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Table 3 Baseline characteristics for ADDRESS sequence subgroups

From: Influence of enrollment sequence effect on observed outcomes in the ADDRESS and PROWESS studies of drotrecogin alfa (activated) in patients with severe sepsis

Variable

First 2 patients (n = 916)

3rd and subsequent patients (n = 1,724)

P value

Male, number (percentage)

517 (56.4%)

999 (57.9%)

0.46

Age in years, mean ± SD

58.3 ± 16.8

58.9 ± 16.6

0.36

Region, number (percentage)

  

<0.001

   Europe

265 (28.9%)

581 (33.7%)

 

   US and Canada

480 (52.4%)

681 (39.5%)

 

   Other countries

171 (18.7%

462 (26.8%)

 

Racial origin, number (percentage)

  

0.001

   African descent

67 (7.3%)

98 (5.7%)

 

   Caucasian

694 (75.8%)

1,221 (70.8%)

 

   Hispanic

57 (6.2%)

144 (8.4%)

 

   Asian

62 (6.7%)

168 (9.7%)

 

   Other

36 (3.9%)

93 (5.4%)

 

   Number of organ failures, mean ± SD

1.5 ± 0.7

1.4 ± 0.7

0.19

   APACHE II score, mean ± SD

18.3 ± 5.7

18.1 ± 5.9

0.22

   Acute physiology score, mean ± SD

14.1 ± 5.4

13.7 ± 5.4

0.07

   Number of patients with chronic health points (percentage)

221 (24.1%)

476 (27.6%)

0.08

   Recent surgery, number (percentage)

321 (35.0%)

681 (39.5%)

0.06

   Time from first organ failure to start of study drug in hours, mean ± SD

24.1 ± 13.6

21.8 ± 13.7

<0.001

   Community-acquired infection, number (percentage)

688 (75.1%)

1,235 (71.6%)

0.06

   Heparin use at baseline, number (percentage)

504 (55.0%)

1,047 (60.7%)

0.005

  1. Frequencies were analyzed using a chi-square test. Means were analyzed using a type III sum squares analysis of variance on the ranks. ADDRESS, ADministration of DRotrecogin alfa (activated) in Early Stage Severe Sepsis; APACHE, Acute Physiology and Chronic Health Evaluation; SD, standard deviation.