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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-006914-62 | EudraCT Number |
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The purpose of the study is to see if sorafenib plus best supportive care (i.e. in addition to the non-cancer treatments patients would normally receive) is an effective treatment for lung cancer compared to best supportive care alone. The safety and tolerability of the two treatment groups will also be compared. The goal of the study is to test the ability of sorafenib to improve survival compared to best supportive care alone.
Acronyms used in Adverse Events section: Disseminated intravascular coagulation (DIC), International normalized ratio (INR), Atrioventricular (AV), Gastrointestinal (GI), Not otherwise specified (NOS), Common Terminology Criteria for Adverse Events (CTCAE), Absolute neutrophil count (ANC), Central nervous system (CNS), Acute respiratory distress syndrome (ARDS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | Experimental | Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID) |
|
| Placebo | Placebo Comparator | Participants received 2 tablets of placebo orally twice daily (BID) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | Drug | Sorafenib 400 mg twice daily (BID) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival (OS) was defined as the time from date of randomization to date of death due to any cause. Overall survival of subjects alive at the time of analysis will be censored at their last date of follow-up or database cut off date whichever came first. | From randomization of the first subject until 36 months later |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | Progression-free survival (PFS) was defined as the time from date of randomization to date of first observed disease progression (radiological or clinical, whichever is earlier) or death due to any cause, if death occurs before progression is documented. Progressive Disease (PD) is defined as at least a 20% increase in the sum of longest diameter (LD) of measured lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Appearance of new lesions will also constitute progressive disease. In exceptional circumstances unequivocal progression of a non-measured lesion may be accepted as evidence of disease progression. |
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Inclusion Criteria:
Ability to understand and willingness to sign a written Informed Consent
Advanced relapsed or refractory predominantly non squamous NSCLC. The diagnosis must have been confirmed cyto-/ histologically
Patients must have measurable or non-measurable disease
At least two but not more than three prior standard treatment regimens for NSCLC
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Male or female subjects >/= 18 years of age (>/=20 for Japan) at the time of Informed Consent
Life expectancy of at least 12 weeks
Ability to swallow oral medication
Both men and women using adequate barrier birth control measures during the course of the trial and 4 weeks after the completion of trial
Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to start of the study drug:
Exclusion Criteria:
Excluded medical conditions:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fayetteville | Arkansas | 72703 | United States | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | Sorafenib (Nexavar, BAY43-9006) | Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID) |
| FG001 | Placebo | Participants received 2 tablets of placebo orally twice daily (BID) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment |
|
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| Placebo | Drug | Placebo - 2 tablets twice daily (BID) |
|
| From randomization of the first subject until 36 months later assessed every 6 weeks |
| Disease Control | Disease control (DC) was defined as the proportion of patients whose best response was Complete Response [CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target)] or Partial Response [PR: at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD] or Stable Disease [SD: steady state of disease which was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD)]. | From randomization of the first subject until 36 months later assessed every 6 weeks |
| Objective Tumor Response | Objective tumor response was defined as the proportion of patients whose best response was Complete Response [CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target)] or Partial Response [PR: at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD] over the whole duration of study. | From randomization of the first subject until 36 months later assessed every 6 weeks |
