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Table 6 HR, RMST and derived statistics on survival for four randomized controlled trials in various cancer sites conducted by the Medical Research Council

From: Restricted mean survival time: an alternative to the hazard ratio for the design and analysis of randomized trials with a time-to-event outcome

Statistic

ASTEC

BA06

ICON4

OE02

t max (yr)

6.8

6.7

6.4

10.8

t final ∗ (yr)

6.1

6.7

6.3

10.8

S (t ∗)

0.72

0.39

0.082

0.11

N (events a)

1394 (188)

962 (483)

749 (417)

802 (655)

Design HR

0.75

0.75

0.75

0.75

Achieved HR

1.16

0.85

0.82

0.85

(Cox model)

    

P-value for HR

0.3

0.07

0.04

0.03

(logrank test)

    

P-value for non-PH

0.06

0.7

0.6

0.1

(G-T test b)

    

RMST in control

5.39

3.69

2.46

2.68

arm ( μ ̂ 0 )

    

RMST in research

5.28

4.02

2.79

3.13

arm ( μ ̂ 1 )

    

Diff. Δ ̂ =

-0.11 (0.10)

0.33 (0.18)

0.33 (0.17)

0.46 (0.26)

μ ̂ 1 - μ ̂ 0 (SE)

    

P-value for

0.3

0.07

0.05

0.08

Δ ̂ (RMST test)

    

P-value for

0.07

0.4

0.7

0.04

non-PH c

    
  1. See text for details.
  2. aEvents occurring in the interval (0,t *).
  3. bGrambsch-Therneau test
  4. cFrom a flexible parametric hazards model with a time-dependent treatment effect.