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Table 1 Disease-free failure estimates, follow up time and hazard ratios

From: Follow up after sample size re-estimation in a breast cancer randomized trial for disease-free survival

 

All randomized patientsa

Original cohort of randomized patientsa

Immediate/follicular phase

Scheduled/luteal phase

Immediate/follicular phase

Scheduled/luteal phase

Total randomized

255

244

167

167

Year

Total (Failures)

Failure probability

(95% CI)

Total (Failures)

Failure probability

(95% CI)

Total (Failures)

Failure probability

(95% CI)

Total (Failures)

Failure probability

(95% CI)

1

246 (10)

0.04 (0.02, 0.07)

226 (18)

0.07 (0.05, 0.11)

163 (5)

0.03 (0.01, 0.07)

157 (11)

0.07 (0.4, 0.12)

3

210 (36)

0.18 (0.14, 0.23)

178 (45)

0.26 (0.21, 0.32)

137 (26)

0.19 (0.13, 0.25)

124 (31)

0.25 (0.19, 0.33)

5

118 (26)

0.29 (0.24, 0.36)

102 (20)

0.36 (0.30, 0.43)

116 (17)

0.29 (0.23, 0.36)

102 (18)

0.36 (0.29, 0.44)

Total eventsb

78

85

54

62

Average follow up time, years (SD)

4.41(1.5)

4.08 (1.8)

4.77 (1.6)

4.42 (1.9)

Event rateb

69.4

85.4

67.8

83.9

HRb (95% CI)

1.24 (0.91, 1.68)

1.25 (0.86, 1.79)

  1. a A total of 499 of 509 of all randomized patients and 334 of 340 original-cohort patients were evaluable. Of the initial cohort, 278 were recruited at the time of sample size re-estimation (SSRE)
  2. b Per 1000 person years; through 6 years of follow up