| Time to Progression | Time to progression (TTP) was defined as the time from date of randomization to date of first observed disease progression (radiological or clinical, whichever is earlier). | From randomization of the first subject until 36 months later assessed every 6 weeks |
| Mean Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire for Palliative Care (EORTC QLQ-C15-PAL) - Global Health Status | The EORTC QLQ-C15-PAL is an abbreviated 15-item version of the EORTC core quality of life questionnaire (EORTC QLQ-C30) developed for use in palliative care. The 'Global Health status' subscale consists of question 15 of the questionnaire. The score of 'Global Health status' ranges from 0 (very poor) to 100 (excellent). The change of score ranges from -100 (maximum degree of worsening) to 100 (maximum degree of improvement). | Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle) |
| Mean Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Coughing Subscale | A clinically valid 13-item tool for assessing disease- and treatment-specific symptoms in lung cancer patients in clinical trials. The coughing subscale uses question 1 of the questionnaire. The scale ranges from 0 to 100. Higher score means higher level of symptomatology/problems. The change of score ranges from -100 (decrease in level of symptomatology/problems) to 100 (increase in level of symptomatology/problems). | Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle) |
| Mean Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Dyspnea | A clinically valid 13-item tool for assessing disease- and treatment-specific symptoms in lung cancer patients in clinical trials. The dyspnea subscale uses questions 3, 4 and 5 of the questionnaire. The scale ranges from 0 to 100. Higher score means higher level of symptomatology/problems. The change of score ranges from -100 (decrease in level of symptomatology/problems) to 100 (increase in level of symptomatology/problems). | Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle) |
| Mean Change From Baseline in EuroQol-5D (EQ-5D) - Index Score | The Euro-Qol 5D (EQ-5D) is a validated assessment tool of Health Related Quality of Life (HRQOL) and utilities consisting of 15 statements. Patients select those statements that best describe their current health state regarding mobility, self-care, usual activities, pain/discomfort, and anxiety/depression which is converted into a utility value. Range of scale is from -0.594 (worst possible health state) to 1 (perfect health) based on UK weights. The change of score ranges from -1.594 (high degree of worsening) to 1.594 (high degree of improvement). | Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle) |
| Mean Change From Baseline in EuroQol-5D (EQ-5D) - VAS Score | A visual analogue scale (EQ VAS) used by patients to rate their current health state from 100 (best imaginable health state) to 0 (worst imaginable health state). The change of score ranges from -100 (high degree of worsening) to 100 (high degree of improvement) | Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle) |
| Stanford |
| California |
| 94305 |
| United States |
| Philadelphia | Pennsylvania | 19107 | United States |
| Ramos Mejía | Buenos Aires | B1704ESN | Argentina |
| Buenos Aires | Ciudad Auton. de Buenos Aires | C1430ERF | Argentina |
| Córdoba | Córdoba Province | 5000 | Argentina |
| Córdoba | Córdoba Province | X5016KEH | Argentina |
| Rosario | Santa Fe Province | 2000 | Argentina |
| Rosario | Santa Fe Province | S2000DSK | Argentina |
| Santa Fe | S3000FFV | Argentina |
| Vienna | State of Vienna | 1090 | Austria |
| Graz | 8036 | Austria |
| Linz | 4010 | Austria |
| Antwerp | 2020 | Belgium |
| Bruxelles - Brussel | 1200 | Belgium |
| Charleroi | 6000 | Belgium |
| Genk | 3600 | Belgium |
| Brasília | Federal District | 70680-650 | Brazil |
| Belo Horizonte | Minas Gerais | 30150-281 | Brazil |
| Porto Alegre | Rio Grande do Sul | 90050 170 | Brazil |
| Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Santo André | São Paulo | 09020 110 | Brazil |
| São José dos Campos | São Paulo | 12245750 | Brazil |
| São Paulo | São Paulo | 01224-010 | Brazil |
| São Paulo | São Paulo | 05651-900 | Brazil |
| Plovdiv | Bulgaria |
| Sofia | 1784 | Bulgaria |
| Sofia | Bulgaria |
| Varna | 9002 | Bulgaria |
| Varna | 9010 | Bulgaria |
| Montreal | Quebec | H2W 1S6 | Canada |
| Santiago | Santiago Metropolitan | 838-0455 | Chile |
| Santiago | 838-0456 | Chile |
| Guangzhou | Guangdong | 510060 | China |
| Nanjing | Jiangsu | 210002 | China |
| Chengdu | Sichuan | 610041 | China |
| Hangzhou | Zhejiang | 310016 | China |
| Hangzhou | Zhejiang | 310022 | China |
| Beijing | 100021 | China |
| Beijing | 100071 | China |
| Beijing | 100142 | China |
| Beijing | 100853 | China |
| Guangzhou | 510080 | China |
| Shanghai | 200030 | China |
| Shanghai | 200433 | China |
