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The purpose of this surveillance is to collect more safety and efficacy data in "non-study" patients during concomitant and adjuvant temozolomide therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients | Patients with newly diagnosed and operated glioblastoma multiforme. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Primary surgical treatment | Procedure | Primary surgery for tumor resection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Median Progression Free Survival After Primary Surgical Treatment, Concomitant and Adjuvant Chemotherapy With Temozolomide, for Patients With Newly Diagnosed Glioblastoma Multiforme | After primary surgical treatment and concomitant and adjuvant chemotherapy with temozolomide |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with newly diagnosed glioblastoma multiforme.
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| ID | Title | Description |
|---|---|---|
| FG000 | Temozolomide | Surgery followed by temozolomide concomitant with radiotherapy (dosed according to the Summary of Product Characteristics [SPC]), then adjuvant monochemotherapy temozolomide (dosed according to the SPC) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Radiotherapy | Radiation | Radiotherapy is given with concomitant temozolomide. Dosing according to European Summary of Product Characteristics. |
|
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| Temozolomide | Drug | Temozolomide is first given with concomitant radiotherapy, and then as monotherapy (adjuvant chemotherapy). Dosing according to European Summary of Product Characteristics. |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Temozolomide | Surgery followed by temozolomide concomitant with radiotherapy (dosed according to the Summary of Product Characteristics [SPC]), then adjuvant monochemotherapy temozolomide (dosed according to the SPC) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean age data based on 165 participants (one less than the Intent-to-treat (ITT) population of 166) due to missing data for 1 participant. | Mean | Standard Deviation | years |
| |||||||||||||||||||||
| Sex/Gender, Customized | Gender information only available for the Intent-to-Treat population of 166 participants. | Number | participants |
| ||||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Median Progression Free Survival After Primary Surgical Treatment, Concomitant and Adjuvant Chemotherapy With Temozolomide, for Patients With Newly Diagnosed Glioblastoma Multiforme | Intent-to-Treat population | Posted | Median | Standard Error | Months | After primary surgical treatment and concomitant and adjuvant chemotherapy with temozolomide |
|
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|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Temozolomide | 49 | 166 | 41 | 166 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PANCYTOPENIA | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| CARDIAC FAILURE | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
| |
| VISUAL IMPAIRMENT | Eye disorders | MedDRA 12.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| PERITONITIS | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| DEATH | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| IMPAIRED HEALING | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| FEMUR FRACTURE | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
| |
| LIVER FUNCTION TEST ABNORMAL | Investigations | MedDRA 12.1 | Systematic Assessment |
| |
| TRANSAMINASES INCREASED | Investigations | MedDRA 12.1 | Systematic Assessment |
| |
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
| |
| MALIGNANT NEOPLASM PROGRESSION | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
| |
| BRAIN OEDEMA | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| CONVULSION | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| GRAND MAL CONVULSION | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| HYDROCEPHALUS | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
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| PARTIAL SEIZURES | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| SOCIAL STAY HOSPITALISATION | Social circumstances | MedDRA 12.1 | Systematic Assessment |
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| APPENDICECTOMY | Surgical and medical procedures | MedDRA 12.1 | Systematic Assessment |
| |
| CEREBROSPINAL FLUID DRAINAGE | Surgical and medical procedures | MedDRA 12.1 | Systematic Assessment |
| |
| CEREBROSPINAL FLUID RESERVOIR PLACEMENT | Surgical and medical procedures | MedDRA 12.1 | Systematic Assessment |
| |
| HOSPITALISATION | Surgical and medical procedures | MedDRA 12.1 | Systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CONSTIPATION | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
Publishing or dissemination of study results requires a written approval of the sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D011878 | Radiotherapy |
| D011827 | Radiation |
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D055585 | Physical Phenomena |
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Unavailable |
|