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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-005056-24 | EudraCT Number |
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This study will look at whether our drug (sorafenib) in combination with chemotherapy delivered directly into your tumor using beads (DC Bead) will slow the progression of the disease. The beads used with the chemotherapy will slowly release the chemotherapy reducing the adverse effects that normally occur with chemotherapy.
Safety issues will be reported in Adverse Event section. In addition to the secondary outcome measures, Biomarkers and Patient Report Outcome will also be analyzed as other variables.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) + TACE | Experimental | Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Patients were then also treated with Transarterial Chemoembolization (TACE) performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of sorafenib, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.) |
|
| Placebo + TACE | Placebo Comparator | Placebo was to be orally administered as 2 tablets bid (twice daily). Patients were then also treated with TACE performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of placebo, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | Drug | 800 mg sorafenib (4 tablets) will be taken daily (400mg b.i.d. [twice daily], 2 tablets). Transarterial Chemoembolization (TACE) using DC Bead |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Progression (TTP) - Independent Radiological Review (Primary Analysis) | TTP is defined as the time (days) from randomization to radiological confirmed disease progression. Participants without progression at the time of analysis were censored at their last date of tumor evaluation. | From randomization of the first participant until 28 months later (cut-off date) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall Survival (OS) was defined as the time (days) from randomization to death due to any cause. Participants still alive at the time of analysis were censored at their last date of last contact. | From randomization of the first participant until 28 months later (cut-off date) |
| Time to Untreatable Progression (TTUP) |
Not provided
Inclusion Criteria:
For subjects without cirrhosis, histological or cytological confirmation is mandatory
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| La Jolla | California | 92037 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26809111 | Derived | Lencioni R, Llovet JM, Han G, Tak WY, Yang J, Guglielmi A, Paik SW, Reig M, Kim DY, Chau GY, Luca A, Del Arbol LR, Leberre MA, Niu W, Nicholson K, Meinhardt G, Bruix J. Sorafenib or placebo plus TACE with doxorubicin-eluting beads for intermediate stage HCC: The SPACE trial. J Hepatol. 2016 May;64(5):1090-1098. doi: 10.1016/j.jhep.2016.01.012. Epub 2016 Jan 22. |
| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sorafenib (Nexavar, BAY43-9006) + TACE | Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Participants were then also treated with Transarterial Chemoembolization (TACE) performed with doxorubicin capable beads (DC Bead) (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of sorafenib, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | 4 tablets of placebo will be taken daily (2 tablets b.i.d). TACE using DC Bead |
|
Time to untreatable progression (TTUP) was defined as the time (days) from randomization to untreatable progression. Participants without untreatable progression at the time of analysis were censored at their last date of tumor evaluation. |
| From randomization of the first participant until 28 months later (cut-off date) |
| Time to Vascular Invasion/Extrahepatic Spread (TTVI/ES) | Time to vascular invasion/extrahepatic spread (TTVI/ES) was defined as the time (days) from randomization to vascular invasion/extrahepatic spread. Participants without vascular invasion/extrahepatic spread at the time of analysis were censored at their last date of tumor evaluation. | From randomization of the first participant until 28 months later (cut-off date) |
| Tumor Response - Independent Radiological Review | Tumor Response was defined as the number of participants with a confirmed Complete Response (CR)=disappearance of all clinical and radiological tumor lesions, Partial Response (PR)= at least 30% decrease in sum of the longest diameters (LD) of tumor lesions, Stable Disease (SD)= neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease, or Progressive Disease (PD)=at least 20% increase in the sum of LD of measured lesions, observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. | From randomization of the first participant until 28 months later (cut-off date) |
| Tumor Response - Investigator Assessment | Tumor Response was defined as the number of participants with a confirmed Complete Response (CR)=disappearance of all clinical and radiological tumor lesions, Partial Response (PR)= at least 30% decrease in sum of the longest diameters (LD) of tumor lesions, Stable Disease (SD)= neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease, or Progressive Disease (PD)=at least 20% increase in the sum of LD of measured lesions, observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. | From randomization of the first participant until 28 months later (cut-off date) |
