des rash, rash generalized, rash macular, rash maculo-papular, rash papular, dermatitis allergic, and urticaria
AFINITOR
N=78 Placebo
N=39
All grades
% Grade 3
% Grade 4
% All grades
% Grade 3
% Grade 4
%
Any adverse reaction 97 36 3 92 23 3
Gastrointestinal disorders
Stomatitisa 62 9 0 26 3 0
Vomiting 22 1 0 13 0 0
Diarrhea 17 0 0 5 0 0
Constipation 10 0 0 3 0 0
Infections and infestations
Respiratory tract infectionb 31 1 1 23 0 0
Gastroenteritisc 10 4 1 3 0 0
Pharyngitis streptococcal 10 0 0 3 0 0
General disorders and administration site conditions
Pyrexia 23 6 0 18 3 0
Fatigue 14 0 0 3 0 0
Psychiatric disorders
Anxiety, aggression or other behavioral disturbanced 21 5 0 3 0 0
Skin and subcutaneous tissue disorders
Rashe 21 0 0 8 0 0
Acne 10 0 0 5 0 0
Amenorrhea occurred in 17% of AFINITOR-treated females aged 10 to 55 years (3 of 18) and none of the females in the placebo group. For this same group of AFINITOR-treated females, the following menstrual abnormalities were reported: dysmenorrhea (6%), menorrhagia (6%), metrorrhagia (6%), and unspecified menstrual irregularity (6%).
The following additional adverse reactions occurred in less than 10% of AFINITOR-treated patients: nausea (8%), pain in extremity (8%), insomnia (6%), pneumonia (6%), epistaxis (5%), hypersensitivity (3%), increased blood luteinizing hormone (LH) levels (1%) and pneumonitis (1%).
Table 11: Key Laboratory Abnormalities Reported in AFINITOR-treated Patients with SEGA in Study 1 Grading according to CTCAE Version 3.0
AFINITOR
N=78 Placebo
N=39
All grades
% Grade 3
% Grade 4
% All grades
% Grade 3
% Grade 4
%
Hematology
Elevated partial thromboplastin time 72 3 0 44 5 0
Neutropenia 46 9 0 41 3 0
Anemia 41 0 0 21 0 0
Clinical chemistry
Hypercholesterolemia 81 0 0 39 0 0
Elevated aspartate transaminase (AST) 33 0 0 0 0 0
Hypertriglyceridemia 27 0 0 15 0 0
Elevated alanine transaminase (ALT) 18 0 0 3 0 0
Hypophosphatemia 9 1 0 3 0 0
Longer-term follow-up of 34.2 months (range 4.7 to 47.1 months) from a non-randomized, open-label, 28-patient trial resulted in the following additional notable adverse reactions and key laboratory abnormalities: cellulitis (29%), hyperglycemia (25%), and elevated creatinine (14%).
6.6 Postmarketing Experience
The following adverse reactions have been identified during post approval use of AF |
