Table 2.
Incidence of adverse events reported in >2 subjects by preferred term, period & treatment group.
| Preferred term | Placebo-only | Placebo–Cocaine | Treatment–Cocaine | |||
|---|---|---|---|---|---|---|
| Nepicastat (n = 15) |
Placebo (n = 5) |
Nepicastat (n = 15) |
Placebo (n = 5) |
Nepicastat (n = 14)a |
Placebo (n = 4)b |
|
| Insomnia | 2 (13) | 0 (0) | 1 (6) | 1 (20) | 4 (29) | 1 (25) |
| Vessel puncture site pain | 0 (0) | 0 (0) | 2 (13) | 1 (20) | 4 (29) | 0 (0) |
| Dyspepsia | 0 (0) | 0 (0) | 1 (6) | 0 (0) | 2 (14) | 1 (25) |
| Gastroesophageal reflux disease | 1 (6) | 0 (0) | 0 (0) | 0 (0) | 3 (21) | 0 (0) |
| Headache | 0 (0) | 1 (20) | 1 (6) | 0 (0) | 2 (14) | 1 (25) |
| Neck pain | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 2 (14) | 1 (25) |
| Arthralgia | 0 (0) | 0 (0) | 1 (6) | 0 (0) | 2 (14) | 0 (0) |
| Dizziness | 0 (0) | 0 (0) | 0 (0) | 1 (20) | 0 (0) | 2 (50) |
| Back pain | 1 (6) | 1 (20) | 0 (0) | 0 (0) | 0 (0) | 1 (25) |
| Myalgia | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 2 (50) |
| Nausea | 1 (6) | 0 (0) | 0 (0) | 0 (0) | 1 (7) | 1 (25) |
| Depressed mood | 1 (6) | 0 (0) | 0 (0) | 0 (0) | 1 (7) | 1 (25) |
| Abnormal dreams | 2 (13) | 0 (0) | 0 (0) | 1 (20) | 0 (0) | 1 (25) |
| Vessel puncture site hematoma | 0 (0) | 0 (0) | 2 (13) | 0 (0) | 0 (0) | 0 (0) |
Values reflect the number (%) of subjects.
Subject 117 completed the “placebo only” and “placebo–cocaine” periods only.
Subject 112 completed the “placebo-only” period and a partial “placebo–cocaine” period.