angioedema (1%).
Table 9: Key Laboratory Abnormalities Reported in AFINITOR-treated Patients with Renal Angiomyolipoma Grading according to CTCAE Version 3.0
AFINITOR
N=79 Placebo
N=39
All grades
% Grade 3
% Grade 4
% All grades
% Grade 3
% Grade 4
%
Hematology
Anemia 61 0 0 49 0 0
Leucopenia 37 0 0 21 0 0
Neutropenia 25 0 1 26 0 0
Lymphopenia 20 1 0 8 0 0
Thrombocytopenia 19 0 0 3 0 0
Clinical chemistry
Hypercholesterolemia 85 1 0 46 0 0
Hypertriglyceridemia 52 0 0 10 0 0
Hypophosphatemia 49 5 0 15 0 0
Alkaline phosphatase increased 32 1 0 10 0 0
Elevated aspartate transaminase (AST) 23 1 0 8 0 0
Elevated alanine transaminase (ALT) 20 1 0 15 0 0
Fasting hyperglycemia 14 0 0 8 0 0
6.5 Clinical Study Experience in Subependymal Giant Cell Astrocytoma with Tuberous Sclerosis Complex
The data described below are based on a randomized (2:1), double-blind, placebo-controlled trial (Study 1) of AFINITOR in 117 patients with subependymal giant cell astrocytoma (SEGA) and tuberous sclerosis complex (TSC). The median age of patients was 9.5 years (range 0.8 to 26 years), 93% were Caucasian, and 57% were male. The median duration of blinded study treatment was 52 weeks (range 24 to 89 weeks) for patients receiving AFINITOR and 47 weeks (range 14 to 88 weeks) for those receiving placebo.
The most common adverse reactions reported for AFINITOR (incidence ≥ 30%) were stomatitis and respiratory tract infection. The most common Grade 3-4 adverse reactions (incidence ≥ 2%) were stomatitis, pyrexia, pneumonia, gastroenteritis, aggression, agitation, and amenorrhea. The most common key laboratory abnormalities (incidence ≥ 50%) were hypercholesterolemia and elevated partial thromboplastin time. The most common Grade 3-4 laboratory abnormality (incidence ≥ 3%) was neutropenia.
There were no adverse reactions resulting in permanent discontinuation. Dose adjustments (interruptions or reductions) due to adverse reactions occurred in 55% of AFINITOR-treated patients. The most common adverse reaction leading to AFINITOR dose adjustment was stomatitis.
Table 10 compares the incidence of adverse reactions reported with an incidence of ≥ 10% for patients receiving AFINITOR and occurring more frequently with AFINITOR than with placebo. Laboratory abnormalities are described separately in Table 11.
Table 10: Adverse Reactions Reported in ≥10% of AFINITOR-treated Patients with SEGA in Study 1 Grading according to CTCAE Version 3.0
a Includes mouth ulceration, stomatitis, and lip ulceration
b Includes respiratory tract infection, upper respiratory tract infection, and respiratory tract infection viral
c Includes gastroenteritis, gastroenteritis viral, and gastrointestinal infection
d Includes agitation, anxiety, panic attack, aggression, abnormal behavior, and obsessive compulsive disorder
e Inclu |
