N/A
N=682
Temodal (Temozolomide) Post Marketing Surveillance Protocol (Study P05557AM2)
Glioblastoma · Glioma · Astrocytoma
Bottom Line
View on ClinicalTrials.gov: NCT00723827 ↗Enrolled (actual)
682
Serious AEs
15.1%
Results posted
Jan 2013
Primary outcome: Primary: Number of Participants Experiencing Adverse Events (AEs) — 324 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Temozolomide (Drug); Radiotherapy (Radiation)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Experiencing Adverse Events (AEs) |
324 | — |
| PRIMARY Number of Participants Experiencing Unexpected Adverse Drug Reactions (ADRs) |
49 | — |
| PRIMARY Number of Temozolomide Misuse or Abuse Events |
1 | — |
| PRIMARY Number of Temozolomide Drug Interactions |
5 | — |
| PRIMARY Efficacy: Number of Participants Experiencing Complete Response (CR), Partial Response (PR), or Stable Disease(SD) |
82; 143; 322 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00723827). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.