TOP
|
INLYTA (axitinib) tablet(六)
14 |
2 |
11 |
1 |
Headache |
14 |
1 |
11 |
0 |
Pain in extremity |
13 |
1 |
14 |
1 |
Rash |
13 |
<1 |
32 |
4 |
Proteinuria |
11 |
3 |
7 |
2 |
Dysgeusia |
11 |
0 |
8 |
0 |
Dry skin |
10 |
0 |
11 |
0 |
Dyspepsia |
10 |
0 |
2 |
0 |
Pruritus |
7 |
0 |
12 |
0 |
Alopecia |
4 |
0 |
32 |
0 |
Erythema |
2 |
0 |
10 |
<1 |
Selected adverse reactions (all grades) that were reported in <10% of patients treated with Inlyta included dizziness (9%), upper abdominal pain (8%), myalgia (7%), dehydration (6%), epistaxis (6%), anemia (4%), hemorrhoids (4%), hematuria (3%), tinnitus (3%), lipase increased (3%), pulmonary embolism (2%), rectal hemorrhage (2%), hemoptysis (2%), deep vein thrombosis (1%), retinal-vein occlusion/thrombosis (1%), polycythemia (1%), transient ischemic attack (1%), and RPLS (<1%).
Table 2 presents the most common laboratory abnormalities reported in ≥10% patients who received Inlyta or sorafenib.
Table 2. Laboratory Abnormalities Occurring in ≥10% of Patients Who Received Inlyta or Sorafenib
Laboratory Abnormality |
N |
Inlyta |
N |
Sorafenib |
All Grades* |
Grade 3/4 |
All Grades* |
Grade 3/4 |
% |
% |
% |
% |
ALP: alkaline phosphatase; ALT: alanine aminotransferase; AST: aspartate aminotransferase |
National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0
|
Hematology |
|
|
|
|
|
|
Hemoglobin decreased |
320 |
35 |
<1 |
316 |
52 |
4 |
Lymphocytes (absolute) decreased |
317 |
33 |
3 |
309 |
36 |
4 |
Platelets decreased |
312 |
15 |
<1 |
310 |
14 |
0 |
White blood cells decreased |
320 |
11 |
0 |
315 |
16 |
<1 |
Chemistry |
|
|
|
|
|
|
Creatinine increased |
336 |
55 |
0 |
318 |
41 |
<1 |
Bicarbonate decreased |
314 |
44 |
<1 |
291 |
43 |
0 |
Hypocalcemia |
336 |
39 |
1 |
|