Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2006-002688-26 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Evaluation of gemcitabine and cisplatin in combination with either sorafenib or placebo for the treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC)
During follow-up, it was determined that there was one additional patient on placebo that was still receiving treatment as of 06 APR 2010 and therefore 10 patients' data are reported in the current CSR addendum, 6 in the sorafenib + GC group and 4 in the placebo + GC group, and as before all in the ITT (non-squamous) population.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) + GC | Experimental | Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met. |
|
| Placebo + GC | Placebo Comparator | Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | Drug | Multikinase inhibitor, Sorafenib 400 mg po bid; applied in combination with chemotherapy components: Gemcitabine 1250 mg/m^2 IV, Cisplatin 75 mg/m^2 IV |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) in the ITT (Non-squamous) Population | Overall survival (OS) was defined as the time from date of randomization to death due to any cause. Patients still alive at the time of analysis were censored at their last date of last contact. | from randomization of the first patient until 38 months or date of death of any cause whichever came first |
| Measure | Description | Time Frame |
|---|---|---|
| OS in the ITT (Both Squamous and Non-squamous) Population | OS was defined as the time from date of randomization to death due to any cause. Patients still alive at the time of analysis were censored at their last date of last contact. | from randomization of the first patient until 38 months or date of death of any cause whichever came first |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Excluded medical conditions:
Excluded therapies and medications, previous and concomitant:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Innsbruck | 6020 | Austria | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22851564 | Result | Paz-Ares LG, Biesma B, Heigener D, von Pawel J, Eisen T, Bennouna J, Zhang L, Liao M, Sun Y, Gans S, Syrigos K, Le Marie E, Gottfried M, Vansteenkiste J, Alberola V, Strauss UP, Montegriffo E, Ong TJ, Santoro A; NSCLC [non-small-cell lung cancer] Research Experience Utilizing Sorafenib (NExUS) Investigators Study Group. Phase III, randomized, double-blind, placebo-controlled trial of gemcitabine/cisplatin alone or with sorafenib for the first-line treatment of advanced, nonsquamous non-small-cell lung cancer. J Clin Oncol. 2012 Sep 1;30(25):3084-92. doi: 10.1200/JCO.2011.39.7646. Epub 2012 Jul 30. |
| Label | URL |
|---|---|
| Click here and search for Bayer Product information provided by EMA | View source |
Not provided
All 904 randomized patients were included in the intent to treat (ITT) population. A total of 901 patients received at least one dose of study medication and were included in the safety population. Study medication included administration of any one of the following treatments: gemcitabine, cisplatin, sorafenib or placebo.
This study was conducted at 93 centers across 16 countries, which enrolled and randomized at least one patient. From a total of 1011 patients who were screened, 904 patients were randomized between 23 FEB 2007 and 03 MAR 2009.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Sorafenib (Nexavar, BAY43-9006) + GC | Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo 2 tablets po bid; applied in combination with chemotherapy components: Gemcitabine 1250 mg/m^2 IV, Cisplatin 75 mg/m^2 IV |
|
| Gemcitabine | Drug | Chemotherapy component; Gemcitabine 1250 mg/m^2 IV |
|
| Cisplatin | Drug | Chemotherapy component; Cisplatin 75 mg/m^2 IV |
|
| OS in the ITT (Squamous) Population |
OS was defined as the time from date of randomization to death due to any cause. Patients still alive at the time of analysis were censored at their last date of last contact. |
| from randomization of the first patient until 38 months or date of death of any cause whichever came first |
| Progression-free Survival (PFS) in the ITT (Non-squamous) Population | PFS was defined as the time from date of randomization to disease progression (radiological or clinical, whichever was earlier, based on Investigator-assessment using Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0) or death due to any cause, whichever occured first. Patients without progression or death at the time of analysis were censored at their last date of tumor evaluation. Disease progression: increase in the sum of tumor lesion sizes or new lesions. | from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks |
| Time to Progression (TTP) in the ITT (Non-squamous) Population | TTP was defined as the time from date of randomization to disease progression (radiological or clinical, whichever was earlier, based on Investigator-assessment using RECIST version 1.0). Patients without progression at the time of analysis or death before progression were censored at their last date of tumor evaluation. Disease progression: increase in the sum of tumor lesion sizes or new lesions. | from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks |
| Percentage of Participants With Different Tumor Response in the ITT (Non-squamous) Population | Tumor response (= Best Overall Response) of a patient was defined as the best tumor response (confirmed Complete Response (CR: disappearance of tumor lesions), confirmed Partial Response (PR: a decrease of at least 30% in the sum of tumor lesion sizes), Stable Disease (SD: steady state of disease), or Progressive Disease (PD: an increase in the sum of tumor lesions sizes or new lesions)) observed during trial period assessed according to the RECIST criteria (version 1.0) based on Investigator-assessment. | from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks |
| Disease Control (DC) in the ITT (Non-squamous) Population | DC was defined as the total number of patients whose best response was not PD according to RECIST (version 1.0) by Investigator-assessment (= total number of CR + total number of PR + total number of SD; CR or PR had to be maintained for at least 28 days from the first demonstration of that rating, SD had to be documented at least once more than 6 weeks from baseline). PD: an increase in the sum of tumor lesions sizes or new lesions. | from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks |
| Duration of Response in the ITT (Non-squamous) Population | Duration of response was defined as the time from date of first documented objective response of PR or CR, whichever was noted earlier, to date of disease progression or death (if death occurred before progression was documented). Patients without disease progression at the time of analysis or death before progression were censored at the last date of tumor evaluation. Disease progression: increase in the sum of tumor lesion sizes or new lesions. | from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks |
| Duration of Stable Disease (SD) in the ITT (Non-squamous) Population | Duration of SD was defined as the time from date of randomization to date that disease progression (radiological or clinical, whichever was earlier) was first documented. Patients without disease progression at the time of analysis or death before progression were censored at the date of their last tumor assessment.(Disease progression: increase in the sum of tumor lesion sizes or new lesions.) Duration of stable disease was only evaluated in patients failing to achieve a best response of CR or PR. | from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks |
| Time to Response (TTR) in the ITT (Non-squamous) Population | TTR for patients who achieved a best response (CR or PR) was defined as the time from date of randomization to the earliest date that response was first documented. | from randomization of the first patient until 38 months or date of death of any cause whichever came first |
| Functional Assessment of Cancer Treatment-Lung (FACT-L) Scores in the ITT (Non-squamous) Population | The FACT-L measures health related quality of life (HRQOL) and composes of five domains: the four domains (physical well being, emotional well being, social well being, functional well being) from the Functional Assessment of Cancer Treatment-General scale (FACT-G) and the lung cancer subscale (LCS). The FACT-L total score ranges from 0 to 136, higher scores represent better HRQOL. | from randomization of the first patient until 38 months |
| Lung Cancer Subscale (LCS) Scores in the ITT (Non-squamous) Population | LCS is a subscale of FACT-L measuring lung cancer specific symptoms. The LCS scores range from 0 to 28, higher scores represent fewer lung cancer symptoms. | from randomization of the first patient to 38 months later or death whatever occurs first. |
| Time to Symptomatic Deterioration (TSD) in the ITT (Non-squamous) Population | TSD is defined as the time from randomization to the date of symptomatic deterioration (≥3 point decline in the LCS score that is maintained for at least 2 consecutive cycles) or death if death occurs before these 2 consecutive cycles are completed. | from randomization of the first patient to 38 months later or death whatever occurs first |
| Euro Quality of Life - 5D (EQ-5D) Index Scores in the ITT (Non-squamous) Population | The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index score which ranges from -0.594 to 1 when the United Kingdom (UK) weights are applied (0=death, 1=perfect health). Higher index scores represent better health states. | from randomization of the first patient until 38 months later or death whatever occurs first |
| EQ-5D Visual Analog Scale (VAS) Scores in the ITT (Non-squamous) Population | The EQ-5D also contains a visual analog scale (EQ-VAS), which records the respondent's self-rated health status on a vertical graduated visual analog scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). | from randomization of the first patient until 38 months later or death whatever occurs first |
| Linz |
| 4010 |
| Austria |
| Vienna | 1130 | Austria |
| Vienna | 1140 | Austria |
| Brasschaat | 2930 | Belgium |
| Bruxelles - Brussel | 1200 | Belgium |
| Edegem | 2650 | Belgium |
| Leuven | 3000 | Belgium |
| Liège | 4000 | Belgium |
| Namur | 5000 | Belgium |
| Salvador | Estado de Bahia | 40050410 | Brazil |
| Salvador | Estado de Bahia | 40170-070 | Brazil |
| Salvador | Estado de Bahia | 41820 021 | Brazil |
| BrasÃlia | Federal District | 70840 901 | Brazil |
| Goiânia | Goiás | 74075040 | Brazil |
| Goiânia | Goiás | 74605-070 | Brazil |
| Belo Horizonte | Minas Gerais | 30110-090 | Brazil |
| Rio de Janeiro | Rio de Janeiro | 20231 050 | Brazil |
| Porto Alegre | Rio Grande do Sul | 90050 170 | Brazil |
| Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Jaú | São Paulo | 17210-120 | Brazil |
| Santo André | São Paulo | 09060-870 | Brazil |
| Santo André | São Paulo | 09090-780 | Brazil |
| São Paulo | São Paulo | 01221020 | Brazil |
| São Paulo | São Paulo | 01331020 | Brazil |
| São Paulo | São Paulo | 05403-010 | Brazil |
| São Paulo | São Paulo | 05651-901 | Brazil |
| Sorocaba | São Paulo | 18030-510 | Brazil |
| Montreal | Quebec | H3A 1A1 | Canada |
| Guangzhou | Guangdong | 510060 | China |
| Wuhan | Hubei | 430030 | China |
| Nanjing | Jiangsu | 210002 | China |
| Hangzhou | Zhejiang | 310016 | China |
| Hangzhou | Zhejiang | 310022 | China |
| Beijing | 100021 | China |
| Shanghai | 200030 | China |
| Shanghai | 200433 | China |
| Nicosia | 2006 | Cyprus |
| HUS | 00029 | Finland |
| Preitilä | 21540 | Finland |
| Tampere | FIN-33521 | Finland |
| Bayonne | 64100 | France |
| Grenoble | 38043 | France |
| Grenoble | 38100 | France |
| Hyères | 83400 | France |
| Le Mans | 72015 | France |
| Marseille | 13275 | France |
| Nantes | 44805 | France |
| Nîmes | 30907 | France |
| Paris | 75908 | France |
| Perpignan | 66000 | France |
| Pierre-Bénite | 69495 | France |
| Strasbourg | 67901 | France |
| Tours | 37044 | France |
| Heidelberg | Baden-Wurttemberg | 69126 | Germany |
| Karlsruhe | Baden-Wurttemberg | 76137 | Germany |
| Löwenstein | Baden-Wurttemberg | 74245 | Germany |
| Gauting | Bavaria | 82131 | Germany |
| Hamburg | Free and Hanseatic City of Hamburg | 21075 | Germany |
| Frankfurt am Main | Hesse | 60431 | Germany |
| Hofheim | Hesse | 65719 | Germany |
| Cologne | North Rhine-Westphalia | 51109 | Germany |
| Essen | North Rhine-Westphalia | 45122 | Germany |
| Leipzig | Saxony | 04207 | Germany |
| Großhansdorf | Schleswig-Holstein | 22927 | Germany |
| Bad Berka | Thuringia | 99437 | Germany |
| Heraklion | Crete | 711 10 | Greece |
| Athens | Greece | 11527 | Greece |
| Athens | 11527 | Greece |
| Budapest | 1121 | Hungary |
| Budapest | 1125 | Hungary |
| Deszk | 6772 | Hungary |
| Mátraháza | 3233 | Hungary |
| Székesfehérvár | 8000 | Hungary |
| Törökbálint | 2045 | Hungary |
| Ashkelon | 7830604 | Israel |
| Holon | 58100 | Israel |
| Kfar Saba | 4428164 | Israel |
| Rehovot | 7610001 | Israel |
| Tel Litwinsky | 5262000 | Israel |
| Rozzano | Milano | 20089 | Italy |
| Monza | Monza-Brianza | 20052 | Italy |
| Aviano | Pordenone | 33081 | Italy |
| Bologna | 40138 | Italy |
| Catania | 95122 | Italy |
| Florence | 50134 | Italy |
| Livorno | 57124 | Italy |
| Milan | 20132 | Italy |
| Roma | 00152 | Italy |
| Sassari | 07100 | Italy |
| Venezia | 30122 | Italy |
| Verona | 37134 | Italy |
| Guadalajara | Jalisco | 44280 | Mexico |
| Mexico City | Mexico City | 14080 | Mexico |
| Monterrey | Nuevo León | 64460 | Mexico |
| 's-Hertogenbosch | 5211 RW | Netherlands |
| Ede | 6716 RP | Netherlands |
| Harderwijk | 3844 DG | Netherlands |
| Heerlen | 6419 PC | Netherlands |
| Nieuwegein | 3435 CM | Netherlands |
| A Coruña | A Coruña | 15006 | Spain |
| Barcelona | Barcelona | 08025 | Spain |
| Terrassa | Barcelona | 08227 | Spain |
| Cruces/Barakaldo | Bilbao | 48903 | Spain |
| Madrid | Madrid | 28040 | Spain |
| Madrid | Madrid | 28041 | Spain |
| Málaga | Málaga | 29010 | Spain |
| Seville | Sevilla | 41013 | Spain |
| Valencia | Valencia | 46010 | Spain |
| Valencia | Valencia | 46014 | Spain |
| Valencia | Valencia | 46015 | Spain |
| Basel | Canton of Basel-City | 4031 | Switzerland |
| Bern | Canton of Bern | 3010 | Switzerland |
| Genéve | Canton of Geneva | 1205 | Switzerland |
| Cambridge | Cambridgeshire | CB2 0QQ | United Kingdom |
| Aberdeen | Grampian | AB25 2ZN | United Kingdom |
| Leicester | Leicestershire | LE1 5WW | United Kingdom |
| London | London | SE1 9RT | United Kingdom |
| London | London | SW3 6JJ | United Kingdom |
| Sutton | Surrey | SM2 5PT | United Kingdom |
| Wolverhampton | West Midlands | WV10 0QP | United Kingdom |
| Birmingham | B15 2TH | United Kingdom |
| FG001 | Placebo + GC | Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met. |
| Received Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Follow-up Period |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sorafenib (Nexavar, BAY43-9006) + GC | Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met. |
| BG001 | Placebo + GC | Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met. |
| 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 | Median | Full Range | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| histology of the tumor | Number | Participants |
| ||||||||||||||||
| Time since initial diagnosis | Median | Full Range | Weeks |
| |||||||||||||||
| Smoking history | Number | Participants |
| ||||||||||||||||
| Tumor stage at randomization | Categorized information on tumor size, lymph node involvement and metastases. Stages I-IV. The higher the stage the more advanced cancer. Stage IIIB versus IV was a stratification factor for randomization. Stage IIIB (according to American Joint Committee on Cancer): primary tumor any stage, regional lymph node stage N3, no distant metastasis OR primary tumor stage T4, regional lymph node any stage, no distant metastasis. Stage IV: primary tumor any stage, regional lymph node any stage, distant metastasis present. | Number | Participants |