| Los Angeles |
| California |
| 90095-7077 |
| United States |
| San Francisco | California | 94115 | United States |
| Gainesville | Florida | 32610-0316 | United States |
| Miami | Florida | 33136 | United States |
| Orlando | Florida | 32804 | United States |
| Atlanta | Georgia | 30309-1231 | United States |
| Ann Arbor | Michigan | 48109-0330 | United States |
| Detroit | Michigan | 48202 | United States |
| Abbott Northwestern Hospital | Minneapolis | Minnesota | 55407 | United States |
| St Louis | Missouri | 63104 | United States |
| New York | New York | 10029 | United States |
| Cleveland | Ohio | 44195 | United States |
| Columbus | Ohio | 43210-1240 | United States |
| Portland | Oregon | 97239 | United States |
| Richmond | Virginia | 23249 | United States |
| Seattle | Washington | 98101 | United States |
| Seattle | Washington | 98109-1023 | United States |
| Camperdown | New South Wales | 2050 | Australia |
| St Leonards | New South Wales | 2065 | Australia |
| Greenslopes | Queensland | 4120 | Australia |
| Clayton | Victoria | 3168 | Australia |
| Heidelberg | Victoria | 3084 | Australia |
| Melbourne | Victoria | 3004 | Australia |
| Nedlands | Western Australia | 6009 | Australia |
| Innsbruck | 6020 | Austria |
| Vienna | 1090 | Austria |
| Bruxelles - Brussel | 1070 | Belgium |
| Bruxelles - Brussel | 1090 | Belgium |
| Bruxelles - Brussel | 1200 | Belgium |
| Leuven | 3000 | Belgium |
| Liège | 4000 | Belgium |
| Calgary | Alberta | T2N 4N1 | Canada |
| Halifax | Nova Scotia | B3H 2Y9 | Canada |
| Toronto | Ontario | M5G 2N2 | Canada |
| Guangzhou | Guangdong | 510060 | China |
| Guangzhou | Guangdong | 510080 | China |
| Xi'an | Shannxi | 710032 | China |
| Beijing | 100021 | China |
| Beijing | 100142 | China |
| Shanghai | 200032 | China |
| Shanghai | 200438 | China |
| Créteil | 94010 | France |
| Lille | 59037 | France |
| Lyon | 69003 | France |
| Lyon | 69288 | France |
| Marseille | 13005 | France |
| Paris | 75020 | France |
| Paris | 75571 | France |
| Vandœuvre-lès-Nancy | 54500 | France |
| Villejuif | 94800 | France |
| Villejuif | 94805 | France |
| Freiburg im Breisgau | Baden-Wurttemberg | 79106 | Germany |
| Heidelberg | Baden-Wurttemberg | 69120 | Germany |
| Tübingen | Baden-Wurttemberg | 72076 | Germany |
| Erlangen | Bavaria | 91054 | Germany |
| München | Bavaria | 81377 | Germany |
| Regensburg | Bavaria | 93042 | Germany |
| Frankfurt am Main | Hesse | 60590 | Germany |
| Hanover | Lower Saxony | 30625 | Germany |
| Essen | North Rhine-Westphalia | 45136 | Germany |
| Essen | North Rhine-Westphalia | 45147 | Germany |
| Münster | North Rhine-Westphalia | 48149 | Germany |
| Mainz | Rhineland-Palatinate | 55131 | Germany |
| Homburg | Saarland | 66421 | Germany |
| Jena | Thuringia | 07743 | Germany |
| Berlin | 13353 | Germany |
| Hamburg | 20246 | Germany |
| Bari | Apulia | 70021 | Italy |
| Naples | Campania | 80131 | Italy |
| Bologna | Emilia-Romagna | 40138 | Italy |
| Rome | Lazio | 00133 | Italy |
| Rome | Lazio | 00185 | Italy |
| Milan | Lombardy | 20122 | Italy |
| Milan | Lombardy | 20133 | Italy |
| Turin | Piedmont | 10126 | Italy |
| Palermo | Sicily | 90127 | Italy |
| Pisa | Tuscany | 56124 | Italy |
| Padova | Veneto | 35128 | Italy |
| Verona | Veneto | 37134 | Italy |
| Singapore | 119228 | Singapore |
| Singapore | 169610 | Singapore |
| Daegu | 700-721 | South Korea |
| Gyeonggi-do | 411-706 | South Korea |
| Seoul | 110-744 | South Korea |
| Seoul | 120-752 | South Korea |
| Seoul | 135-710 | South Korea |
| Gangnam Severance Hospital, Yonsei University | Seoul | 135-720 | South Korea |
| Santiago de Compostela | A Coruña | 15706 | Spain |
| Badalona | Barcelona | 08916 | Spain |
| Sabadell | Barcelona | 08208 | Spain |
| Cruces/Barakaldo | Bilbao | 48903 | Spain |
| Barcelona | Catalonia | 08035 | Spain |
| Fundación Hospital Alcorcón | Alcorcón | Madrid | 28922 | Spain |
| Hospital Central de Asturias | Oviedo | Principality of Asturias | 33006 | Spain |
| San Cristóbal de La Laguna | Santa Cruz de Tenerife | 38320 | Spain |
| A Coruña | 15006 | Spain |
| Alicante | 03010 | Spain |
| Barcelona | 08036 | Spain |
| Córdoba | 14004 | Spain |
| Madrid | 28034 | Spain |
| Madrid | 28046 | Spain |
| Hospital Universitario Virgen del RocÃo | Seville | 41013 | Spain |
| Valencia | 46014 | Spain |
| Changhua Christian Hospital | Changhua | 500 | Taiwan |
| Taipei | 10002 | Taiwan |
| Taipei | 11217 | Taiwan |
| FG001 | Placebo + TACE | Placebo was to be orally administered as 2 tablets bid (twice daily). Participants were then also treated with TACE performed with doxorubicin capable beads (DC Bead) (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of placebo, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.) |
| Participants Received Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sorafenib (Nexavar, BAY43-9006) + TACE | Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Participants were then also treated with Transarterial Chemoembolization (TACE) performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of sorafenib, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.) |
