| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2009-00646 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CDR0000445405 | |||
| NCCTG-N047B | |||
| N047B | Other Identifier | North Central Cancer Treatment Group | |
| N047B | Other Identifier | CTEP | |
| U10CA025224 | U.S. NIH Grant/Contract | View source |
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This phase II trial is studying how well vorinostat works in treating patients with progressive or recurrent glioblastoma multiforme. Drugs used in chemotherapy, such as vorinostat, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vorinostat before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving it after surgery may kill any remaining tumor cells.
PRIMARY OBJECTIVES:
I. Determine the efficacy of vorinostat (SAHA), in terms of 6-month progression-free survival, in patients with progressive or recurrent glioblastoma multiforme.
II. Determine the safety and toxicity of this drug in these patients.
SECONDARY OBJECTIVES:
I. Determine the pharmacokinetics of this drug in these patients. II. Determine the biologic effect of this drug in target tissues, including primary tumor tissue, in these patients.
III. Correlate genetic alteration of tumors with response in patients treated with this drug.
OUTLINE: This is an open-label, multicenter study. Patients are stratified according to planned surgery (yes [stratum 1] vs no [stratum 2]) and number of prior chemotherapy regimens for progressive/recurrent disease (≤ 1 [stratum 1A] vs ≥ 2 [stratum 1B]).
STRATUM 1: Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. (not undergoing surgery)
STRATUM 2: Beginning 3 days prior to surgery, patients receive oral SAHA once or twice daily for a total of 6 doses. Patients then undergo surgery to remove the tumor. Beginning within 1-4 weeks after surgery, patients receive oral SAHA twice daily for 2 weeks. (undergoing surgery)
Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for up to 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stratum 1 (not undergoing surgery) | Experimental | Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. |
|
| Stratum 2 (undergoing surgery) | Experimental | Beginning 3 days prior to surgery, patients receive oral SAHA once or twice daily for a total of 6 doses. Patients then undergo surgery to remove the tumor. Beginning within 1-4 weeks after surgery, patients receive oral SAHA twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vorinostat | Drug | Given orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Successes (Patients Alive and Progression-free) | Estimated using the Binomial point estimator (number of successes divided by the total number of evaluable patients) and the Binomial 95% confidence interval estimated by the exact method. Definition of progression: Bidimensionally measurable disease: >25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions. Evaluable disease (i.e., contrast enhancing mass on MRI and/or CT that is not bidimensionally measurable but clearly evaluable for response to therapy): unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians: appearance of new lesions. | At 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | Estimated using Kaplan-Meier survival curve. | From study registration to date of death due to any cause or last follow-up (up to 5 years) |
| Confirmed Tumor Response | A confirmed tumor response will be defined as an objective status of complete response (CR), partial response (PR), or regression (REGR) on two consecutive evaluations, which include neuroimaging, lasting during a period of at least 6 weeks. Confidence intervals for the true proportion will be calculated using the exact binomial method. Bidimensionally measurable disease:≥50% reduction in product of perpendicular diameters of contrast enhancement or mass with no new lesions with the patient being on stable or decreased steroid dose. Evaluable disease (i.e., contrast enhancing mass on MRI and/or CT that is not bidimensionally measurable but clearly evaluable for response to therapy): unequivocal reduction in size of contrast-enhancement or decrease in mass effect as agreed upon independently by primary physician and quality control physicians; no new lesions. Patient should be on stable or decreased steroid dose. |
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Inclusion Criteria:
Histologically confirmed grade 4 astrocytoma (glioblastoma multiforme), including gliosarcoma, at primary diagnosis or recurrence
Measurable or evaluable disease by MRI or CT scan
Performance status - ECOG 0-2
WBC ≥ 3,000/mm^3
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Hemoglobin ≥ 8 g/dL
AST ≤ 3 times upper limit of normal (ULN)
Bilirubin normal
Creatinine ≤ 1.5 times ULN
No myocardial infarction within the past 6 months
No congestive heart failure
No life-threatening ventricular arrhythmia requiring ongoing maintenance therapy
No known HIV positivity
Not immunocompromised except if related to the use of corticosteroids
No known hypersensitivity to any of the components of the study drug
No uncontrolled infection
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 6 months after completion of study treatment
No other malignancy
No other severe disease that would preclude study participation
Prior adjuvant chemotherapy allowed
More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
More than 2 weeks since prior small molecule cell cycle inhibitor
Concurrent corticosteroids allowed as long as dose has been stable for ≥ 1 week
At least 8 weeks since prior radiotherapy
More than 6 weeks since prior stereotactic radiosurgery or interstitial brachytherapy, unless 1 of the following criteria is met:
