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Table 4 Risk-Profile

From: EVITA: a tool for the early EValuation of pharmaceutical Innovations with regard to Therapeutic Advantage

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   ...
  1. 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]