| BG001 | Placebo + TACE | Placebo was to be orally administered as 2 tablets bid (twice daily). Participants were then also treated with TACE performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of placebo, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.) |
| BG002 | Total | Total of all reporting groups |
| 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 at enrollment | Measures on a scale from grade 0 (best) to grade 5 (worst) cancer's affect on patient's life. 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 | Scores on a scale |
| |||||||||||||||
| Number of target lesions | Number | Participants |
| ||||||||||||||||
| Number of non-target lesions | Number | Participants |
| ||||||||||||||||
| Alfa-fetoprotein | Number | Participants |
| ||||||||||||||||
| Child pugh classification | Used to assess the severity of a participant's liver disease, the prognosis, and the appropriate treatment. A Child-Pugh class A (well-compensated disease); class B (significant functional compromise); and class C (decompensated disease). | Number | Participants |
| |||||||||||||||
| Time of first study medication since initial diagnosis | This variable shows time from the first diagnosis of HCC until the first treatment with study drug. | Median | Full Range | Months |
| ||||||||||||||
| Time of first study medication since first progression | This variable shows the time from the first treatment with study drug until radiological confirmed disease progression. | Median | Full Range | Months |
| ||||||||||||||
| Time of first study medication since most recent progression | Median | Full Range | Months |
|
| 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 | Time to Progression (TTP) - Independent Radiological Review (Primary Analysis) | TTP is defined as the time (days) from randomization to radiological confirmed disease progression. Participants without progression at the time of analysis were censored at their last date of tumor evaluation. | Intent-to-treat (ITT) | Posted | Median | 95% Confidence Interval | Days | From randomization of the first participant until 28 months later (cut-off date) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Overall Survival (OS) was defined as the time (days) from randomization to death due to any cause. Participants still alive at the time of analysis were censored at their last date of last contact. | Intent-to-treat (ITT) | Posted | Median | 95% Confidence Interval | Days | From randomization of the first participant until 28 months later (cut-off date) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Untreatable Progression (TTUP) | Time to untreatable progression (TTUP) was defined as the time (days) from randomization to untreatable progression. Participants without untreatable progression at the time of analysis were censored at their last date of tumor evaluation. | Intent-to-treat (ITT) | Posted | Median | 95% Confidence Interval | Days | From randomization of the first participant until 28 months later (cut-off date) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Vascular Invasion/Extrahepatic Spread (TTVI/ES) | Time to vascular invasion/extrahepatic spread (TTVI/ES) was defined as the time (days) from randomization to vascular invasion/extrahepatic spread. Participants without vascular invasion/extrahepatic spread at the time of analysis were censored at their last date of tumor evaluation. | Intent-to-treat (ITT) | Posted | Median | 95% Confidence Interval | Days | From randomization of the first participant until 28 months later (cut-off date) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Tumor Response - Independent Radiological Review | Tumor Response was defined as the number of participants with a confirmed Complete Response (CR)=disappearance of all clinical and radiological tumor lesions, Partial Response (PR)= at least 30% decrease in sum of the longest diameters (LD) of tumor lesions, Stable Disease (SD)= neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease, or Progressive Disease (PD)=at least 20% increase in the sum of LD of measured lesions, observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. | Intent-to-treat (ITT) | Posted | Number | Participants | From randomization of the first participant until 28 months later (cut-off date) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Tumor Response - Investigator Assessment | Tumor Response was defined as the number of participants with a confirmed Complete Response (CR)=disappearance of all clinical and radiological tumor lesions, Partial Response (PR)= at least 30% decrease in sum of the longest diameters (LD) of tumor lesions, Stable Disease (SD)= neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease, or Progressive Disease (PD)=at least 20% increase in the sum of LD of measured lesions, observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. | Intent-to-treat (ITT) | Posted | Number | Participants | From randomization of the first participant until 28 months later (cut-off date) |