More than 2 weeks since prior valproic acid
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| Name | Affiliation | Role |
|---|---|---|
| Evanthia Galanis | North Central Cancer Treatment Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Central Cancer Treatment Group | Rochester | Minnesota | 55905 | United States |
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Participants were recruited from 24 medical clinics in the United States between September 2005 to May 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Stratum 1 (Not Undergoing Surgery) | Patients not receiving pre-surgery SAHA with ≤1 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest. |
| FG001 | Stratum 2 (Undergoing Surgery) | Beginning 3 days prior to surgery, patients receive oral vorinostat (SAHA) once or twice daily for a total of 6 doses. Patients then undergo surgery to remove the tumor. Beginning within 1-4 weeks after surgery, patients receive oral SAHA twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest. surgery : Patients undergo surgery to remove tumor |
| FG002 | Stratum 3 (Not Undergoing Surgery) | Patients not receiving pre-surgery SAHA with ≥2 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Stratum 1 (Not Undergoing Surgery) | Patients not receiving pre-surgery SAHA with ≤1 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Proportion of Successes (Patients Alive and Progression-free) | Estimated using the Binomial point estimator (number of successes divided by the total number of evaluable patients) and the Binomial 95% confidence interval estimated by the exact method. Definition of progression: Bidimensionally measurable disease: >25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions. Evaluable disease (i.e., contrast enhancing mass on MRI and/or CT that is not bidimensionally measurable but clearly evaluable for response to therapy): unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians: appearance of new lesions. | 68 Stratum 1 patients were enrolled. 2 stratum 1 patients did not receive treatment. Therefore, the remaining 66 patients were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | At 6 months |
|
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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 | Stratum 1 (Not Undergoing Surgery) | vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia supraventricular | Cardiac disorders | MedDRA 6 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin decreased | Blood and lymphatic system disorders | MedDRA 6 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Evanthia Galanis, M.D. | Mayo Clinic | (507) 284-3902 | galanis.evanthia@mayo.edu |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| D018316 | Gliosarcoma |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| ID | Term |
|---|---|
| D000077337 | Vorinostat |
| D013514 | Surgical Procedures, Operative |
| D003226 | Congresses as Topic |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| conventional surgery | Procedure | Patients undergo surgery to remove tumor |
|
|
| Assessed up to 5 years |
| Time to Progression | Estimated using Kaplan-Meier survival curve. Definition of progression: Bidimensionally measurable disease: >25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions. Evaluable disease (i.e., contrast enhancing mass on MRI and/or CT that is not bidimensionally measurable but clearly evaluable for response to therapy): unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians: appearance of new lesions. | From registration to disease progression (up to 5 years) |
| Other Medical Problems |
|
| Poor tolerance of study treatment |
|
| Adverse Event |
|
| BG001 | Stratum 2 (Undergoing Surgery) | Beginning 3 days prior to surgery, patients receive oral vorinostat (SAHA) once or twice daily for a total of 6 doses. Patients then undergo surgery to remove the tumor. Beginning within 1-4 weeks after surgery, patients receive oral SAHA twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest. surgery : Patients undergo surgery to remove tumor |
| BG002 | Stratum 3 (Not Undergoing Surgery) | Patients not receiving pre-surgery SAHA with ≥2 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Stratum 1 Patients That Started Treatment |
Patients not receiving pre-surgery SAHA with ≤1 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest. |
| OG001 | Stratum 2 (Undergoing Surgery) | Beginning 3 days prior to surgery, patients receive oral vorinostat (SAHA) once or twice daily for a total of 6 doses. Patients then undergo surgery to remove the tumor. Beginning within 1-4 weeks after surgery, patients receive oral SAHA twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest. surgery : Patients undergo surgery to remove tumor |
| OG002 | Stratum 3 (Not Undergoing Surgery) | Patients not receiving pre-surgery SAHA with ≥2 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest. |
|
|
| Secondary | Survival | Estimated using Kaplan-Meier survival curve. | Stratum 1: 68 patients were enrolled. 2 patients did not receive treatment. Therefore, the remaining 66 patients were analyzed. The patient that survived 28 months was alive at last follow-up. | Posted | Median | Full Range | months | From study registration to date of death due to any cause or last follow-up (up to 5 years) |
|
|
|
