Table 3. GENCAT Study and Historical Control Incidences of Carbamazepine-Induced Cutaneous Adverse Reactions.
| Adverse Event | Patients, No. | ||
|---|---|---|---|
| GENCAT Study (N = 1130) | Historical Control | ||
| BioBank Japan Data (N = 1312) | JMDC Claims Database (N = 12 060) | ||
| Carbamazepine-induced cutaneous adverse reaction,a No. (%) | 23 (2.0) | 44 (3.4) | 610 (5.1) |
| Stevens-Johnson syndrome or toxic epidermal necrolysis | 0 | 3 | 6 |
| Drug-induced hypersensitivity syndrome | 3 | 1 | NA |
| Maculopapular eruption | 9 | 6 | NA |
| Erythema multiforme | 5 | 15 | NA |
| Fixed drug eruption | 0 | 0 | NA |
| Others | 0 | 8 | NA |
| Unknown | 6 | 11 | NA |
| Statistical analysis, compared with GENCAT study | NA | ||
| P value | .048 | <.001 | |
| Odds ratio (95% CI) | 0.60 (0.36-1.0) | 0.39 (0.26-0.59) | |
Abbreviations: GENCAT, Genotype-Based Carbamazepine Therapy; JMDC, Japan Medical Data Centre; NA, not available, regarding information on specific cutaneous adverse drug reactions.
a
In the GENCAT study, all 23 patients who developed definite or probable carbamazepine-induced cutaneous adverse reactions were negative for HLA-A*31:01.