TABLE 3.

Tafenoquine pharmacokinetic data for six subjects reporting at least one adverse effect classified as severe (n = 1) or moderate (n = 5)

Adverse event	Treatment duration (days)a	Cumulative dose (mg)b	Dosing stopped	Clast (ng/ml)c	CL/F (liters/h/kg)	V/F (liters/kg)	t½ (days)
Severe event
Diarrhea and/or abdominal pain	2	400	No	*	0.059	24.4	12.0
Moderate events
Insomnia	1	200	No	*	0.059	23.2	11.3
Hyperesthesia	12	800	Yes	283	0.046	20.7	13.1
Abdominal pain	20	1,000	Yes	253	0.053	27.8	15.1
Depression	24	1,000	Yes	275	0.061	25.1	12.0
Vomiting and/or nausea	3	600	No	315	0.077	26.1	9.8

^aNumber of days from starting dosing until adverse event reported.

^bTotal amount of drug taken before adverse event reported.

^cLast plasma tafenoquine concentration before adverse event reported. *, adverse event was reported before first plasma sample was drawn.