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

Study Purpose

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 Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	N/A and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT00723827
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Merck Sharp & Dohme LLC
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Completed
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma, Glioma, Astrocytoma

Arms & Interventions

Arms

: All Participants

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).

Interventions

Drug: - Temozolomide

Administration of temozolomide based on the product labeling.

Radiation: - Radiotherapy

Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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