each system organ class grouping, adverse reactions are presented in order of decreasing frequency. The frequency estimates for adverse reactions are defined as: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000); and Not known (cannot be estimated from available data – spontaneous reports). Table 9: Adverse Reactions Reported in of Patients in Non-Small Cell Lung ≥5% Cancer Clinical Trial (by MedDRA System Organ Class and Preferred Term) ABRAXANE Solvent-based paclitaxel (100 mg/m2/week) (200 mg/m2 every and carboplatin 3 weeks) and carboplatin (N=514) (N=524) System Organ Frequency Preferred Term All Grade 3 All Grades Grade 3 Class Grades or Higher Toxicity2 or Higher Toxicity2 Toxicity3 (%) Toxicity3 (%) (%) (%) Blood and Very Anaemia1 97 27 91 7 lymphatic Common Leukopenia1 89 24 83 23 system Neutropenia1 84 47 83 58 disorders1 Thrombocytopenia1 67 18 55 9 Skin and Very Alopecia 56 <1 60 0 subcutaneous Common Rash 10 0 8 <1 tissue disorders Nervous system Very Peripheral neuropathy4 48 3 64 12 disorders Common Common Dysgeusia 7 0 6 0 Headache 7 <1 4 <1 Dizziness 6 0 4 <1 General Very Fatigue 25 4 23 4 disorders and Common Asthenia 16 3 15 4 administration Oedema peripheral 10 0 4 <1 site conditions Common Pyrexia 9 0 8 0 Chest pain 5 <1 4 <1 Very Nausea 27 <1 25 <1 intestinal Common Constipation 16 <1 13 <1 disorders Diarrhoea 15 <1 11 0 Vomiting 12 <1 12 <1 Common Stomatitis 6 0 4 0 Respiratory Very Dyspnoea 12 3 12 3 thoracic and Common mediastinal Common Cough 9 <1 7 0 disorders Epistaxis 7 0 2 0 Haemoptysis 4 <1 5 0 9: Adverse Reactions Reported in of Patients in ≥5% Cell Lung Cancer Clinical Trial (by MedDRA System Organ Class and Preferred Term) (Continued)
each system organ class grouping, adverse reactions are presented in order of decreasing frequency. The frequency estimates for adverse reactions are defined as: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000); and Not known (cannot be estimated from available data – spontaneous reports). Table 9: Adverse Reactions Reported in ≥5% of Patients in Non-Small Cell Lung Cancer Clinical Trial (by MedDRA System Organ Class and Preferred Term) System Organ Class Frequency Preferred Term ABRAXANE (100 mg/m2/week) and carboplatin (N=514) Solvent-based paclitaxel (200 mg/m2 every 3 weeks) and carboplatin (N=524) All Grades Toxicity2 (%) Grade 3 or Higher Toxicity3 (%) All Grades Toxicity2 (%) Grade 3 or Higher Toxicity3 (%) Blood and lymphatic system disorders1 Very Common Anaemia1 97 27 91 7 Leukopenia1 89 24 83 23 Neutropenia1 84 47 83 58 Thrombocytopenia1 67 18 55 9 Skin and subcutaneous tissue disorders Very Common Alopecia 56 <1 60 0 Rash 10 0 8 <1 Nervous system disorders Very Common Peripheral neuropathy4 48 3 64 12 Common Dysgeusia 7 0 6 0 Headache 7 <1 4 <1 Dizziness 6 0 4 <1 General disorders and administration site conditions Very Common Fatigue 25 4 23 4 Asthenia 16 3 15 4 Oedema peripheral 10 0 4 <1 Common Pyrexia 9 0 8 0 Chest pain 5 <1 4 <1 disorders Very Common Nausea 27 <1 25 <1 Constipation 16 <1 13 <1 Diarrhoea 15 <1 11 0 Vomiting 12 <1 12 <1 Common Stomatitis 6 0 4 0 Respiratory thoracic and mediastinal disorders Very Common Dyspnoea 12 3 12 3 Common Cough 9 <1 7 0 Epistaxis 7 0 2 0 Haemoptysis 4 <1 5 0 9: Adverse Reactions Reported in ≥5% of Patients in Cell Lung Cancer Clinical Trial (by MedDRA System Organ Class and Preferred Term) (Continued) intestinal
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