Table 2.
Population | Size, n | Injured, n | Mean risk (CI) | Relative risk (CI) | P-value |
---|---|---|---|---|---|
Total | 459 | 56 | 0.12 (0.10–0.15) | ||
Sex | |||||
Male | 181 | 15 | 0.08 (0.05–0.13) | ||
Female | 278 | 41 | 0.15 (0.11–0.19) | 1.78 (1.02–3.12) | 0.044 |
Age | |||||
<Median | 214 | 28 | 0.13 (0.09–0.18) | ||
>Median | 245 | 28 | 0.11 (0.08–0.16) | 0.87 (0.54–1.43) | 0.32 |
Population type | |||||
Bifascicular block | 115 | 9 | 0.08 (0.04–0.14) | ||
Vasovagal | 344 | 47 | 0.14 (0.10–0.18) | 1.59 (0.81–3.14) | 0.089 |
Prior year, n | |||||
<Median | 239 | 15 | 0.06 (0.04–0.10) | ||
>Median | 220 | 41 | 0.19 (0.14–0.24) | 2.97 (1.69–5.21) | <0.0001 |
Prodrome | |||||
Absent | 61 | 15 | 0.25 (0.15–0.37) | ||
Present | 28 | 11 | 0.39 (0.24–0.58) | 1.60 (0.85–3.02) | 0.075 |
Drug therapy | |||||
Placebo | 172 | 24 | 0.14 (0.10–0.20) | ||
Active | 172 | 23 | 0.13 (0.09–0.19) | 0.96 (0.56–1.63) | 0.88 |
The mean age in the total study population was 45 and the median number of faints in the year before randomization was 3. Prodromal symptoms were recorded in POST 3 and 4. The bifascicular heart block population was in POST 3 and the vasovagal population was in POST 2 and 4.
CI, confidence interval.