| Secondary | Confirmed Tumor Response | A confirmed tumor response will be defined as an objective status of complete response (CR), partial response (PR), or regression (REGR) on two consecutive evaluations, which include neuroimaging, lasting during a period of at least 6 weeks. Confidence intervals for the true proportion will be calculated using the exact binomial method. Bidimensionally measurable disease:≥50% reduction in product of perpendicular diameters of contrast enhancement or mass with no new lesions with the patient being on stable or decreased steroid dose. Evaluable disease (i.e., contrast enhancing mass on MRI and/or CT that is not bidimensionally measurable but clearly evaluable for response to therapy): unequivocal reduction in size of contrast-enhancement or decrease in mass effect as agreed upon independently by primary physician and quality control physicians; no new lesions. Patient should be on stable or decreased steroid dose. | Stratum 1: 68 patients were enrolled. 2 patients did not receive treatment. Therefore, the remaining 66 patients were analyzed. Stratum 2: Since the patients underwent surgery, response is not applicable and hence 0 patients analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Assessed up to 5 years |
|
|
|
| Secondary | Time to Progression | Estimated using Kaplan-Meier survival curve. Definition of progression: Bidimensionally measurable disease: >25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions. Evaluable disease (i.e., contrast enhancing mass on MRI and/or CT that is not bidimensionally measurable but clearly evaluable for response to therapy): unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians: appearance of new lesions. | Stratum 1: 68 patients were enrolled. 2 stratum 1 patients did not receive treatment. Therefore, the remaining 66 patients were analyzed. The patient that survived 28 months was progression-free at last follow-up. | Posted | Median | Full Range | months | From registration to disease progression (up to 5 years) |
|
|
|
| 13 |
| 66 |
| 65 |
| 66 |
| EG001 | Stratum 2 (Undergoing Surgery) | surgery : Patients undergo surgery to remove tumor | 3 | 15 | 14 | 15 |
| EG002 | Stratum 3 (Not Undergoing Surgery) | vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest. | 4 | 20 | 19 | 20 |
| Abdominal pain | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
|
| Disease progression | General disorders | MedDRA 6 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 6 | Systematic Assessment |
|
| Bladder infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 6 | Systematic Assessment |
|
| Mucosal infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 6 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 6 | Systematic Assessment |
|
| Amylase increased | Investigations | MedDRA 6 | Systematic Assessment |
|
| Leukocyte count decreased | Investigations | MedDRA 6 | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 6 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 6 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 6 | Systematic Assessment |
|
| Blood glucose increased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
|
| Serum phosphate decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
|
| Serum potassium decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
|
| Serum sodium decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
|
| Serum sodium increased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
|
| Muscle weakness left-sided | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
|
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
|
| Central nervous system necrosis | Nervous system disorders | MedDRA 6 | Systematic Assessment |
|
| Cognitive disturbance | Nervous system disorders | MedDRA 6 | Systematic Assessment |
|
| Depressed level of consciousness | Nervous system disorders | MedDRA 6 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 6 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 6 | Systematic Assessment |
|
| Hydrocephalus | Nervous system disorders | MedDRA 6 | Systematic Assessment |
|
| Intracranial hemorrhage | Nervous system disorders | MedDRA 6 | Systematic Assessment |
|
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 6 | Systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA 6 | Systematic Assessment |
|
| Speech disorder | Nervous system disorders | MedDRA 6 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 6 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 6 | Systematic Assessment |
|
| Confusion | Psychiatric disorders | MedDRA 6 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 6 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 6 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 6 | Systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA 6 | Systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA 6 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 6 | Systematic Assessment |
|
| Vitreous hemorrhage | Eye disorders | MedDRA 6 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
|
| Esophageal mucositis | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
|
| Esophagitis | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
|
| Hemorrhoids | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
|
| Mucositis oral | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
|
| Oral hemorrhage | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 6 | Systematic Assessment |
|
| Edema limbs | General disorders | MedDRA 6 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 6 | Systematic Assessment |
|
| Fever | General disorders | MedDRA 6 | Systematic Assessment |
|
| Gait abnormal | General disorders | MedDRA 6 | Systematic Assessment |
|
| Localized edema | General disorders | MedDRA 6 | Systematic Assessment |
|
| Abdominal infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
|
| Bladder infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
|
| Gingival infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
|
