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

Study Overview
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Brief Summary
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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.

Official Title
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Temodal (Temozolomide) Post Marketing Surveillance Protocol

Conditions
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Glioblastoma, Glioma, Astrocytoma

Intervention / Treatment
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* Drug: Temozolomide
* Radiation: Radiotherapy


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All Participants<br>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<br>* Administration of temozolomide based on the product labeling.<br>* Other names: MK-7365;Radiation: Radiotherapy<br>* Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme.<br>* Other names: irradiation;|

What is the study measuring?
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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) |