Table 2 Description of both populations

From: Prediction of early death among patients enrolled in phase I trials: development and validation of a new model based on platelet count and albumin

 

Training data set ( n =2110)

Validation data set ( n =306)

 

Parameters

n , % (95 CI)

n , % (95 CI)

P -value ( χ 2 -test)

Early death

  

0.003

 Yes

344, 16.3% (14.7–17.8)

30, 9.8% (6.4–13.1)

 

 Missing data

0

0

 

Gender

  

<0.001

 Women

1194, 56.6% (54.5–58.7)

135, 44.1% (38.5–49.7)

 

 Missing data

0

0

 

Primaries

  

<0.001

 Colorectal cancers

367/17.4% (15.7–19.0)

87/28.4% (23.3–33.4)

 

 Oesophago-gastric cancers

275/13.0% (11.6–14.4)

15/4.9% (2.5–7.3)

 

 Gynaecological cancers

249/11.8% (10.4–13.2)

18/5.9% (3.2–8.5)

 

 Sarcomas

216/10.2% (8.9–11.5)

15/4.9% (2.5–7.3)

 

 Lung cancers

214/10.1% (8.8–11.4)

10/3.3% (1.3–5.3)

 

 Melanoma

157/7.4% (6.3–8.5)

21/6.9% (4.1–9.7)

 

 Prostate cancer

148/7.0% (5.9–8.1)

1/0.3% (0–0.9)

 

 Breast cancers

142/6.7% (5.6–7.8)

40/13.1% (9.3–16.9)

 

 Other genitourinary cancers

108/5.1% (4.2–6.0)

17/5.6% (3.0–8.2)

 

 Head and neck

94/4.5% (3.6–5.4)

71/23.2% (18.5–27.9)

 

 Others

140/6.6% (5.5–7.6)

11 (3.6%)

 

 Missing data

0

  

ECOG-PS

  

<0.001

 0

857/40.6% (38.4–42.8)

155/50.7% (45.1–56.3)

 

 1

1186/56.2% (54.1–58.4)

140/45.8% (40.2–51.4)

 

 2

67/3.2% (2.4–3.9)

11/3.6% (1.5–5.7)

 

 Missing data

0

0

 

First-in-man

 Yes

930/44.1% (42.0–46.1)

0/0% (−)

 

 Missing data

0

  

Investigational treatments

  

<0.001

 Targeted agent (single-agent)

940/44.5% (42.4–46.6)

  

 Cytotoxic agents

460/21.8% (19.3–24.3)

306/100% (−)

 

 Targeted+cytotoxic agents

543/25.7% (23.8–27.6)

  

 Combination of targeted agents

167/7.9% (6.7–9.0)

  

 Missing data

0

  
  1. Abbreviation: CI=confidence interval.