Skip to main content

Table 3 Summary of adverse events

From: Randomized, double-blind, placebo-controlled phase I dose escalation study of Dan Qi Tong Mai tablet in healthy volunteers

ParameterAdverse event
Increase in no. daily stoolsElevated ALT and ASTCough and runny nose
No. cases511
Cohort (no. of cases)4 (1), 8 (2), 11 (2)4 (1)11 (1)
GroupActive ingredientsActive ingredientsPlacebo
SeverityMildMildMild
Duration, days1–2516
Relationship to study drugProbably or possibly relatedProbably relatedUnrelated
OutcomeRecovered spontaneouslyRecovered spontaneouslyRecovered spontaneously
  1. ALT Alanine aminotransferase, AST Aspartate transaminase