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A multicenter uncontrolled study of sorafenib in patients with unresectable and/or metastatic renal cell carcinoma (RCC) to assess the pharmacokinetic profile, safety and tolerability, and efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | Experimental | 400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | Drug | 400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics Measured as Area Under Curve (AUC[0-12h]) | The AUC(0-12h) was the observed AUC, calculated using a combination of linear and log trapezoidal rules, from pre-dose to 12 hours post-dose. The normalized AUC (AUC norm) is AUC (0-12h) divided by (dose [mg]/weight [kg]). | 12 hours after at least 21 days of uninterrupted dosing |
| Pharmacokinetics Measured as Concentration (Cmax at Tmax and Cmin at Tmin) | Cmax (maximum concentration) was measured at the time point at which the maximum concentration (Tmax) was observed. Cmin (minimum concentration) was measured at the time point at which the minimum concentration (Tmin) was observed. | 12 hours after at least 21 days of uninterrupted dosing |
| Pharmacokinetics Measured as Concentration (Cmax Normalized at Tmax and Cmin Normalized at Tmin) | Cmax (maximum concentration) was measured at the time point at which the maximum concentration (Tmax) was observed. Cmin (minimum concentration) was measured at the time point at which the minimum concentration (Tmin) was observed. The normalized variables (Cmax norm and Cmin norm) are the variables (Cmax and Cmin, see Primary Outcome Measure 2) divided by [dose (mg)/weight (kg)]. | 12 hours after at least 21 days of uninterrupted dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | Progression-free survival (PFS) was defined as the time from the date of receipt of first dose of study drug to disease progression, radiological or clinical, or death, whichever was earlier. Subjects still alive without tumor progression at the time of analysis were censored at their date of last tumor evaluation. | Number of days from date of first dose of study drug to date first observed disease progression or death (whichever was earlier) was documented up to 17.25 months |
Not provided
Inclusion Criteria:
Patients who have a life expectancy of at least 12 weeks
Patients, who suffer from unresectable and/or metastatic, measurable RCC histologically or cytologically documented. Patients with rare subtypes of RCC such as pure papillary cell tumor, mixed tumor containing predominantly sarcomatoid cells, Bellini carcinoma, medullary carcinoma, or chromophobe oncocytic tumors are excluded from study participation.
Patients who have received not more than one prior systemic therapy for advanced disease which was completed at least 30 days prior to the first dose of study medication.
Patients who have at least one uni-dimensional measurable lesion by Computed Tomography (CT)-scan or Magnetic Resonance Imaging (MRI) according to Response Evaluation Criteria in Solid Tumours (RECIST)
Patients with "Intermediate" or "low" risk per the Motzer score
Patients who have an Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1
Adequate bone marrow, liver and renal function at screening as assessed by the following:
Total bilirubin < 1.5 x the upper limit of normal.
Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) < 2.5 x upper limit of normal (< 5 x upper limit of normal for patients with liver involvement of their cancer).
Amylase and lipase < 1.5 x the upper limit of normal.
Exclusion Criteria:
Excluded concomitant medications:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing | Jiangsu | 210003 | China | |||
A total of 51 Asian subjects were enrolled in the trial. Twelve failed screening (11 protocol violations, 1 adverse event); the remaining 39 received at least 1 dose of study drug.
