Table 2.
Demographic and Clinical Characteristics of Responders and Non-responders to Placebo in Fatigue Clinical Trials
| Responders (n= 59; 56%) |
Non-responders (n= 46; 44%) |
P value | |
|---|---|---|---|
| Gender | |||
| Female | 37 (63) | 26 (57) | 0.52 |
| Race | 0.53 | ||
| Asian | 1 (2) | 1 (2) | |
| Black | 7 (12) | 3 (7) | |
| Caucasian | 43 (73) | 36 (78) | |
| Hispanic | 7 (12) | 6 (13) | |
| Other | 1 (2) | 0 (0) | |
| Median Age (Range), in years | 59 (37–84) | 58 (37–78) | 0.63 |
| Marital Status | 0.75 | ||
| Married | 40 (70) | 29 (66) | |
| Divorced | 9 (16) | 7 (16) | |
| Single | 8 (14) | 8 (18) | |
| Education | 0.16 | ||
| College or higher | 28 (49) | 24 (53) | |
| High school | 13 (23) | 15 (33) | |
| Less than high school | 16 (28) | 6 (14) | |
| Primary Cancer Diagnosis | 0.49 | ||
| Breast | 18 (31) | 17 (37) | |
| Gastrointestinal | 5 (8) | 2 (4) | |
| Genitourinary | 4 (7) | 8 (17) | |
| Lung | 13 (22) | 7 (15) | |
| Gynecologic | 2 (3) | 2 (4) | |
| Head and neck | 5 (8) | 1 (2) | |
| Hematologic | 9 (15) | 5 (11) | |
| Others | 3 (5) | 4 (9) | |
| Mini-Mental Score (Median, Range) | 30 (24–30) | 30 (24–30) | 0.70 |
| PerformanceStatus (Median, Range) | 2(0–4) | 2 (0–3) | 0.169 |
|
Median Baseline FACIT-F Score (Range) |
|||
| Physical Wellbeing | 13 (3–25) | 17 (7–24) | 0.001 |
| Social/Family | 23 (7–28) | 24 (13–28) | 0.17 |
| Emotional | 18 (6–24) | 18 (9–24) | 0.72 |
| Functional | 12 (4–25) | 14 (6–28) | 0.19 |
| Fatigue subscale | 16 (1–47) | 19 (4–43) | 0.045 |
| Total FACIT-F score | 80 (38–141) | 94 (61–134) | 0.004 |
| Median Baseline ESAS (Range) | |||
| Pain | 4 (0–10) | 3 (0–10) | 0.112 |
| Fatigue | 7 (4–10) | 7 (4–10) | 0.44 |
| Nausea | 0 (0–9) | 0 (0–6) | 0.24 |
| Depression | 3 (0–8) | 2 (0–9) | 0.11 |
| Anxiety | 3 (0–8) | 2 (0–8) | 0.01 |
| Drowsiness | 5 (0–10) | 4 (0–10) | 0.88 |
| Shortness of breath | 2 (0–10) | 2 (0–10) | 0.42 |
| Appetite | 3 (0–10) | 3 (0–10) | 0.89 |
| Sleep | 5 (0–10) | 5 (0–10) | 0.34 |
| Well-Being | 5 (0–9) | 5 (0–9) | 0.44 |