0% for patients receiving AFINITOR 10 mg daily versus placebo.
Table 4: Adverse Reactions Reported ≥ 10% of Patients with Advanced PNET Grading according to CTCAE Version 3.0
a Includes stomatitis, aphthous stomatitis, gingival pain/swelling/ulceration, glossitis, glossodynia, lip ulceration, mouth ulceration, tongue ulceration, and mucosal inflammation.
b Includes diarrhea, enteritis, enterocolitis, colitis, defecation urgency, and steatorrhea.
c Includes pneumonitis, interstitial lung disease, pulmonary fibrosis and restrictive pulmonary disease.
AFINITOR
N=204 Placebo
N=203
All grades Grade 3 Grade 4 All grades Grade 3 Grade 4
% % % % % %
Any adverse reaction 100 49 13 98 32 8
Gastrointestinal disorders
Stomatitisa 70 7 0 20 0 0
Diarrheab 50 5 0.5 25 3 0
Abdominal pain 36 4 0 32 6 1
Nausea 32 2 0 33 2 0
Vomiting 29 1 0 21 2 0
Constipation 14 0 0 13 0.5 0
Dry mouth 11 0 0 4 0 0
General disorders and administration site conditions
Fatigue/malaise 45 3 0.5 27 2 0.5
Edema (general and peripheral) 39 1 0.5 12 1 0
Fever 31 0.5 0.5 13 0.5 0
Asthenia 19 3 0 20 3 0
Infections and infestations
Nasopharyngitis/rhinitis/URI 25 0 0 13 0 0
Urinary tract infection 16 0 0 6 0.5 0
Investigations
Weight decreased 28 0.5 0 11 0 0
Metabolism and nutrition disorders
Decreased appetite 30 1 0 18 1 0
Diabetes mellitus 10 2 0 0.5 0 0
Musculoskeletal and connective tissue disorders
Arthralgia 15 1 0.5 7 0.5 0
Back pain 15 1 0 11 1 0
Pain in extremity 14 0.5 0 6 1 0
Muscle spasms 10 0 0 4 0 0
Nervous system disorders
Headache/migraine 30 0.5 0 15 1 0
Dysgeusia 19 0 0 5 0 0
Dizziness 12 0.5 0 7 0 0
Psychiatric disorders
Insomnia 14 0 0 8 0 0
Respiratory, thoracic and mediastinal disorders
Cough/productive cough 25 0.5 0 13 0 0
Epistaxis 22 0 0 1 0 0
Dyspnea/dyspnea exertional 20 2 0.5 7 0.5 0
Pneumonitisc 17 3 0.5 0 0 0
Oropharyngeal pain 11 0 0 6 0 0
Skin and subcutaneous disorders
Rash 59 0.5 0 19 0 0
Nail disorders 22 0.5 0 2 0 0
Pruritus/pruritus generalized 21 0 0 13 0 0
Dry skin/xeroderma 13 0 0 6 0 0
Vascular disorders
Hypertension 13 1 0 6 1 0
Median duration of treatment (wks) 37 16
In female patients aged 18 to 55 years, irregular menstruation o |