Subjects were outpatients with histologically or cytologically confirmed, unresectable and/or metastatic, measurable clear Renal Cell Carcinoma (RCC) who had received not more than one prior systemic therapy. They were enrolled between 29 Dec 2005 and 29 Sep 2006 at 4 centers in China and 4 in Taiwan.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sorafenib (Nexavar, BAY43-9006) | 400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Sorafenib (Nexavar, BAY43-9006) | 400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID) |
| 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 | Pharmacokinetics Measured as Area Under Curve (AUC[0-12h]) | The AUC(0-12h) was the observed AUC, calculated using a combination of linear and log trapezoidal rules, from pre-dose to 12 hours post-dose. The normalized AUC (AUC norm) is AUC (0-12h) divided by (dose [mg]/weight [kg]). | A full pharmacokinetics (PK) profile was obtained in 32 of the 39 patients after at least 21 days of uninterrupted twice daily (BID) dosing. | Posted | Mean | Standard Deviation | mg*hour/Liter | 12 hours after at least 21 days of uninterrupted dosing |
|
From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
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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 | Sorafenib (Nexavar, BAY43-9006) | 400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin | Blood and lymphatic system disorders | NCI CTC 3.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin | Blood and lymphatic system disorders | NCI CTC 3.0 | Non-systematic Assessment |
The median for ´Overall Survival (OS)´ and the median for ´Overall Response Duration´ reported are the median of each distribution including the censored data. The correct estimates of these medians were not evaluable.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | BAYER | clinical-trials-contact@bayerhealthcare.com |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000077157 | Sorafenib |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Overall Survival (OS) | Overall survival (OS) was measured from the date of first dose of study drug until the date of death due to any cause. Survival time for subjects still alive at the time of analysis was censored at the date of last contact. | Time from start of therapy to death up to 17.25 months |
| Time to Progression (TTP) | Time to progression (TTP) was defined as the time from date of receipt of first dose of study drug to disease progression, radiological or clinical. Subjects without tumor progression at the time of analysis were censored at their last date of tumor evaluation. | Time from start of study medication to clinical or radiological disease progression which ever occurs first up to 17.25 months |
| Disease Control (DC) | The DC was defined as subjects who had a best response rating of complete response (CR), partial response (PR), or stable disease (SD) according to Response Evaluation Criteria in Solid Tumors (RECIST) that was maintained for at least 28 days from the first demonstration of that rating. CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target). PR: at least a 30% decrease in the sum of longest diameters (LD) of target lesions taking as reference the baseline sum LD. SD: steady state of disease; do not qualify for PR or progressive disease (PD). | From start to end of study medication up to 17.25 months |
| Overall Best Response | The best overall response was defined as the number of subjects with a confirmed CR, PR, SD, or PD. Tumor response was evaluated using RECIST. PD: at least a 20% increase in the sum of LD of measured lesions taking as ref. the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Appearance of new lesions will also constitute PD. In exceptional circumstances, unequivocal progression of a non-measured lesion may be accepted as evidence of disease progression. | Best response observed from start to end of study medication up to 17.25 months |
| Overall Response Duration | Overall response duration was to be calculated for subjects who had a confirmed PR or CR, defined as the time from first assessment showing a PR or CR to progression or death. | From PR or CR to progression or death up to 17.25 months |
| Time to Objective Response | Time to objective response was defined as the time from the date of receipt of first dose of study drug to first assessment showing a confirmed PR or CR. | Time from start of study medication to first documented PR or CR up to 17.25 months |
| Beijing |
| 100021 |
| China |
| Shanghai | 200032 | China |
| Shanghai | 200127 | China |
| Tainan | Tainan | 70428 | Taiwan |
| Taipei | 10002 | Taiwan |
| Taipei | 112 | Taiwan |
| Taoyuan | 333 | Taiwan |
| Withdrawal by Subject |
|
| Disease progression |
|
| Switched to commercial drug |
|
| Reason not reported |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Eastern Cooperative Oncology Group (ECOG) Scale | Eastern Cooperative Oncology Group (ECOG) Performance Status is a scale that measures how cancer affects a patient. The scale ranges from 0 (fully active) to 5 (dead). Subjects entering this study must have had an ECOG score of 0 or 1 (restricted in physically strenuous activity but ambulatory). | Number | participants |
|
| Motzer risk factors | The 5 Motzer risk factors correlate with overall survival in metastatic RCC. Patients with no factors (low-risk) have a favorable survival risk, patients with 1 or 2 risk factors survive a shorter time and constitute an intermediate-risk group, and those with 3 or more risk factors have the poorest survival and represent a poor-risk group. | Number | participants |
|
| Renal Cell Carcinoma subtype | Patients were categorized into 1 or 2 subgroups depending on the tumor histology: Clear cell or predominantly clear cell. | Number | participants |
|
| Time since first progression | Time since first progression was defined as the time from the first progression of the patient's disease after initial diagnosis until randomization into this study. | Mean | Standard Deviation | years |
|
