Ear and labyrinth disorders: Vertigo (5%)
Vascular disorders: Hypotension (9%), hematoma (6%)
Respiratory, thoracic and mediastinal disorders: Oropharyngeal pain (4%), interstitial lung disease or pneumonitis (2%), pulmonary edema (3%) a
Gastrointestinal disorders: Dyspepsia (6%), gastritis (3%) a
General disorders and administration site conditions: Chills (5%)
Investigations: Weight increased (6%)
Injury, poisoning and procedural complications: Contusion (6%)
a Grouped terms
Sepsis: e.g. sepsis, staphylococcal/Enterobacter/Escherichia sepsis
Hypersensitivity: includes one report of anaphylactic shock
Myocardial infarction or ischemia: e.g. myocardial infarction and acute myocardial infarction, angina pectoris
Gastritis: gastritis, gastritis erosive, gastritis hemorrhagic
Pulmonary edema: pulmonary edema, pulmonary congestion
Table 5 summarizes new or worsening laboratory abnormalities. Common (≥ 10%) Grade 3 or higher non-hematologic laboratory abnormalities were hyperglycemia (non-fasting), lipase increase, and hyperuricemia. The most common (≥ 20%) Grade 3 or higher hematologic laboratory abnormalities were lymphopenia, anemia, thrombocytopenia, and neutropenia. Grade 4 hematologic abnormalities occurring in ≥ 5% were thrombocytopenia (13%), neutropenia (8%), anemia (6%), and lymphopenia (6%).

Table 5: Most Common (≥ 20%) New or Worsening Laboratory Abnormalities Reported in Patients with Advanced SM (Study 2 and Study 3)
RYDAPT (100 mg twice daily)
N=142
Test All Grades
% Grade ≥ 3
%
Hematology
     Lymphopenia 66 42
     Leukopenia 61 19
     Anemia 60 38
     Thrombocytopenia 50 27
     Neutropenia 49 22
Chemistry
     Hyperglycemiaa 80 18
     Alk phos increase 39 9
     Hypocalcemia 39 2
     Lipase increase 37 18
     Hyperuricemia 37 11
     GGT increaseb 35 9
     Hyponatremia 34 5
     AST increase 32 3
     ALT increase 31 4
     Hyperbilirubinemia 29 4
     Hypoalbuminemia 27 1
     Hypokalemia 25 6
     Creatinine increase 25 < 1
     Hyperkalemia 23 4
     Hypophosphatemia 22 1
     Amylase increase 20 7
     Hypomagnesemia 20 0
Includes abnormalities occurring up to 28 days after last midostaurin dose, if new or worsened from baseline or if baseline was unknown.
a Non-fasting
b Among 116 eva luable patients.
7 DRUG INTERACTIONS
7.1 Effect of Strong Cytochrome P450 (CYP) 3A Inhibitors and Inducers
Table 6 lists the potential effects of the coadministrat