Table 1 Demographic and Baseline Characteristics (ITT Analysis Set)
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 |