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Clinical trial of BAY43-9006 in patients with hepatocellular carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | Experimental | Sorafenib (Nexavar, BAY43-9006) administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) (morning and evening, every 12 hours as far as possible); Dose modification (delayed or reduced) was permitted due to toxicity. |
|
| Placebo | Placebo Comparator | Sorafenib (Nexavar, BAY43-9006) matching placebo (2 placebo tablets) orally administered bid (twice daily). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | Drug | Multikinase Inhibitor; Sorafenib: 400mg bid of sorafenib |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Progression (TTP) | Time to progression (TTP) was defined as the time from date of randomization to radiological progression / recurrence. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation. | From randomization of the first subject until radiological progression or recurrence whichever came first, assessed up to 39 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall survival (OS) was defined as the time from date of randomization to death due to any cause. Subjects still alive at their last date of follow-up were censored at the time of analysis. | From randomization of the first subject until 39 months later. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya | Aichi-ken | 460-0001 | Japan | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21664811 | Result | Kudo M, Imanaka K, Chida N, Nakachi K, Tak WY, Takayama T, Yoon JH, Hori T, Kumada H, Hayashi N, Kaneko S, Tsubouchi H, Suh DJ, Furuse J, Okusaka T, Tanaka K, Matsui O, Wada M, Yamaguchi I, Ohya T, Meinhardt G, Okita K. Phase III study of sorafenib after transarterial chemoembolisation in Japanese and Korean patients with unresectable hepatocellular carcinoma. Eur J Cancer. 2011 Sep;47(14):2117-27. doi: 10.1016/j.ejca.2011.05.007. |
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Of 552 subjects screened, 458 were randomized and were valid for the efficacy analyses (intent to treat [ITT] population), and 456 received at least 1 dose of study drug and were valid for the safety analyses. 229 subjects were randomized to each group (sorafenib or placebo).
The first subject was enrolled on 27 Aug 2006. The final data collection date for the primary endpoint analysis was 10 Jul 2009. The study was conducted at 77 centers from 2 countries: Korea (7 centers) and Japan (70). 76 centers enrolled at least 1 subject (7 centers in Korea and 69 in Japan). The last subject's last visit occurred on 19 Nov 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sorafenib (Nexavar, BAY43-9006) | Sorafenib (Nexavar, BAY43-9006) administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) (morning and evening, every 12 hours as far as possible); Dose modification (delayed or reduced) was permitted due to toxicity. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Placebo | Drug | Placebo: matching placebo |
|
| Chiba |
| Chiba |
| 260-8677 |
| Japan |
| Kashiwa | Chiba | 277-8577 | Japan |
| Matsuyama | Ehime | 791-0280 | Japan |
| Tōon | Ehime | 791-0295 | Japan |
| Fukui-shi | Fukui | 918-8503 | Japan |
| Fukuoka | Fukuoka | 814-0180 | Japan |
| Iizuka | Fukuoka | 820-8505 | Japan |
| Kitakyushu | Fukuoka | 802-8533 | Japan |
| Kitakyushu | Fukuoka | 807-8555 | Japan |
| Kurume | Fukuoka | 830-0011 | Japan |
| Gifu | Gifu | 500-8513 | Japan |
| Isesaki | Gunma | 372-0817 | Japan |
| Maebashi | Gunma | 371-8511 | Japan |
| Hiroshima | Hiroshima | 730-8619 | Japan |
| Hiroshima | Hiroshima | 734-8530 | Japan |
| Hiroshima | Hiroshima | 734-8551 | Japan |
| Kure | Hiroshima | 737-0193 | Japan |
| Sapporo | Hokkaido | 003-0804 | Japan |
| Sapporo | Hokkaido | 060-0033 | Japan |
| Akashi | Hyōgo | 673-8558 | Japan |
| Kobe | Hyōgo | 650-0017 | Japan |
| Kasama | Ibaraki | 309-1793 | Japan |
| Kanazawa | Ishikawa-ken | 920-8641 | Japan |
| Kagoshima | Kagoshima-ken | 890-0061 | Japan |
| Kagoshima | Kagoshima-ken | 890-8520 | Japan |
| Kagoshima | Kagoshima-ken | 892-8512 | Japan |
| Isehara | Kanagawa | 259-1193 | Japan |
| Sagamihara | Kanagawa | 228-8520 | Japan |
| Yokohama | Kanagawa | 232-0024 | Japan |
| Yokohama | Kanagawa | 245-8575 | Japan |
| Kumamoto | Kumamoto | 860-0008 | Japan |
| Kumamoto | Kumamoto | 860-8556 | Japan |
| Kumamoto | Kumamoto | 861-4193 | Japan |
| Kyoto | Kyoto | 606-8507 | Japan |
| Sendai | Miyagi | 980-8574 | Japan |
| Sendai | Miyagi | 983-8520 | Japan |
| Miyazaki | Miyazaki | 880-0003 | Japan |
| Matsumoto | Nagano | 390-8621 | Japan |
| Ōmura | Nagasaki | 856-8562 | Japan |
| Okayama | Okayama-ken | 700-8511 | Japan |
| Kawachi-Nagano | Osaka | 586-8521 | Japan |
| Moriguchi | Osaka | 570-8507 | Japan |
| Osaka | Osaka | 530-8480 | Japan |
| Osaka | Osaka | 534-0021 | Japan |
| Osaka | Osaka | 537-8511 | Japan |
| Osaka | Osaka | 540-0006 | Japan |
| Osaka | Osaka | 543-8555 | Japan |
| Osaka | Osaka | 545-8586 | Japan |
| Osaka | Osaka | 558-8558 | Japan |
| Sayama | Osaka | 589-8511 | Japan |
| Suita | Osaka | 565-0871 | Japan |
| Izunokuni | Shizuoka | 410-2295 | Japan |
