Table 2.

ADRs dechallenge and re-challenge actions and outcomes.

ADRs overall (N = 13,563)
De-challenge		Re-challenge
Action N (%)	Outcome n (%)	Action n (%)	Outcome n (%)
Drug withdrawn 3947 (29.10)	No effect observed 2616 (66.28)	Re-challenge 1401 (10.33)	No recurrence 283 (20.20)
	Reaction abated N = 923 (23.38)		Reaction recurred 74 (5.28)
	Fatal 2 (0.05)		Effect unknown 1044 (74.51)
	Effect unknown 406 (10.29)
Dose not changed 326 (2.40)	No effect observed 115 (35.28)	No Re-challenge 377 (2.78)	Unknown 377 (100)
	Reaction abated 72 (22.09)
	Fatal 1 (0.31)
	Effect unknown 138 (42.33)
Dose reduced 8 (0.06)	No effect observed 3 (37.50)
	Reaction abated 2 (25.00)
	Effect unknown 3 (37.50)

ADRs adverse drug reactions; N number of ADRs; n number of ADRs in a given category.