LENVIMA + everolimus-treated group were diarrhea (21%), fatigue (8%), thrombocytopenia (6%), vomiting (6%), nausea (5%), and proteinuria (5%).
Treatment discontinuation due to an adverse reaction occurred in 29% of patients in the LENVIMA + everolimus-treated group and 12% of patients in the everolimus-treated group.
Table 6 presents the adverse reactions in > 15% of patients in the LENVIMA + Everolimus arm.
Table 6: Grades 1-4 Adverse Reactions in > 15% of Patients in the LENVIMA + Everolimus Arm
LENVIMA 18 mg +
Everolimus 5 mg
(N=62) Everolimus 10 mg
(N=50)
System Organ Class Preferred Term Grade 1-4
(%) Grade 3-4
(%) Grade 1-4
(%) Grade 3-4
(%)
Endocrine Disorders
Hypothyroidism 24 0 2 0
Gastrointestinal Disorders
Constipation 16 0 18 0
Diarrhea 81 19 34 2
Dyspepsia/Gastro-esophageal reflux 21 0 12 0
Abdominal paina 37 3 8 0
Nausea 45 5 16 0
Oral painb 23 2 4 0
Stomatitis/Oral inflammationc 44 2 50 4
Vomiting 48 7 12 0
General Disorders and Administration Site Conditions
Fatigued 73 18 40 2
Peripheral edema 42 2 20 0
Pyrexia/Increased body temperature 21 2 10 2
Investigations
Weight decreased 34 3 8 0
Metabolism and Nutrition Disorders
Decreased appetite 53 5 18 0
Musculoskeletal and Connective Tissue Disorders
Arthralgia/Myalgiae 55 5 32 0
Musculoskeletal chest pain 18 2 4 0
Nervous System Disorders
Headache 19 2 10 2
Psychiatric Disorders
Insomnia 16 2 2 0
Renal and Urinary Disorders
Proteinuria/Urine protein present 31 8 14 2
Renal failure eventf 18 10 12 2
Respiratory, Thoracic and Mediastinal Disorders
Cough 37 0 30 0
Dysphonia 18 0 4 0
Dyspnea/Exertional dyspnea 35 5 28 8
Skin and Subcutaneous Tissue Disorders
Rashg 35 0 40 0
Vascular Disorders
Hemorrhagic eventsh 32 6 26 2
Hypertension/Increased blood pressure 42 13 10 2
a Includes abdominal discomfort, gastrointestinal pain, lower abdominal pain, and upper abdominal pain
b Includes gingival pain, glossodynia, and oropharyngeal pain
c Includes aphthous stomatitis, gingival inflammation, glossitis, and mouth ulceration
d Includes asthenia, fatigue, lethargy and malaise
e Includes arthralgia, back pain, extremity pain, musculoskeletal pain, and myalgia
f Includes blood creatinine increased, blood urea increased, creatinine renal clearance decreased, nephropathy toxic, renal failure, renal failure acute, and re
