Safety evaluation of Tarceva is based on 856 cancer patients who received Tarceva as monotherapy, 308 patients who received Tarceva 100 or 150 mg plus gemcitabine, and 1228 patients who received Tarceva concurrently with other chemotherapies.
There have been reports of serious events, including fatalities, in patients receiving Tarceva for treatment of NSCLC, pancreatic cancer or other advanced solid tumors.
Non-Small Cell Lung Cancer
Adverse events, regardless of causality, that occurred in at least 10% of patients treated with single-agent Tarceva at 150 mg and at least 3% more often than in the placebo group in the randomized trial of patients with NSCLC are summarized by NCI-CTC (version 2.0) Grade in Table 5.
The most common adverse reactions in patients receiving single-agent Tarceva 150 mg were rash and diarrhea. Grade 3/4 rash and diarrhea occurred in 9% and 6%, respectively, in Tarceva-treated patients. Rash and diarrhea each resulted in study discontinuation in 1% of Tarceva-treated patients. Six percent and 1% of patients needed dose reduction for rash and diarrhea, respectively. The median time to onset of rash was 8 days, and the median time to onset of diarrhea was 12 days. Table 5: Adverse Events Occurring More Frequently (≥ 3%) in the Single Agent Tarceva Group than in the Placebo Group and in ≥10% of Patients in the Tarceva Group Tarceva 150 mg N = 485 lacebo N = 242 NCI CTC Grade Any Grade Grade 3 Grade 4 Any Grade Grade 3 Grade 4 MedDRA Preferred Term % % % % % % Rash 75 8 <1 17 0 0 Diarrhea 54 6 <1 18 <1 0 Anorexia 52 8 1 38 5 <1 Fatigue 52 14 4 45 16 4 Dyspnea 41 17 11 35 15 11 Cough 33 4 0 29 2 0 Nausea 33 3 0 24 2 0 Infection 24 4 0 15 2 0 Vomiting 23 2 <1 19 2 0 Stomatitis 17 <1 0 3 0 0 Pruritus 13 <1 0 5 0 0 Dry skin 12 0 0 4 0 0 Conjunctivitis 12 <1 0 2 <1 0 Keratoconjunctivitis sicca 12 0 0 3 0 0 Abdominal pain 11 2 <1 7 1 <1
还有"Adverse Events Occurring More Frequently (≥ 3%) in the Single Agent Tarceva Group than in the Placebo Group and in ≥10% of Patients in the Tarceva Group Tarceva 150 mg"这句,是指用单药的副作用反应比加用"安慰剂"(感觉翻译不对)要更多吗?
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发表于 2008-4-29 08:44:18
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