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 |
... |
||
|
|
|||
|
Risk Score Assessment. The severity grading is carried out according to the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) [4], the frequency according to the Guideline on Summary of Product Characteristics (SPC) [5] |
|||
|
Püntmann et al. BMC Clinical Pharmacology 2010 10:5 doi:10.1186/1472-6904-10-5 |
|||