| Caen | 14073 | France |
| Dijon | 21000 | France |
| La Roche-sur-Yon | 85025 | France |
| La Tronche | 38700 | France |
| Lille | 59020 | France |
| Lyon | 69317 | France |
| Saint-Herblain | 44805 | France |
| Tours | 37044 | France |
| Heidelberg | Baden-Wurttemberg | 69126 | Germany |
| Karlsruhe | Baden-Wurttemberg | 76137 | Germany |
| Mannheim | Baden-Wurttemberg | 68167 | Germany |
| Ulm | Baden-Wurttemberg | 89091 | Germany |
| Gauting | Bavaria | 82131 | Germany |
| München | Bavaria | 80336 | Germany |
| Hamburg | Free and Hanseatic City of Hamburg | 21075 | Germany |
| Kassel | Hesse | 34125 | Germany |
| Cologne | North Rhine-Westphalia | 51109 | Germany |
| Großhansdorf | Schleswig-Holstein | 22927 | Germany |
| Bad Berka | Thuringia | 99437 | Germany |
| Athens | 11527 | Greece |
| Heraklion | 711 10 | Greece |
| Thessaloniki | 570 10 | Greece |
| Shatin | N.T | Hong Kong |
| Hong Kong | Hong Kong |
| Kowloon | Hong Kong |
| Budapest | 1125 | Hungary |
| Budapest | 1529 | Hungary |
| Edelény | 3780 | Hungary |
| Farkasgyepű | 8582 | Hungary |
| Törökbálint | 2045 | Hungary |
| Zalaegerszeg | 8900 | Hungary |
| Mumbai | Maharashtra | 422004 | India |
| Pune | Maharashtra | 411001 | India |
| Kerala | 682304 | India |
| Bandung | 40161 | Indonesia |
| Jakarta | 11420 | Indonesia |
| Zrifin | Israel | 6093000 | Israel |
| Holon | Israel |
| Jerusalem | 9112001 | Israel |
| Jerusalem | 9372212 | Israel |
| Kfar Saba | 4428164 | Israel |
| Petah Tikva | 4941492 | Israel |
| Rozzano | Milano | 20089 | Italy |
| Monza | Monza-Brianza | 20052 | Italy |
| Orbassano | Torino | 10043 | Italy |
| Avellino | 83100 | Italy |
| Genova | 16132 | Italy |
| Livorno | 57124 | Italy |
| Parma | 43100 | Italy |
| Perugia | 06156 | Italy |
| Roma | 00151 | Italy |
| Nagoya | Aichi-ken | 464-8681 | Japan |
| Kashiwa | Chiba | 277-8577 | Japan |
| Fukuoka | Fukuoka | 811-1395 | Japan |
| Akashi | Hyōgo | 673-8558 | Japan |
| Sakai | Osaka | 591-8555 | Japan |
| Sayama | Osaka | 589-8511 | Japan |
| Itabashi-ku | Tokyo | 173-8606 | Japan |
| Koto-ku | Tokyo | 135-8550 | Japan |
| Amsterdam | 1081HV | Netherlands |
| Harderwijk | 3844 DG | Netherlands |
| Heerlen | 6419 PC | Netherlands |
| Helmond | 5707 HA | Netherlands |
| Nieuwegein | 3435 CM | Netherlands |
| Zwolle | 8025 AB | Netherlands |
| Lahore | Punjab Province | 54000 | Pakistan |
| Karachi | Sindh | 74700 | Pakistan |
| Callao | CALLAO 2 | Peru |
| Lima | LIMA 11 | Peru |
| Lima | LIMA 1 | Peru |
| Lima | LIMA 27 | Peru |
| Lima | LIMA 34 | Peru |
| San Borja | Peru |
| Cebu City | 6000 | Philippines |
| Manila | 1000 | Philippines |
| Metro Manila | 1000 | Philippines |
| Quezon City | 1104 | Philippines |
| Kielce | 25-316 | Poland |
| Krakow | 31-115 | Poland |
| Olsztyn | 10-357 | Poland |
| Rzeszów | 35-021 | Poland |
| Szczecin | 70-891 | Poland |
| Warsaw | 01-138 | Poland |
| Kazan' | 420029 | Russia |
| Moscow | 105 005 | Russia |
| Moscow | 115478 | Russia |
| Moscow | 129128 | Russia |
| Saint Petersburg | 198255 | Russia |
| Yaroslavl | 150054 | Russia |
| Singapore | 119228 | Singapore |
| Singapore | 308433 | Singapore |
| Port Elizabeth | Eastern Cape | 6045 | South Africa |
| Johannesburg | Gauteng | 2196 | South Africa |
| Prietoria | Gauteng | 0084 | South Africa |
| Durban | KwaZulu-Natal | 4126 | South Africa |
| Cape Town | Western Cape | 7500 | South Africa |
| Seoul | Seoul Teugbyeolsi | 110-744 | South Korea |
| Seoul | 135-710 | South Korea |
| Seoul | 136-705 | South Korea |
| Seoul | 137-701 | South Korea |
| Seoul | 138-736 | South Korea |
| Barcelona | Barcelona | 08025 | Spain |
| Barcelona | Barcelona | 08036 | Spain |
| Cruces/Barakaldo | Bilbao | 48903 | Spain |
| Lleida | Lleida | 25198 | Spain |
| Lugo | Lugo | 27003 | Spain |
| Madrid | Madrid | 28040 | Spain |
| Málaga | Málaga | 29010 | Spain |
| Ourense | Ourense | 32005 | Spain |
| Seville | Sevilla | 41013 | Spain |
| Zamora | Zamora | 49021 | Spain |
| Falun | 791 82 | Sweden |
| Gothenburg | 413 45 | Sweden |
| Linköping | 581 85 | Sweden |
| Lund | 221 85 | Sweden |
| Stockholm | 171 76 | Sweden |
| Kaohsiung City | 80756 | Taiwan |
| Taichung | 404 | Taiwan |
| Taichung | 40705 | Taiwan |
| Taipei | 10016 | Taiwan |
| Taoyuan | 333 | Taiwan |
| Bangkok | 10700 | Thailand |
| Chiang Mai | 50200 | Thailand |
| Songkhla | 90110 | Thailand |
| Ankara | Turkey (Türkiye) |
| Instanbul | 34662 | Turkey (Türkiye) |
| Istanbul | Turkey (Türkiye) |
| Izmir | Turkey (Türkiye) |
| Kocaeli | 41400 | Turkey (Türkiye) |
| Bristol | Avon | BS10 5NB | United Kingdom |
| Cambridge | Cambridgeshire | CB2 0QQ | United Kingdom |
| London | London | NW3 2QG | United Kingdom |
| London | London | SW3 6JJ | United Kingdom |
| Greater Manchester | Manchester | M20 4BX | United Kingdom |
