Status:

COMPLETED

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

Lead Sponsor:

Merck Sharp & Dohme LLC

Conditions:

Glioblastoma

Glioma

Eligibility:

All Genders

Brief Summary

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 t...

Eligibility Criteria

Inclusion

  • 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

  • N/A

Key Trial Info

Start Date :

March 1 2008

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

September 1 2011

Estimated Enrollment :

682 Patients enrolled

Trial Details

Trial ID

NCT00723827

Start Date

March 1 2008

End Date

September 1 2011

Last Update

January 30 2015

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