Table 3.
Potentially relevant adverse events associated with the use of cariprazine 1.5 mg/day as observed in Durgam et al15,a
| Adverse event | Cariprazine 1.5 mg/day (n=l 45) | Placebo group15 (n= 151) | Pooled placebo group24 (n=584) | ||
|---|---|---|---|---|---|
| n (%) | n (%) | NNH (95% CI) | n (%) | NNH (95% CI) | |
| Extrapyramidal symptoms | 13 (9.0) | 7 (4.6) | 24 (NS) | 45 (7.7) | 80 (NS) |
| Headache | 16(11.0) | 16 (10.6) | 229 (NS) | 74(12.7) | NA |
| Insomnia | 15 (10.3) | 1 1 (7.3) | 33 (NS) | 64(11.0) | NA |
| Somnolence or sedation | 7 (4.8) | 5 (3.3) | 66 (NS) | 32 (5.5) | NA |
| Akathisia | 13 (9.0) | 7 (4.6) | 24 (NS) | 21 (3.6) | 19 (10–209) |
| Constipation | 14(9.7) | 5 (3.3) | 16(9-133) | 29 (5.0) | 22 (NS) |
| Nausea | 7 (4.8) | 5 (3.3) | 66 (NS) | 29 (5.0) | NA |
| Anxiety | 6(4.1) | 5 (3.3) | 121 (NS) | 24 (4.1) | 3,529 (NS) |
| Vomiting | 4 (2.8) | 5 (3.3) | NA | 20 (3.4) | NA |
| Dizziness | 5 (3.4) | 3 (2.0) | 69 (NS) | 12(2.1) | 72 (NS) |
| Weight increased | 3(2.1) | 1 (0.7) | 72 (NS) | 8(1.4) | 143 (NS) |
Note:
a
Data for pooled placebo group was taken from Earley et al24 and NNH values were calculated by the author.
Abbreviations: CI, confidence interval; NA, not applicable (adverse-event rate higher for placebo); NNH, number needed to harm; NS, not significant at the p<0.05 threshold and thus the 95% CI is not shown.