nt groups, respectively. The most common adverse reactions (irrespective of causality) leading to treatment discontinuation were pneumonitis and dyspnea. Infections, stomatitis, and pneumonitis were the most common reasons for treatment delay or dose reduction. The most common medical interventions required during AFINITOR treatment were for infections, anemia, and stomatitis.
Table 6 compares the incidence of treatment-emergent adverse reactions reported with an incidence of ≥ 10% for patients receiving AFINITOR 10 mg daily versus placebo. Within each MedDRA system organ class, the adverse reactions are presented in order of decreasing frequency.
Table 6: Adverse Reactions Reported in at Least 10% of Patients with RCC and at a Higher Rate in the AFINITOR Arm than in the Placebo Arm Grading according to CTCAE Version 3.0
a Stomatitis (including aphthous stomatitis), and mouth and tongue ulceration.
b Includes all preferred terms within the ‘infections and infestations’ system organ class, the most common being nasopharyngitis (6%), pneumonia (6%), urinary tract infection (5%), bronchitis (4%), and sinusitis (3%), and also including aspergillosis (<1%), candidiasis (<1%), and sepsis (<1%).
c Includes pneumonitis, interstitial lung disease, lung infiltration, pulmonary alveolar hemorrhage, pulmonary toxicity, and alveolitis.
AFINITOR 10 mg/day
N=274 Placebo
N=137
All grades Grade 3 Grade 4 All grades Grade 3 Grade 4
% % % % % %
Any adverse reaction 97 52 13 93 23 5
Gastrointestinal disorders
Stomatitisa 44 4 <1 8 0 0
Diarrhea 30 1 0 7 0 0
Nausea 26 1 0 19 0 0
Vomiting 20 2 0 12 0 0
Infections and infestationsb 37 7 3 18 1 0
General disorders and administration site conditions
Asthenia 33 3 <1 23 4 0
Fatigue 31 5 0 27 3 <1
Edema peripheral 25 <1 0 8 <1 0
Pyrexia 20 <1 0 9 0 0
Mucosal inflammation 19 1 0 1 0 0
Respiratory, thoracic and mediastinal disorders
Cough 30 <1 0 16 0 0
Dyspnea 24 6 1 15 3 0
Epistaxis 18 0 0 0 0 0
Pneumonitisc 14 4 0 0 0 0
Skin and subcutaneous tissue disorders
Rash 29 1 0 7 0 0
Pruritus 14 <1 0 7 0 0
Dry skin 13 <1 0 5 0 0
Metabolism and nutrition disorders
Anorexia 25 1 0 14 <1 0
Nervous system disorders
Headache 19 <1 <1 9 <1 0
Dysgeusia 10 0 0 2 0 0
Musculoskeletal and connective tissue disorders
Pain in extremity 10 1 0 7 0 0
Median duration of treatment (d) 141 60
Other notable adverse reactions occurring more frequently with AFINITOR than with placebo, but with an incidence of < 10% include:
Gastrointestinal disorders: Abdominal pain (9%), dry mouth (8%), hemorrhoids (5%), dysphagia (4%)
Gene |
