; Gastrointestinal hemorrhage a 14 9
General disorders and administration site conditions
Edema a 40 7
Fatigue a 34 9
Pyrexia 27 4
Infections and infestations
Upper respiratory tract infection a 30 1
Urinary tract infection a 16 3
Pneumonia a 10 8
Herpesvirus infection a 10 1
Musculoskeletal and connective tissue disorders
Musculoskeletal pain a 35 4
Arthralgia 19 2
Nervous system disorders
Headache a 26 1
Dizziness 13 0
Respiratory, thoracic and mediastinal disorders
Dyspnea a 23 7
Cough a 18 < 1
Pleural effusion 13 4
Epistaxis 12 3
Skin and subcutaneous disorders
Rash a 14 3
Investigations
QT prolonged 11 < 1
Psychiatric disorders
Insomnia 11 0
Renal disorders
Renal insufficiency a 11 5
Toxicity was graded per NCI CTCAE v3.
Represents adverse reactions, excluding laboratory terms, occurring up to 28 days after last midostaurin dose, regardless of baseline grade.
a Grouped terms
Upper respiratory tract infection: e.g. nasopharyngitis, upper respiratory tract infections
Urinary tract infection: e.g. urinary tract infection, cystitis
Pneumonia: e.g. pneumonia, lung infection
Herpesvirus infection: e.g. oral herpes, herpes zoster
Headache: e.g. headache, sinus headache
Dyspnea: e.g. dyspnea, bronchospasm, respiratory failure
Cough: e.g. cough, productive cough
Diarrhea: e.g. diarrhea, gastroenteritis, colitis
Abdominal pain: e.g. abdominal pain, abdominal pain upper
Gastrointestinal hemorrhage: e.g. gastrointestinal hemorrhage, hemorrhoidal hemorrhage, duodenal ulcer hemorrhage
Fatigue: e.g. fatigue, asthenia
Rash: e.g. rash, rash maculo-papular, erythema multiforme
Musculoskeletal pain: e.g. back pain, musculoskeletal pain, pain in extremity
Renal insufficiency: e.g. blood creatinine increased, renal failure, acute kidney injury
Edema: e.g. edema, edema peripheral
Gastrointestinal Toxicities Leading to Treatment Modification:
In patients with advanced SM, the median time to onset of nausea was 9 days, with 75% of cases beginning within the first 3 months. The median time to onset of vomiting was 1 month.
Other clinically significant adverse reactions occurring in ≤ 10% of patients included:
Infections and infestations: Sepsis (9%) a, bronchitis (6%), cellulitis or erysipelas (5%)
Blood and lymphatic system disorders: Febrile neutropenia (8%)
Cardiac disorders: Cardiac failure (6%), myocardial infarction or ischemia (4%) a
Immune system disorders: Hypersensitivity (4%) a
Nervous system disorders: Disturbance in atte
