Table 2.
Serious Adverse Event Ratesa in LIFE (at Yale) and CRANNY trials.
| Serious Adverse Events | LIFE (n = 200)b |
CRANNY (n = 185)c |
||
|---|---|---|---|---|
| Observed Counts | Rates (95% CI) | Observed Counts | Rates (95% CI) | |
| Anticipated/Unrelated | ||||
| Mortality | 8 | 1.5 (0.7, 3.2) | 33 | 19.7 (10.3, 37.9) |
| Hospitalization | 171 | 32.2 (26.1, 39.8) | 83 | 49.7 (34.8, 70.8) |
| Total SAE | 179 | 33.7 (27.2, 41.8) | 116 | 69.4 (49.1, 98.1) |
| Anticipated/Related | ||||
| Mortality | 0 | 0 | 0 | 0 |
| Hospitalization | 5 | 0.9 (0.3, 2.8) | 0 | 0.0 (0.0, 1.8)d |
| Total SAE | 5 | 0.9 (0.3, 2.8) | 0 | 0.0 (0.0, 1.8)d |
| Unanticipated/Unrelated | ||||
| Mortality | 0 | 0 | 0 | 0 |
| Hospitalization | 0 | 0 | 0 | 0 |
| Total SAE | 0 | 0 | 0 | 0 |
| Unanticipated/Related | ||||
| Mortality | 0 | 0 | 0 | 0 |
| Hospitalization | 0 | 0 | 0 | 0 |
| Total SAE | 0 | 0 | 0 | 0 |
a
Rates and 95% confidence intervals (CI) in events/100 person-years are generated from generalized linear models using Poisson distributions, natural logarithms of time at risk offset, and overdispersion adjustments.
b
Person-years in study was 530.7.
c
Person-years in study was 167.2.
d
The upper 95% CI for zero events were calculated using the “Rule of Three” method.