Stopping rules
adverse drug reaction, wheezing, urticaria
ADVERSE EVENTS, ADVERSE DRUG REACTION, URTICARIA, ADVERSE REACTION, ANAPHYLACTIC SHOCK
Our stopping criteria were based on three ethical principles- safety, benefit or futility of the trial. Development of serious adverse events such as anaphylactic shock, urticaria, wheezing attacks or any other form of serious adverse drug reaction will trigger discontinuation. Our patients have been reviewed over the period and no adverse reaction has been observed.