Human Gene Therapy - April 2023 - 319

Table 3. Most commonly reported adverse events (‡ 10 trials)
Total
Grade 3
CTCAE
Lymphopenia/
(%, AE/pt)
Dyspnea
(%, AE/pt)
Neutropenia
(%, AE/pt)
Nausea
(%, AE/pt)
Hyponatremia
(%, AE/pt)
Hyper AST/ALT
(%, AE/pt)
Anemia
(%, AE/pt)
Headache
(%, AE/pt)
Weakness/fatigue
(%, AE/pt)
Leukopenia
(%, AE/pt)
Renal
(%, AE/pt)
Vomiting
(%, AE/pt)
Anorexia/malnutrition
(%, AE/pt)
Fever
(%, AE/pt)
Diarrhea
(%, AE/pt)
Thrombo-cytopenia
(%, AE/pt)
Chills
(%, AE/pt)
Trials Grade 3
Grade 4 Ad5 alone
Ad5 with
Chemo
pa
Ad5 with
Rad
pa
Ad5 with
Surgery
pa
Grade 4
Ad5 alone Ad5 with Chemo pa
14 17.2% (36/209) 3.3% (7/209) 7.0% (3/43) 17.7% (14/79) 0.17 25.4% (16/63) 0.02 12.5% (3/24) 0.66 0% (0/43) 7.6% (6/79) 0.09
11 7.7% (16/208) 1.0% (2/208) 5.4% (3/56) 11.3% (11/97) 0.26 4.7% (2/43) 1.00 0% (0/12) 1.00 0% (0/56) 2.1% (2/97) 0.53 0% (0/43)
12 4.0% (7/174) 4.6% (8/174) 7.4% (2/27) 9.5% (4/42) 1.00 1.1% (1/93) 0.13 0% (0/12) 1.00 0% (0/27) 19.0% (8/42)
19 7.1% (25/351)
7.1% (12/170) 9.9% (11/111) 0.50 4.7% (2/43) 0.74 0% (0/27) 0.38
11 5.3% (9/169) 1.8% (3/169) 0% (0/56) 8.9% (5/56) 0.06 9.1% (3/33)
0.05 4.2% (1/24) 0.30 1.8% (1/56) 3.6% (2/56) 1.00 0% (0/33)
16 5.7% (15/264) 1.1% (3/264) 2.4% (2/84) 6.3% (3/48) 0.35 3.7% (4/108) 0.70 25% (6/24) 0.00 0% (0/84) 4.2% (2/48) 0.13 0.9% (1/108) 1.00
23 5.2% (21/407) 1.0% (4/407) 5.1% (5/98) 8.1% (11/135) 0.44 2.0% (3/150) 0.27 8.3% (2/24) 0.62 0% (0/98) 1.5% (2/135) 0.51
11 5.7% (12/211)
3.3% (3/91) 7.2% (5/69) 1.00 4.2% (1/24) 1.00 11.1% (3/27) 0.13
25 5.4% (23/424) 0.2% (1/424) 9.6% (11/114) 9.9% (12/121) 1.00 0% (0/150) 0.00
13 2.1% (4/192) 3.1% (6/192) 0% (0/42) 11.1% (4/36)
0.04
0% (0/39) 0.07 0% (0/114)
0.7% (1/150) 1.00
0% (0/87) 1.00 0% (0/27) 1.00 2.4% (1/42) 13.9% (5/36) 0.09 0% (0/87) 0.33
12 2.8% (6/218) 0.5% (1/218) 0% (0/16) 3.4% (2/59) 1.00 3.1% (4/131) 1.00 0% (0/12) 1.00 0% (0/16) 1.7% (1/59) 1.00 0% (0/131)
18 2.7% (8/293) 0.3% (1/293) 1.2% (1/86) 4.9% (6/123) 0.24 1.8% (1/57) 1.00 0% (0/27) 1.00 0% (0/86) 0.8% (1/123) 1.00
13 3.0% (7/232)
23 2.5% (10/393)
13 2.1% (4/189)
1.1% (1/91) 6.7% (4/60) 0.08 1.8% (1/57) 1.00 4.2% (1/24) 0.38
2.5% (5/201) 7.4% (4/54) 0.10 0.9% (1/111) 0.43 0% (0/27) 1.00
0% (0/96) 3.8% (2/52) 0.12 6.9% (2/29) 0.05 0% (0/12) 1.00
16 1.2% (3/248) 0.8% (2/248) 1.4% (1/69) 4.0% (2/50) 0.57 0% (0/117) 0.37 0% (0/12) 1.00 1.4% (1/69) 2.0% (1/50) 1.00 0% (0/117) 0.37
12 1.5% (4/268)
Bold values indicate statistical significance.
Chemo= chemotherapy; Rad = radiation.
aCompared to Ad5 alone.
CTCAE, Common Terminology Criteria for Adverse Events.
1.3% (2/155) 4.1% (2/49) 0.24 0% (0/64) 1.00
8.3% (2/24) 0.04
0.02 0% (0/93)
Ad5 with
Rad
pa
Ad5 with
Surgery
pa
4.2% (1/24) 0.36
j 319

Human Gene Therapy - April 2023

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Human Gene Therapy - April 2023 - Cover3
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