| Sunto | Shizuoka | 411-8777 | Japan |
| Shimotsuke | Tochigi | 329-0498 | Japan |
| Chuo-ku | Tokyo | 104-0045 | Japan |
| Itabashi-ku | Tokyo | 173-8610 | Japan |
| Meguro-ku | Tokyo | 152-8902 | Japan |
| Minato-ku | Tokyo | 105-8470 | Japan |
| Musashino | Tokyo | 180-8610 | Japan |
| Nerima-ku | Tokyo | 177-8521 | Japan |
| Shinjuku-ku | Tokyo | 160-0023 | Japan |
| Yonago | Tottori | 683-8504 | Japan |
| Toyama | Toyama | 930-8550 | Japan |
| Yamagata | Yamagata | 990-9585 | Japan |
| Shimonoseki | Yamaguchi | 750-0061 | Japan |
| Ube | Yamaguchi | 755-8505 | Japan |
| Chūō | Yamanashi | 409-3898 | Japan |
| Seoul | Seoul Teugbyeolsi | 152-703 | South Korea |
| Daegu | 700-721 | South Korea |
| Incheon | 405-760 | South Korea |
| Seoul | 110-744 | South Korea |
| Seoul | 135710 | South Korea |
| Seoul | 138-736 | South Korea |
| Seoul | South Korea |
Sorafenib (Nexavar, BAY43-9006) matching placebo (2 placebo tablets) orally administered bid (twice daily). |
| Received Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sorafenib (Nexavar, BAY43-9006) | Sorafenib (Nexavar, BAY43-9006) administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) (morning and evening, every 12 hours as far as possible); Dose modification (delayed or reduced) was permitted due to toxicity. |
| BG001 | Placebo | Sorafenib (Nexavar, BAY43-9006) matching placebo (2 placebo tablets) orally administered bid (twice daily). |
| 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 |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Child Pugh Status | A Child-Pugh (CP) score (determined by encephalopathy grade, ascites, serum bilirubin and albumin, prothrombin time) is used to assess the prognosis of chronic liver disease, mainly cirrhosis. One of the inclusion criterion for this study was a CP class A (good operative risk); class B (moderate risk) score or class C (poor operative risk) was excluded. | Number | Participants |
| |||||||||||||||
| Eastern Cooperative Oncology Group (ECOG) performance status | Eastern Cooperative Oncology Group (ECOG) Performance Status is a scale that measures how cancer affects a patient. 0 = fully active, 1 = restricted strenuous activity, 2 = ambulatory, 3 = limited selfcare, 4 = completely disabled, 5 = dead. Subjects entering this study must have had an ECOG score of 0 or 1. | Number | Participants |
| |||||||||||||||
| Responder group to transcatheter arterial chemoembolization (TACE) | Responder Group A: percentage of tumor necrosis or tumor shrinkage is 100 percentage. Responder Group B: percentage of tumor necrosis or tumor shrinkage is 25 percentage or more to less than 100 percentage. Subjects entering this study is a responder to TACE. | Number | Participants |
| |||||||||||||||
| Number of Prior transcatheter arterial chemoembolization (TACE) | Subjects entering this study must have had previous TACE at a maximum of 2 times. | 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 | Time to Progression (TTP) | Time to progression (TTP) was defined as the time from date of randomization to radiological progression / recurrence. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation. | Intention to treat (ITT) population. | Posted | Median | 95% Confidence Interval | days | From randomization of the first subject until radiological progression or recurrence whichever came first, assessed up to 39 months. |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Overall survival (OS) was defined as the time from date of randomization to death due to any cause. Subjects still alive at their last date of follow-up were censored at the time of analysis. | Median overall survival (OS) and 95% Confidence interval (CI) were not estimable in Placebo Group and Upper Limit of 95% CI was not in Sorafenib Group because of more than half (188 for Placebo,186 for Sorafenib) of the individual study populations censored. Number of death is shown in "Post-Hoc Outcome Measure". | Posted | From randomization of the first subject until 39 months later. |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Post-Hoc | Number of Death Cases Due to Any Cause | Intention to treat (ITT) population. "Overall Survival" is shown in "Secondary Outcome Measure: Overall Survival". | Posted | Number | Participants | From randomization of the first subject until death due to any cause assessed up to 55 months. |
|
|
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Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - 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 (Nexavar, BAY43-9006) administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) (morning and evening, every 12 hours as far as possible); Dose modification (delayed or reduced) was permitted due to toxicity. | 44 | 229 | 229 | 229 | ||
| EG001 | Placebo | Sorafenib (Nexavar, BAY43-9006) matching placebo (2 placebo tablets) orally administered bid (twice daily). | 21 | 227 | 193 | 227 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NEUTROPHILS | 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 |
| |
| INR | 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 |
| |
