nge 0.03 to 22.0) for patients who received INLYTA and 5.0 months (range 0.03 to 20.1) for patients who received sorafenib. Dose modifications or temporary delay of treatment due to an adverse reaction occurred in 199/359 patients (55%) receiving INLYTA and 220/355 patients (62%) receiving sorafenib. Permanent discontinuation due to an adverse reaction occurred in 34/359 patients (9%) receiving INLYTA and 46/355 patients (13%) receiving sorafenib.
The most common (≥20%) adverse reactions observed following treatment with INLYTA were diarrhea, hypertension, fatigue, decreased appetite, nausea, dysphonia, palmar-plantar erythrodysesthesia (hand-foot) syndrome, weight decreased, vomiting, asthenia, and constipation. Table 1 presents adverse reactions reported in ≥10% patients who received INLYTA or sorafenib.
Table 1. Adverse Reactions Occurring in ≥10% of Patients Who Received INLYTA or Sorafenib
Adverse Reaction*
INLYTA
Sorafenib
(N=359)
(N=355)
All Grades†
Grade 3/4
All Grades†
Grade 3/4
%
%
%
%
* Percentages are treatment-emergent, all-causality events † National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0
Diarrhea
55
11
53
7
Hypertension
40
16
29
11
Fatigue
39
11
32
5
Decreased appetite
34
5
29
4
Nausea
32
3
22
1
Dysphonia
31
0
14
0
Palmar-plantar erythrodysesthesia syndrome
27
5
51
16
Weight decreased
25
2
21
1
Vomiting
24
3
17
1
Asthenia
21
5
14
3
Constipation
20
1
20
1
Hypothyroidism
19
<1
8
0
Cough
15
1
17
1
Mucosal inflammation
15
1
12
1
Arthralgia
15
2
11
1
Stomatitis
15
1
12
<1
Dyspnea
15
3
12
3
Abdominal pain
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
%