| Sutton | Surrey | SM2 5PT | United Kingdom |
| Leeds | West Yorkshire | LS9 7TF | United Kingdom |
| Aberdeen | AB25 2ZN | United Kingdom |
| Participants Received Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Survival Follow up |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sorafenib (Nexavar, BAY43-9006) | Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID) |
| BG001 | Placebo | Participants received 2 tablets of placebo orally twice daily (BID) |
| 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 |
| ||||||||||||||||
| Region (CRF [case report form]) | Number | Participants |
| ||||||||||||||||
| Number of participants with prior anti-cancer therapy and diagnostic procedures | Number | Participants |
| ||||||||||||||||
| Brain metastasis | Number | Participants |
| ||||||||||||||||
| Prior EGFR (Epidermal Growth Factor Receptor) inhibitor treatment | Number | Participants |
| ||||||||||||||||
| ECOG (Eastern Cooperative Oncology Group) performance status | A scale that measures how cancer affects the daily life of a patient on an ordinal scale from grade 0 (best) to grade 5 (worst). | 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 | Overall Survival | Overall survival (OS) was defined as the time from date of randomization to date of death due to any cause. Overall survival of subjects alive at the time of analysis will be censored at their last date of follow-up or database cut off date whichever came first. | Full Analysis Set (FAS) | Posted | Median | 95% Confidence Interval | Days | From randomization of the first subject until 36 months later |
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| Secondary | Progression-free Survival | Progression-free survival (PFS) was defined as the time from date of randomization to date of first observed disease progression (radiological or clinical, whichever is earlier) or death due to any cause, if death occurs before progression is documented. Progressive Disease (PD) is defined as at least a 20% increase in the sum of longest diameter (LD) of measured lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Appearance of new lesions will also constitute progressive disease. In exceptional circumstances unequivocal progression of a non-measured lesion may be accepted as evidence of disease progression. | Full Analysis Set (FAS) | Posted | Median | 95% Confidence Interval | Days | From randomization of the first subject until 36 months later assessed every 6 weeks |
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| Secondary | Disease Control | Disease control (DC) was defined as the proportion of patients whose best response was Complete Response [CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target)] or Partial Response [PR: at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD] or Stable Disease [SD: steady state of disease which was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD)]. | Full Analysis Set (FAS) | Posted | Number | Proportion of participants | From randomization of the first subject until 36 months later assessed every 6 weeks |
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| Secondary | Objective Tumor Response | Objective tumor response was defined as the proportion of patients whose best response was Complete Response [CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target)] or Partial Response [PR: at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD] over the whole duration of study. | Full Analysis Set (FAS) | Posted | Number | Proportion of participants | From randomization of the first subject until 36 months later assessed every 6 weeks |
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| Secondary | Time to Progression | Time to progression (TTP) was defined as the time from date of randomization to date of first observed disease progression (radiological or clinical, whichever is earlier). | Full Analysis Set (FAS) | Posted | Median | 95% Confidence Interval | Days | From randomization of the first subject until 36 months later assessed every 6 weeks |
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| Secondary | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire for Palliative Care (EORTC QLQ-C15-PAL) - Global Health Status | The EORTC QLQ-C15-PAL is an abbreviated 15-item version of the EORTC core quality of life questionnaire (EORTC QLQ-C30) developed for use in palliative care. The 'Global Health status' subscale consists of question 15 of the questionnaire. The score of 'Global Health status' ranges from 0 (very poor) to 100 (excellent). The change of score ranges from -100 (maximum degree of worsening) to 100 (maximum degree of improvement). | Patient report outcomes (PRO) analysis set | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle) |
