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. Author manuscript; available in PMC: 2016 Jan 1.
Published in final edited form as: Pediatr Crit Care Med. 2015 Jan;16(1):1–10. doi: 10.1097/PCC.0000000000000272

Table 5.

Sample Sizes Requireda for THAPCA Trials Using a Binary Primary Outcome of Survival with VABS-II >=70

Assumed Rate
of Survival
with VABS-II
>=70 in
Normothermia
Arm		 In hospital
Scenario: 15%
Hypothermia
benefit
80% power		 In hospital
Scenario: 15%
Hypothermia
benefit
85% power		 In hospital
Scenario: 15%
Hypothermia
benefit
90% power		 Out of hospital
Scenario: 20%
Hypothermia
benefit
80% power		 Out of hospital
Scenario: 20%
Hypothermia
benefit
85% power		 Out of hospital
Scenario: 20%
Hypothermia
benefit
90% power
15% 274 312 360 170 192 222
20% 312 352 402 190 214 246
25% 340 386 446 204 230 264
30% 362 410 474 214 240 278
35% 376 426 494 220 248 286
40% 384 434 504 222 250 288
45% 384 434 504 220 248 286
50% 376 426 494 214 240 278
55% 362 410 474 204 230 264
a

Estimated sample sizes assume a two-sided chi-squared test with Type I error of 5%, and reflect inflation for conservative interim monitoring as described in text.