, and dysphonia. The most common serious adverse reactions (at least 2%) were pneumonia (4%), hypertension (3%), and dehydration (3%).
Adverse reactions led to dose reductions in 68% of patients receiving LENVIMA and 5% of patients receiving placebo; 18% of patients discontinued LENVIMA and 5% discontinued placebo for adverse reactions. The most common adverse reactions (at least 10%) resulting in dose reductions of LENVIMA were hypertension (13%), proteinuria (11%), decreased appetite (10%), and diarrhea (10%); the most common adverse reactions (at least 1%) resulting in discontinuation of LENVIMA were hypertension (1%) and asthenia (1%).
Table 4 presents the percentage of patients in Study 1 experiencing adverse reactions at a higher rate in LENVIMA-treated patients than patients receiving placebo in the double-blind phase of the DTC study.
Table 4: Adverse Reactions Occurring in Patients with a Between-Group Difference of Greater than or Equal to 5% in All Grades or Greater than or Equal to 2% in Grades 3 and 4
LENVIMA 24 mg
N=261 Placebo
N=131
Adverse Reaction All Grades
(%) Grades 3-4
(%) All Grades
(%) Grades 3-4
(%)
Vascular Disorders
Hypertensiona 73 44 16 4
Hypotension 9 2 2 0
Gastrointestinal Disorders
Diarrhea 67 9 17 0
Nausea 47 2 25 1
Stomatitisb 41 5 8 0
Vomiting 36 2 15 0
Abdominal painc 31 2 11 1
Constipation 29 0.4 15 1
Oral paind 25 1 2 0
Dry mouth 17 0.4 8 0
Dyspepsia 13 0.4 4 0
General Disorders and Administration Site Conditions
Fatiguee 67 11 35 4
Edema peripheral 21 0.4 8 0
Musculoskeletal and Connective Tissue Disorders
Arthralgia/Myalgiaf 62 5 28 3
Metabolism and Nutrition Disorders
Weight decreased 51 13 15 1
Decreased appetite 54 7 18 1
Dehydration 9 2 2 1
Nervous System Disorders
Headache 38 3 11 1
Dysgeusia 18 0 3 0
Dizziness 15 0.4 9 0
Renal and Urinary Disorders
Proteinuria 34 11 3 0
Skin and Subcutaneous Tissue Disorders
Palmar-plantar erythrodysesthesia 32 3 1 0
Rashg 21 0.4 3 0
Alopecia 12 0 5 0
Hyperkeratosis 7 0 2 0
Respiratory, Thoracic and Mediastinal Disorders
Dysphonia 31 1 5 0
Cough 24 0 18 0
Epistaxis 12 0 1 0
Psychiatric Disorders
Insomnia 12 0 3 0
Infections and Infestations
Dental and oral infectionsh 10 1 1 0
Urinary tract infection 11 1 5 0
Cardiac Disorders
Electrocardiogram QT prolonged 9 2 2 0
a Includes hypertension, hypertensive crisis, increased blood pressure diastolic, and increased blood pressure
b Includes aphthous stoma |
