Table 5.
Reported Adverse Events (10% or more subjects reporting) for Males and Females in Naltrexone or Placebo Conditions
| Total Sample | Overall | Males | Females | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Male Total | (A) | Female Total | PLAC | (B) | NTX | PLAC | (C) | NTX | ||
| Study Specific Adverse Events | ||||||||||
| Headache, n (%) | 101 (61.6) | 69 (59.5) | 32 (66.7) | 36 (62.1) | 33 (56.9) | 16 (66.7) | 16 (66.7) | |||
| Nausea, n (%) | 66 (40.2) | 41 (35.3) | ** | 25 (52.1) | 10 (17.2) | *** | 31 (53.4) | 12 (50.0) | 13 (54.2) | |
| Vomiting, n (%) | 34 (20.7) | 21 (18.1) | 13 (27.1) | 7 (12.1) | * | 14 (24.1) | 6 (25.0) | 7 (29.2) | ||
| Increased Sexual Desire, n (%) | 45 (27.4) | 34 (29.3) | 11 (22.9) | 14 (24.1) | 20 (34.5) | 8 (33.3) | * | 3 (12.5) | ||
| Decreased Sexual Desire, n (%) | 46 (28.0) | 32 (27.6) | 14 (29.2) | 13 (22.4) | 19 (32.8) | 8 (33.3) | 6 (25.0) | |||
| Anxiety/Irritability, n (%) | 100 (61.0) | 69 (59.5) | 31 (64.6) | 34 (58.6) | 35 (60.3) | 15 (62.5) | 16 (66.7) | |||
| General Adverse Events | ||||||||||
| Insomnia, n (%) | 19 (11.6) | 12 (10.3) | 7 (14.6) | 5 (8.6) | 7 (12.1) | 4 (16.7) | 3 (12.5) | |||
| Aches/Pains, n (%) | 28 (17.1) | 17 (14.7) | 11 (22.9) | 7 (12.1) | 10 (17.2) | 6 (25.0) | 5 (20.8) | |||
| Upper Respiratory Problems, n (%) | 59 (36.0) | 43 (37.1) | 16 (33.3) | 22 (37.9) | 21 (36.2) | 11 (45.8) | 5 (20.8) | |||
| Other GI Problems, n (%) | 39 (23.8) | 23 (19.8) | * | 16 (33.3) | 9 (15.5) | 14 (24.1) | 9 (37.5) | 7 (29.2) | ||
| Musculoskeletal, n (%) | 32 (19.5) | 25 (21.6) | 7 (14.6) | 8 (13.8) | * | 17 (29.3) | 3 (12.5) | 4 (16.7) | ||
*
p < 0.10
**
p < 0.05
***
p < 0.001; all reported p-values are for 2-sided Chi Square Test
(A)
Test of Male vs. Female
(B)
Test of Naltrexone vs. Placebo in Males only
(C)
Test of Naltrexone vs. Placebo in Females only
Note: PLAC= placebo; NTX=high dose naltrexone; GI: gastro-intestinal