lopecia, nausea, vomiting, anorexia, headache, and constipation (see Table 7). Forty-nine percent (49%) of patients treated with TEMODAR reported one or more severe or life-threatening reactions, most commonly fatigue (13%), convulsions (6%), headache (5%), and thrombocytopenia (5%). Overall, the pattern of reactions during the maintenance phase was consistent with the known safety profile of TEMODAR.
TABLE 7: Number (%) of Patients with Adverse Reactions: All and Severe/Life Threatening (Incidence of 5% or Greater) Concomitant PhaseRT Alone (n=285) Concomitant PhaseRT+TMZ (n=288)* Maintenance PhaseTMZ(n=224)
All Grade ≥3 All Grade ≥3 All Grade ≥3
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
Disorders of the Immune System
Allergic Reaction 7 (2) 1 (<1) 13 (5) 0 6 (3) 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 |
