Table 3.

Reasons for early discontinuation during dose titration period (up to week 3) in TEMPO 3:4

Reason for discontinuation (n = 47)	n (%)
Reported an AAE	41 (87)
Discontinued (AD)	30 (64)
Discontinued for other reason (NAD)	11 (23)
Discontinued without reporting AAE	1 (2)
Subject withdrew consent	4 (9)
Protocol deviation	1 (2)

AAE, aquaretic adverse event; AD, aquaretic-discontinued; NAD, non–aquaretic-discontinued; TEMPO, Tolvaptan Efficacy and Safety in Management of Autosomal Dominant Polycystic Kidney Disease and its Outcomes.