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. Author manuscript; available in PMC: 2017 Dec 1.
Published in final edited form as: Clin Trials. 2016 Jun 30;13(6):612–620. doi: 10.1177/1740774516655101

Table 2.

Patient Characteristics by Compliant Status

100% Compliant
(N=1267)
Non Compliant
(N=373)
Total
(N=1640)
P-value

Age 0.031
  Mean (SD) 57.5 (9.5) 58.6 (11.6) 57.7 (10.0)
  Median 57.0 59.0 58.0
  Range (24.0–95.0) (26.0–86.0) (24.0–95.0)
Race <0.012
  White 1168 (92.2%) 321 (86.1%) 1489 (90.8%)
  Black or African American 68 (5.4%) 41 (11.0%) 109 (6.6%)
  Native Hawaiian or Other Pacific Islander 1 (0.1%) 0 (0.0%) 1 (0.1%)
  Asian 15 (1.2%) 4 (1.1%) 19 (1.2%)
  American Indian or Alaska Native 4 (0.3%) 4 (1.1%) 8 (0.5%)
  Not reported 11 (0.9%) 3 (0.8%) 14 (0.9%)
Gender <0.012
  Female 985 (77.7%) 226 (60.6%) 1211 (73.8%)
  Male 281 (22.2%) 147 (39.4%) 428 (26.1%)
  Unknown 1 (0.1%) 0 (0.0%) 1 (0.1%)
ECOG Performance Status <0.012
  Unknown 32 6 38
  0 981 (79.4%) 259 (70.6%) 1240 (77.4%)
  1–2 254 (20.6%) 108 (29.4%) 362 (22.6%)
Tumor Status 0.662
  Unknown 1035 252 1287
  Resected with no residual 80 (34.5%) 41 (33.9%) 121 (34.3%)
  Resected with known residual 32 (13.8%) 12 (9.9%) 44 (12.5%)
  Unresected 109 (47.0%) 60 (49.6%) 169 (47.9%)
  Recurrent 11 (4.7%) 8 (6.6%) 19 (5.4%)
Cancer Type <0.012
  Unknown 1 (0.1%) 0 (0.0%) 1 (0.1%)
  Breast 404 (31.9%) 54 (14.5%) 458 (27.9%)
  Breast/Gynecologic 397 (31.3%) 45 (12.1%) 442 (27.0%)
  GI 268 (21.2%) 230 (61.7%) 498 (30.4%)
  Gyn 7 (0.6%) 9 (2.4%) 16 (1.0%)
  Head and Neck 139 (11.0%) 20 (5.4%) 159 (9.7%)
  Heme 5 (0.4%) 1 (0.3%) 6 (0.4%)
  Lung 10 (0.8%) 3 (0.8%) 13 (0.8%)
  Prostate 15 (1.2%) 7 (1.9%) 22 (1.3%)
  Other 21 (1.7%) 4 (1.1%) 25 (1.5%)
Clinical Stage 0.812
  Unknown 1194 366 1560
  Stage I 23 (31.5%) 3 (42.9%) 26 (32.5%)
  Stage II 24 (32.9%) 2 (28.6%) 26 (32.5%)
  Stage III 19 (26.0%) 2 (28.6%) 21 (26.3%)
  Other 7 (9.6%) 0 (0.0%) 7 (8.8%)
Length of Time on Study (in Days) <0.011
  Mean (SD) 95.0 (102.4) 112.3 (86.9) 98.9 (99.3)
  Median 87.0 102.0 88.0
  Range (1.0–2079.0) (2.0–1071.0) (1.0–2079.0)
Overall QOL 0.423
  >=8 267 (21.1%) 71 (19.0%) 338 (20.6%)
  <8 1000 (78.9%) 302 (81.0%) 1302 (79.4%)
Overall QOL 0.123
  >=6 397 (31.3%) 101 (27.1%) 498 (30.4%)
  <6 870 (68.7%) 272 (72.9%) 1142 (69.6%)
AE Grade >=3 (Y/N) 0.363
  Not Collected 395 65 460
  N 825 (94.6%) 296 (96.1%) 1121 (95.0%)
  Y 47 (5.4%) 12 (3.9%) 59 (5.0%)
AE Grade >=2 (Y/N) 0.333
  Not Collected 395 65 460
  N 698 (80.0%) 238 (77.3%) 936 (79.3%)
  Y 174 (20.0%) 70 (22.7%) 244 (20.7%)
Dose Reduced (Y/N) <0.013
  Y 43 (3.4%) 34 (9.1%) 77 (4.7%)
  N 1224 (96.6%) 339 (90.9%) 1563 (95.3%)
Dose Delayed (Y/N) <0.013
  Y 263 (20.8%) 132 (35.4%) 395 (24.1%)
  N 1004 (79.2%) 241 (64.6%) 1245 (75.9%)
Study Type <0.012
  Cancer Control 1208 (95.3%) 331 (88.7%) 1539 (93.8%)
  QOL 11 (0.9%) 1 (0.3%) 12 (0.7%)
  Treatment Trial 48 (3.8%) 41 (11.0%) 89 (5.4%)
1

Kruskal Wallis

2

Chi-Square

3

Fisher Exact