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patients receiving SUTENT and reported more commonly in patients receiving SUTENT than in patients<br />
receiving placebo.<br />
Table 5. Adverse Reactions Reported in the Phase 3 pNET Study in at Least 10% of Patients who<br />
Received SUTENT and More Commonly Than in Patients Given Placebo*<br />
pNET<br />
Adverse Reaction,<br />
SUTENT (n=83)<br />
Placebo (n=82)<br />
n (%)<br />
All Grades Grade 3/4 a All Grades Grade 3/4<br />
Any 82 (99) 45 (54) 78 (95) 41 (50)<br />
Constitutional<br />
Asthenia<br />
Fatigue<br />
Weight decreased<br />
28 (34)<br />
27 (33)<br />
13 (16)<br />
4 (5)<br />
4 (5)<br />
1(1)<br />
22 (27)<br />
22 (27)<br />
9 (11)<br />
3 (4)<br />
7 (9)<br />
0 (0)<br />
Gastrointestinal<br />
Diarrhea<br />
Stomatitis/oral<br />
Syndromes b<br />
Nausea<br />
Abdominal pain c<br />
Vomiting<br />
Dyspepsia<br />
49 (59)<br />
40 (48)<br />
37 (45)<br />
32 (39)<br />
28 (34)<br />
12 (15)<br />
4 (5)<br />
5 (6)<br />
1 (1)<br />
4 (5)<br />
0 (0)<br />
0 (0)<br />
32 (39)<br />
15 (18)<br />
24 (29)<br />
28 (34)<br />
25 (31)<br />
5 (6)<br />
2 (2)<br />
0 (0)<br />
1 (1)<br />
8 (10)<br />
2 (2)<br />
0 (0)<br />
Cardiac<br />
Hypertension 22 (27) 8 (10) 4 (5) 1 (1)<br />
Dermatology<br />
Hair color changes<br />
Hand-foot syndrome<br />
Rash<br />
Dry skin<br />
Neurology<br />
Dysgeusia<br />
Headache<br />
24 (29)<br />
19 (23)<br />
15 (18)<br />
12 (15)<br />
17 (21)<br />
15 (18)<br />
1 (1)<br />
5 (6)<br />
0 (0)<br />
0 (0)<br />
0 (0)<br />
0 (0)<br />
1 (1)<br />
2 (2)<br />
4 (5)<br />
9 (11)<br />
4 (5)<br />
11 (13)<br />
0 (0)<br />
0 (0)<br />
0 (0)<br />
0 (0)<br />
0 (0)<br />
1 (1)<br />
Musculoskeletal<br />
Arthralgia 12 (15) 0 (0) 5 (6) 0 (0)<br />
Psychiatric<br />
Insomnia 15 (18) 0 (0) 10 (12) 0 (0)<br />
Hemorrhage/Bleeding<br />
Bleeding events d<br />
Epistaxis<br />
18 (22)<br />
0 (0)<br />
8 (10)<br />
3 (4)<br />
17 (21)<br />
1 (1)<br />
4 (5)<br />
0 (0)<br />
*Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0<br />
a Grade 4 ARs in patients on SUTENT included fatigue (1%).<br />
b Includes aphthous stomatitis, gingival pain, gingivitis, glossitis, glossodynia, mouth ulceration, oral<br />
discomfort, oral pain, tongue ulceration, mucosal dryness, mucosal inflammation, and dry mouth.<br />
c Includes abdominal discomfort, abdominal pain, and abdominal pain upper.<br />
d Includes hematemesis, hematochezia, hematoma, hemoptysis, hemorrhage, melena, and metrorrhagia.<br />
Table 6 provides common (≥10%) treatment-emergent laboratory abnormalities.
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