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Extension to study 11515 (NCT00661375) which was a multicenter study of sorafenib in patients with renal cell carcinoma (RCC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | Experimental | Sorafenib 200 mg tablets (400 mg [2 x 200 mg tablets] twice daily [bid] or 400 mg once daily [od] or 400 mg every other day [qod]) administered orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | Drug | Sorafenib 200 mg tablets (400 mg [2 x 200 mg tablets] twice daily [bid] or 400 mg once daily [od] or 400 mg every other day [qod]) administered orally |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | Time from initiation of treatment to disease progression (radiological or clinical, whichever earlier) or death (if death occurs before progression). | From start of treatment of the first subject until 45 months later, assessed every 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Best Tumor Response | Best tumor response, including Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter) according to the Response Evaluation Criteria in Solid Tumors (RECIST) | From start of treatment of the first subject until 45 months later, assessed every 8 weeks |
Not provided
Inclusion Criteria:
Patients are classified into two groups as below at transition date from Study 11515 to this study.
Population I: Patients who are willing to continue the study drug, for whom the investigator consider continuation of the study drug is appropriate, and who do not meet the criteria of removal from the study in Study 11515 at the end of Study 11515.
Population II: Patients who have been monitored only for survival status at the end of Study 11515.
Population 1
Population 2
1. Patients who give written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akita | Akita | 010-8543 | Japan | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21481133 | Result | Naito S, Tsukamoto T, Murai M, Fukino K, Akaza H. Overall survival and good tolerability of long-term use of sorafenib after cytokine treatment: final results of a phase II trial of sorafenib in Japanese patients with metastatic renal cell carcinoma. BJU Int. 2011 Dec;108(11):1813-9. doi: 10.1111/j.1464-410X.2011.10281.x. Epub 2011 Apr 11. |
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95 subjects were enrolled in this extension study; 95 were valid for the safety analysis and 94 were valid for the intent-to treat (ITT) analysis. 92 subjects entered Follow-up period which started 30 days after last dose. 3 subjects did not enter the Follow-up period because they died within 30 days after last dose.
This was an extension study of Study 11515 (NCT00661375), in which the first subject was enrolled on 10 Nov 2004. This extension study was started in December 2005, and the last subject completed the study on 11 Jul 2008. The study was conducted in 41 centers in Japan.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sorafenib (Nexavar, BAY43-9006) | Sorafenib 200 mg tablets (400 mg [2 x 200 mg tablets] twice daily [bid] or 400 mg once daily [od] or 400 mg every other day [qod]) administered orally |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period |
|
Not provided
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Not provided
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| Overall Survival (OS) | Time from initiation of treatment to death due to any cause. | From start of treatment of the first subject until 45 months later, assessed every 3 months |
| Overall Response Duration | Time from the date of first objective response (CR or PR, whichever is first recorded) to the date when progressive disease (PD, at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions) is first documented according to RECIST. | From start of treatment of the first subject until 45 months later, assessed every 8 weeks |
| Time to Objective Response | Time from initiation of treatment to the date when an objective response (CR or PR, whichever is first recorded) is first documented according to RECIST. | From start of treatment of the first subject until 45 months later, assessed every 8 weeks |
| Overall Disease Control | Subjects who have a best response rating of CR, PR or Stable Disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started) per RECIST that is maintained for at least 28 days from the first demonstration of that rating. | From start of treatment of the first subject until 45 months later, assessed every 8 weeks |
| Asahi |
| Chiba |
| 289-2511 |
| Japan |
| Chiba | Chiba | 260-8677 | Japan |
| Chiba | Chiba | 260-8717 | Japan |
| Matsuyama | Ehime | 791-0280 | Japan |
| Fukuoka | Fukuoka | 812-0033 | Japan |
| Fukuoka | Fukuoka | 812-8582 | Japan |
| Kurume | Fukuoka | 830-0011 | Japan |
| Isesaki | Gunma | 372-0817 | Japan |
| Maebashi | Gunma | 371-8511 | Japan |
| Sapporo | Hokkaido | 003-0804 | Japan |
| Sapporo | Hokkaido | 060-8543 | Japan |
| Sapporo | Hokkaido | 060-8648 | Japan |
| Sunagawa | Hokkaido | 073-0196 | Japan |
| Tsukuba | Ibaraki | 305-8576 | Japan |
| Morioka | Iwate | 020-8505 | Japan |
| Kagoshima | Kagoshima-ken | 890-8520 | Japan |
| Kyoto | Kyoto | 602-8566 | Japan |
| Kyoto | Kyoto | 606-8507 | Japan |
| Tsu | Mie-ken | 514-8507 | Japan |
| Natori-shi | Miyagi | 981-1293 | Japan |
| Kashihara | Nara | 634-8522 | Japan |
| Kurashiki | Okayama-ken | 710-8602 | Japan |
| Okayama | Okayama-ken | 700-8558 | Japan |
| Osaka | Osaka | 537-8511 | Japan |
| Sayama | Osaka | 589-8511 | Japan |
| Suita | Osaka | 565-0871 | Japan |
| Hidaka | Saitama | 350-1298 | Japan |
| Irima-gun | Saitama | 350-0495 | Japan |
| Tokorozawa | Saitama | 359-8513 | Japan |
| Hamamatsu | Shizuoka | 431-3192 | Japan |
| Sunto | Shizuoka | 411-8777 | Japan |
| Utsunomiya | Tochigi | 320-0834 | Japan |
| Tokushima | Tokushima | 770-8503 | Japan |
| Arakawa-ku | Tokyo | 116-8567 | Japan |
| Bunkyo-ku | Tokyo | 113-8655 | Japan |
| Chuo-ku | Tokyo | 104-0045 | Japan |
| Itabashi-ku | Tokyo | 173-0003 | Japan |
| Shinjuku-ku | Tokyo | 162-8666 | Japan |
| Yamagata | Yamagata | 990-9585 | Japan |
