Randomized controlled trials: who fails run-in?

Table 4 Logistic regression models of run-in failure: full factorial study females

	Unadjusted OR (95 % CI)^a	p	Final model: adjusted OR (95 % CI) C index = 0.62	p	Final model + perceived toxicity adjusted OR (95 % CI)^b C index = 0.66	p
Total participants			N = 301		N =301
Race		0.06
White	Reference
Black	0.92 (0.34–2.52)
Other	2.85 (0.50–16.13)
Unknown/refused	4.75 (1.38–16.38)
Hispanic ethnicity		0.05
No	Reference
Yes	3.07 (0.98–9.59)
Marital status		0.04
Married/cohabitating	Reference
Single	1.95 (1.04–3.66)
Education		0.08
Did not graduate high school	2.75 (1.05–7.23)
Graduated high school	1.69 (0.79–3.63)
Any college education	Reference
Smoking status		0.07
Never	Reference
Former	1.80 (0.91–3.56)
Current	2.55 (1.06–6.17)
Number of prescription medications		0.03		0.03		0.03
0	Reference		Reference		Reference
1	0.43 (0.14–1.30)		0.43 (0.14–1.30)		0.40 (0.13–1.26)
2	0.21 (0.05–0.87)		0.21 (0.05–0.87)		0.21 (0.05–0.87)
3+	0.99 (0.41–2.39)		0.99 (0.41–2.39)		0.97 (0.39–2.38)
Experienced muscular pain in last year		0.07
None	Reference
Some	0.39 (0.11–1.31)
Severe	3.66 (0.79–16.96)
Experienced muscular weakness in last year		0.10
None/some	Reference
Severe	5.32 (0.73–38.71)
Refused any questions during enrollment self-administered questionnaires^c		0.03
No	Reference
Yes	2.41 (1.11–5.27)
Had a perceived toxicity during run-in						0.001
No					Reference
Yes					12.26 (2.79–54.00)

^aIncluded were all variables that had p < 0.1 from Table 1 and baseline factors from Table 2
^bFinal model plus perceived toxicity, the post-enrollment factor from Table 2
^cNot a priori potential predictors

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