Table 2.
Number(n) of ICSRs in men in VigiBase by androgen deprivation therapy (ADT), with sotalol (positive control) and in the entire database through 08/09/2018.
| ndeath/ntotal,(%) | aLQTS* | TdP* | Sudden death* |
n/naLQTS±TdP±Sudden-death, (%) with ADT considered suspect by reporter** |
|
|---|---|---|---|---|---|
| Enzalutamide | 5,430/31,896(17%) | 19 | 4 | 13 | 30/32(93.8%) |
| Abiraterone | 1,240/14,261(8.7%) | 19 | 7 | 10 | 29/31(92.5%) |
| Bicalutamide | 724/10,144(7.1%) | 23 | 16 | 11 | 28/41(68.3%) |
| Leuprorelin | 1,871/22,113(8.5%) | 33 | 16 | 18 | 28/55(50.9%) |
| Finasteride | 1,062/33,877(3.1%) | 52 | 20 | 32 | 20/87(23%) |
| Goserelin | 471/5,821(8.1%) | 8 | 2 | 15 | 17/22(77.3%) |
| Degarelix | 82/2,787(2.9%) | 7 | 4 | 3 | 10/11(90.9%) |
| Triptorelin | 52/1,517(3.4%) | 6 | 3 | 2 | 5/8(62.5%) |
| Dutasteride | 248/15,177(1.6%) | 26 | 7 | 11 | 5/38(13.2%) |
| Flutamide | 163/4075(4.0%) | 4 | 2 | 3 | 3/7(42.9%) |
| Sotalol | 210/9541(2.2%) | 134 | 152 | 29 | NA |
| Entire database | 161,130/6,560,565(2.5%) | 7,288 | 2,769 | 4,880 | NA |
These numbers in ADT and sotalol rows correspond to the A values in the contingency table displayed in supplemental Table 2, explaining how ROR (=AD/BC) is calculated. For example, there were 9,541 ADRs reported with sotalol, and 152 cases of TdP (1.59%) as compared to 6,551,176 total ADRs on all other drugs in men, including 2,617 cases of TdP (0.04%). This results in a ROR of 40.51 for the association between sotalol and TdP (see Table 3).
The numerator is the number of ICSRs where the ADT was considered by the reporter to be suspect of directly inducing the aLQTS or TdP or sudden death. The denominator is the number of ICSRs where the ADT was associated to a drug-induced aLQTS or TdP or sudden death, in which the reporter may have considered the ADT as suspect, interacting or concomitant.