Table 5.
Per person day rate of Adverse Events and Serious Adverse Events during first 28 days with estimates (95% CI) and p-value based on negative binomial regression with a likelihood ratio test.
| Type of AE/SAE | Losartan (n = 58) | Placebo (n = 59) | P-value |
|---|---|---|---|
| Respiratory | 0.008 (0.004,0.014) | 0.016 (0.01,0.025) | 0.0518 |
| ENT | 0.005 (0.002,0.011) | 0.002 (0.001,0.006) | 0.1912 |
| Skin | 0.002 (0.001,0.007) | 0 (NA*) | NA* |
| Renal | 0.001 (0.000,0.006) | 0.003 (0.001,0.007) | 0.443 |
| Gastrointestinal | 0.003 (0.001,0.011) | 0.002 (0.000,0.008) | 0.7465 |
| Cardiovascular | 0.006 (0.003,0.012) | 0.004 (0.002,0.009) | 0.3852 |
| Constitutional | 0.004 (0.002,0.010) | 0.008 (0.004,0.015) | 0.2117 |
| Neurologic | 0.002 (0.001,0.007) | 0.001 (0.000,0.005) | 0.6161 |
| Any | 0.033 (0.022,0.049) | 0.037 (0.025,0.055) | 0.6806 |
Events are reported as rates per person-day because the patients could have had more than one event.
*Because there were no Skin AEs/SAEs in the Placebo arm, the MLE does not exist (it's on the boundary of the parameter space) and thus asymptotic confidence intervals and p-values fail.