Weight decreased 13 0 2 0
White blood cell count
decreased
11 11 5 2
Cardiac disorders Atrial arrhythmiaq 13 4 7 2
Renal and urinary
disorders
Renal insufficiencyr 19 5 10 0
Abbreviations: N = number of patients.
Preferred terms were retrieved by applying the Medical Dictionary for Regulatory Activities (MedDRA) version 19.1.
BRIGHT AML 1003 used National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Adverse reactions include events that commenced within 28 days after the last treatment dose.
a. Adverse reactions with ≥10% incidence in the DAURISMO with low-dose cytarabine arm or the low-dose cytarabine arm are included. b. No Grade 5 events in the DAURISMO with low-dose cytarabine or low-dose cytarabine alone arm. c. Hemorrhage includes petechiae, epistaxis, hematoma, contusion, rectal hemorrhage, anal hemorrhage, ecchymosis, gingival bleeding, hematuria,mouth hemorrhage, purpura, cerebral hemorrhage, eye contusion, eye hemorrhage, gastric hemorrhage, gastrointestinal hemorrhage, hematemesis,hemoptysis, hemorrhage, implant site hematoma, injection site bruising, retroperitoneal hematoma, thrombotic thrombocytopenic purpura, trachealhemorrhage, conjunctival hemorrhage, disseminated intravascular coagulation, eyelid hematoma, hematochezia, hemorrhage intracranial,hemorrhoidal hemorrhage, lower gastrointestinal hemorrhage, retinal hemorrhage, and subdural hematoma. d. Fatigue includes asthenia and fatigue.
e. Edema includes edema peripheral, edema, fluid overload, fluid retention, and swelling face.
f. Mucositis includes mucosal inflammation, oropharyngeal pain, stomatitis, anal ulcer, gingival pain, laryngeal inflammation, esophagitis, oral pain,aphthous ulcer, mouth ulceration, and pharyngeal inflammation. g. Chest pain includes chest pain and non-cardiac chest pain. h. Musculoskeletal pain includes pain in extremity, arthralgia, back pain, myalgia, musculoskeletal pain, musculoskeletal chest pain, neck pain, andbone pain.
i. Muscle spasms includes muscle spasms and muscle tightness.
j. Abdominal pain includes abdominal pain, abdominal pain upper, and abdominal pain lower. k. Diarrhea includes diarrhea, colitis, and gastroenteritis.
l. Dyspnea includes dyspnea, hypoxia, bronchospasm, and respiratory failure. m. Cough includes cough and productive cough.
n. Dysgeusia includes dysgeusia and ageusia.
o. Rash includes rash, pruritus, erythema, skin ulcer, rash maculo-papular, and rash pruritic. p. Pneumonia includes pneumonia, pneumonia aspiration, and lunginfection. q. Atrial arrhythmia includes atrial fibrillation, bradycardia, tachycardia, and sinus tachycardia.
r. Renal insufficiency includes acute kidney injury, blood creatinine increased, oliguria, and renal failure.
The adverse reactions muscle spasms (4 in 12 patients) and decreased appetite (2 in 10 patients) worsened (i.e.
progressed from Grades ≤ 2 to Grade 3 or higher) after the first 90 days of therapy in BRIGHT AML 1003.
Additional clinically-significant adverse reactions occurring in < 10% of patients treated with DAURISMO andlow-dose cytarabine in BRIGHT AML 1003 include:
Dental disorders: loose tooth and toothache
Skin and subcutaneous tissue disorders: alopecia
Cardiac disorders: QT interval prolonged
Changes in selected post-baseline laboratory values that were observed i |
