Glioblastoma Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 682 |
Est. completion date | September 2011 |
Est. primary completion date | September 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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: |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Merck Sharp & Dohme Corp. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | Yes |
Primary | 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) | Yes |
Primary | 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) | Yes |
Primary | 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) | Yes |
Primary | 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) | No |
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