17 (3.1%)
2 (0.4%)
0 (0%)
Common
Musculoskeletal pain
11 (2.0%)
2 (0.4%)
0 (0%)
Renal and urinary disorders
Common
Chromaturia
17 (3.1%)
0 (0%)
0 (0%)
General disorders and administration site conditions
Very common
Fatigue/asthenia
373 (68.6%)
93 (17.1%)
1 (0.2%)
Very common
Mucosal inflammation
134 (24.6%)
8 (1.5%)
0 (0%)
Very common
Oedema d
83 (15.3%)
4 (0.7%)
0 (0%)
Common
Pyrexia
37 (6.8%)
3 (0.6%)
0 (0%)
Common
Chills
34 (6.3%)
2 (0.4%)
0 (0%)
Common
Pain
21 (3.9%)
0 (0%)
0 (0%)
Common
Chest pain
13 (2.4%)
2 (0.4%)
0 (0%)
Common
Influenza like illness
11 (2.0%)
0 (0%)
0 (0%)
Investigations
Very common
Ejection fraction decreased/abnormal
86 (15.8%)
16 (2.9%)
0 (0%)
Very common
Weight decreased
58 (10.7%)
1 (0.2%)
0 (0%)
Common
Platelet count decreased
41 (7.5%)
15 (2.8%)
2 (0.4%)
Common
White blood cell count decreased e
37 (6.8%)
16 (2.9%)
0 (0%)
Common
Lipase increased
36 (6.6%)
19 (3.5%)
11 (2%)
Common
Haemoglobin decreased
25 (4.6%)
8 (1.5%)
0 (0%)
Common
Blood amylase increased
19 (3.5%)
11 (2.0%)
2 (0.4%)
Common
Blood creatine phosphokinase increased
19 (3.5%)
7 (1.3%)
2 (0.4%)
Common
Aspartate aminotransferase increased
18 (3.3%)
7 (1.3%)
0 (0%)
Common
Blood creatinine increased
17 (3.1%)
3 (0.6%)
0 (0%)
Common
Blood pressure increased
15 (2.8%)
2 (0.4%)
0 (0%)
Common
Alanine aminotransferase increased
14 (2.6%)
7 (1.3%)
2 (0.4%)
Any adverse event
524 (96.3%)
297 (54.6%)
59 (10.8%)
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 3 – Adverse reactions reported in the phase 3 pNET study 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
24 (28.9%)
6 (7.2%)
4 (4.8%)
Ver