| Time since initial diagnosis | Time since initial diagnosis was the mean time from initial diagnosis to randomization into the study. | Mean | Standard Deviation | years |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | Pharmacokinetics Measured as Concentration (Cmax at Tmax and Cmin at Tmin) | Cmax (maximum concentration) was measured at the time point at which the maximum concentration (Tmax) was observed. Cmin (minimum concentration) was measured at the time point at which the minimum concentration (Tmin) was observed. | A full PK profile was obtained in 32 of the 39 patients after at least 21 days of uninterrupted BID dosing. | Posted | Mean | Standard Deviation | mg/L | 12 hours after at least 21 days of uninterrupted dosing |
|
|
|
| Primary | Pharmacokinetics Measured as Concentration (Cmax Normalized at Tmax and Cmin Normalized at Tmin) | Cmax (maximum concentration) was measured at the time point at which the maximum concentration (Tmax) was observed. Cmin (minimum concentration) was measured at the time point at which the minimum concentration (Tmin) was observed. The normalized variables (Cmax norm and Cmin norm) are the variables (Cmax and Cmin, see Primary Outcome Measure 2) divided by [dose (mg)/weight (kg)]. | A full PK profile was obtained in 32 of the 39 patients after at least 21 days of uninterrupted BID dosing. | Posted | Mean | Standard Deviation | Kg/L | 12 hours after at least 21 days of uninterrupted dosing |
|
|
|
| Secondary | Progression Free Survival (PFS) | Progression-free survival (PFS) was defined as the time from the date of receipt of first dose of study drug to disease progression, radiological or clinical, or death, whichever was earlier. Subjects still alive without tumor progression at the time of analysis were censored at their date of last tumor evaluation. | All subjects who received at least 1 dose of drug (the intent to treat [ITT] population) were included in the analysis. Thirty-nine patients received at least 1 dose of drug. | Posted | Median | 95% Confidence Interval | months | Number of days from date of first dose of study drug to date first observed disease progression or death (whichever was earlier) was documented up to 17.25 months |
|
|
|
| Secondary | Overall Survival (OS) | Overall survival (OS) was measured from the date of first dose of study drug until the date of death due to any cause. Survival time for subjects still alive at the time of analysis was censored at the date of last contact. | All subjects who received at least 1 dose of drug (the intent to treat [ITT] population) were included in the analysis. Thirty-nine patients received at least 1 dose of drug. | Posted | Median | Full Range | months | Time from start of therapy to death up to 17.25 months |
|
|
|
| Secondary | Time to Progression (TTP) | Time to progression (TTP) was defined as the time from date of receipt of first dose of study drug to disease progression, radiological or clinical. Subjects without tumor progression at the time of analysis were censored at their last date of tumor evaluation. | All subjects who received at least 1 dose of drug (the intent to treat [ITT] population) were included in the analysis. Thirty-nine patients received at least 1 dose of drug. | Posted | Median | 95% Confidence Interval | months | Time from start of study medication to clinical or radiological disease progression which ever occurs first up to 17.25 months |
|
|
|
| Secondary | Disease Control (DC) | The DC was defined as subjects who had a best response rating of complete response (CR), partial response (PR), or stable disease (SD) according to Response Evaluation Criteria in Solid Tumors (RECIST) that was maintained for at least 28 days from the first demonstration of that rating. CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target). PR: at least a 30% decrease in the sum of longest diameters (LD) of target lesions taking as reference the baseline sum LD. SD: steady state of disease; do not qualify for PR or progressive disease (PD). | All subjects who received at least 1 dose of drug (the intent to treat [ITT] population) were included in the analysis. Thirty-nine patients received at least 1 dose of drug. | Posted | Number | participants | From start to end of study medication up to 17.25 months |
|
|
|
| Secondary | Overall Best Response | The best overall response was defined as the number of subjects with a confirmed CR, PR, SD, or PD. Tumor response was evaluated using RECIST. PD: at least a 20% increase in the sum of LD of measured lesions taking as ref. the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Appearance of new lesions will also constitute PD. In exceptional circumstances, unequivocal progression of a non-measured lesion may be accepted as evidence of disease progression. | All subjects who received at least 1 dose of drug (the intent to treat [ITT] population) were included in the analysis. Thirty-nine patients received at least 1 dose of drug. | Posted | Number | participants | Best response observed from start to end of study medication up to 17.25 months |
|
|
|
| Secondary | Overall Response Duration | Overall response duration was to be calculated for subjects who had a confirmed PR or CR, defined as the time from first assessment showing a PR or CR to progression or death. | All subjects who received at least 1 dose of drug (the intent to treat [ITT] population) were included in the analysis. Thirty-nine patients received at least 1 dose of drug. The overall response duration was determined on the 5 subjects who had a PR. | Posted | Median | Full Range | months | From PR or CR to progression or death up to 17.25 months |
|
|
|
| Secondary | Time to Objective Response | Time to objective response was defined as the time from the date of receipt of first dose of study drug to first assessment showing a confirmed PR or CR. | All subjects who received at least 1 dose of drug (the intent to treat [ITT] population) were included in the analysis. Thirty-nine patients received at least 1 dose of drug. Time to objective response was determined on the 5 subjects who had a PR. | Posted | Median | Full Range | months | Time from start of study medication to first documented PR or CR up to 17.25 months |
|
|
|
| 12 |
| 39 |
| 39 |
| 39 |