|
Not provided
Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Acute respiratory distress syndrome (ARDS), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sorafenib (Nexavar, BAY43-9006) + TACE | Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Patients were then also treated with TACE performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of sorafenib on cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.) | 86 | 153 | 150 | 153 | ||
| EG001 | Placebo + TACE | Placebo was to be orally administered as 2 tablets bid (twice daily). Patients were then also treated with TACE performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of placebo on cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.) | 56 | 151 | 139 | 151 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| BLOOD - OTHER | Blood and lymphatic system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| EDEMA: LIMB | Blood and lymphatic system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| HEMOGLOBIN | Blood and lymphatic system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| LYMPHOPENIA | Blood and lymphatic system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| PLATELETS | Blood and lymphatic system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| CARDIAC GENERAL - OTHER | Cardiac disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| CARDIAC ISCHEMIA/INFARCTION | Cardiac disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| CARDIOPULMONARY ARREST | Cardiac disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| HYPERTENSION | Cardiac disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| LEFT VENTRICULAR SYSTOLIC DYSFUNCTION | Cardiac disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| SUPRAVENTRICULAR ARRHYTHMIA, ATRIAL FIBRILLATION | Cardiac disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| DIABETES | Endocrine disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| ASCITES | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| DEHYDRATION | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| DIARRHEA | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| GASTRITIS | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| GI - OTHER | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| HEARTBURN | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| ILEUS | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| LEAK, GI, BILIARY TREE | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| PERFORATION, GI, DUODENUM | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| PERFORATION, GI, GALLBLADDER | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| PERFORATION, GI, STOMACH | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| CONSTITUTIONAL SYMPTOMS - OTHER | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| DEATH NOT ASSOCIATED WITH CTCAE TERM, DISEASE PROGRESSION NOS | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| DEATH NOT ASSOCIATED WITH CTCAE TERM, MULTI-ORGAN FAILURE | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| DEATH NOT ASSOCIATED WITH CTCAE TERM, SUDDEN DEATH | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| FATIGUE | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| FEVER | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| PAIN, ABDOMEN NOS | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| PAIN, BACK | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| PAIN, BONE | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| PAIN, CHEST WALL | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| PAIN, GALLBLADDER | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| PAIN, JOINT | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| PAIN, PLEURA | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| PAIN, STOMACH | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| SYNDROMES - OTHER | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| CHOLECYSTITIS | Hepatobiliary disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| HEPATOBILIARY - OTHER | Hepatobiliary disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| LIVER DYSFUNCTION | Hepatobiliary disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| PANCREATITIS | Hepatobiliary disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| INFECTION (DOCUMENTED CLINICALLY), BLADDER (URINARY) | Infections and infestations | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| INFECTION (DOCUMENTED CLINICALLY), BLOOD | Infections and infestations | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| INFECTION (DOCUMENTED CLINICALLY), BRONCHUS | Infections and infestations | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| INFECTION (DOCUMENTED CLINICALLY), COLON | Infections and infestations | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| INFECTION (DOCUMENTED CLINICALLY), LIVER | Infections and infestations | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| INFECTION (DOCUMENTED CLINICALLY), LUNG (PNEUMONIA) | Infections and infestations | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| INFECTION (DOCUMENTED CLINICALLY), PERITONEAL CAVITY | Infections and infestations | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| INFECTION (DOCUMENTED CLINICALLY), SKIN (CELLULITIS) | Infections and infestations | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| INFECTION (DOCUMENTED CLINICALLY), UPPER AIRWAY NOS | Infections and infestations | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| INFECTION WITH NORMAL ANC, APPENDIX | Infections and infestations | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| INFECTION WITH NORMAL ANC, BILIARY TREE | Infections and infestations | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| INFECTION WITH NORMAL ANC, BLADDER (URINARY) | Infections and infestations | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| INFECTION WITH NORMAL ANC, BLOOD | Infections and infestations | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| INFECTION WITH NORMAL ANC, LIVER | Infections and infestations | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| INFECTION WITH NORMAL ANC, PERITONEAL CAVITY | Infections and infestations | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| INFECTION WITH NORMAL ANC, SKIN (CELLULITIS) | Infections and infestations | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| INFECTION WITH NORMAL ANC, URINARY TRACT NOS | Infections and infestations | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| INFECTION WITH UNKNOWN ANC, BONE (OSTEOMYELITIS) | Infections and infestations | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| INFECTION WITH UNKNOWN ANC, LUNG (PNEUMONIA) | Infections and infestations | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| INFECTION WITH UNKNOWN ANC, PANCREAS | Infections and infestations | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| ALKALINE PHOSPHATASE | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| ALT | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| AMYLASE | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| AST | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| BILIRUBIN (HYPERBILIRUBINEMIA) | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| CREATININE | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| HYPERGLYCEMIA | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| HYPOGLYCEMIA | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| LIPASE | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| METABOLIC/LAB - OTHER | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| FRACTURE | Musculoskeletal and connective tissue disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| JOINT-FUNCTION | Musculoskeletal and connective tissue disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| MUSCLE WEAKNESS, LEFT-SIDED | Musculoskeletal and connective tissue disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| SECONDARY MALIGNANCY (POSSIBLY RELATED TO CANCER TREATMENT) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| COGNITIVE DISTURBANCE | Nervous system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| CONFUSION | Nervous system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| ENCEPHALOPATHY | Nervous system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| SEIZURE | Nervous system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| OBSTRUCTION, GU, PROSTATE | Renal and urinary disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| RENAL - OTHER | Renal and urinary disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| RENAL FAILURE | Renal and urinary disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| URINARY RETENTION | Renal and urinary disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| ARDS | Respiratory, thoracic and mediastinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| DYSPNEA (SHORTNESS OF BREATH) | Respiratory, thoracic and mediastinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| PULMONARY - OTHER | Respiratory, thoracic and mediastinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| RASH/DESQUAMATION | Skin and subcutaneous tissue disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| ULCERATION | Skin and subcutaneous tissue disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| ARTERY INJURY, EXTREMITY - LOWER | Vascular disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| ARTERY INJURY, OTHER NOS | Vascular disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| HEMORRHAGE PULMONARY, BRONCHOPULMONARY NOS | Vascular disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| HEMORRHAGE WITH SURGERY | Vascular disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| HEMORRHAGE, GI, ABDOMEN NOS | Vascular disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| HEMORRHAGE, GI, ESOPHAGUS | Vascular disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| HEMORRHAGE, GI, LIVER | Vascular disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| HEMORRHAGE, GI, LOWER GI NOS | Vascular disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| HEMORRHAGE, GI, PERITONEAL CAVITY | Vascular disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| HEMORRHAGE, GI, RECTUM | Vascular disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| HEMORRHAGE, GI, STOMACH | Vascular disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| HEMORRHAGE, GI, UPPER