tegories are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), and not known (cannot be estimated from the available data). The current safety database for axitinib is too small to detect rare and very rare adverse reactions.
Categories have been assigned based on absolute frequencies in the clinical study data. Within each system organ class, adverse reactions with the same frequency are presented in order of decreasing seriousness.
Table 1. Adverse reactions reported in the RCC study in patients who received axitinib (N= 359)
|
System Organ Class
|
Frequency Category
|
Adverse Reactions
|
All Gradesa
%
|
Grade 3a
%
|
Grade 4a
%
|
|
Blood and lymphatic system disorders
|
Common
|
Anaemia
|
2.8
|
0.3
|
0
|
|
Thrombocytopenia
|
1.7
|
0.3
|
0
|
|
Uncommon
|
Neutropenia
|
0.3
|
0.3
|
0
|
|
Polycythaemiab
|
0.3
|
0
|
0
|
|
Leukopenia
|
0.3
|
0
|
0
|
|
Endocrine disorders
|
Very Common
|
Hypothyroidismb
|
18.4
|
0.3
|
0
|
|
Uncommon
|
Hyperthyroidismb
|
0.6
|
0
|
0
|
|
Metabolism and nutrition disorders
|
Very Common
|
Decreased appetite
|
28.4
|
3.3
|
0.3
|
|
Common
|
Dehydration
|
4.7
|
2.5
|
0
|
|
Uncommon
|
Hyperkalaemia
|
0.8
|
0.6
|
0
|
|
Hypercalcaemia
|
0.6
|
0
|
0
|
|
Nervous system disorders
|
Very Common
|
Headache
|
10.3
|
0.6
|
0
|
|
Dysgeusia
|
10.3
|
0
|
0
|
|
Common
|
Dizziness
|
5.6
|
0
|
0
|
|
Unco
|
|
