburn/dyspepsia | 41 (25) | 45 | 100% | 3 (4) | 3 | 100% |
| Pain, other | 40 (25) | 48 | 96% | 0 (0) | 0 | — |
| Pain, abdominal | 22 (14) | 30 | 100% | 2 (3) | 2 | 100% |
| Eructation/belching | 14 (9) | 14 | 100% | 0 (0) | 0 | — |
| Dysphagia | 13 (8) | 13 | 100% | 0 (0) | 0 | — |
| Chest pain | 13 (8) | 13 | 92% | 2 (3) | 2 | 100% |
| Nausea | 12 (7) | 17 | 94% | 1 (1) | 1 | 100% |
| Incision pain | 12 (7) | 14 | 100% | 7 (9) | 7 | 100% |
| Cramps, abdominal | 8 (5) | 8 | 100% | 0 (0) | 0 | — |
| Wound redness or irritation | 8 (5) | 8 | 100% | 5 (7) | 5 | 100% |
| Bloating, abdominal | 7 (4) | 8 | 100% | 1 (1) | 2 | 100% |
| Constipation | 7 (4) | 7 | 100% | 7 (9) | 7 | 100% |
| Emesis/vomiting | 6 (4) | 8 | 88% | 2 (3) | 2 | 100% |
| Headache | 6 (4) | 6 | 100% | 2 (3) | 2 | 100% |
| Appetite increased | 5 (3) | 6 | 100% | 2 (3) | 3 | 100% |
Only adverse events attributed by the investigator to the device, procedure, or therapy that occurred in at least 3% of vBloc group participants are displayed.