TABLE 2.

Adverse events in G6PDn and G6PDd subjects during 7 days oral administration of PQ and its enantiomers.

Parameters	No. Of subjects	Adverse event	Drug-related?	Comments
G6PDn
Hematological	1/15	• Elevated MetHgB • Dyspnea on exertion • Headache	Yes	Exaggerated MetHgB response to all forms of PQ, symptomatic with RPQ
Liver enzyme markers	2/15	• Increase in AST and ALT	No	• One consumed alcohol during SPQ arm • One subject during placebo arm; found on followup to have history of gallbladder trouble
G6PDd
Hematological	1/2	• Bilirubin increase above preset stop criterion	Yes	Indicative of excess oxidative damage to red cells due to G6PD deficiency

Note: All subjects were monitored during the study period and on followup by the study physician until symptoms and signs normalized.