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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 characteristicsStudy part p-value**
Part A
(n = 70)
Part B
(n = 102)
Total
(n = 172)
Gender n (%)
 Male52 (74.3%)69 (67.6%)121 (70.3%)0.3490
 Female18 (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
 Median73.0073.5073.00 
 Range33.00–88.0045.00–93.0033.00–93.00 
Pooled geographic region n (%)
 North America40 (57.1%)27 (26.5%)67 (39.0%)0.0001
 Europe22 (31.4%)63 (61.8%)85 (49.4%) 
 Rest of the World8 (11.4%)12 (11.8%)20 (11.6%) 
ECOG PS at baseline, n (%)
 ECOG PS 038 (54.3%)66 (64.7%)104 (60.5%)0.1697
 ECOG PS 132 (45.7%)36 (35.3%)68 (39.5%) 
Site of primary tumor, n (%)
 Non-skin9 (12.9%)7 (6.9%)16 (9.3%)0.1097
 Skin55 (78.6%)91 (89.2%)146 (84.9%) 
 Not applicable0 (0.0%)4 (3.9%)4 (2.3%) 
 Missing6 (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
 Median83.0064.0066.00 
 Range16.00–404.000.00–288.000.00–404.00 
Time since initial diagnosis (years)
 Mean (SD)2.19 (0.80)2.27 (0.76)2.24 (0.78)0.4631
 Median2.002.002.00 
 Min - Max1.00–3.001.00–3.001.00–3.00 
Time since first metastatic disease (months)
 Mean (SD)16.94 (23.44)5.46 (7.66)10.13 (16.98)<.0001
 Median9.492.335.73 
 Min - Max1.51–156.750.36–49.580.36–156.75 
  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