Table 3.
Association of androgen deprivation therapies (ADT) with the reporting-Odds-Ratio (ROR) for aLQTS, TdP and sudden death in VigiBase (through 08/09/2018).
ROR[CI95] | |||
---|---|---|---|
aLQTS | TdP | Sudden death | |
Enzalutamide | (−) | (−) | (−) |
Abiraterone | (−) | (−) | (−) |
Bicalutamide | 2.1[1.4-3.1] | 3.8[2.3-6.1] | (−) |
Leuprorelin | (−) | 1.7 [1.1-2.8] | (−) |
Finasteride | 1.4[1.1-1.8] | (−) | (−) |
Goserelin | (−) | (−) | 3.5[2.1-5.8] |
Degarelix | 2.3[1.1-4.8] | 3.4[1.3-9.1] | (−) |
Triptorelin | 3.6[1.6-8] | 4.7[1.5-14.6] | (−) |
Dutasteride | 1.6[1.1-2.3] | (−) | (−) |
Flutamide | (−) | (−) | (−) |
Sotalol | 13.03[10.97-15.48] | 40.51[34.36-47.77] | 4.11[2.85-5.93] |
Significantly (p<0.05) increased ROR and their 95% confidence-interval [CI95] when comparing reporting-rate for aLQTS, TdP and sudden death associated with sotalol (positive control) or androgen deprivation therapies versus the full database. Association not significantly increased are displayed by (−).