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. Author manuscript; available in PMC: 2021 Dec 1.
Published in final edited form as: Lancet Oncol. 2020 Dec;21(12):1620–1629. doi: 10.1016/S1470-2045(20)30527-1

Table 2:

Treatment effects comparing disease free survival and overall survival between 3 months and 6 months of therapy with 6 months group as reference group

Cohort Disease Free Survival with 5 years of follow up Overall Survival
HR (95% CI) * One-sided FDRadj p-value† for non-inferiority of 3 months therapy Two-sided FDRadj p-value¥ for superiority of 6 months therapy HR (95% CI) * One-sided FDRadj p-value† for non-inferiority of 3 months therapy Two-sided FDRadj p-value¥ for superiority of 6 months therapy
Overall 1.08 (1.02 to 1.15) 0.25 0.044 1.02 (0.95-1.11) 0.058 0.64
CAPOX 0.98 (0.88 to 1.08) 0.027 0.67 0.96 (0.85-1.08) 0.033 0.62
FOLFOX 1.16 (1.07 to 1.26) 0.80 0.0061 1.07 (0.97-1.18) 0.34 0.38
Low Risk 1.04 (0.94 to 1.15) 0.16 0.58 0.95 (0.84-1.08) 0.033 0.58
High Risk 1.13 (1.03 to 1.22) 0.63 0.031 1.08 (0.98-1.19) 0.39 0.29

HR denotes hazard ratio, CI confidence interval, FDRadj false discovery rate adjusted, mITT modified intention-to-treat

*

Two-sided 95% CI without adjustment of multicity;

†

If the observed one-sided FDRadj p-value is less than 0.025, then 3 months of therapy is declared statistically non-inferior to 6 months of therapy after adjusting for multicity.

¥

If the observed two-sided FDRadj p-value is less than 0.05, then 6 months of therapy is declared statistically superior to 3 months of therapy after adjusting for multicity.