Table 3.

Baseline demographics, intervention compliance, and adverse events by randomization arm

CharacteristicOverall (n = 85)Atorvastatin (n = 22)Sulindac (n = 21)ORAFTI®Synergy1 (n = 20)Control (n = 22)Pa
Age, y0.07
 Median5861556457
 Range41–7844–7841–7448–7844–72
Gender, n (%)0.51
 Women29 (34.1)5 (22.7)9 (42.9)8 (40.0)7 (31.8)
 Men56 (65.9)17 (77.3)12 (57.1)12 (60.0)15 (68.2)
BMI, kg/m20.78
 Median28.327.229.027.929.4
 Range15.5–51.315.5–42.018.4–51.019.8–39.622.5–51.3
Cigarette smoking status, n (%)0.42
 Never35 (41.2)9 (40.9)9 (42.9)11 (55.0)6 (27.3)
 Current13 (15.3)5 (22.7)4 (19.1)1 (5.0)3 (13.6)
 Former37 (43.5)8 (36.4)8 (38.1)8 (40.0)13 (59.1)
Alcohol, drinks per day, n (%)0.16
 None33 (38.8)9 (40.9)6 (28.6)12 (60.0)6 (27.3)
 ≤145 (52.9)10 (45.5)14 (66.7)7 (35.0)14 (63.6)
 2–35 (5.6)3 (13.6)0 (0.0)1 (5.0)1 (4.6)
 ≥42 (2.4)0 (0.0)1 (4.8)0 (0.0)1 (4.6)
Family history of CRC, n (%)0.42
 Yes21 (24.7)5 (22.7)6 (28.6)7 (35.0)3 (13.6)
 No64 (75.3)17 (77.3)15 (71.4)13 (65.0)19 (86.4)
History of surgical resection, n (%)1.00
 Yes25 (29.4)7 (31.8)6 (28.6)6 (30.0)6 (27.3)
 No60 (70.6)15 (68.2)15 (71.4)14 (70.0)16 (72.7)
Intervention compliance: planned doses received, %0.02
 Median96.799.396.497.486.4
 Range1.4–108.128.9–101.75.6–108.150.0–103.11.4–103.9
Adverse events, n (%)b
 Any grade60 (70.6)15 (68.2)14 (66.7)12 (60.0)19 (86.4)0.25
 Grade 148 (56.5)11 (50.0)12 (57.1)10 (50.0)15 (68.2)0.60
 Grade 226 (30.6)5 (22.7)4 (19.0)4 (20.0)13 (59.1)0.02
 Grade 35 (5.9)2 (9.1)2 (9.5)0 (0.0)1 (4.5)0.71
  • aP value for comparison across randomization arms, using Fisher's exact test.

  • bMaximum severity adverse event per participant.