| CONDUCTION ABNORMALITY, AV BLOCK-3RD DEGREE (COMPLETE AV BLOCK) | Cardiac disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| CARDIAC ISCHEMIA/INFARCTION | Cardiac disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| DIABETES | Endocrine disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| HYPERTHYROIDISM | 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 |
| |
| DEHYDRATION | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| DIARRHEA | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| DYSPHAGIA | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| GI - OTHER (SPECIFY) | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| FEVER | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| FATIGUE | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| PAIN, BACK | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| PAIN, ABDOMEN NOS | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| CHOLECYSTITIS | Hepatobiliary disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| LIVER DYSFUNCTION | Hepatobiliary disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| HEPATOBILIARY - OTHER (SPECIFY) | Hepatobiliary disorders | 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 WITH NORMAL ANC, BLOOD | 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, LIVER | Infections and infestations | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| INFECTION WITH NORMAL ANC, LUNG (PNEUMONIA) | 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 |
| |
| 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 |
| |
| 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 (SPECIFY) | 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 |
| |
| MUSCULOSKELETAL - OTHER (SPECIFY) | Musculoskeletal and connective tissue disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| CNS ISCHEMIA | Nervous system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| ENCEPHALOPATHY | Nervous system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| MOOD ALTERATION, DEPRESSION | Nervous system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| SYNCOPE (FAINTING) | Nervous system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| RENAL - OTHER (SPECIFY) | Renal and urinary 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 |
| |
| DERMATOLOGY - OTHER (SPECIFY) | 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 |
| |
| CNS HEMORRHAGE | 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, COLON | 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, VARICES (ESOPHAGEAL) | 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, 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 |
| |
| ARTERY INJURY, AORTA | Vascular disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| VASCULAR - OTHER (SPECIFY) | Vascular disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| THROMBOSIS/THROMBUS/EMBOLISM | Vascular disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NEUTROPHILS | 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 |
| |
| LEUKOCYTES | 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 |
| |
| HYPERTENSION | Cardiac 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 |
| |
| 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 |
| |
| MUCOSITIS (CLINICAL EXAM), 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 |
| |
| FEVER | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| WEIGHT GAIN | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| FATIGUE | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| WEIGHT LOSS | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| PAIN, BACK | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| PAIN, EXTREMITY-LIMB | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| PAIN, ABDOMEN NOS | 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 |
| |
| FLU-LIKE SYNDROME | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| INFECTION - OTHER (SPECIFY) | 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 |
| |
| 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 |
| |
| LIPASE | 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 |
| |
| METABOLIC/LAB - OTHER (SPECIFY) | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| PROTEINURIA | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| MUSCULOSKELETAL - OTHER (SPECIFY) | Musculoskeletal and connective tissue disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| NEUROPATHY: SENSORY | Nervous system 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 |
| |
| HAND-FOOT SKIN REACTION | Skin and subcutaneous tissue disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| DERMATOLOGY - OTHER (SPECIFY) | 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 |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Bayer HealthCare AG | clinical-trials-contact@bayerhealthcare.com |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| 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
| Male |
|
| Status B |
|
| Grade 1 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Responder Group B |
|
| 2 |
|
| Hazard Ratio (HR) |
| 0.8735 |
| 95 |
| 0.6972 |
| 1.0942 |
Hazard Ratio: Sorafenib/Placebo. |
| No |
| Superiority or Other |
|