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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Glioblastoma Astrocytoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Temozolomide

Drug

Administration of temozolomide based on the product labeling.

Other names: Temodal, Temodar, SCH 052365, MK-7365

Radiotherapy

Radiation

Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme.

Other names: Radiation therapy, irradiation

Primary outcomes

Number of Participants Experiencing Adverse Events (AEs)

Time frame: Complete study duration & 30 days after completion (up to approximately 7.5 months)

An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of vaccine, whether or not considered related to the medicinal product.
Number of Participants Experiencing Unexpected Adverse Drug Reactions (ADRs)

Time frame: Complete study duration & 30 days after completion (up to approximately 7.5 months)

An unexpected ADR was defined as an adverse reaction, whose nature, severity, specificity, or outcome is not consistent with the term or description used in the applicable product information.
Number of Temozolomide Misuse or Abuse Events

Time frame: Complete study duration & 30 days after completion (up to approximately 7.5 months)

Drug abuse was defined as the use of the study drug for a non-therapeutic effect.

Misuse was defined as use of the study medication in a way that was not prescribed.
Number of Temozolomide Drug Interactions

Time frame: Complete study duration & 30 days after completion (up to approximately 7.5 months)

Drug interaction was defined as a chemical or physiological reaction that can occur when two different drugs are taken together.
Efficacy: Number of Participants Experiencing Complete Response (CR), Partial Response (PR), or Stable Disease(SD)

Time frame: Complete study duration (up to approximately 6.5 months)

The response ratings were based on the judgment of the investigator.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

Temodal (Temozolomide) Post Marketing Surveillance Protocol

Important dates

Study start: 2008
Primary completion: 2011
Study completion: 2011
First posted: Jul 29, 2008
Registry last updated: Jan 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed