) 0
Gastrointestinal System Disorders
Abdominal Pain 2 (1) 0 7 (2) 1 (<1) 11 (5) 1 (<1)
Constipation 18 (6) 0 53 (18) 3 (1) 49 (22) 0
Diarrhea 9 (3) 0 18 (6) 0 23 (10) 2 (1)
Nausea 45 (16) 1 (<1) 105 (36) 2 (1) 110 (49) 3 (1)
Stomatitis 14 (5) 1 (<1) 19 (7) 0 20 (9) 3 (1)
Vomiting 16 (6) 1 (<1) 57 (20) 1 (<1) 66 (29) 4 (2)
Injury and Poisoning
Radiation Injury NOS 11 (4) 1 (<1) 20 (7) 0 5 (2) 0
Musculoskeletal System Disorders
Arthralgia 2 (1) 0 7 (2) 1 (<1) 14 (6) 0
Platelet, Bleeding and Clotting Disorders
Thrombocytopenia 3 (1) 0 11 (4) 8 (3) 19 (8) 8 (4)
Psychiatric Disorders
Insomnia 9 (3) 1 (<1) 14 (5) 0 9 (4) 0
Respiratory System Disorders
Coughing 3 (1) 0 15 (5) 2 (1) 19 (8) 1 (<1)
Dyspnea 9 (3) 4 (1) 11 (4) 5 (2) 12 (5) 1 (<1)
Skin and Subcutaneous Tissue Disorders
Alopecia 179 (63) 0 199 (69) 0 124 (55) 0
Dry Skin 6 (2) 0 7 (2) 0 11 (5) 1 (<1)
Erythema 15 (5) 0 14 (5) 0 2 (1) 0
Pruritus 4 (1) 0 11 (4) 0 11 (5) 0
Rash 42 (15) 0 56 (19) 3 (1) 29 (13) 3 (1)
Special Senses Other, Disorders
Taste Perversion 6 (2) 0 18 (6) 0 11 (5) 0
Myelosuppression (neutropenia and thrombocytopenia), which is a known dose-limiting toxicity for most cytotoxic agents, including TEMODAR, was observed. When laboratory abnormalities and adverse reactions were combined, Grade 3 or Grade 4 neutrophil abnormalities including neutropenic reactions were observed in 8% of the patients, and Grade 3 or Grade 4 platelet abnormalities, including thrombocytopenic reactions, were observed in 14% of the patients treated with TEMODAR.
Refractory Anaplastic Astrocytoma:
Tables 8 and 9 show the incidence of adverse reactions in the 158 patients in the anaplastic astrocytoma study for whom data are available. In the absence of a control group, it is not clear in many cases whether these reactions should be attributed to |
