Table 4

Sensitivity of the MDASI-Immunotherapy EPT based on changes in ECOG PS in patients with worsening PS from baseline to week 9 (n=10)

Variable	Baseline, mean (SD)	Week 9, mean (SD)	95% CI of the difference	Effect size
MDASI-Immunotherapy EPT subscale
Symptom severity*	1.5 (1.5)	1.9 (1.4)	−1.2–0.4	−0.29
Symptom interference†	2.9 (3.0)	2.8 (2.5)	−2.0–2.1	0.02
MDASI-Immunotherapy EPT symptom item
Rash‡	0.8 (1.8)	0.9 (1.5)	−1.2–1.0	−0.06
Fever and/or chills‡	0.5 (1.3)	1.3 (2.7)	−2.6–1.0	−0.63
Headache‡	1.2 (1.8)	1.2 (1.6)	−1.4–1.4	0
Swelling of hands, legs, or feet	0.5 (1.3)	1.0 (1.6)	−1.4–0.4	−0.39
Numbness/tingling‡	1.6 (3.0)	1.7 (1.8)	−1.5–1.3	−0.03
Dry mouth‡	1.1 (1.4)	2.6 (2.9)	−3.1–0.6	−1.04
Fatigue	3.4 (3.0)	3.7 (2.8)	−3.0–2.4	−0.10
Sadness	1.9 (3.0)	2.4 (3.3)	−3.0–2.0	−0.17
Night sweats	1.1 (1.6)	1.0 (1.3)	−1.1–1.3	0.06
Lack of appetite	1.6 (2.6)	2.0 (2.7)	−3.4–2.6	−0.15
Distress/feeling upset	2.3 (3.2)	2.4 (2.8)	−1.7–1.5	−0.03
Shortness of breath	0.8 (1.7)	0.8 (1.5)	−0.3–0.3	0
Diarrhea	0.9 (1.7)	1.6 (2.7)	−1.8–0.4	−0.42
Pain	2.0 (2.4)	2.6 (3.1)	−1.4–0.2	−0.24
Drowsiness	2.7 (2.3)	3.2 (2.0)	−1.7–0.7	−0.22
Pain in the abdomen	1.8 (2.2)	1.6 (1.8)	−1.0–1.4	0.09
Difficulty remembering	0.9 (1.3)	2.0 (2.2)	−2.4–0.2	−0.85
Disturbed sleep	2.5 (2.3)	3.7 (2.8)	−2.8–0.4	−0.52
Nausea	1.0 (1.4)	1.4 (2.5)	−1.5–0.7	−0.28
Vomiting	0.4 (1.3)	0.4 (1.3)	--§	0

*The average of the 13 core and seven immunotherapy-specific symptom items.
†The average of the six interference items.
‡Significant at p<0.01 using paired t test.
§Could not be computed because the SE of the difference was 0.
ECOG, Eastern Cooperative Oncology Group; MDASI-Immunotherapy EPT, Immunotherapy for Early-Phase Trials module of the MD Anderson Symptom Inventory; PS, performance status.