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Table 1 Characteristics of trials and outcomes 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

Center 1 Set (N = 303)

Center 2 Set (N = 227)

P Chi2

N (%)

Median (Min-Max)

N (%)

Median (Min-Max)

 

Number of trials

51

 

40

  

Patients by trials

 

4 (1–31)

 

2 (1–22)

 

Trial randomization

    

0.13

 Yes

30 (59)

 

25 (63)

  

 No

21 (41)

 

15 (37)

  

Trial promotion

    

0.08

 Academic

25 (49)

 

27 (68)

  

 Industrial

26 (51)

 

13 (32)

  

Protocol defined treatments

    

<0.001

 Chemotherapy-based regimen

154 (51)

 

157 (69)

  

 Targeted therapies only (targeted therapies and/or endocrine therapy)

149 (49)

 

70 (31)

  

Protocol specified “life expectancy” criterion (per patient)

    

0.003

 Yes

73 (24)

 

82 (36)

  

 No

230 (76)

 

145 (64)

  

Treatment duration (months)

 

4 (0–44)

 

4 (0–49)

 

Reason for discontinuing trial

    

<0.001

 Progression

198 (65)

 

136 (60)

  

 Programmed end of the trial

42 (14)

 

6 (3)

  

 Toxicity

32 (10)

 

37 (16)

  

 Death

12 (4)

 

2 (1)

  

 Patient Retrial

8 (3)

 

9 (4)

  

 Other

8 (3)

 

18 (8)

  

 NA

3 (1)

 

19 (8)

  

Median follow-up (months)

 

17 (0–77)

 

12 (0–50)

 

Three-month mortality rate

37 (12)

 

20 (9)

  

Six-month mortality rate

59 (20)

 

41 (18)

  
  1. Abreviations: NA not available