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. 2012 Feb 17;14(2):176–186. doi: 10.1208/s12248-012-9327-8

Table II.

Actual Significance Levels of False Covariate Inclusion or Drug Effect Detection Corresponding to a Nominal Level of 0.05, versus the Number of Patients Per Arm

Models Number of patients per arm Type I error rate (%)
One-compartment, IV bolus model 5 8.8
7.5 7
12.5 6.8
25 7.2
37.5 5.9
50 6.2
125 4.6
One-compartment, zero-order input model 2 8.87
6 6.54
10 6.23
20 6.03
24 6.16
30 5.46
36 5.72
40 5.36
46 5.66
52 5.71
60 4.86
66 5.24
80 5
Linear disease, slope effect model 10 8.53
20 5.42
30 5.76
44 5.44
60 5.16
80 5.02
120 4.8
Indirect transit compartment model (FPG-HbA1c) 2 6.5
5 5.4
10 4.9
15 4.3
20 6.01
25 6.1
30 5.7
35 5.8
40 5.3
HIV viral load, bi-exponential model 25 5.2
45 4.9
65 5
82 4.9
100 4.9
115 4.9
Digoxin two-compartment, linear effect model 4 20.44
8 15.58
14 13.34
20 13.09
30 13.67
50 12.66