Table 4 Risk-Profile
severity grading | frequency | therapy investigated | therapeutic standard |
|---|---|---|---|
adverse events (AE) | |||
grades 5 + 4 | ≥10% | -4.0 | -4.0 |
(death related to AE or life-threatening AE or disabling AE) | ≥1% | -3.0 | -3.0 |
≥0.1% | -2.0 | -2.0 | |
<0.1% | -1.0 | -1.0 | |
0 | 0 | 0 | |
grade 3 | ≥10% | -2.5 | -2.5 |
(severe and undesirable AE) | ≥1% | -2.0 | -2.0 |
≥0.1% | -1.0 | -1.0 | |
<0.1% | 0 | 0 | |
0 | 0 | 0 | |
grades 2 + 1 | ≥10% | -1.5 | -1.5 |
(moderate AE or mild AE) | ≥1% | -1.0 | -1.0 |
≥0.1% | -0.5 | -0.5 | |
<0.1% | 0 | 0 | |
0 | 0 | 0 | |
Interactions | |||
frequent or serious clinical consequence | -2.0 | -2.0 | |
occasional or may have clinical consequence | -1.5 | -1.5 | |
dose change | -1.0 | -1.0 | |
unlikely/probably or no clinical consequence | 0 | 0 | |
no information available | -1.0 | -1.0 | |
sum | ... | ... | |
risk score | ... | ||