Temodal (Temozolomide) Post Marketing Surveillance Protocol (Study P05557AM2)

Merck Sharp & Dohme (MSD)

Status: Completed

Conditions: Glioblastoma; Glioma; Astrocytoma

Treatments: Radiation: Radiotherapy; Drug: Temozolomide

Study type: Observational

Funder types: Industry

Identifiers

NCT00723827

P05557

Details and patient eligibility

About

The purpose of this surveillance is to evaluate the postmarketing safety and efficacy of Temodal capsule (temozolomide) under actual conditions of use, and to understand some of the following points that are in question and doubt:

• Incidence of adverse events under actual conditions of use (Serious and Nonserious Adverse Events);
• Adverse Drug Reactions not shown in the directions for use (will be stated as Unexpected Adverse Reaction);
• Adverse Event caused by misuse, abuse, or drug interactions;
• Other information concerned with safety or efficacy.

Enrollment: 682 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants who are prescribed with temozolomide by local labeling:

  • participants with newly diagnosed glioblastoma multiforme;
  • participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.

Exclusion criteria

• N/A

Trial design

682 participants in 1 patient group

All Participants

Description:

Participants with newly diagnosed glioblastoma multiforme (treat with temozolomide \& radiotherapy) or participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy (treat with temozolomide).

Treatment:

Drug: Temozolomide

Radiation: Radiotherapy