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
*One patient who was randomized to RT only arm received RT + temozolomide
RT + TMZ = radiotherapy plus temozolomide; LT = life threatening; SGPT = serum glutamic pyruvic transaminase
(= alanine aminotransferase [ALT]); NOS = not otherwise specified.
Note: Grade 5 (fatal) adverse events are included in the Grade >/= 3 column.
Myelosuppression, (neutropenia and thrombocytopenia), which are known dose limiting toxicities for most cytotoxic agents, including TEMODAR, were observed. When laboratory abnormalities and adverse events were combined, Grade 3 or Grade 4 neutrophil abnormalities including neutropenic events were observed in 8% of the patients and Grade 3 or Grade 4 platelet abnormalities, including thrombocytopenic events were observed in 14% of the patients treated with TEMODAR.
Refractory Anaplastic Astrocytoma
Tables 3 and 4 show the incidence of adverse events in the 158 patients in the anaplastic astrocytoma study for whom data are available. In |