| Platelets | Blood and lymphatic system disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Anorexia | Gastrointestinal disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Obstruction, GI, Small Bowel NOS | Gastrointestinal disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Fever | General disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Pain, Abdomen NOS | General disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| No Code In CTCAE | General disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Infection With Normal ANC, Biliary Tree | Infections and infestations | NCI CTC 3.0 | Non-systematic Assessment |
|
| Infection With Normal ANC, Paranasal | Infections and infestations | NCI CTC 3.0 | Non-systematic Assessment |
|
| Infection With Normal ANC, Urinary Tract NOS | Infections and infestations | NCI CTC 3.0 | Non-systematic Assessment |
|
| Infection With Unknown ANC, Skin (Cellulitis) | Infections and infestations | NCI CTC 3.0 | Non-systematic Assessment |
|
| Fracture | Musculoskeletal and connective tissue disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Seizure | Nervous system disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Pulmonary - Other | Respiratory, thoracic and mediastinal disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Hand-Foot Skin Reaction | Skin and subcutaneous tissue disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Hemorrhage, GI, Duodenum | Vascular disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Hemorrhage - Other | Vascular disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Hemorrhage Pulmonary, Bronchus | Vascular disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Hemorrhage, GU, Urinary NOS | Vascular disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| PTT | Blood and lymphatic system disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Edema: Limb | Blood and lymphatic system disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Supraventricular Arrhythmia, Sinus Tachycardia | Cardiac disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Hypertension | Cardiac disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Anorexia | Gastrointestinal disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Distension | Gastrointestinal disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Mucositis (Functional/Symptomatic), Oral Cavity | Gastrointestinal disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Mucositis (Clinical Exam), Oral Cavity | Gastrointestinal disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| GI - Other | Gastrointestinal disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Periodontal | Gastrointestinal disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Fever | General disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Weight Gain | General disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Insomnia | General disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Weight Loss | General disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Pain, Back | General disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Pain, Chest/Thorax NOS | General disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Pain, Chest Wall | General disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Pain, Dental/Teeth/Peridontal | General disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Pain, Extremity - Limb | General disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Pain, Abdomen NOS | General disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Pain, Head/Headache | General disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Pain, Joint | General disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Pain, Bone | General disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Pain, Other | General disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Pain, Stomach | General disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Flu-Like Syndrome | General disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Infection With Normal ANC, Urinary Tract NOS | Infections and infestations | NCI CTC 3.0 | Non-systematic Assessment |
|
| Infection - Other | Infections and infestations | NCI CTC 3.0 | Non-systematic Assessment |
|
| Infection With Unknown ANC, Skin (Cellulitis) | Infections and infestations | NCI CTC 3.0 | Non-systematic Assessment |
|
| Alkaline Phosphatase | Metabolism and nutrition disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| ALT | Metabolism and nutrition disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Amylase | Metabolism and nutrition disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| AST | Metabolism and nutrition disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Creatinine | Metabolism and nutrition disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Bilirubin (Hyperbilirubinemia) | Metabolism and nutrition disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Hypercalcemia | Metabolism and nutrition disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Hyperuricemia | Metabolism and nutrition disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Lipase | Metabolism and nutrition disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Hypophosphatemia | Metabolism and nutrition disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Metabolic/Lab - Other | Metabolism and nutrition disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Incontinence, Urinary | Renal and urinary disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Nasal/Paranasal Reactions | Respiratory, thoracic and mediastinal disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Dyspnea (Shortness Of Breath) | Respiratory, thoracic and mediastinal disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Voice Changes | Respiratory, thoracic and mediastinal disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Hand-Foot Skin Reaction | Skin and subcutaneous tissue disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Rash/Desquamation | Skin and subcutaneous tissue disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Flushing | Skin and subcutaneous tissue disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
Not provided
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Progressive Disease (PD) |
|
| not evaluated |
|