Table 1

Participant characteristics

TotalPlaceboLD naproxenHD naproxenP value
N%N%N%N%
Total 541002342.61527.81629.6
Age 0.58
Mean (SD)4412.643.71446.412.742.310.8
Age group
20–291018.4626.1213.3212.50.81
30–39916.728.7213.3531.3
40–491527.8730.4426.8425.0
50–591527.8626.1533.3425.0
60–6947.414.3213.316.3
70–7011.914.300.000.0
Gender
Male1833.31043.5533.3318.70.29
Female3666.71356.51066.71381.3
Race
White5092.62295.71386.61593.80.71
Other35.614.316.716.2
Unknown11.900.016.700.0
Ethnicity
Not Hispanic or Latino5194.4231001386.71593.80.06
Hispanic or Latino11.900.000.016.3
Not Reported23.700.0213.300.0
Type of MMR deficiency
LLS47.428.716.716.31
LS positive5092.62191.31493.31593.8
MMR gene
MLH1 1836.0733.3750.0426.70.2
MSH2 1632.0523.8321.4853.3
MSH6 918.0314.3428.57213.3
PMS2 48.0419.000.000.0
EPCAM 36.029.500.016.7
History of cancer
Negative2953.71356.5853.38500.94
Cancer diagnosis2546.31043.5743.7850
Type of cancer (n)*
CRC13544
Endometrial6132
Urothelial0000
Ovarian1100
Other12426
Accrual
Site 0.58
Brigham1425.9521.7426.7531.25
Huntsman611.1313.0320.000.0
MDACC1731.5626.1533.3637.5
Michigan1731.5939.1320.0531.25
Compliance
Average
Days on agent186.48187.6185.7185.60.92
 (min, max)172 to 215180 to 215172 to 203177 to 194
Days missed2.713.152.72.090.87
 (min, max)0 to 190 to 160 to 19 0 to 13
Percentage of study drug taken94.3794.6994.0294.250.68
 (min, max)81.9 to 10081.9 to 10085.9 to 98.982.3 to 1000.68
  • *Patients can present with more than one cancer type.

  • CRC, colorectal cancer; HD, high dose; LD, low dose; LLS, Lynch-like syndrome; LS, Lynch syndrome; MMR, mismatch repair.