GI NOS | Vascular disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| HEMORRHAGE, GI, VARICES (ESOPHAGEAL) | Vascular disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| HEMORRHAGE, GI, VARICES (RECTAL) | Vascular disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| PERIPHERAL ARTERIAL ISCHEMIA | Vascular disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| THROMBOSIS/THROMBUS/EMBOLISM | Vascular disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| VASCULAR - OTHER | Vascular disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| VISCERAL ARTERIAL ISCHEMIA | Vascular disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| EDEMA: LIMB | Blood and lymphatic system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| HEMOGLOBIN | Blood and lymphatic system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| PLATELETS | Blood and lymphatic system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| HYPERTENSION | Cardiac disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| DIABETES | Endocrine disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| ANOREXIA | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| ASCITES | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| DIARRHEA | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| DISTENSION | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| GASTRITIS | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| GI - OTHER | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| HEARTBURN | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| MUCOSITIS (FUNCTIONAL/SYMPTOMATIC), ORAL CAVITY | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| FATIGUE | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| FEVER | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| FLU-LIKE SYNDROME | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| INSOMNIA | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| PAIN, ABDOMEN NOS | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| PAIN, BACK | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| PAIN, CHEST/THORAX NOS | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| PAIN, EXTREMITY-LIMB | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| PAIN, HEAD/HEADACHE | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| PAIN, JOINT | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| PAIN, LIVER | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| PAIN, MUSCLE | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| PAIN, STOMACH | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| RIGORS/CHILLS | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| WEIGHT LOSS | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| ALT | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| AMYLASE | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| AST | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| BILIRUBIN (HYPERBILIRUBINEMIA) | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| HYPERGLYCEMIA | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| HYPOALBUMINEMIA | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| HYPOKALEMIA | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| HYPOPHOSPHATEMIA | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| LIPASE | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| METABOLIC/LAB - OTHER | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| MOOD ALTERATION, ANXIETY | Nervous system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| URINARY FREQUENCY | Renal and urinary disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| DYSPNEA (SHORTNESS OF BREATH) | Respiratory, thoracic and mediastinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| VOICE CHANGES | Respiratory, thoracic and mediastinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| ALOPECIA | Skin and subcutaneous tissue disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| DERMATOLOGY - OTHER | Skin and subcutaneous tissue disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| DRY SKIN | Skin and subcutaneous tissue disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| HAND-FOOT SKIN REACTION | Skin and subcutaneous tissue disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| RASH/DESQUAMATION | Skin and subcutaneous tissue disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| HEMORRHAGE PULMONARY, NOSE | Vascular disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
|
The investigator must discuss and obtain written consent of the sponsor on the intended publication. The investigator must send a draft manuscript of the publication or abstract to the sponsor thirty days in advance of the submission inorder to obtain approval.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | BAYER | clinical-trial-contact@bayerhealthcare.com |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver 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
| 65 - 74 years |
|
| >=75 years |
|
| Male |
|
| Grade 0 |
|
| 2 |
|
| 3 |
|
| 4 |
|
| 5 |
|
| 1 |
|
| 2 |
|
| 3 |
|
| 4 |
|
| 5 |
|
| 6 |
|
| 7 |
|
| 8 |
|
| 10 |
|
| 14 |
|
| >/=400 ng/mL |
|
| Class A |
|
| Class B |
|
|
|
|
|
|
|
|
|
|
|
|
|
|