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Table 1 Demographic and Baseline Characteristics (ITT Analysis Set)

From: Psychometric properties of a custom Patient-Reported Outcomes Measurement Information System (PROMIS) physical function short form and worst stiffness numeric rating scale in tenosynovial giant cell tumors

  Randomized to Placebo(N = 59) Randomized to Pexidartinib(N = 61) Total(N = 120)
Age (yrs)
 Mean 44.3 44.6 44.5
 SD 13.58 13.23 13.35
 Median 45.0 44.0 44.5
 Minimum 18 22 18
 Maximum 79 75 79
Sex
 Male 23 (39.0) 26 (42.6) 49 (40.8)
 Female 36 (61.0) 35 (57.4) 71 (59.2)
Race
 White 54 (91.5) 52 (85.2) 106 (88.3)
 Black or African American 1 (1.7) 3 (4.9) 4 (3.3)
 Asian 2 (3.4) 1 (1.6) 3 (2.5)
 American Indian or Alaskan Native 0 2 (3.3) 2 (1.7)
 Native Hawaiian or Other Pacific Islander 2 (3.4) 2 (3.3) 4 (3.3)
 Other/Specify 0 1 (1.6) 1 (0.8)
 Multi-Racial 0 1 (1.6) 1 (0.8)
Ethnicity
 Hispanic/Latino 8 (13.8) 9 (15.5) 17 (14.7)
 Not Hispanic or Latino 50 (86.2) 49 (84.5) 99 (85.3)
 Missing 1 3 4
Height (cm)
 n 56 59 115
 Mean 170.64 170.37 170.50
 SD 10.501 9.417 9.917
 Median 170.00 171.00 170.00
 Minimum 152.0 149.0 149.0
 Maximum 198.0 195.0 198.0
Weight (kg)
 n 59 61 120
 Mean 82.11 83.33 82.73
 SD 20.122 23.830 22.001
 Median 81.00 80.00 80.65
 Minimum 48.0 43.0 43.0
 Maximum 134.6 151.0 151.0
Geographic region
 US Region 22 (37.3) 23 (37.7) 45 (37.5)
 Ex-US Region 37 (62.7) 38 (62.3) 75 (62.5)
Time from Diagnosis to Randomization (days)
 Mean 1427.8 2449.3 1947.1
 SD 1495.24 3098.69 2488.77
 Median 926.0 1456.0 1272.0
 Minimum 42 15 15
 Maximum 8088 14,912 14,912
PVNS/ GCT-TS
 PVNS 53 (89.8) 52 (85.2) 105 (87.5)
 GCT-TS 6 (10.2) 9 (14.8) 15 (12.5)
 Both 0 0 0
Extremity Involvement
 Upper 5 (8.5) 5 (8.2) 10 (8.3)
 Shoulder 1 (1.7) 1 (1.6) 2 (1.7)
 Elbow 0 1 (1.6) 1 (0.8)
 Wrist 2 (3.4) 2 (3.3) 4 (3.3)
 Hand 0 0 0
 Finger 1 (1.7) 0 1 (0.8)
 Spine 1 (1.7) 1 (1.6) 2 (1.7)
 Lower 54 (91.5) 56 (91.8) 110 (91.7)
 Hip 7 (11.9) 6 (9.8) 13 (10.8)
 Knee 39 (66.1) 34 (55.7) 73 (60.8)
 Ankle 7 (11.9) 14 (23.0) 21 (17.5)
 Foot 1 (1.7) 2 (3.3) 3 (2.5)
 Toe 0 0 0
Most Disturbing Symptom
 Pain 13 (27.7) 12 (25.5) 25 (26.6)
 Stiffness 6 (12.8) 9 (19.1) 15 (16.0)
 Difficulty with Everyday Activities 28 (59.6) 26 (55.3) 54 (57.4)
 Missing 12 14 26
Global Rating of Concept
How Much has Tumor Limited Physical Functioning
  Not at All 4 (8.5) 2 (4.3) 6 (6.4)
  A Little 10 (21.3) 17 (36.2) 27 (28.7)
  Somewhat 23 (48.9) 18 (38.3) 41 (43.6)
  Severely 9 (19.1) 9 (19.1) 18 (19.1)
  Extremely 1 (2.1) 1 (2.1) 2 (2.1)
  Missing 12 14 26