y versus placebo.
Table 2: Adverse Reactions Reported ≥ 10% of Patients with Advanced HR+ BC* Grading according to CTCAE Version 3.0
* 160 patients (33.2%) were exposed to AFINITOR therapy for a period of ≥ 32 weeks
a Exemestane (25 mg/day)
b Includes stomatitis, mouth ulceration, aphthous stomatitis, glossodynia, gingival pain, glossitis and lip ulceration
c Includes all preferred terms within the ‘infections and infestations’ system organ class, the most common being nasopharyngitis (10%), urinary tract infection (10%), upper respiratory tract infection (5%), pneumonia (4%), bronchitis (4%), cystitis (3%), sinusitis (3%), and also including candidiasis (<1%), and sepsis (<1%), and hepatitis C (<1%).
d Includes pneumonitis, interstitial lung disease, lung infiltration, and pulmonary fibrosis
e Exposure to AFINITOR or placebo
AFINITOR (10 mg/day)
+ exemestanea
N=482 Placebo
+ exemestanea
N=238
All grades Grade 3 Grade 4 All grades Grade 3 Grade 4
% % % % % %
Any adverse reaction 100 41 9 90 22 5
Gastrointestinal disorders
Stomatitisb 67 8 0 11 0.8 0
Diarrhea 33 2 0.2 18 0.8 0
Nausea 29 0.2 0.2 28 1 0
Vomiting 17 0.8 0.2 12 0.8 0
Constipation 14 0.4 0 13 0.4 0
Dry mouth 11 0 0 7 0 0
General disorders and administration site conditions
Fatigue 36 4 0.4 27 1 0
Edema peripheral 19 1 0 6 0.4 0
Pyrexia 15 0.2 0 7 0.4 0
Asthenia 13 2 0.2 4 0 0
Infections and infestations
Infectionsc 50 4 1 25 2 0
Investigations
Weight decreased 25 1 0 6 0 0
Metabolism and nutrition disorders
Decreased appetite 30 1 0 12 0.4 0
Hyperglycemia 14 5 0.4 2 0.4 0
Musculoskeletal and connective tissue disorders
Arthralgia 20 0.8 0 17 0 0
Back pain 14 0.2 0 10 0.8 0
Pain in extremity 9 0.4 0 11 2 0
Nervous system disorders
Dysgeusia 22 0.2 0 6 0 0
Headache 21 0.4 0 14 0 0
Psychiatric disorders
Insomnia 13 0.2 0 8 0 0
Respiratory, thoracic and mediastinal disorders
Cough 24 0.6 0 12 0 0
Dyspnea 21 4 0.2 11 0.8 0.4
Epistaxis 17 0 0 1 0 0
Pneumonitisd 19 4 0.2 0.4 0 0
Skin and subcutaneous tissue disorders
Rash 39 1 0 6 0 0
Pruritus 13 0.2 0 5 0 0
Alopecia 10 0 0 5 0 0
Vascular disorders
Hot flush 6 0 0 14 0 0
Median duration of treatmente 23.9 weeks 13.4 weeks
Key observed laboratory abnormalities are presented in Table 3.
Table 3: Key Laboratory Abnormalities Reported in ≥ 10% of Patients with Advanced HR+ BC Grading according to CTCAE Version 3.0
a Exemest |
