Table 2.

Adverse events^a

Patient ID	Gender	Adverse Event	Level of Severity	Possibility of Being Caused by Drug	History of Similar Event	Action Taken	Resolution	Cause of Study Exit?
002	Male	Muscle cramps	Mild	Unlikely	No	None	Spontaneously resolved, drug not stopped	N
		Headache	Mild	Unlikely	Yes	None	Spontaneously resolved, drug not stopped, reappears	N
		Diarrhea	Mild	Unlikely	Yes	None	Spontaneously resolved, drug not stopped	N
		Diarrhea	Mild	Unlikely	Yes	None	Spontaneously resolved, drug not stopped	N
		Gastroenteritis	Moderate	No	Yes	Study drug stopped for 4 wk.	Resolved with ceftriaxone and hydrocortisone, drug resumed	N
		Cellulitis–leg	Moderate	Unlikely	No	Rosiglitazone held until antibiotic stopped.	Resolved with antibiotics	N
004	Male	Muscle cramps	Mild	No	Unknown	None	Spontaneously resolved, drug not stopped	N
005	Male	Dizziness	Mild	Possibly	Yes	None	Spontaneously resolved	N
006	Male	Penile swelling	Mild	Possibly	No	Study drug held	Resolved spontaneously. Held drug for 3 days	N
		Hives	Mild	Possibly	No	Study drug stopped at 6 wk	Hives resolved with benadryl, drug not resumed	Y
010	Male	ARF high-K med, noncompliantb	Severe	No	Yes	Psych evaluation for med noncompliance	Resumed meds. Psych evaluation. Creatinine before event: 1.8, creatinine after event: 1.6	N
011	Male	Viral illness	Moderate	Unlikely	Yes	Rosiglitazone and lisinopril held until vomiting subsided	Resolved in 48 h	N

^aFive patients—001, 003, 007, 008, and 009—did not have adverse effects.

^bARF, acute renal failure.