Judgment results | Judgment Index |
|---|
①| ② | ③ | ④ | ⑤ |
|---|
Definite relevance | + | + | -- | + | + |
Probable relevance | + | + | -- | + | ? |
Difficult to determine | + | + | ± | ± | ? |
Probable irrelevance | + | -- | ± | ± | ? |
Definite irrelevance | -- | -- | + | -- | -- |
- AE Judgment Index: ①Whether or not there is a successive relationship between time of treatment onset and time of AE occurrence. ② Whether or not suspicious AE is in accordance with the known AE of the medicine. ③ Whether or not the suspicious AE can be explained by the effect of combination of medicine, patient’s clinical condition, or other therapies. ④ Whether or not suspicious AE disappears or is relieved after drug withdrawal or dosage reduction. ⑤ Whether or not similar reactions occur after using the suspicious drugs again
- + means affirmative, --means negative, ± means difficult to determine, ? means unclear situation
- 1- Definite relevance, 2-Probable relevance, 3-Difficult to determine, 4-Probable irrelevance, 5-Definite irrelevance
- The incidence of ADR is calculated by using the sum of the cases of 1 + 2 + 3 as numerator, and the number of all cases as denominator
