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

NCT00723827 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 682

Last updated 2015-01-30

Study results available
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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 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.

Conditions

Interventions

DRUG

Temozolomide

Administration of temozolomide based on the product labeling.

RADIATION

Radiotherapy

Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme.

Sponsors & Collaborators

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2011-09-30
Completion
2011-09-30

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00723827 on ClinicalTrials.gov