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

Completed

• Conditions: Astrocytoma; Glioblastoma; Glioma
• Interventions: Drug: Temozolomide; Radiation: Radiotherapy

• Registration Number: NCT00723827
• Lead Sponsor: Merck Sharp & Dohme LLC

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-07-25
• Study First Submitted QC: 2008-07-25
• Study First Posted: 2008-07-29
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Results First Submitted: 2012-12-05
• Results First Submitted QC: 2012-12-05
• Results First Posted: 2013-01-08
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-19
• Last Update Posted: 2015-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 682

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.

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Exclusion Criteria

• N/A

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All Participants	Temozolomide	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).
All Participants	Radiotherapy	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).

Primary Outcome Measures

Name	Time	Method
Number of Temozolomide Misuse or Abuse Events	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 Participants Experiencing Adverse Events (AEs)	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)	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 Drug Interactions	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)	Complete study duration (up to approximately 6.5 months)	The response ratings were based on the judgment of the investigator.