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Adverse drug reactions
|
Intervention group (n = 31) n (%)
|
Non-intervention group (n = 39) n (%)
|
P-value (Any)
|
|---|
|
Grade
|
Any
|
3 ~ 4
|
Any
|
3 ~ 4
| |
|
Hand-foot skin reactiona
|
23(74.2)
|
2(6.5)
|
19(48.7)
|
3(7.7)
|
0.049*
|
|
Diarrhea
|
21(67.7)
|
2(6.5)
|
5(12.8)
|
1(2.6)
|
< 0.001**
|
|
Hypertension
|
16(51.6)
|
6(19.4)
|
15(38.5)
|
5(12.5)
|
0.336
|
|
Anorexia
|
15(48.4)
|
1(3.2)
|
6(15.4)
|
-
|
0.002**
|
|
Hair loss
|
13(41.9)
|
-
|
5(12.8)
|
-
|
0.012*
|
|
Thrombocytopenia
|
11(35.5)
|
2(6.5)
|
4(10.3)
|
3(7.7)
|
0.018*
|
|
AST increased
|
11(35.5)
|
5(16.1)
|
6(15.4)
|
3(7.7)
|
0.091
|
|
Hoarseness
|
10(32.3)
|
-
|
4(10.3)
|
-
|
0.034*
|
|
ALT increased
|
9(29.0)
|
-
|
6(15.4)
|
3(7.7)
|
0.242
|
|
Serum amylase increased
|
9(29.0)
|
6(19.4)
|
3(7.7)
|
1(2.6)
|
0.026*
|
|
Fatigue
|
7(22.6)
|
-
|
1(2.6)
|
-
|
0.018*
|
|
Stomatitis
|
6(19.4)
|
-
|
1(2.6)
|
-
|
0.039*
|
|
Hypothyroidism
|
5(16.1)
|
-
|
3(7.7)
|
-
|
0.452
|
|
Blood bilirubin increased
|
5(16.1)
|
1(3.2)
|
3(7.7)
|
1(2.6)
|
0.452
|
|
Rash maculo-papular
|
4(12.9)
|
-
|
4(10.3)
|
-
|
1.000
|
-
aPalmar-plantar erythrodysesthesia syndrome (NCI-CTCAE).
- *P < 0.05.
- **P < 0.01.
