Table 4.

Trial pill tolerability by group.

Reason for permanent discontinuation of study pills, n a	Overall (n = 2423)	Vitamin D3 (n = 1211)	Placebo (n = 1212)
Withdrew consent while on study pills	35	18	17
Adverse Event	89	50	39
Nephrolithiasisb	46	26	20
Other adverse eventc	36	20	16
Deathd	7	4	3
Safety labs—high serum calcium	10	6	4
Safety labs—high urine calcium	3	1	2
Safety labs— low GFR	2	1	1
Participant decisione	170	92	78
Other reason	9	4	5
Did not complete end-of-study encounterf	87	40	47

^aReasons for permanent discontinuation are mutually exclusive.

^bNephrolithiasis diagnosed by either a study physician or physician outside of D2d based on clinical, radiologic findings, or both. All cases—except 5—were classified as “possibly” or “probably related” to study pills.

^cOther adverse event that led to discontinuation of study pills at the discretion of the site study physician or participant decision.

^dDoes not include 4 participants who stopped pills for another reason and died at a later date.

^eA participant requested discontinuation of study pills for any other reason other than an adverse event.

^fFor participant who did not complete the end-of-study encounter, the study pill discontinuation date is the date of the last encounter that was completed.