235 (63) 354 (98) 172 (48) 169 (100) 123 (73)
Constitutional
Fatigue 215 (57) 35 (9) 199 (55) 47 (13) 125 (74) 19 (11)
Asthenia 78 (21) 26 (7) 85 (24) 20 (6) 16 (9) 4 (2)
Fever 61 (16) 3 (1) 129 (36) 0 (0) 26 (15) 2 (1)
Weight decreased 43 (12) 0 (0) 52 (14) 2 (1) 19 (11) 1 (1)
Chills 41 (11) 3 (1) 108 (30) 0 (0) 18 (11) 0 (0)
Gastrointestinal
Diarrhea 218 (58) 22 (6) 71 (20) 0 (0) 93 (55) 8 (5)
Nausea 182 (49) 14 (4) 134 (37) 5 (1) 92 (54) 4 (2)
Mucositis/stomatitis 153 (41) 10 (3) 13 (4) 2 (<1) 90 (53) 7 (4)
Vomiting 104 (28) 15 (4) 49 (14) 3 (1) 63 (37) 7 (4)
Dyspepsia 104 (28) 3 (1) 14 (4) 0 (0) 77 (46) 1 (1)
Abdominal pain¶ 74 (20) 9 (2) 39 (11) 5 (1) 34 (20) 5 (3)
Constipation 59 (16) 0 (0) 44 (12) 1 (<1) 57 (34) 1 (1)
Dry mouth 44 (12) 0 (0) 26 (7) 1 (<1) 10 (6) 0 (0)
Flatulence 36 (10) 0 (0) 8 (2) 0 (0) 24 (14) 0 (0)
Glossodynia 37 (10) 0 (0) 2 (1) 0 (0) 25 (15) 0 (0)
Cardiac
Hypertension 101 (27) 34 (9) 13 (4) 1 (<1) 48 (28) 10 (6)
Edema, peripheral 42 (11) 2 (1) 15 (4) 2 (1) 28 (17) 1 (1)
Dermatology
Dry skin 64 (17) 1 (<1) 23 (6) 0 (0) 29 (17) 0 (0)
Rash 85 (23) 3 (1) 31 (9) 2 (1) 64 (38) 1 (1)
Hair color changes 54 (14) 0 (0) 1 (<1) 0 (0) 29 (17) 0 (0)
Hand-foot syndrome 77 (21) 19 (5) 3 (1) 0 (0) 21 (12) 5 (3)
Skin discoloration 60 (16) 0 (0) 0 (0) 0 (0) 55 (33) 0 (0)
Alopecia 30 (8) 0 (0) 30 (8) 0 (0) 20 (12) 0 (0)
Neurology
Altered taste# 166 (44) 1 (<1) 51 (14) 0 (0) 73 (43) 0 (0)
Headache 68 (18) 3 (1) 61 (17) 0 (0) 43 (25) 2 (1)
Dizziness 28 (8) 1 (<1) 39 (11) 1 (<1) 27 (16) 3 (2)
Musculoskeletal
Back pain 68 (18) 11 (3) 43 (12) 6 (2) 29 (17) 1 (1)
Myalgia/limb pain 84 (22) 6 (2) 91 (25) 6 (2) 60 (36) 2 (2)
Arthralgia 66 (18) 4 (1) 60 (17) 1 (<1) 48 (28) 2 (1)
Respiratory
Cough 62 (17) 2 (1) 43 (12) 0 (0) 29 (17) 1 (1)
Dyspnea 57 (15) 15 (4) 64 (18) 14 (4) 47 (28) 8 (5)
Metabolism/Nutrition
AnorexiaÞ 139 (37) 6 (2) 145 (40) 6 (2) 53 (31) 1 (1)
Dehydration 30 (8) 8 (2) 17 (5) 2 (1) 19 (11) 5 (3)
Hemorrhage/Bleeding
Bleeding, all sites 104 (28) 10 (3)ß 25 (7) 2 (1) 44 (26) 1 (1)
Psychiatric
Insomnia 42 (11) 1 (<1) 31 (9) 0 (0) 22 (13) 1 (1)
Depression 28 (8) 0 (0) 42 (12) 4 (1) 14 (8) 1 (1)
Grade 4 hematology laboratory abnormalities in the Phase 3 MRCC study include neutropenia (1% on SUTENT, 0% on IFN-α) and anemia (<1% each arm). Grade 3 hematology laboratory abnormalities included neutropenia (11% on SUTENT, 7% on IFN-α), lymphopenia (12% on SUTENT, 22% on IFN-α), thrombocytopenia (8% on SUTENT, 0% on IFN-α), leukopenia (5% on SUTENT, 2% on IFN-α) and anemia (3% on SUTENT, 4% on IFN-α).
In the SUTENT-treated cytokine-refractory MRCC patients, Grade 4 hematology abnormalities included anemia (2%), neutropenia (1%) and lymphopenia (1%). Grade 3 abnormalities were lymphopenia (20%) neutropenia (12%), leukopen
