%) treatment-emergent adverse reactions for patients receiving SUTENT and reported more commonly in patients receiving SUTENT than in patients receiving placebo.
Table 5. Adverse Reactions Reported in the Phase 3 pNET Study in at Least 10% of Patients who Received SUTENT and More Commonly Than in Patients Given Placebo* Adverse Reaction,
n (%) pNET
SUTENT (n=83) Placebo (n=82)
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 fatigue (1%).
Includes aphthous stomatitis, gingival pain, gingivitis, glossitis, glossodynia, mouth ulceration, oral discomfort, oral pain, tongue ulceration, mucosal dryness, mucosal inflammation, and dry mouth.
Includes abdominal discomfort, abdominal pain, and abdominal pain upper.
Includes hematemesis, hematochezia, hematoma, hemoptysis, hemorrhage, melena, and metrorrhagia.
Any 82 (99) 45 (54) 78 (95) 41 (50)
Constitutional
Asthenia 28 (34) 4 (5) 22 (27) 3 (4)
Fatigue 27 (33) 4 (5) 22 (27) 7 (9)
Weight decreased 13 (16) 1(1) 9 (11) 0 (0)
Gastrointestinal
Diarrhea 49 (59) 4 (5) 32 (39) 2 (2)
Stomatitis/oral Syndromes‡ 40 (48) 5 (6) 15 (18) 0 (0)
Nausea 37 (45) 1 (1) 24 (29) 1 (1)
Abdominal pain§ 32 (39) 4 (5) 28 (34) 8 (10)
Vomiting 28 (34) 0 (0) 25 (31) 2 (2)
Dyspepsia 12 (15) 0 (0) 5 (6) 0 (0)
Cardiac
Hypertension 22 (27) 8 (10) 4 (5) 1 (1)
Dermatology
Hair color changes 24 (29) 1 (1) 1 (1) 0 (0)
Hand-foot syndrome 19 (23) 5 (6) 2 (2) 0 (0)
Rash 15 (18) 0 (0) 4 (5) 0 (0)
Dry skin 12 (15) 0 (0) 9 (11) 0 (0)
Neurology
Dysgeusia 17 (21) 0 (0) 4 (5) 0 (0)
Headache 15 (18) 0 (0) 11 (13) 1 (1)
Musculoskeletal
Arthralgia 12 (15) 0 (0) 5 (6) 0 (0)
Psychiatric
Insomnia 15 (18) 0 (0) 10 (12) 0 (0)
Hemorrhage/Bleeding
Bleeding events¶ 18 (22) 0 (0) 8 (10) 3 (4)
Epistaxis 17 (21) 1 (1) 4 (5) 0 (0)
Table 6 provides common (≥10%) treatment-emergent laboratory abnormalities.
Table 6. Laboratory Abnormalities Reported in the Phase 3 pNET Study in at Least 10% of Patients Who Received SUTENT Laboratory Parameter, n (%) pNET
SUTENT Placebo
N All Grades* Grade 3/4*† N All Grades* Grade 3/4*‡
Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0
Grade 4 laboratory abnormalities in patients on SUTENT included creatinine (4%), lipase (4%), glucose decreased (2%), glucose increased (2%), neutrophils (2%), ALT (1%), AST (1%), platelets (1%), potassium increased (1%) and total bilirubin (1%).
Grade 4 laboratory abnormalities in patients on placebo included creatinine (3%), alkaline phosphatase (1%), glucose increased (1%) and lipase (1%).
Gastrointestinal
AST increased 82 59 (72) 4 (5) 80 56 (70) 2 (3)
ALT increased 82 50 (61) 3 (4) 80 44 (55) 2 (3)
Alkaline phosphatase increased 82 52 (63) 8 (10) 80 56 (70) 9 (11)
Total bilirubin increased 82 30 (37) 1 (1) 80 22 (28) 3 (4)
Amylase increased 74 15 (20) 3 (4) 74 7 (10) 1 (1)
Lipase increased 75 13 (17) 4 (5) 72 8 (11) 3 (4)
Renal/Metabolic
Glucose increased 82 58 (71) 10 (12) 80 62 (78) 14 (18)
Albumin decreased 81 33 (41) 1 (1) 79 29 |