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| Secondary | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Coughing Subscale | A clinically valid 13-item tool for assessing disease- and treatment-specific symptoms in lung cancer patients in clinical trials. The coughing subscale uses question 1 of the questionnaire. The scale ranges from 0 to 100. Higher score means higher level of symptomatology/problems. The change of score ranges from -100 (decrease in level of symptomatology/problems) to 100 (increase in level of symptomatology/problems). | Patient report outcomes (PRO) analysis set | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle) |
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| Secondary | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Dyspnea | A clinically valid 13-item tool for assessing disease- and treatment-specific symptoms in lung cancer patients in clinical trials. The dyspnea subscale uses questions 3, 4 and 5 of the questionnaire. The scale ranges from 0 to 100. Higher score means higher level of symptomatology/problems. The change of score ranges from -100 (decrease in level of symptomatology/problems) to 100 (increase in level of symptomatology/problems). | Patient report outcomes (PRO) analysis set | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle) |
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| Secondary | Mean Change From Baseline in EuroQol-5D (EQ-5D) - Index Score | The Euro-Qol 5D (EQ-5D) is a validated assessment tool of Health Related Quality of Life (HRQOL) and utilities consisting of 15 statements. Patients select those statements that best describe their current health state regarding mobility, self-care, usual activities, pain/discomfort, and anxiety/depression which is converted into a utility value. Range of scale is from -0.594 (worst possible health state) to 1 (perfect health) based on UK weights. The change of score ranges from -1.594 (high degree of worsening) to 1.594 (high degree of improvement). | Patient report outcomes (PRO) analysis set | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle) |
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| Secondary | Mean Change From Baseline in EuroQol-5D (EQ-5D) - VAS Score | A visual analogue scale (EQ VAS) used by patients to rate their current health state from 100 (best imaginable health state) to 0 (worst imaginable health state). The change of score ranges from -100 (high degree of worsening) to 100 (high degree of improvement) | Patient report outcomes (PRO) analysis set | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle) |
|
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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) | Participants received 2 tablets of Sorafenib (2x200 mg) orally twice daily (BID) | 136 | 346 | 332 | 346 | ||
| EG001 | Placebo | Participants received 2 tablets of placebo orally twice daily (BID) | 111 | 351 | 289 | 351 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DIC | 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 |
| |
| INR | 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 |
| |
| Neutrophils | 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 |
| |
| Conduction abnormality, AV Block - 3rd Degree (Complete AV Block) | Cardiac disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Hypertension | Cardiac disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Supraventricular arrhythmia, Atrial Tach/Paroxysmal AT | Cardiac disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Supraventricular arrhythmia, Atrial fibrillation | Cardiac disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Auditory/Ear - Other | Ear and labyrinth disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Ocular - Other | Eye 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 |
| |
| Esophagitis | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| GI - Other | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Gastritis | 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 |
| |
| 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 |
| |
| Obstruction, GI, Small bowel NOS | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Stricture, GI, Biliary tree | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Stricture, GI, Esophagus | 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, Death NOS | 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 |
| |
| 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, 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, Pain NOS | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Pain, Tumor pain | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Weight loss | General 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 |
| |
