Learn More About the Safety Profile of GLIADEL® Wafer (carmustine implant)

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Learn More About the Safety Profile of GLIADEL® Wafer (carmustine implant)

The Safety Profile of GLIADEL Wafer in Patients With HGG

Incidence of Adverse Reactions Occurring in GLIADEL Wafer–Treated Patients With Newly Diagnosed High-Grade Glioma (Between Arm Difference of ≥4%)1

Table showing the incidence of adverse reactions occurring in Gliadel Wafer-treated patients vs those on placebo.Table showing the incidence of adverse reactions occurring in Gliadel Wafer-treated patients vs those on placebo.Table showing the incidence of adverse reactions occurring in Gliadel Wafer-treated patients vs those on placebo.Table showing the incidence of adverse reactions occurring in Gliadel Wafer-treated patients vs those on placebo.

aIncluded (1) fluid; cavity, dural, or subdural (CDS); or subdural fluid collection; (2) cerebrospinal fluid (CSF) leak; (3) wound dehiscence, breakdown, or poor healing; and (4) subgaleal or wound effusions (including yellow discharge at the incision).

Incidence of Local Adverse Reactions in GLIADEL Wafer–Treated Patients With Newly Diagnosed High-Grade Glioma1,a

Table showing incidence of local adverse reactions in Gliadel Wafer-treated patients vs those on placebo.Table showing incidence of local adverse reactions in Gliadel Wafer-treated patients vs those on placebo.Table showing incidence of local adverse reactions in Gliadel Wafer-treated patients vs those on placebo.Table showing incidence of local adverse reactions in Gliadel Wafer-treated patients vs those on placebo.

aNot seen at baseline or worsened if present at baseline.

The Safety Profile of GLIADEL Wafer in Patients With Recurrent GBM

Incidence of Adverse Reactions Occurring in GLIADEL Wafer–Treated Patients With Recurrent High-Grade Glioma (Between Arm Difference of ≥4%)1

Table showing incidence of adverse reactions occurring in Gliadel Wafer-treated patients vs those on placebo.Table showing incidence of adverse reactions occurring in Gliadel Wafer-treated patients vs those on placebo.Table showing incidence of adverse reactions occurring in Gliadel Wafer-treated patients vs those on placebo.Table showing incidence of adverse reactions occurring in Gliadel Wafer-treated patients vs those on placebo.

aIncluded (1) fluid, CDS, or subdural fluid collection; (2) CSF leak; (3) wound dehiscence, breakdown, or poor healing; and (4) subgaleal or wound effusions (including yellow discharge at the incision).

Incidence of Seizures, Hydrocephalus, and Cerebral Edema1

Table showing incidence of seizures in Gliadel Wafter-treated patients vs those on placebo.Table showing incidence of seizures in Gliadel Wafter-treated patients vs those on placebo.Table showing incidence of seizures in Gliadel Wafter-treated patients vs those on placebo.Table showing incidence of seizures in Gliadel Wafter-treated patients vs those on placebo.

aDays are from implantation to onset of first new or worsening seizure.

bNot seen at baseline or worsened if present at baseline.