| |||||||||||||||
| ECOG (Eastern Cooperative Oncology Group) Performance Status at randomization | ECOG 0 versus 1 was a stratification factor for randomization. ECOG Performance Status is a rating of daily living abilities, from 0 to 5: 0= fully active without restriction. 1= restricted in physically strenuous activity; 2= ambulatory, capable of all selfcare; 3= capable of limited selfcare; 4= completely disabled; 5= dead. | Number | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Survival (OS) in the ITT (Non-squamous) Population | Overall survival (OS) was defined as the time from date of randomization to death due to any cause. Patients still alive at the time of analysis were censored at their last date of last contact. | Evaluation of OS based on ITT (non-squamous) population. Patients alive at the time of analysis were censored at their last date of follow-up (last visit or contact or at the data cut-off date). In the case of an incomplete date, where day was missing, day 15 (the middle of the month) was used. | Posted | Median | 95% Confidence Interval | days | from randomization of the first patient until 38 months or date of death of any cause whichever came first |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | OS in the ITT (Both Squamous and Non-squamous) Population | OS was defined as the time from date of randomization to death due to any cause. Patients still alive at the time of analysis were censored at their last date of last contact. | Evaluation of OS based on ITT (both non-squamous and squamous) population. Patients alive at the time of analysis were censored at their last date of follow-up (last visit or contact or at the data cut-off date). In the case of an incomplete date, where day was missing, day 15 (the middle of the month) was used. | Posted | Median | 95% Confidence Interval | days | from randomization of the first patient until 38 months or date of death of any cause whichever came first |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | OS in the ITT (Squamous) Population | OS was defined as the time from date of randomization to death due to any cause. Patients still alive at the time of analysis were censored at their last date of last contact. | Evaluation of OS based on ITT (squamous) population. Patients alive at the time of analysis were censored at their last date of follow-up (last visit or contact or at the data cut-off date). In the case of an incomplete date, where day was missing, day 15 (the middle of the month) was used. No statistical testing performed. | Posted | Median | 95% Confidence Interval | days | from randomization of the first patient until 38 months or date of death of any cause whichever came first |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) in the ITT (Non-squamous) Population | PFS was defined as the time from date of randomization to disease progression (radiological or clinical, whichever was earlier, based on Investigator-assessment using Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0) or death due to any cause, whichever occured first. Patients without progression or death at the time of analysis were censored at their last date of tumor evaluation. Disease progression: increase in the sum of tumor lesion sizes or new lesions. | Evaluation of PFS based on ITT (non-squamous) population. PFS for patients with no tumour assessments after baseline was censored at one day. | Posted | Median | 95% Confidence Interval | days | from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Progression (TTP) in the ITT (Non-squamous) Population | TTP was defined as the time from date of randomization to disease progression (radiological or clinical, whichever was earlier, based on Investigator-assessment using RECIST version 1.0). Patients without progression at the time of analysis or death before progression were censored at their last date of tumor evaluation. Disease progression: increase in the sum of tumor lesion sizes or new lesions. | Evaluation of TTP based on ITT (non-squamous) population. TTP for patients with no tumour assessments after baseline was censored at one day. | Posted | Median | 95% Confidence Interval | days | from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Different Tumor Response in the ITT (Non-squamous) Population | Tumor response (= Best Overall Response) of a patient was defined as the best tumor response (confirmed Complete Response (CR: disappearance of tumor lesions), confirmed Partial Response (PR: a decrease of at least 30% in the sum of tumor lesion sizes), Stable Disease (SD: steady state of disease), or Progressive Disease (PD: an increase in the sum of tumor lesions sizes or new lesions)) observed during trial period assessed according to the RECIST criteria (version 1.0) based on Investigator-assessment. | Evaluation of Tumour Response based on ITT (non-squamous) population. | Posted | Number | percentage of participants | from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Disease Control (DC) in the ITT (Non-squamous) Population | DC was defined as the total number of patients whose best response was not PD according to RECIST (version 1.0) by Investigator-assessment (= total number of CR + total number of PR + total number of SD; CR or PR had to be maintained for at least 28 days from the first demonstration of that rating, SD had to be documented at least once more than 6 weeks from baseline). PD: an increase in the sum of tumor lesions sizes or new lesions. | Evaluation of Disease Control based on ITT (non-squamous) population. | Posted | Number | percentage of participants | from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response in the ITT (Non-squamous) Population | Duration of response was defined as the time from date of first documented objective response of PR or CR, whichever was noted earlier, to date of disease progression or death (if death occurred before progression was documented). Patients without disease progression at the time of analysis or death before progression were censored at the last date of tumor evaluation. Disease progression: increase in the sum of tumor lesion sizes or new lesions. | Evaluation of duration of response based on ITT (non-squamous) population. No statistical testing performed. | Posted | Median | 95% Confidence Interval | days | from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Stable Disease (SD) in the ITT (Non-squamous) Population | Duration of SD was defined as the time from date of randomization to date that disease progression (radiological or clinical, whichever was earlier) was first documented. Patients without disease progression at the time of analysis or death before progression were censored at the date of their last tumor assessment.(Disease progression: increase in the sum of tumor lesion sizes or new lesions.) Duration of stable disease was only evaluated in patients failing to achieve a best response of CR or PR. | Evaluation of duration of stable disease based on ITT (non-squamous) population. No statistical testing performed. | Posted | Median | 95% Confidence Interval | days | from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Response (TTR) in the ITT (Non-squamous) Population | TTR for patients who achieved a best response (CR or PR) was defined as the time from date of randomization to the earliest date that response was first documented. | Evaluation of TTR based on ITT (non-squamous) population. No statistical testing performed. | Posted | Median | 95% Confidence Interval | days | from randomization of the first patient until 38 months or date of death of any cause whichever came first |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Functional Assessment of Cancer Treatment-Lung (FACT-L) Scores in the ITT (Non-squamous) Population | The FACT-L measures health related quality of life (HRQOL) and composes of five domains: the four domains (physical well being, emotional well being, social well being, functional well being) from the Functional Assessment of Cancer Treatment-General scale (FACT-G) and the lung cancer subscale (LCS). The FACT-L total score ranges from 0 to 136, higher scores represent better HRQOL. | All patients valid for the ITT analysis who have a baseline and at least one post baseline value. | Posted | Least Squares Mean | 95% Confidence Interval | scores on a scale | from randomization of the first patient until 38 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Lung Cancer Subscale (LCS) Scores in the ITT (Non-squamous) Population | LCS is a subscale of FACT-L measuring lung cancer specific symptoms. The LCS scores range from 0 to 28, higher scores represent fewer lung cancer symptoms. | All patients valid for the ITT analysis who have a baseline and at least one post baseline value. | Posted | Least Squares Mean | 95% Confidence Interval | scores on a scale | from randomization of the first patient to 38 months later or death whatever occurs first. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Symptomatic Deterioration (TSD) in the ITT (Non-squamous) Population | TSD is defined as the time from randomization to the date of symptomatic deterioration (≥3 point decline in the LCS score that is maintained for at least 2 consecutive cycles) or death if death occurs before these 2 consecutive cycles are completed. | All patients valid for the ITT analysis who have a baseline and at least one post baseline value. | Posted | Median | 95% Confidence Interval | months | from randomization of the first patient to 38 months later or death whatever occurs first |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Euro Quality of Life - 5D (EQ-5D) Index Scores in the ITT (Non-squamous) Population | The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index score which ranges from -0.594 to 1 when the United Kingdom (UK) weights are applied (0=death, 1=perfect health). Higher index scores represent better health states. | All patients valid for the ITT analysis who have a baseline and at least one post baseline value. | Posted | Least Squares Mean | 95% Confidence Interval | scores on a scale | from randomization of the first patient until 38 months later or death whatever occurs first |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | EQ-5D Visual Analog Scale (VAS) Scores in the ITT (Non-squamous) Population | The EQ-5D also contains a visual analog scale (EQ-VAS), which records the respondent's self-rated health status on a vertical graduated visual analog scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). | All patients valid for the ITT analysis who have a baseline and at least one post baseline value. | Posted | Least Squares Mean | 95% Confidence Interval | scores on a scale | from randomization of the first patient until 38 months later or death whatever occurs first |
|
Not provided
Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
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) + GC | Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met. | 270 | 452 | 440 | 452 | ||
| EG001 | Placebo + GC | Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met. | 198 | 449 | 435 | 449 |
| 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 |
| |
| Bone marrow cellularity | Blood and lymphatic system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Edema: Head and Neck | 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 arrhythmia - Other | Cardiac 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, Conduction abnormality NOS | Cardiac disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Hypertension | Cardiac disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Hypotension | Cardiac disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Left ventricular systolic dysfunction | Cardiac disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Pericarditis | Cardiac disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Supraventricular arrhythmia, Atrial fibrillation | Cardiac disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Supraventricular arrhythmia, Atrial flutter | Cardiac disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Supraventricular arrhythmia, Supraventricular tachycardia | Cardiac disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Ventricular arrhythmia, Ventricular arrhythmia NOS | Cardiac disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Ventricular arrhythmia, Ventricular tachycardia | Cardiac disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Diabetes | Endocrine disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Endocrine - Other | Endocrine disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Optic disc edema | Eye disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Vitreous hemorrhage | 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 |
| |
| Enteritis | 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 |
| |
| Ileus | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Mucositis (functional/symptomatic), Esophagus | 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, Colon | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Obstruction, GI, Gallbladder | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Obstruction, GI, Ileum | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Perforation, GI, Colon | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Perforation, GI, Stomach | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Stricture, GI, Colon | 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 |
| |
| 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 |
| |
| Hypothermia | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| No code in CTCAE | 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, Gallbladder | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Pain, Head/Headache | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Pain, Neuralgia/Peripheral nerve | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Pain, Other | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Pain, Pelvis | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Pain, Stomach | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Pain, Tumor pain | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Tumor lysis syndrome | 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 |
| |
| Febrile neutropenia | Infections and infestations | 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), Kidney | 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), Pleura (Empyema) | 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 - Other | Infections and infestations | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Infection with normal ANC, Abdomen NOS | Infections and infestations | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Infection with normal ANC, Anal/perianal | 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, Bronchus | Infections and infestations | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Infection with normal ANC, Catheter-related | 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, Meninges (Meningitis) | Infections and infestations | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Infection with normal ANC, Scrotum | 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, Soft tissue NOS | 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, Blood | 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, Pleura (Empyema) | Infections and infestations | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Infection with unknown ANC, Soft tissue NOS | Infections and infestations | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Infection with unknown ANC, Wound | Infections and infestations | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Intraop injury, Jejunum | Injury, poisoning and procedural complications | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Intraop injury, Lung | Injury, poisoning and procedural complications | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| ALT | 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 |
| |
| GFR | 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 |
| |
| 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 |
| |
| Hypomagnesemia | 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 |
| |
| Hypophosphatemia | 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 |
| |
| Muscle weakness, Extremity - lower | Musculoskeletal and connective tissue disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Muscle weakness, Whole body/generalized | Musculoskeletal and connective tissue disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Musculoskeletal - Other | Musculoskeletal and connective tissue disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Soft tissue necrosis, Extremity - lower | 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 |
| |
| Confusion | 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 |
| |
| Neurology - Other | Nervous system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Neuropathy: Cranial, CN II Vision | 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 |
| |
| Personality | 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 |
| |
| Tremor | 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 |
| |
| ARDS | Respiratory, thoracic and mediastinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Airway obstruction, Bronchus | Respiratory, thoracic and mediastinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Bronchospasm | 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 |
| |
| 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 |
| |
| Erythema multiforme | 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 |
| |
| Artery injury, Aorta | Vascular disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| CNS hemorrhage | Vascular disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Hemorrhage - Other | 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 pulmonary, Nose | Vascular disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Hemorrhage pulmonary, Respiratory tract NOS | 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, Anus | 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, Duodenum | 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 |
| |
| Peripheral arterial ischemia | Vascular disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Phlebitis | 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 |
| |
| Visceral arterial ischemia | Vascular disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
|
| 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 |
| |
| Leukocytes | 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 |
| |
| 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 |
| |
| Hypertension | Cardiac disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth 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 |
| |
| Dysphagia | 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 |
| |
| Taste Alteration | 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, 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 |
| |
| Pain, Stomach | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Pain, Throat/Pharynx/Larynx | 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 |
| |
| Creatinine | 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 |
| |
| Hypomagnesemia | 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 |
| |
| Hypophosphatemia | 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 |
| |
| 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 |
| |
| 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 |
|
Inclusion of squamous patients stopped in FEB 2008, as 11961 (NCT00558636) trial reported higher mortality for this subgroup. Squamous patients in 12006 (NCT00449033) trial discontinued drug as a precaution endorsed by Data Monitoring Committee.
The investigator, whilst free to use data from the study for scientific purposes, must not publish any document relating to the Trial without first notifying Bayer in writing and obtaining written consent. Bayer recognizes the right of the investigator to publish the results upon completion of the study. The investigator must send a draft manuscript of the publication or abstract to Bayer 60 days ahead of submission to obtain approval prior to submission of the final version for publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Bayer HealthCare AG | clinical-trials-contact@bayerhealthcare.com |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| 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 |
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| 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 |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
Not provided
Not provided
| Reason Missing |
|
| Male |
|
| Squamous |
|
| Passive smoker |
|
| Past or present smoker |
|
| Not available |
|
| Stage IV |
|
| 1 |
|
|
|
|
|
|
| Placebo + GC |
Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met. |
|
|
|
Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
|
|
|
Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met. |
|
|
|
Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
|
|
|
Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
|
|
Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|