Table 5 Adverse events associated with Gliadel wafers combined with standard radiotherapy (RT) and concurrent followed by adjuvant temozolomide (TMZ) compared with adverse events in (1) the phase III RT/TMZ clinical trial, (2) the phase III Gliadel clinical trials, and (3) the Attenello et al.’s retrospective comparison of patients who underwent craniotomy with and without Gliadel wafer implantation

Grade 3 and 4 AEs, 9 Gliadel wafers + RT/TMZ, %

372

2.7 %

4.3 %

3.0 %

4.8 %

7.8 %

3.0 %

1.3 %

0.3 %

0.3 %

10.2 %

0.2 %

2.15 %

Grade 3 and 4 AEs, Phase III RT/TMZ trial, [11, 12] RT/TMZ treatment arm, %

287

7.0 %

13.0 %

2.0 %

16.0 %

3.0 %

6.0 %

AEs, Gliadel phase III clinical trials, Gliadel wafer arm, % [8–10, 25]

120

23.0 %

16.0 %

9.0 %

5.0 %

16.0 %

33.0 %

27.0 %

700 %

18.0 %

AEs, Gliadel phase III clinical trials, placebo wafer arm, % [8–10, 25]

120

19.0 %

12.0 %

2.0 %

6.0 %

10.0 %

38.0 %

15.0 %

47.0 %

17.0 %

AEs, Attenello et al., [46] Gliadel wafer arm, %

288

2.3 %

2.8 %

1.2 %

14.6 %

0.3 %

11.2 %

AEs, Attenello et al., [46] placebo arm, %

725

2.1 %

2.2 %

0.7 %

15.7 %

0.3 %

8.9 %