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 Type
OBSERVATIONAL
Enrollment
682
Administration of temozolomide based on the product labeling.
Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Complete study duration (up to approximately 6.5 months)
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