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

Temodal (Temozolomide) Post Marketing Surveillance Protocol

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.

Study Overview

• Status: Completed
• Conditions: Glioma; Glioblastoma; Astrocytoma
• Intervention / Treatment: Drug: Temozolomide; Radiation: Radiotherapy

• Study Type: Observational
• Enrollment (Actual): 682

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Participants with newly diagnosed glioblastoma multiforme.

Participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All Participants; 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).	Drug: Temozolomide; Administration of temozolomide based on the product labeling.; Other Names: Temodar; Temodal; SCH 052365; MK-7365; Radiation: Radiotherapy; Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme.; Other Names: Radiation therapy; irradiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Experiencing Adverse Events (AEs)	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.	Complete study duration & 30 days after completion (up to approximately 7.5 months)
Number of Participants Experiencing Unexpected Adverse Drug Reactions (ADRs)	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.	Complete study duration & 30 days after completion (up to approximately 7.5 months)
Number of Temozolomide Misuse or Abuse Events	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.	Complete study duration & 30 days after completion (up to approximately 7.5 months)
Number of Temozolomide Drug Interactions	Drug interaction was defined as a chemical or physiological reaction that can occur when two different drugs are taken together.	Complete study duration & 30 days after completion (up to approximately 7.5 months)
Efficacy: Number of Participants Experiencing Complete Response (CR), Partial Response (PR), or Stable Disease(SD)	The response ratings were based on the judgment of the investigator.	Complete study duration (up to approximately 6.5 months)

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: July 25, 2008
• First Submitted That Met QC Criteria: July 25, 2008
• First Posted (Estimate): July 29, 2008

Study Record Updates

• Last Update Posted (Estimate): January 30, 2015
• Last Update Submitted That Met QC Criteria: January 19, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma; Astrocytoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Alkylating; Alkylating Agents; Temozolomide
• Other Study ID Numbers: P05557