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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00723827
Other study ID # P05557
Secondary ID
Status Completed
Phase N/A
First received July 25, 2008
Last updated January 19, 2015
Start date March 2008
Est. completion date September 2011

Study information

Verified date January 2015
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority South Korea: Institutional Review BoardSouth Korea: Korea Food and Drug Administration (KFDA)
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Drug:
Temozolomide
Administration of temozolomide based on the product labeling.
Radiation:
Radiotherapy
Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

Outcome

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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