egimens (1.8% in the 90 mg group and 4.5% in the 90→180 mg group).
Table 3 and Table 4 summarize the common adverse reactions and laboratory abnormalities observed in ALTA.
Table 3: Adverse Reactions in ≥ 10% (All Grades*) or ≥ 2% (Grades 3-4) of Patients by Dose Group in ALTA (N=219)
Adverse Reactions 90 mg once daily
N = 109 90→180 mg once daily
N = 110
All Grades
(%) Grades 3-4
(%) All Grades
(%) Grades 3-4
(%)
* Per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 † Includes abdominal distension, abdominal pain, and epigastric discomfort ‡ Includes asthenia and fatigue § Includes dyspnea and exertional dyspnea ¶ Includes one Grade 5 event # Includes headache and sinus headache Þ Includes peripheral sensory neuropathy and paresthesia SS Includes acneiform dermatitis, exfoliative rash, rash, pruritic rash, and pustular rash À Includes musculoskeletal pain and myalgia È Includes diplopia, photophobia, blurred vision, reduced visual acuity, visual impairment, vitreous floaters, visual field defect, macular edema, and vitreous detachment
Gastrointestinal Disorders
Nausea 33 0.9 40 0.9
Diarrhea 19 0 38 0
Vomiting 24 1.8 23 0
Constipation 19 0.9 15 0
Abdominal Pain† 17 0 10 0
General Disorders And Administration Site Conditions
Fatigue‡ 29 1.8 36 0
Pyrexia 14 0 6.4 0.9
Respiratory, Thoracic And Mediastinal Disorders
Cough 18 0 34 0
Dyspnea§ 27 2.8 21 1.8¶
ILD/Pneumonitis 3.7 1.8 9.1 2.7
Hypoxia 0.9 0 2.7 2.7
Nervous System Disorders
Headache# 28 0 27 0.9
Peripheral NeuropathyÞ 13 0.9 13 1.8
Skin And Subcutaneous Tissue Disorders
RashSS 15 1.8 24 3.6
Vascular Disorders
Hypertension 11 5.5 21 6.4
Musculoskeletal And Connective Tissue Disorders
Muscle Spasms 12 0 17 0
Back pain 10 1.8 15 1.8
MyalgiaÀ 9.2 0 15 0.9
Arthralgia 14 0.9 14 0
Pain in extremity 11 0 3.6 0.9
Metabolism And Nutrition Disorders
Decreased Appetite 22 0.9 15 0.9
Eye Disorders
Visual DisturbanceÈ 7.3 0 10 0.9
Infections
Pneumonia 4.6 2.8¶ 10 5.5¶
Psychiatric Disorders
Insomnia 11 0 7.3 0
Table 4: Laboratory Abnormalities in ≥20% (All Grades*) of Patients by Regimen in ALTA (N=219)
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