Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| BO20800 | Other Identifier | Hoffmann-La Roche |
Not provided
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This is a Phase IIIb, multicenter, randomized, placebo-controlled trial to evaluate the safety and efficacy of chemotherapy+bevacizumab followed by bevacizumab+erlotinib versus bevacizumab+erlotinib placebo in subjects with locally advanced or metastatic NSCLC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bevacizumab | Drug | Intravenous repeating dose |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | PFS was defined as the length of time from randomization until documented disease progression or death from any cause, whichever occurred earlier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Data presented until cut-off date 18 July 2008. | Approximately 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Prospectively Identified Treatment Emergent Adverse Events (TEAE) During Chemotherapy Phase | Treatment-emergent adverse events were events between administration of study drug and up to 30 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.. Number of participants who had Grade >=3TEAEs of pulmonary hemorrhage, gastrointestinal (GI) perforation, arterial thromboembolic (ATE) events, proteinuria, congestive heart failure (CHF), and hypertension were presented. Data presented up to data cutoff 18 July 2008. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Donald Strickland, M.D. | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sacred Heart Medical Onc Group | Mobile | Alabama | 36608 | United States | ||
| St. Edward Mercy Medical Ctr |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24101054 | Derived | Johnson BE, Kabbinavar F, Fehrenbacher L, Hainsworth J, Kasubhai S, Kressel B, Lin CY, Marsland T, Patel T, Polikoff J, Rubin M, White L, Yang JC, Bowden C, Miller V. ATLAS: randomized, double-blind, placebo-controlled, phase IIIB trial comparing bevacizumab therapy with or without erlotinib, after completion of chemotherapy, with bevacizumab for first-line treatment of advanced non-small-cell lung cancer. J Clin Oncol. 2013 Nov 1;31(31):3926-34. doi: 10.1200/JCO.2012.47.3983. Epub 2013 Oct 7. |
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This study was conducted in 14 countries between 10 January 2006 and 19 June 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bevacizumab + Chemotherapy | Participants received one of six chemotherapy regimens (Carboplatin + Paclitaxel or Carboplatin + Gemcitabine or Carboplatin + Docetaxel or Cisplatin + Gemcitabine or Cisplatin + Docetaxel / Cisplatin + vinorelbine) followed by Bevacizumab on Day 1 of each cycle up to 4 cycles. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Chemotherapy Phase |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Oral repeating dose |
|
| erlotinib HCl | Drug | Oral repeating dose |
|
| Approximately 3 years |
| Number of Participants With Prospectively Identified Treatment Emergent Adverse Events (TEAE) During Post-Chemotherapy Phase | Treatment-related adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state and are judged by the investigator to be possibly, probably or definitely related to study medication. Pulmonary hemorrhage, GI perforation, ATE events, proteinuria, CHF, and hypertension were prospectively identified TEAEs of grade >=3. Data presented until cut-off date 28 January 2009. | Approximately 3 years |
| Number of Participants With Any Adverse Events During Post-Chemotherapy Phase | An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event. Data presented up to data cutoff 19 June 2009. | Approximately 3.5 years |
| Incidence of Study Treatment Discontinuation for Reasons Other Than Disease Progression in Chemotherapy Phase | Participants who experienced disease progression were discontinued from the study. Data presented up to data cutoff (18 July 2008). | Approximately 3 years |
| Incidence of Study Treatment Discontinuation | Participants in post-chemotherapy phase were discontinued from the study for the reasons other than disease progression. Data presented Up to data cutoff 18 July 2008. | Approximately 3 years |
| Overall Survival | Overall survival was defined as the length of time from randomization to death. | Approximately 3.5 years |
| Fort Smith |
| Arizona |
| 72917 |
| United States |
| Mayo Clinic | Scottsdale | Arizona | 85259 | United States |
| Arizona Cancer Center | Tucson | Arizona | 85724 | United States |
| Central Hem/Onc Medical Group | Alhambra | California | 91801 | United States |
| Comp Blood & Cancer Center | Bakersfield | California | 93309 | United States |
| South Bay Oncology | Campbell | California | 95008 | United States |
| Bay Area Cancer Research Grp | Concord | California | 94598 | United States |
| Pacific Onc & Hem Assoc | Encinitas | California | 92024 | United States |
| Pacific Coast Hem/Onc | Fountain Valley | California | 92708 | United States |
| Cancer Care Associates | Fresno | California | 93720 | United States |
| St. Jude Heritage Med Group | Fullerton | California | 92835 | United States |
| Ronald H. Yanagihara | Gilroy | California | 95020 | United States |
| Glendale Adventist Medical Ctr | Glendale | California | 91206 | United States |
| Scipps Clinic | La Jolla | California | 92037-1027 | United States |
| Loma Linda Univ Medical Center | Loma Linda | California | 92354 | United States |
| Pacific Shores Medical Group | Long Beach | California | 90813 | United States |
| Kenmar Research Institute LLC | Los Angeles | California | 90057 | United States |
| UCLA Medical Ctr | Los Angeles | California | 90095 | United States |
| Sutter Gould Med Foundation | Modesto | California | 95355 | United States |
| North Valley Hem Onc Med Grp | Northridge | California | 91325 | United States |
| Hem Onc Med Grp Orange Cty | Orange | California | 92868 | United States |
| Medical Oncology Care Assoc | Orange | California | 92868 | United States |
| Ventura Co Hem-Onc Specialists | Oxnard | California | 93030 | United States |
| Wilshire Oncology Medical Grp | Pomona | California | 91767 | United States |
| Sutter Cancer Center | Sacramento | California | 95816 | United States |
| Mercy General Hospital | Sacramento | California | 95819 | United States |
| Los Palos Oncology & Hem | Salinas | California | 93901 | United States |
| Kaiser Permanente | San Diego | California | 92120 | United States |
| Naval Medical Center | San Diego | California | 92134 | United States |
| Pacific Hematology Oncology | San Francisco | California | 94115 | United States |
| Kaiser Permanente Santa Teresa | San Jose | California | 95119 | United States |
| Sansum Medical Clinic, Inc. | Santa Barbara | California | 93105 | United States |
| Santa Barbara Hem Onc Med Grp | Santa Barbara | California | 93105 | United States |
| Central Coast Medical Oncology | Santa Maria | California | 93454 | United States |
| The Angeles Clinic | Santa Monica | California | 90404 | United States |
| Redwood Regional Med Grp | Santa Rosa | California | 95403 | United States |
| Cancer Care Associates | Torrance | California | 90505 | United States |
| Mile High Oncology | Denver | Colorado | 80210 | United States |
| Front Range Cancer Specialists | Fort Collins | Colorado | 80524 | United States |
| Washington Onc Hem Center PC | Washington D.C. | District of Columbia | 20037 | United States |
| Center for Hematology-Oncology | Boca Raton | Florida | 33486 | United States |
| Halifax Medical Center | Daytona Beach | Florida | 32115 | United States |
| Florida Wellcare Alliance | Inverness | Florida | 34452 | United States |
| Baptist Cancer Institute | Jacksonville | Florida | 32207 | United States |
| Jackson Memorial Hospital | Miami | