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Table 1 Sociodemographic / clinical characteristics of Part A and Part B patients of JAVELIN Merkel 200 trial, FACT-M PRO analysis set (n = 172)*

From: Update on the psychometric properties and minimal important difference (MID) thresholds of the FACT-M questionnaire for use in treatment-naïve and previously treated patients with metastatic Merkel cell carcinoma

Sociodemographic / clinical characteristics

Study part

 

p-value**

Part A

(n = 70)

Part B

(n = 102)

Total

(n = 172)

Gender n (%)

 Male

52 (74.3%)

69 (67.6%)

121 (70.3%)

0.3490

 Female

18 (25.7%)

33 (32.4%)

51 (29.7%)

 

Age (years)

 Mean (SD)

70.20 (11.19)

72.53 (9.81)

71.58 (10.42)

0.1505

 Median

73.00

73.50

73.00

 

 Range

33.00–88.00

45.00–93.00

33.00–93.00

 

Pooled geographic region n (%)

 North America

40 (57.1%)

27 (26.5%)

67 (39.0%)

0.0001

 Europe

22 (31.4%)

63 (61.8%)

85 (49.4%)

 

 Rest of the World

8 (11.4%)

12 (11.8%)

20 (11.6%)

 

ECOG PS at baseline, n (%)

 ECOG PS 0

38 (54.3%)

66 (64.7%)

104 (60.5%)

0.1697

 ECOG PS 1

32 (45.7%)

36 (35.3%)

68 (39.5%)

 

Site of primary tumor, n (%)

 Non-skin

9 (12.9%)

7 (6.9%)

16 (9.3%)

0.1097

 Skin

55 (78.6%)

91 (89.2%)

146 (84.9%)

 

 Not applicable

0 (0.0%)

4 (3.9%)

4 (2.3%)

 

 Missing

6 (8.6%)

0 (0.0%)

6 (3.5%)

 

Tumor size at baseline (mm)

 n (missing)

61 (9)

100 (2)

161 (11)

 

 Mean (SD)

103.69 (79.68)

79.46 (58.48)

88.64 (68.09)

0.0280

 Median

83.00

64.00

66.00

 

 Range

16.00–404.00

0.00–288.00

0.00–404.00

 

Time since initial diagnosis (years)

 Mean (SD)

2.19 (0.80)

2.27 (0.76)

2.24 (0.78)

0.4631

 Median

2.00

2.00

2.00

 

 Min - Max

1.00–3.00

1.00–3.00

1.00–3.00

 

Time since first metastatic disease (months)

 Mean (SD)

16.94 (23.44)

5.46 (7.66)

10.13 (16.98)

<.0001

 Median

9.49

2.33

5.73

 

 Min - Max

1.51–156.75

0.36–49.58

0.36–156.75

 
  1. ECOG PS = Eastern Cooperative Oncology Group Performance Status (0 = fully active; 1 = restricted in physically strenuous activity); SD = standard deviation;
  2. *Of note, in the process of data cleaning of a subsequent Part B data cut, baseline data of four patients were set to missing as their assessment had taken place after treatment initiation. For the present analysis, however, it was deemed irrelevant that treatment had already started, as the psychometric properties of the FACT-M should not be influenced by assessment time point. Hence, these patients are included in the psychometric analyses, explaining discrepancies between the sample size reported herein and the sample size used for the analyses of HRQoL outcomes over time where n = 98 patients (instead of n = 102) are included in PAS of the FACT-M
  3. ** P-value for between-group comparisons: T-test for continuous variables, Chi2 or Fisher’s exact for categorical variables