| Penile infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 6 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 6 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 6 | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
|
| Vaginal infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
|
| Arterial injury - Extremity-lower | Injury, poisoning and procedural complications | MedDRA 6 | Systematic Assessment |
|
| Vascular access complication | Injury, poisoning and procedural complications | MedDRA 6 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 6 | Systematic Assessment |
|
| Alkaline phosphatase increased | Investigations | MedDRA 6 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 6 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 6 | Systematic Assessment |
|
| CD4 lymphocytes decreased | Investigations | MedDRA 6 | Systematic Assessment |
|
| Creatine phosphokinase increased | Investigations | MedDRA 6 | Systematic Assessment |
|
| Creatinine increased | Investigations | MedDRA 6 | Systematic Assessment |
|
| Laboratory test abnormal | Investigations | MedDRA 6 | Systematic Assessment |
|
| Leukocyte count decreased | Investigations | MedDRA 6 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 6 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 6 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 6 | Systematic Assessment |
|
| Serum cholesterol increased | Investigations | MedDRA 6 | Systematic Assessment |
|
| Weight gain | Investigations | MedDRA 6 | Systematic Assessment |
|
| Weight loss | Investigations | MedDRA 6 | Systematic Assessment |
|
| Acidosis | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
|
| Alkalosis | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
|
| Blood bicarbonate decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
|
| Blood glucose increased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
|
| Serum albumin decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
|
| Serum calcium decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
|
| Serum calcium increased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
|
| Serum glucose decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
|
| Serum magnesium increased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
|
| Serum phosphate decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
|
| Serum potassium decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
|
| Serum potassium increased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
|
| Serum sodium decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
|
| Serum sodium increased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
|
| Muscle weakness | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
|
| Muscle weakness left-sided | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
|
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
|
| Muscle weakness right-sided | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
|
| Treatment related secondary malignancy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 6 | Systematic Assessment |
|
| Accessory nerve disorder | Nervous system disorders | MedDRA 6 | Systematic Assessment |
|
| Ataxia | Nervous system disorders | MedDRA 6 | Systematic Assessment |
|
| Cognitive disturbance | Nervous system disorders | MedDRA 6 | Systematic Assessment |
|
| Depressed level of consciousness | Nervous system disorders | MedDRA 6 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 6 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 6 | Systematic Assessment |
|
| Extrapyramidal disorder | Nervous system disorders | MedDRA 6 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 6 | Systematic Assessment |
|
| Ischemia cerebrovascular | Nervous system disorders | MedDRA 6 | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA 6 | Systematic Assessment |
|
| Neurological disorder NOS | Nervous system disorders | MedDRA 6 | Systematic Assessment |
|
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 6 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 6 | Systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA 6 | Systematic Assessment |
|
| Sinus pain | Nervous system disorders | MedDRA 6 | Systematic Assessment |
|
| Speech disorder | Nervous system disorders | MedDRA 6 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 6 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 6 | Systematic Assessment |
|
| Confusion | Psychiatric disorders | MedDRA 6 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 6 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 6 | Systematic Assessment |
|
| Libido decreased | Psychiatric disorders | MedDRA 6 | Systematic Assessment |
|
| Hemorrhage urinary tract | Renal and urinary disorders | MedDRA 6 | Systematic Assessment |
|
| Urinary frequency | Renal and urinary disorders | MedDRA 6 | Systematic Assessment |
|
| Urogenital disorder | Renal and urinary disorders | MedDRA 6 | Systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
|
| Laryngeal mucositis | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
|
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
|
| Rash desquamating | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
|
| Hemorrhage | Vascular disorders | MedDRA 6 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 6 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 6 | Systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA 6 | Systematic Assessment |
|
Not provided
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000588 |
| Amines |
| D006877 | Hydroxamic Acids |
| D006898 | Hydroxylamines |
| D006880 | Hydroxy Acids |
| D002264 | Carboxylic Acids |
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |