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
RT+TMZ=radiotherapy plus temozolomide; NOS=not otherwise specified.
Note: Grade 5 (fatal) adverse reactions are included in the Grade ≥3 column.
* One patient who was randomized to RT only arm received RT+temozolomide.
Subjects Reporting any Adverse Reaction 258 (91) 74 (26) 266 (92) 80 (28) 206 (92) 82 (37)
Body as a Whole — General Disorders
Anorexia 25 (9) 1 (<1) 56 (19) 2 (1) 61 (27) 3 (1)
Dizziness 10 (4) 0 12 (4) 2 (1) 12 (5) 0
Fatigue 139 (49) 15 (5) 156 (54) 19 (7) 137 (61) 20 (9)
Headache 49 (17) 11 (4) 56 (19) 5 (2) 51 (23) 9 (4)
Weakness 9 (3) 3 (1) 10 (3) 5 (2) 16 (7) 4 (2)
Central and Peripheral Nervous System Disorders
Confusion 12 (4) 6 (2) 11 (4) 4 (1) 12 (5) 4 (2)
Convulsions 20 (7) 9 (3) 17 (6) 10 (3) 25 (11) 7 (3)
Memory Impairment 12 (4) 1 (<1) 8 (3) 1 (<1) 16 (7) 2 (1)
Disorders of the Eye
Vision Blurred 25 (9) 4 (1) 26 (9) 2 (1) 17 (8) 0
Disorder |