| Allergic reaction | Immune system 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 - Other | Infections and infestations | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Infection with normal ANC, Bone (Osteomyelitis) | Infections and infestations | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Infection with normal ANC, Brain (Encephalitis, infectious) | Infections and infestations | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Infection with normal ANC, Bronchus | 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 |
| |
| Infection with normal ANC, Upper airway NOS | 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, Upper airway NOS | Infections and infestations | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Acidosis (metabolic or respiratory) | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Hyperuricemia | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Hypocalcemia | 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 |
| |
| Hyponatremia | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Device/Prosthesis | Musculoskeletal and connective tissue disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Fracture | Musculoskeletal and connective tissue disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Muscle weakness, Extremity - lower | Musculoskeletal and connective tissue disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Muscle weakness, Extremity - upper | Musculoskeletal and connective tissue disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Apnea | Nervous system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| CNS ischemia | Nervous system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Confusion | Nervous system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Neurology - Other | Nervous system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Neuropathy: motor | Nervous system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Neuropathy: sensory | Nervous system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Pyramidal tract dysfunction | Nervous system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Speech impairment | 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 | 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 |
| |
| Chest tube drainage or leak | Respiratory, thoracic and mediastinal 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 |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Pleural effusion | 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 |
| |
| Pneumothorax | 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 |
| |
| Dermatology - Other | 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 |
| |
| 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 pulmonary, Bronchopulmonary NOS | Vascular disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Hemorrhage pulmonary, Lung | 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, Rectum | Vascular disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Thrombosis/Embolism (vascular access) | 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 |
| |
| Pain, Head/Headache | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin | 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 |
| |
| Constipation | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Diarrhea | 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 |
| |
| 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, 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, 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, Muscle | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Weight loss | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Infection with normal ANC, Upper airway NOS | Infections and infestations | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| ALT | 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 |
| |
| 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 |
| |
| Metabolic/Lab - Other | 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 |
| |
| Dizziness | Nervous system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Neuropathy: sensory | Nervous system 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 |
| |
| 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 |
|
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 in order to obtain approval.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | BAYER | clinical-trials-contact@bayerhealthcare.com |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract 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
| Consent Withdrawn |
|
| >= 65 and < 75 years |
|
| >= 75 years |
|
| Male |
|
| Group 2 (S. America, Eastern Europe, Asia-Pacific) |
|
| 3 regimens |
|
| 4 regimens |
|
| 5 regimens |
|
| Yes |
|
| Missing |
|
| Yes |
|
| 0 |
|
| 1 |
|
| 2 |
|
| Participants |
|
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