Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Temozolomide | Drug | Administration of temozolomide based on the product labeling. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
Not provided
Not provided
Inclusion Criteria:
Participants who are prescribed with temozolomide by local labeling:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Participants with newly diagnosed glioblastoma multiforme.
Participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | participants | Complete study duration & 30 days after completion (up to approximately 7.5 months) |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| EOSINOPHILIA | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NAUSEA | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| D005910 | Glioma |
| D001254 | Astrocytoma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077204 | Temozolomide |
| D011878 | Radiotherapy |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
Not provided
Not provided
Not provided
Not provided
Not provided
| Radiotherapy | Radiation | Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme. |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| 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. | Posted | Number | participants | Complete study duration & 30 days after completion (up to approximately 7.5 months) |
|
|
|
| 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. | Posted | Number | Events | Complete study duration & 30 days after completion (up to approximately 7.5 months) |
|
|
|
| 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. | Posted | Number | events | Complete study duration & 30 days after completion (up to approximately 7.5 months) |
|
|
|
| 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. | Posted | Number | participants | Complete study duration (up to approximately 6.5 months) |
|
|
|
| 103 |
| 682 |
| 132 |
| 682 |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
|
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
|
| PANCYTOPENIA | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
|
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
|
| CARDIAC ARREST | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
|
| MYOCARDIAL ISCHAEMIA | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
|
| VISION BLURRED | Eye disorders | MedDRA 14.1 | Systematic Assessment |
|
| VISUAL IMPAIRMENT | Eye disorders | MedDRA 14.1 | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| DYSPHAGIA | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| ASTHENIA | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| CHEST DISCOMFORT | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| CHILLS | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| CONDITION AGGRAVATED | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| DISEASE PROGRESSION | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| FACE OEDEMA | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| OEDEMA PERIPHERAL | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| HEPATITIS | Hepatobiliary disorders | MedDRA 14.1 | Systematic Assessment |
|
| HEPATITIS ACUTE | Hepatobiliary disorders | MedDRA 14.1 | Systematic Assessment |
|
| APPENDICITIS | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| CELLULITIS | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| CENTRAL NERVOUS SYSTEM INFECTION | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| HEPATITIS B | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| LOCALISED INFECTION | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| PNEUMONIA | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| SEPSIS | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| STAPHYLOCOCCAL INFECTION | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| URINARY TRACT INFECTION | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
|
| WOUND INFECTION | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| RADIATION NECROSIS | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
|
| SUBDURAL HAEMORRHAGE | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
|
| WOUND COMPLICATION | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
|
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| OXYGEN SATURATION DECREASED | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| HYPERCALCAEMIA | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| METABOLIC ACIDOSIS | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| METASTASES TO MENINGES | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
|
| METASTASES TO SPINE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
|
| METASTATIC NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
|
| NEOPLASM RECURRENCE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
|
| BRAIN OEDEMA | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| CEREBRAL CYST | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| CEREBRAL INFARCTION | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| CONVULSION | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| DEPRESSED LEVEL OF CONSCIOUSNESS | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| DYSARTHRIA | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| HAEMORRHAGE INTRACRANIAL | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| HYDROCEPHALUS | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| INTRACRANIAL PRESSURE INCREASED | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| MYELOPATHY | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| PARTIAL SEIZURES | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| SOMNOLENCE | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| STUPOR | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
|
| RENAL FAILURE ACUTE | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
|
| ACUTE RESPIRATORY DISTRESS SYNDROME | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| INTERSTITIAL LUNG DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| PNEUMONIA ASPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
The institution has the right to publish/present the study results. The institution agrees not to publish/present any interim results of the Study without the Sponsor's prior written consent. The institution further agrees to provide the Sponsor 30 days written notice prior to submission. The Sponsor has the right to review and comment. If the parties disagree, the institution agrees to meet with the Sponsor, prior to submission, to discuss and resolve any such issues or disagreement.
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013812 | Therapeutics |
| D055585 | Physical Phenomena |
| Title | Measurements |
|---|
|