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Table 2 The estimated PFS and OS hazard ratios at the end of the four example trials

From: Impact of lack-of-benefit stopping rules on treatment effect estimates of two-arm multi-stage (TAMS) trials with time to event outcome

Trial

Control arm

Experimental arm

Hazard ratio (95% CI)

 

Treatment

N a

e b

Treatment

N a

e b

PFSc

P value

OSd

P value

ICON3

Carbo/CAP

1350

827

Carbo, TAX

698

431

0.93(0.83–1.03)

0.15

0.97(0.86–1.09)

0.63

RE04

IFN-α

502

340

IFN-α, IL-2,5FU

504

351

1.02(0.89–1.16)

0.81

1.05(0.90–1.21)

0.55

ICON4

Plat.

378

220

Plat., TAX

361

199

0.81(0.69–0.95)

0.01

0.82(0.68–0.99)

0.04

RE01

MPA

176

167

IFN-α

174

155

0.68(0.54–0.84)

<0.01

0.75(0.60–0.93)

<0.01

  1. aNumber of patients;
  2. boverall survival events, that is deaths from any cause;
  3. cprogression-free survival;
  4. doverall survival.
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Trials

ISSN: 1745-6215