| Ube | Yamaguchi | 755-8505 | Japan |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Follow-up |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sorafenib (Nexavar, BAY43-9006) | Sorafenib 200 mg tablets (400 mg [2 x 200 mg tablets] twice daily [bid] or 400 mg once daily [od] or 400 mg every other day [qod]) administered orally |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Age, Customized | Number | participants |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Eastern Cooperative Oncology Group (ECOG) performance status | ECOG performance status is a rating of daily living abilities, from 0 to 5. 0=Fully active without restriction. 1= Restricted in physically strenuous activity. 2= Ambulatory, capable of all selfcare. 3=Capable of limited selfcare. 4= Completely disabled. 5= Dead. | 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 | Progression Free Survival (PFS) | Time from initiation of treatment to disease progression (radiological or clinical, whichever earlier) or death (if death occurs before progression). | Intention to treat (ITT) population. | Posted | Median | 95% Confidence Interval | days | From start of treatment of the first subject until 45 months later, assessed every 8 weeks |
|
|
| |||||||||||||||||||||||||
| Secondary | Best Tumor Response | Best tumor response, including Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter) according to the Response Evaluation Criteria in Solid Tumors (RECIST) | ITT population | Posted | Number | participants | From start of treatment of the first subject until 45 months later, assessed every 8 weeks |
|
| |||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Time from initiation of treatment to death due to any cause. | ITT population. The median overall survival (OS) and the lower limit of 95% Confidence interval were not estimable because more than half (n=51) of the study population were censored. The number of participant who died is shown in "Post-Hoc Outcome Measure: Number of Participants who Died". | Posted | From start of treatment of the first subject until 45 months later, assessed every 3 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Overall Response Duration | Time from the date of first objective response (CR or PR, whichever is first recorded) to the date when progressive disease (PD, at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions) is first documented according to RECIST. | ITT population. | Posted | Median | 95% Confidence Interval | days | From start of treatment of the first subject until 45 months later, assessed every 8 weeks |
|
| ||||||||||||||||||||||||||
| Secondary | Time to Objective Response | Time from initiation of treatment to the date when an objective response (CR or PR, whichever is first recorded) is first documented according to RECIST. | ITT population. | Posted | Median | Full Range | days | From start of treatment of the first subject until 45 months later, assessed every 8 weeks |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Disease Control | Subjects who have a best response rating of CR, PR or Stable Disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started) per RECIST that is maintained for at least 28 days from the first demonstration of that rating. | ITT population. | Posted | Number | participants | From start of treatment of the first subject until 45 months later, assessed every 8 weeks |
|
| |||||||||||||||||||||||||||
| Post-Hoc | Number of Participants Who Died | Number of subjects who died due to any cause. | "Overall Survival" is shown in "Secondary Outcome Measure: Overall Survival". | Posted | Number | participants | From start of treatment of the first subject until 45 months later, assessed every 3 months |
|
|
Not provided
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
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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) | Sorafenib 200 mg tablets (400 mg [2 x 200 mg tablets] twice daily [bid] or 400 mg once daily [od] or 400 mg every other day [qod]) administered orally | 34 | 95 | 95 | 95 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin | Blood and lymphatic system disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Leukocytes | Blood and lymphatic system disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Platelets | Blood and lymphatic system disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Prolonged QTC | Cardiac disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Cardiac ischemia/infarction | Cardiac disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Hypertension | Cardiac disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Left ventricular systolic dysfunction | Cardiac disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Constitutional symptoms - other | General disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Fever | General disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Death not associated with CTCAE term, death NOS | General disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Death not associated with CTCAE term, disease progression NOS | General disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Anorexia | Gastrointestinal disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Dehydration | Gastrointestinal disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Distension | Gastrointestinal disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| GI - other | Gastrointestinal disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Ulcer, GI, duodeum | Gastrointestinal disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Hemorrhage pulmonary, bronchus | Vascular disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Hemorrhage, GI, colon | Vascular disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Hemorrhage, GI, duodenum | Vascular disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Liver dysfunction | Hepatobiliary disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Infection - other | Infections and infestations | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Infection with normal ANC, bronchus | Infections and infestations | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Infection with normal ANC, lung (pneumonia) | Infections and infestations | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Infection with normal ANC, upper airway NOS | Infections and infestations | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Edema: limb | Blood and lymphatic system disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Lymphatics - other | Blood and lymphatic system disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| ALT | Metabolism and nutrition disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Amylase | Metabolism and nutrition disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| AST | Metabolism and nutrition disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Bilirubin (hyperbilirubinemia) | Metabolism and nutrition disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| CPK | Metabolism and nutrition disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| GGT | Metabolism and nutrition disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Lipase | Metabolism and nutrition disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Metabolic/lab - other | Metabolism and nutrition disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Proteinuria | Metabolism and nutrition disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Fracture | Musculoskeletal and connective tissue disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| No code in CTCAE | General disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Pain, abdomen NOS | General disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Pain, tumor pain | General disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Pulmonary - other | Respiratory, thoracic and mediastinal disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Syndromes - other | General disorders | NCI CTC v.3.