Astrocytoma, Glioblastoma, Glioma
Conditions
Brief 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.
Interventions
DRUGTemozolomide
Administration of temozolomide based on the product labeling.
RADIATIONRadiotherapy
Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme.
Sponsors
Merck Sharp & Dohme LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing Adverse Events (AEs) | Complete study duration & 30 days after completion (up to approximately 7.5 months) | 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. |
| Number of Participants Experiencing Unexpected Adverse Drug Reactions (ADRs) | Complete study duration & 30 days after completion (up to approximately 7.5 months) | 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. |
| Number of Temozolomide Misuse or Abuse Events | Complete study duration & 30 days after completion (up to approximately 7.5 months) | 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. |
| Number of Temozolomide Drug Interactions | Complete study duration & 30 days after completion (up to approximately 7.5 months) | Drug interaction was defined as a chemical or physiological reaction that can occur when two different drugs are taken together. |
| Efficacy: Number of Participants Experiencing Complete Response (CR), Partial Response (PR), or Stable Disease(SD) | Complete study duration (up to approximately 6.5 months) | The response ratings were based on the judgment of the investigator. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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).
Temozolomide : Administration of temozolomide based on the product labeling.
Radiotherapy : Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme. | 682 |
| Total | 682 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 53.57 years STANDARD_DEVIATION 13.86 |
| Region of Enrollment Korea, Republic Of | 682 participants |
| Sex: Female, Male Female | 297 Participants |
| Sex: Female, Male Male | 385 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 132 / 682 |
| serious Total, serious adverse events | 103 / 682 |
Outcome results
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.
Time frame: Complete study duration (up to approximately 6.5 months)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Efficacy: Number of Participants Experiencing Complete Response (CR), Partial Response (PR), or Stable Disease(SD) | CR | 82 participants |
| All Participants | Efficacy: Number of Participants Experiencing Complete Response (CR), Partial Response (PR), or Stable Disease(SD) | PR | 143 participants |
| All Participants | Efficacy: Number of Participants Experiencing Complete Response (CR), Partial Response (PR), or Stable Disease(SD) | SD | 322 participants |
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.
Time frame: Complete study duration & 30 days after completion (up to approximately 7.5 months)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Number of Participants Experiencing Adverse Events (AEs) | 324 participants |
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.
Time frame: Complete study duration & 30 days after completion (up to approximately 7.5 months)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Number of Participants Experiencing Unexpected Adverse Drug Reactions (ADRs) | 49 participants |
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.
Time frame: Complete study duration & 30 days after completion (up to approximately 7.5 months)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Number of Temozolomide Drug Interactions | 5 events |
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.
Time frame: Complete study duration & 30 days after completion (up to approximately 7.5 months)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Number of Temozolomide Misuse or Abuse Events | 1 Events |