bone pain, musculoskeletal chest pain, musculoskeletal pain, myalgia,neck pain, pain in extremityMucositis includes: aphthous stomatitis, mouth ulceration, mucosal inflammation, oral discomfort, oral pain,oropharyngeal pain, stomatitisOther Common Adverse Reactions in ≥10% of POTELIGEO Arm a, b
General disorders: fatigue (31%), edema (16%)
Gastrointestinal disorders: diarrhea (28%), nausea (16%), constipation (13%)
Blood and lymphatic system disorders: thrombocytopenia (14%), anemia (12%)
Nervous system disorders: headache (14%)
Vascular disorders: hypertension (10%)
Respiratory disorders: cough (11%)
Adverse Reactions in ≥5% but <10% of POTELIGEO Arm a, b
Infections: candidiasis (9%), urinary tract infection (9%), folliculitis (8%), pneumonia
(6%), otitis (5%), herpesvirus infection (5%)
Investigations: renal insufficiency (9%), hyperglycemia (9%), hyperuricemia (8%),
weight increase (8%), weight decrease (6%), hypomagnesemia (6%)
Psychiatric disorders: insomnia (9%), depression (7%)
Skin and subcutaneous disorders: xerosis (8%), alopecia (7%)
Nervous system disorders: dizziness (8%), peripheral neuropathy (7%)
Metabolism and nutrition disorders: decreased appetite (8%)
Respiratory disorders: dyspnea (7%)
General disorders: chills (7%)
Gastrointestinal disorders: vomiting (7%), abdominal pain (5%)
Injury, poisoning and procedural complications: fall (6%)
Musculoskeletal disorders: muscle spasms (5%)
Cardiovascular disorders: arrhythmia (5%)
Eye disorders: conjunctivitis (5%)
Selected Other Adverse Reactions a, b
Tumor lysis syndrome (<1%)
Myocardial ischemia or infarction (<1%)
Cardiac failure (<1%)
a
Includes grouped terms
b
From 184 patients randomized to POTELIGEO
Table 2 summarizes common treatment-emergent laboratory abnormalities having a ≥2% higherincidence with POTELIGEO than with vorinostat.
Table 2: Common New or Worsening Laboratory Abnormalities (≥10%) with ≥2% Higher Incidence inthe POTELIGEO Arm
Laboratory Test a
POTELIGEO
(N=184)
Vorinostat
(N=186)
All Grades
(%)
≥Grade 3
(%)
All Grades
(%)
≥Grade 3
(%)
Chemistry
Albumin Decreased 34 2 27 3
Calcium Decreased 30 3 20 2
Uric Acid Increased 29 29 11 11
Phosphate Decreased 27 5 26 5
Magnesium Decreased 17 <1 8 <1
Glucose Decreased 14 0 8 <1
Calcium Increased 12 <1 8 <1
Hematology
CD4 Lymphocytes Decreased b
63 43 17 8
Lymphocytes Decreased 31 16 12 4
White Blood Cells Decreased 33 2 18 2
a
Includes laboratory abnormalities, reported up to 90 days after treatment, that are new or worsening in grade or with
worsening from baseline unknown.
b Out of 99 eva luable recipients of POTELIGEO and 36 eva luable recipients of vorinostat.
Other common treatment-emergent laboratory abnormalities in the POTELIGEO arm includedhyperglycemia (52%; 4% Grade 3-4), anemia (35%; 2% Grade 3-4), thrombocytopenia (29%,none Grade 3-4), aspartate transaminase (AST) increased (25%; 2% Grade 3-4), alaninetransaminase (ALT) increased (18%; 1% Grade 3-4), alkaline phosphatase increased (17%; 0%Grade 3-4), and neutropenia (10%; 2% Grade 3-4). Grade 4 treatment-emergent laboratoryab |