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic reaction | Immune system disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Auditory/ear - other | Ear and labyrinth disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Blood - other | Blood and lymphatic system disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Leukocytes | Blood and lymphatic system disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Hypertension | Cardiac disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Fever | General disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Hypothermia | General disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Insomnia | General disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Rigors/chills | General disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Weight loss | General disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Dermatology - other | Skin and subcutaneous tissue disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Flushing | Skin and subcutaneous tissue disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Hand-foot skin reaction | Skin and subcutaneous tissue disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Rash/desquamation | Skin and subcutaneous tissue disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Hot flashes | Endocrine disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Anorexia | Gastrointestinal disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Distension | Gastrointestinal disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| GI - other | Gastrointestinal disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Heartburn | Gastrointestinal disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Mucositis (clinical exam), oral cavity | Gastrointestinal disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Mucositis (functional/symptomatic), oral cavity | Gastrointestinal disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Periodontal | Gastrointestinal disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Hemorrhage pulmonary, bronchopulmonary NOS | Vascular disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Hemorrhage pulmonary, nose | Vascular disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Infection - other | Infections and infestations | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Infection with normal ANC, Bronchus | Infections and infestations | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Infection with normal ANC, Lung (Pneumonia) | Infections and infestations | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Edema: head and neck | Blood and lymphatic system disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Edema: limb | Blood and lymphatic system disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Alkaline phosphatase | Metabolism and nutrition disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| ALT | Metabolism and nutrition disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Amylase | Metabolism and nutrition disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| AST | Metabolism and nutrition disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Bilirubin (hyperbilirubinemia) | Metabolism and nutrition disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Creatinine | Metabolism and nutrition disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| GGT | Metabolism and nutrition disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Hyperuricemia | Metabolism and nutrition disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Lipase | Metabolism and nutrition disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Metabolic/lab - other | Metabolism and nutrition disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Proteinuria | Metabolism and nutrition disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Musculoskeletal - other | Musculoskeletal and connective tissue disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Neuropathy - sensory | Nervous system disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Ocular surface disease | Eye disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Pain, abdomen NOS | General disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Pain, back | General disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Pain, chest/thorax NOS | General disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Pain, dental/teeth/peridontal | General disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Pain, extremity/limb | General disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Pain, head/headache | General disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Pain, joint | General disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Pain, other | General disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Pain, stomach | General disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Pain, throat/pharynx/larynx | General disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Pain, tumor pain | General disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Pulmonary - other | Respiratory, thoracic and mediastinal disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Voice changes | Respiratory, thoracic and mediastinal disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Flu-like syndrome | General disorders | NCI CTC v.3.0 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | BAYER | clinical-trials-contact@bayerhealthcare.com |
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077157 | Sorafenib |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| 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 |
Not provided
Not provided
| Protocol driven decision point |
|
| Switch to commercial drug |
|
|
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|