Clinical trial · Observational
Temodal (Temozolomide) Post Marketing Surveillance Protocol (Study P05557AM2)
Temodal (Temozolomide) Post Marketing Surveillance Protocol
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Astrocytoma | Astrocytoma | CURATED_BROADER | 0.80 |
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy | Radiation | — | UNRESOLVED |
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- All Participants
- description
- 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).
- interventionNames
- Drug: Temozolomide
- Radiation: Radiotherapy
Primary outcomes (5)
- measure
- Number of Participants Experiencing Adverse Events (AEs)
- timeFrame
- Complete study duration & 30 days after completion (up to approximately 7.5 months)
- description
- 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.
- measure
- Number of Participants Experiencing Unexpected Adverse Drug Reactions (ADRs)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available