Table 5.

Clinical events, overall and during the posttreatment observational follow-up phase, by randomized treatment assignment (N = 2,259)

Observational phaseOverall
No vitamin DVitamin DNo calciumCalciumNo vitamin DVitamin DNo calciumCalcium
N = 1,014N = 1,014N = 745N = 760N = 1,129N = 1,130N = 835N = 840
N (%)N (%)PN (%)N (%)PN (%)N (%)PN (%)N (%)P
Death21 (2.1)15 (1.5)0.3116 (2.2)15 (2.0)0.8133 (2.9)30 (2.7)0.7028 (3.4)28 (3.3)0.98
Myocardial Infarction with or without coronary revascularization10 (1.0)8 (0.8)0.646 (0.8)9 (1.2)0.4617 (1.5)15 (1.3)0.7214 (1.7)11 (1.3)0.54
Coronary revascularization without myocardial infarction12 (1.2)14 (1.4)0.6912 (1.6)12 (1.6)0.9623 (2.0)26 (2.3)0.6720 (2.4)24 (2.9)0.55
Stroke9 (0.9)11 (1.1)0.6513 (1.7)7 (0.9)0.1614 (1.2)20 (1.8)0.3018 (2.2)10 (1.2)0.12
Transient ischemic attack2 (0.2)4 (0.4)0.691 (0.1)5 (0.7)0.223 (0.3)7 (0.6)0.344 (0.5)5 (0.6)1.00
Cancer
 Any56 (5.5)59 (5.8)0.7746 (6.2)45 (5.9)0.84112 (9.9)107 (9.5)0.7289 (10.7)90 (10.7)0.97
 Colorectal6 (0.6)3 (0.3)0.513 (0.4)4 (0.5)1.008 (0.7)6 (0.5)0.593 (0.4)6 (0.7)0.51
 Breast6 (0.6)6 (0.6)1.002 (0.3)1 (0.1)0.6211 (1.0)8 (0.7)0.493 (0.4)4 (0.5)1.00
 Prostate10 (1.0)15 (1.5)0.3113 (1.7)12 (1.6)0.8036 (3.2)35 (3.1)0.9039 (4.7)32 (3.8)0.38
 Melanoma4 (0.4)6 (0.6)0.535 (0.7)2 (0.3)0.289 (0.8)7 (0.6)0.617 (0.8)5 (0.6)0.56
Urolithiasis18 (1.8)19 (1.9)0.8714 (1.9)16 (2.1)0.7544 (3.9)37 (3.3)0.4329 (3.5)35 (4.2)0.46
Fracture52 (5.1)48 (4.7)0.6831 (4.2)37 (4.9)0.51111 (9.8)101 (8.9)0.4772 (8.6)71 (8.5)0.90
  • NOTE: Observational phase events are those that occurred in participants who consented to the observational phase, regardless of the presence of an end-of-treatment colonoscopy. Data are the numbers of participants who had one or more occurrences of an adverse event and their percentage among all participants who were randomly assigned to the given group.