Table 4.
Adverse events (AEs) with ≥5% incidence and greater incidence in the NB32 + BMOD vs. placebo + BMOD groups, the 10 most common psychiatric AEs, and AEs resulting in discontinuation with ≥0.5% incidence in the NB32 + BMOD group
| Placebo + BMOD |
NB32 + BMOD |
||
|---|---|---|---|
|
|
|||
| N = 200 | N = 584 | ||
|
|
|||
| Variabie | n (%) | P value | |
| All AEs | |||
| Nausea | 21 (10.5) | 199 (34.1) | <0.001 |
| Headache | 35 (17.5) | 139 (23.8) | 0.076 |
| Constipation | 28 (14.0) | 141 (24.1) | 0.003 |
| Dizziness | 9 (4.5) | 85 (14.6) | <0.001 |
| Vomiting | 13 (6.5) | 64 (11.0) | 0.074 |
| Insomnia | 12 (6.0) | 51 (8.7) | 0.291 |
| Dry mouth | 6 (3.0) | 47 (8.0) | 0.014 |
| Anxiety | 7 (3.5) | 30 (5.1) | 0.441 |
| Tremor | 2 (1.0) | 34 (5.8) | 0.003 |
| Abdominal pain, upper | 3 (1.5) | 32 (5.5) | 0.017 |
| Tinnitus | 1 (0.5) | 31 (5.3) | 0.001 |
| Psychiatric AEs | |||
| Insomnia | 12 (6.0) | 51 (8.7) | 0.291 |
| Anxiety | 7 (3.5) | 30 (5.1) | 0.441 |
| Sleep disorder | 6 (3.0) | 14 (2.4) | 0.610 |
| Depressed mood | 8 (4.0) | 11 (1.9) | 0.110 |
| Abnormal dreams | 4 (2.0) | 8 (1.4) | 0.514 |
| Middle insomnia | 2 (1.0) | 6 (1.0) | 1.000 |
| Tension | 1 (0.5) | 7 (1.2) | 0.687 |
| Depression | 5 (2.5) | 2 (0.3) | 0.014 |
| Stress | 4 (2.0) | 3 (0.5) | 0.074 |
| Dissociation | 0 (0) | 6 (1.0) | 0.347 |
| AEs resulting in discontinuation | |||
| Nausea | 0 (0) | 27 (4.6) | <0.001 |
| Urticaria | 1 (0.5) | 10 (1.7) | 0.306 |
| Anxiety | 3 (1.5) | 7 (1.2) | 0.721 |
| Disturbance in attention | 0 (0) | 6 (1.0) | 0.347 |
| Headache | 1 (0.5) | 5 (0.9) | 1.000 |
| Blood pressure increased | 0 (0) | 4 (0.7) | 0.577 |
| Dizziness | 0 (0) | 4 (0.7) | 0.577 |
| Vomiting | 0 (0) | 4 (0.7) | 0.577 |
| Depressed mood | 1 (0.5) | 3 (0.5) | 1.000 |
| Feeling abnormal | 1 (0.5) | 3 (0.5) | 1.000 |
| Abdominal pain | 0 (0) | 3 (0.5) | 0.574 |
| Abdominal pain upper | 0 (0) | 3 (0.5) | 0.574 |
| Disorientation | 0 (0) | 3 (0.5) | 0.574 |
| Dissociation | 0 (0) | 3 (0.5) | 0.574 |
| Feeling jittery | 0 (0) | 3 (0.5) | 0.574 |
| Insomnia | 0 (0) | 3 (0.5) | 0.574 |
| Rash | 0 (0) | 3 (0.5) | 0.574 |
P value is for NB32 + BMOD vs. placebo + BMOD. AEs are listed for all categories of AEs in the top portion of the table and for just the psychiatric category in the middle portion. The bottom portion of the table shows AEs associated into discontinuation. BMOD, behavior modification.