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Table 2 Ranking of risk factors likely to trigger adjudications

From: Discrepancies of assessments in a RECIST 1.1 phase II clinical trial – association between adjudication rate and variability in images and tumors selection

Risk factors likely to trigger adjudications

Odd ratio[95%CI]

P value

Nb and %

of occurrence

Detection of new lesion

1.79 [0.83; 3.9]

0.12

91; 62%

Different image selected at baseline

0.97 [0.47; 2.0]

1.0

85; 57.8%

Different image selected at each time point

0.82 [0.37; 1.79]

0.2

102; 69.4%

Detection of progressive non-target lesion

0.67 [0.31; 1.45]

0.29

52; 35.4%

Selection of non-measurable target lesion

0.52 [0.08; 1.82]

0.25

24; 16.3%

Selection of different target lesions

0.42 [0.16; 1.12]

0.06

123; 83.7%

  1. Risks factors associated with adjudication were assessed in computing the odds ratio with 95% Confidence interval and the corresponding p value. Are reported the number of occurrence of these risks factors per patients and the proportion they represented in our dataset