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. Author manuscript; available in PMC: 2022 Nov 30.
Published in final edited form as: Transplant Cell Ther. 2021 Jul 12;27(11):930.e1–930.e10. doi: 10.1016/j.jtct.2021.07.007

Table 3.

Toxicity relevant symptom burden 30 days after CAR T-cell infusion

Acute CRS Acute ICANS
Grade 0–1 (N=17) Grade 2–4 (N=15) 95% CI Grade 0–1 (N=20) Grade 2–4 (N=12) 95% CI
Mean SD Mean SD Effect size Lower Upper Mean SD Mean SD Effect size Lower Upper
MDASI-Core items
Pain 1.59 2.85 1.6 2.69 0.00 −0.70 0.69 1.65 2.96 1.5 2.43 0.05 −0.66 0.77
Fatigue 2.94 2.79 4.07 2.74 −0.41 −1.10 0.30 2.8 2.86 4.58 2.35 −0.66 −1.38 0.09
Nausea 0.71 1.61 1.2 1.97 −0.27 −0.96 0.43 0.6 1.5 1.5 2.11 −0.51 −1.23 0.22
Sleep 2.76 3.03 2.4 2.8 0.12 −0.57 0.81 2.9 3.09 2.08 2.54 0.28 −0.44 0.99
Distress 1.82 2.51 1.27 1.83 0.25 −0.46 0.94 1.6 2.41 1.5 1.88 0.04 −0.67 0.76
Short breath 1.24 1.89 1.67 2.26 −0.21 −0.90 0.49 1.35 2.03 1.58 2.15 −0.11 −0.82 0.61
Remember 1.06 1.52 1.53 1.88 −0.28 −0.97 0.43 1.05 1.54 1.67 1.92 −0.37 −1.08 0.36
Appetite 1.41 2.43 3 3.34 −0.55 −1.24 0.17 1.4 2.6 3.42 3.18 −0.71 −1.43 0.04
Drowsy 2.18 2.83 3.87 3.36 −0.55 −1.24 0.17 2.35 3.01 4 3.25 −0.53 −1.25 0.21
Dry mouth 1.24 2.44 2.13 2.88 −0.34 −1.03 0.37 1.65 2.81 1.67 2.46 −0.01 −0.72 0.71
Sadness 0.71 1.53 1.53 2.5 −0.40 −1.09 0.31 1 1.86 1.25 2.42 −0.12 −0.83 0.60
Vomiting 0.29 0.77 0.87 2.13 −0.37 −1.06 0.34 0.25 0.72 1.08 2.35 −0.54 −1.25 0.20
Numbness 1.82 2.7 1 1.41 0.37 −0.34 1.06 1.3 2.41 1.67 1.87 −0.17 −0.88 0.55
MDASI-Interference Items
Activity 1.94 2.93 2.64 2.62 −0.25 −0.95 0.47 2.2 2.86 2.36 2.73 −0.06 −0.79 0.68
Mood 1.71 3.02 2 1.8 −0.11 −0.82 0.60 1.9 2.88 1.73 1.74 0.07 −0.67 0.80
Work 2 3.02 2.46 2.33 −0.17 −0.89 0.56 2 2.89 2.55 2.46 −0.20 −0.93 0.54
Relations 1.53 2.65 0.86 1.61 0.30 −0.42 1.00 1.4 2.5 0.91 1.7 0.22 −0.53 0.95
Walking 1.94 2.7 2.92 2.72 −0.36 −1.08 0.38 1.85 2.6 3.4 2.76 −0.58 −1.34 0.20
Enjoyment of life 1.76 2.95 3.07 2.76 −0.46 −1.16 0.27 1.75 2.77 3.45 2.91 −0.60 −1.34 0.16
CAR-T related Symptoms
Diarrhea 0.82 2.01 1.6 3.46 −0.28 −0.97 0.42 0.7 1.87 2 3.79 −0.48 −1.19 0.26
Inability to eat 0.76 2.05 1.2 2.14 −0.21 −0.90 0.49 0.6 1.85 1.58 2.35 −0.48 −1.19 0.26
Rash 0.41 1.18 0 0 0.48 −0.24 1.17 0.35 1.09 0 0 0.40 −0.33 1.12
Malaise 5 4.6 2.13 2.67 0.95 −0.33 2.15 1.4 2.19 2.67 2.74 −0.53 −1.24 0.21
