Table 3.

Investigator-assessed serious AEs potentially related to tolvaptan use

Description	Cause	Days	Relationship	Action	Outcome
Ventricular tachycardia in a 75-year-old man	CHF	3	Possible	Discontinued	Resolved
ARF in a 53-year-old man with decompensated heart failure, atrial tachycardia, gastrointestinal hemorrhage, and catheter site infection	CHF	14, 30, 459 (three events)	Possible	Interrupted use	Resolved
Hyponatremia and convulsions in a 76-year-old woman	SIADH	16, 168	Probable	Dosage increase	Resolved
Hepatorenal syndrome in a 65-year-old woman	Cirrhosis	53	Possible	Interrupted use	Fatal
Clostridium difficile colitis in an 86-year-old woman with CHF, peripheral ischemia, gastrointestinal hemorrhage, and pneumonia	CHF	173	Possible	None	Recovered
ARF in a 48-year-old man with decompensated and worsening heart failure	CHF	218	Possible	Interrupted use	Resolved
Severe dehydration, hypoglycemia, and therapeutic agent toxicity in an 87-year-old woman with recurrent atrial fibrillation	SIADH	238, 238, 238	Possible	Interrupted use	Resolved
Nausea, vomiting, and increased blood creatinine in a 79-year-old man with transient ischemic attack	CHF	329, 315, 315	Possible	Discontinued	Resolved
ARF in a 33-year-old man with heart failure, cardiac tamponade, and respiratory distress	CHF	540	Possible	Interrupted use	Resolved
Dehydration in a 72-year-old woman with depression and gastroenteritis	SIADH	709	Possible	None	Resolved

ARF, acute renal failure.