in exfoliation
12 (2.7%)
0 (0.0%)
0 (0.0%)
Common
Blister
10 (2.3%)
1 (0.2%)
0 (0.0%)
Common
Skin lesion
10 (2.3%)
1 (0.2%)
0 (0.0%)
Muscoloskeletal and connective tissue and bone disorders
Very Common
Pain in extremity/limb
54 (12.3%)
5 (1.1%)
0 (0.0%)
Common
Arthralgia
39 (8.9%)
3 (0.7%)
0 (0.0%)
Common
Myalgia
29 (6.6%)
0 (0.0%)
0 (0.0%)
Common
Muscle spasm
21 (4.8%)
1 (0.2%)
0 (0.0%)
Common
Back pain
11 (2.5%)
2 (0.5%)
0 (0.0%)
Common
Muscular weakness
10 (2.3%)
1 (0.2%)
0 (0.0%)
General disorders and administration site conditions
Very common
Fatigue/Asthenia
287 (65.2%)
64 (14.5%)
5 (1.1%)
Very common
Mucosal inflammation
70 (15.9%)
6 (1.4%)
1 (0.2%)
Very common
Oedema d
59 (13.4%)
1 (0.2%)
0 (0.0%)
Common
Pyrexia
26 (5.9%)
2 (0.5%)
0 (0.0%)
Investigations
Common
Lipase increase
35 (8.0%)
12 (2.7%)
7 (1.6%)
Common
White blood cell count decreased e
33 (7.5%)
15 (3.4%)
0 (0.0%)
Common
Ejection fraction decreased
27 (6.1%)
5 (1.2%)
0 (0.0%)
Common
Haemoglobin decreased
27 (6.1%)
6 (1.4%)
0 (0.0%)
Common
Blood creatinine phosphokinase increased
22 (5.0%)
1 (0.2%)
1 (0.2%)
Common
Platelet count decrease
25 (5.7%)
4 (0.9%)
1 (0.2%)
Common
Weight decreased
23 (5.2%)
1 (0.2%)
0 (0.0%)
Common
Amylase increased
21 (4.8%)
8 (1.8%)
0 (0.0%)
Common
Aspartate aminotransferase increased
18 (4.1%)
2 (0.5%)
1 (0.2%)
Common
Alanine aminotransferase increased
12 (2.7%)
1 (0.2%)
0 (0.0%)
Any adverse event
414 (94.1%)
204 (46.4%)
53 (12.0%)
The following terms have been combined:
a Anorexia and decreased appetite
b Dysgeusia, ageusia and taste disturbance
c Abdominal pain and abdominal pain upper
d Oedema, oedema peripheral and oedema face
e White blood cell count decreased, neutrophil count decreased, and leukocyte count decreased
Table 2 – Adverse reactions reported in cytokine-refractory and treatment-naïve
MRCC studies with SUTENT
System Organ Class
Frequency
Adverse reactions
All Grades
n (%)
Grade 3
n (%)
Grade 4
n (%)
Blood and lymphatic system disorders
Very common
Neutropoenia
89 (16.4%)
46 (8.5%)
5 (0.9%)
Very common
Thrombocytopoenia
86 (15.8%)
37 (6.8%)
5 (0.9%)
Very common
Anaemia
68 (12.5 %)
21 (3.9 %)
4 (0.7 %)
Very Common
Leukopoenia
&nbs |