Lack of energy 2.18 2.38 3.8 3.17 −0.58 −1.28 0.14 2 2.18 4.5 3.23 −0.96 −1.68 −0.18
Tremors 0.59 1.58 0.4 1.3 0.13 −0.57 0.82 0.5 1.47 0.5 1.45 0.00 −0.72 0.72
Muscle weakness 2.06 2.38 1.67 2.64 0.16 −0.54 0.85 1.7 2.27 2.17 2.86 −0.19 −0.90 0.53
Weakness 1.12 1.93 3.67 3.29 −0.96 −1.67 −0.21 1.5 2.69 3.67 2.87 −0.79 −1.51 −0.03
Fever 0.53 1.01 0.87 1.51 −0.27 −0.96 0.44 0.7 1.13 0.67 1.5 0.02 −0.69 0.74
Headache 1 2 1.07 2.43 −0.03 −0.73 0.66 0.8 1.85 1.42 2.68 −0.28 −0.99 0.44
Irritability 1.18 1.81 2 2.73 −0.36 −1.05 0.35 1.2 1.7 2.17 3.01 −0.43 −1.14 0.31
Balance 0.35 1 1.8 2.76 −0.72 −1.41 0.02 0.8 2.35 1.42 1.68 −0.29 −1.00 0.44
Mouth sore 0.35 1.22 0 0 0.39 −0.32 1.08 0.3 1.13 0 0 0.33 −0.39 1.05
Dizziness 0.59 1.7 1.8 2.81 −0.53 −1.22 0.19 0.45 1.57 2.33 2.93 −0.87 −1.59 −0.10
Difficulty Swallowing 0.06 0.24 0.73 2.34 −0.42 −1.11 0.30 0.05 0.22 0.92 2.61 −0.55 −1.26 0.19
Attention 1.82 2.38 1.67 2.35 0.06 −0.63 0.76 1.5 2.28 2.17 2.44 −0.29 −1.00 0.44
Bone aches 1.53 2.24 1.93 2.79 −0.16 −0.85 0.54 1.65 2.54 1.83 2.48 −0.07 −0.79 0.65
Heart bead 0.88 2.18 0.93 1.83 −0.02 −0.72 0.67 0.85 2.03 1 2 −0.07 −0.79 0.64
Swelling 0.65 1.17 1.07 2.69 −0.21 −0.90 0.49 0.3 0.73 1.75 2.99 −0.76 −1.48 0.00
Difficulty Speaking 0.12 0.33 1.87 3.16 −0.81 −1.51 −0.06 0.55 1.47 1.58 3.26 −0.45 −1.16 0.29
Coughing 1.65 2.37 2.93 3.37 −0.44 −1.14 0.27 1.8 2.33 3 3.67 −0.41 −1.13 0.32
Sexual function 1.24 2.56 2.29 3.83 −0.33 −1.03 0.39 1.2 2.61 2.64 4.01 −0.46 −1.19 0.30
Health Status and HRQoL
EQ5D-5L VAS scale* 81.6 18.9 68.1 23.6 0.63 −0.12 1.35 81.6 18.8 64.8 23.6 0.81 0.03 1.54
HRQoL* 8.35 1.69 7.4 1.68 0.56 −0.16 1.26 8.5 1.5 6.92 1.68 1.01 0.23 1.74
PROMIS-29 Domains and Pain rating
Physical function* 45.7 8.76 38.3 12.3 0.70 −0.03 1.40 46.5 10 35.1 8.99 1.18 0.38 1.92
Anxiety 45.6 8.73 48.3 8.07 −0.32 −1.01 0.39 45.5 8.4 49.1 8.24 −0.43 −1.14 0.30
Depression 51.9 2.18 51.3 1.85 0.30 −0.41 0.99 51.3 1.64 52 2.56 −0.35 −1.06 0.38
Fatigue 48.1 11.9 54.2 11 −0.53 −1.22 0.19 47.8 10.8 56.2 11.6 −0.76 −1.48 0.00
Sleep disturbance 49.5 8.1 51.8 7.68 −0.29 −0.98 0.41 50 8.72 51.4 6.47 −0.18 −0.89 0.55
Social roles* 53.2 8.46 46.1 9.08 0.81 0.07 1.51 51.3 10.1 47.5 7.72 0.41 −0.32 1.12
Pain interference 50.2 8.97 49.5 12 0.07 −0.63 0.76 49.7 10.4 50.2 10.7 −0.05 −0.76 0.67
Pain average 2.53 2.72 2.73 2.91 −0.07 −0.76 0.63 2.35 2.83 3.08 2.71 −0.26 −0.97 0.46
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indicates ES>=0.5