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Table 2 Clinical and biological characteristics at baseline for Center 1 and Center 2 sets

From: PRognostic factor of Early Death In phase II Trials or the end of ‘sufficient life expectancy’ as an inclusion criterion? (PREDIT model)

Characteristics at baseline

Center 1 Set (N = 303)

Center 2 Set (N = 227)

P Chi2

N (%)

Median (Min-Max)

N (%)

Median (Min-Max)

 

Sex

    

0.64

 Male

181 (60)

 

131 (58)

  

 Female

122 (40)

 

96 (42)

  

Age

 

62 (IQR, 19)

 

60 (IQR, 23)

0.07

  < 50

55 (18)

 

42 (19)

  

 50–65

116 (38)

 

107 (47)

  

  ≥ 65

132 (44)

 

78 (34)

  

Performance status

    

0.82

 ECOG 0–1

278 (92)

 

207 (91)

  

 ECOG 2

25 (8)

 

20 (9)

  

BMI (kg/m2)

 

25 (16–39)

 

26 (16–45)

-a

  < 18.5

13 (4)

 

9 (4)

  

 18.5–25

147 (49)

 

83 (37)

  

  ≥ 25

143 (47)

 

107 (47)

  

 NA

0

 

28 (12)

  

Previous treatments

 

1 (0–4)

 

1 (0–6)

<0.001

 0

9 (3)

 

106 (47)

  

 1

185 (61)

 

67 (30)

  

 2

74 (24)

 

32 (14)

  

 3

27 (9)

 

19 (8)

  

 4 and more

8 (3)

 

3 (1)

  

Cancer localization

    

0.01

 Sarcomas

123 (40)

 

91 (40)

  

 Urological

78 (26)

 

35 (15)

  

 Gastrointestinal

54 (18)

 

63 (28)

  

 Breast

29 (10)

 

20 (9)

  

 Other

19 (6)

 

18 (8)

  

Involved areas

    

0.55

 Loco-regional disease

18 (6)

 

19 (8)

  

 1–2 metastatic sites

223 (74)

 

164 (72)

  

  ≥ 3 metastatic sites

62 (20)

 

44 (19)

  

Hemoglobin level

    

0.08

  < Normal

106 (35)

 

94 (41)

  

 Normal

196 (65)

 

126 (56)

  

 NA

1 (0.3)

 

7 (3)

  

Leukocyte level

    

0.18

  < Normal

14 (5)

 

15 (6)

  

 Normal

255 (84)

 

171 (75)

  

  > Normal

33 (11)

 

33 (15)

  

 NA

1 (0.3)

 

8 (4)

  

Albumin level

    

-a

  < Normal

25 (8)

 

87 (38)

  

 Normal

236 (78)

 

111 (50)

  

 NA

32 (11)

 

28 (12)

  

LDH level

    

-a

  < Normal

133 (44)

 

137 (60)

  

 Normal

55 (18)

 

51 (23)

  

 NA

111 (37)

 

34 (15)

  
  1. Abbreviations: BMI body mass index, ECOG Eastern Cooperative Oncology Group, IQR interquartile range, LDH lactate dehydrogenase, NA not available
  2. aDue to a non-applicable rate of 10 % or more, BMI, Albumin level and LDH level variables cannot be tested by the chi test