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Table 4 Relevance evaluation standard between AE and investigational drugs

From: A multicenter randomized controlled open-label trial to assess the efficacy of compound kushen injection in combination with single-agent chemotherapy in treatment of elderly patients with advanced non-small cell lung cancer: study protocol for a randomized controlled trial

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