ctions in both study arms were Grade 1 or 2 in severity. Grade 3 or 4 treatment-emergent adverse reactions were reported in 77% versus 55% of patients on SUTENT versus IFN-α, respectively.
Table 3 compares the incidence of common (≥10%) treatment-emergent adverse reactions for patients receiving SUTENT versus IFN-α.
Table 3. Adverse Reactions Reported in at Least 10% of Patients with RCC Who Received SUTENT or IFN-α* Adverse Reaction,
n (%) Treatment-Naïve RCC
SUTENT (n=375) IFN-α (n=360)
All Grades Grade 3/4† All Grades Grade 3/4
Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0
Grade 4 ARs in patients on SUTENT included back pain (1%), arthralgia (<1%), dyspnea (<1%), asthenia (<1%), fatigue (<1%), limb pain (<1%) and rash (<1%).
Grade 4 ARs in patients on IFN-α included dyspnea (1%), fatigue (1%), abdominal pain (<1%) and depression (<1%).
Includes flank pain
Includes ageusia, hypogeusia and dysgeusia
Includes decreased appetite
Includes one patient with Grade 5 gastric hemorrhage
Includes depressed mood
Any 372 (99) 290 (77) 355 (99) 197 (55)
Constitutional
Fatigue 233 (62) 55 (15) 202 (56) 54 (15)
Asthenia 96 (26) 42 (11) 81 (22) 21 (6)
Fever 84 (22) 3 (1) 134 (37) 1 (<1)
Weight decreased 60 (16) 1 (<1) 60 (17) 3 (1)
Chills 53 (14) 3 (1) 111 (31) 0 (0)
Chest Pain 50 (13) 7 (2) 24 (7) 3 (1)
Influenza like illness 18 (5) 0 (0) 54 (15) 1 (<1)
Gastrointestinal
Diarrhea 246 (66) 37 (10) 76 (21) 1 (<1)
Nausea 216 (58) 21 (6) 147 (41) 6 (2)
Mucositis/stomatitis 178 (47) 13 (3) 19 (5) 2 (<1)
Vomiting 148 (39) 19 (5) 62 (17) 4 (1)
Dyspepsia 128 (34) 8 (2) 16 (4) 0 (0)
Abdominal pain§ 113 (30) 20 (5) 42 (12) 5 (1)
Constipation 85 (23) 4 (1) 49 (14) 1 (<1)
Dry mouth 50 (13) 0 (0) 27 (7) 1 (<1)
GERD/reflux esophagitis 47 (12) 1 (<1) 3 (1) 0(0)
Flatulence 52 (14) 0 (0) 8 (2) 0 (0)
Oral pain 54 (14) 2 (<1) 2 (1) 0 (0)
Glossodynia 40 (11) 0 (0) 2 (1) 0 (0)
Hemorrhoids 38 (10) 0 (0) 6 (2) 0 (0)
Cardiac
Hypertension 127 (34) 50 (13) 13 (4) 1 (<1)
Edema, peripheral 91 (24) 7 (2) 17 (5) 2 (1)
Ejection fraction decreased 61 (16) 10 (3) 19 (5) 6 (2)
Dermatology
Rash 109 (29) 6 (2) 39 (11) 1 (<1)
Hand-foot syndrome 108 (29) 32 (8) 3 (1) 0 (0)
Skin discoloration/ yellow skin 94 (25) 1 (<1) 0 (0) 0 (0)
Dry skin 85 (23) 1 (<1) 26 (7) 0 (0)
Hair color changes 75 (20) 0 (0) 1 (<1) 0 (0)
Alopecia 51 (14) 0 (0) 34 (9) 0 (0)
Erythema 46 (12) 2 (<1) 5 (1) 0 (0)
Pruritus 44 (12) 1 (<1) 24 (7) 1 (<1)
Neurology
Altered taste¶ 178 (47) 1 (<1) 54 (15) 0 (0)
Headache 86 (23) 4 (1) 69 (19) 0 (0)
Dizziness 43 (11) 2 (<1) 50 (14) 2 (1)
Musculoskeletal
Back pain 105 (28) 19 (5) 52 (14) 7 (2)
Arthralgia 111 (30) 10 (3) 69 (19) 4 (1)
Pain in extremity/ limb discomfort 150 (40) 19 (5) 107 (30) 7 (2)
Endocrine
Hypothyroidism 61 (16) 6 (2) 3 (1) 0 (0)
Respiratory
Cough 100 (27) 3 (1) 51 (14) 1 (<1)
Dyspnea 99 (26) 24 (6) 71 (20) 15 (4)
Nasopharyngitis 54 (14) 0 (0) 8 (2) 0 (0)
Oropharyngeal Pain 51 (14) 2 (<1) 9 (2) 0 (0)
Upper respiratory tract infection 43 (11) 2 (<1) 9 (2) 0 (0)
Metabolism/Nutrition &nb |
