ral disorders and administration site conditions: Weight decreased (9%), chest pain (5%), chills (4%), impaired wound healing (< 1%)
Respiratory, thoracic and mediastinal disorders: Pleural effusion (7%), pharyngolaryngeal pain (4%), rhinorrhea (3%)
Skin and subcutaneous tissue disorders: Hand-foot syndrome (reported as palmar-plantar erythrodysesthesia syndrome) (5%), nail disorder (5%), erythema (4%), onychoclasis (4%), skin lesion (4%), acneiform dermatitis (3%), angioedema (<1%)
Metabolism and nutrition disorders: Exacerbation of pre-existing diabetes mellitus (2%), new onset of diabetes mellitus (< 1%)
Psychiatric disorders: Insomnia (9%)
Nervous system disorders: Dizziness (7%), paresthesia (5%)
Eye disorders: Eyelid edema (4%), conjunctivitis (2%)
Vascular disorders: Hypertension (4%), deep vein thrombosis (< 1%)
Renal and urinary disorders: Renal failure (3%)
Cardiac disorders: Tachycardia (3%), congestive cardiac failure (1%)
Musculoskeletal and connective tissue disorders: Jaw pain (3%)
Hematologic disorders: Hemorrhage (3%)
Key laboratory abnormalities are presented in Table 7.
Table 7: Key Laboratory Abnormalities Reported in Patients with RCC at a Higher Rate in the AFINITOR Arm than the Placebo Arm Grading according to CTCAE Version 3.0
a Reflects corresponding adverse drug reaction reports of anemia, leukopenia, lymphopenia, neutropenia, and thrombocytopenia (collectively pancytopenia), which occurred at lower frequency.
Laboratory parameter AFINITOR 10 mg/day
N=274 Placebo
N=137
All grades Grade 3 Grade 4 All grades Grade 3 Grade 4
% % % % % %
Hematologya
Hemoglobin decreased 92 12 1 79 5 <1
Lymphocytes decreased 51 16 2 28 5 0
Platelets decreased 23 1 0 2 0 <1
Neutrophils decreased 14 0 <1 4 0 0
Clinical chemistry
Cholesterol increased 77 4 0 35 0 0
Triglycerides increased 73 <1 0 34 0 0
Glucose increased 57 15 <1 25 1 0
Creatinine increased 50 1 0 34 0 0
Phosphate decreased 37 6 0 8 0 0
Aspartate transaminase (AST) increased 25 <1 <1 7 0 0
Alanine transaminase (ALT) increased 21 1 0 4 0 0
Bilirubin increased 3 <1 <1 2 0 0
6.4 Clinical Study Experience in Renal Angiomyolipoma with Tuberous Sclerosis Complex
The data described below are based on a randomized (2:1), double-blind, placebo-controlled trial of AFINITOR in 118 patients with renal angiomyolipoma as a feature of TSC (n=113) or sporadic lymphangioleiomyomatosis (n=5). The median age of patients was 3 |
