Table 3.

Number of patients with adverse events (%)*

Concomitant phase radiotherapy alone (n = 285)
Concomitant phase radiotherapy + temozolomide (n = 288)
Maintenance phase temozolomide (n = 224)
AllGrade ≥ 3AllGrade ≥ 3AllGrade ≥ 3
Subjects reporting any adverse event258 (91)74 (26)266 (92)80 (28)206 (92)82 (37)
Body as a whole—general disorders
    Anorexia25 (9)1 (<1)56 (19)2 (1)61 (27)3 (1)
    Dizziness10 (4)012 (4)2 (1)12 (5)0
    Fatigue139 (49)15 (5)156 (54)19 (7)137 (61)20 (9)
    Headache49 (17)11 (4)56 (19)5 (2)51 (23)9 (4)
    Weakness9 (3)3 (1)10 (3)5 (2)16 (7)4 (2)
Central and peripheral nervous system disorders
    Confusion12 (4)6 (2)11 (4)4 (1)12 (5)4 (2)
    Convulsions20 (7)9 (3)17 (6)10 (3)25 (11)7 (3)
    Memory impairment12 (4)1 (<1)8 (3)1 (<1)16 (7)2 (1)
Disorders of the eye
    Vision blurred25 (9)4 (1)26 (9)2 (1)17 (8)0
Disorders of the immune system
    Allergic reaction7 (2)1 (<1)13 (5)06 (3)0
Gastrointestinal system disorders
    Abdominal pain2 (1)07 (2)1 (<1)11 (5)1 (<1)
    Constipation18 (6)053 (18)3 (1)49 (22)0
    Diarrhea9 (3)018 (6)023 (10)2 (1)
    Nausea45 (16)1 (<1)105 (36)2 (1)110 (49)3 (1)
    Stomatitis14 (5)1 (<1)19 (7)020 (9)3 (1)
    Vomiting16 (6)1 (<1)57 (20)1 (<1)66 (29)4 (2)
Injury and poisoning
    Radiation injury NOS11 (4)1 (<1)20 (7)05 (2)0
Musculoskeletal system disorders
    Arthralgia2 (1)07 (2)1 (<1)14 (6)0
Platelet, bleeding and clotting disorders
    Thrombocytopenia3 (1)011 (4)8 (3)19 (8)8 (4)
Psychiatric disorders
    Insomnia9 (3)1 (<1)14 (5)09 (4)0
Respiratory system disorders
    Coughing3 (1)015 (5)2 (1)19 (8)1 (<1)
    Dyspnea9 (3)4 (1)11 (4)5 (2)12 (5)1 (<1)
Skin and s.c. tissue disorders
    Alopecia179 (63)0199 (69)0124 (55)0
    Dry skin6 (2)07 (2)011 (5)1 (<1)
    Erythema15 (5)014 (5)02 (1)0
Pruritus4 (1)011 (4)011 (5)0
Rash42 (15)056 (19)3 (1)29 (13)3 (1)
Special senses other, disorders
    Taste perversion6 (2)018 (6)011 (5)0
  • NOTE: Grade 5 (fatal) adverse events are included in the grade ≥3 column.

    Abbreviation: NOS, not otherwise specified.

  • * Incidence of ≥5%.

  • One patient who was randomized to radiotherapy only arm received radiotherapy + temozolomide.