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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Temodal (Temozolomide) Post Marketing Surveillance Protocol|
- Number of Participants Experiencing Adverse Events (AEs) [ Time Frame: Complete study duration & 30 days after completion (up to approximately 7.5 months) ] [ Designated as safety issue: Yes ]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) ] [ Designated as safety issue: Yes ]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) ] [ Designated as safety issue: Yes ]
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) ] [ Designated as safety issue: Yes ]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) ] [ Designated as safety issue: No ]The response ratings were based on the judgment of the investigator.
|Study Start Date:||March 2008|
|Study Completion Date:||September 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
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).
Administration of temozolomide based on the product labeling.
Other Names:Radiation: Radiotherapy
Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme.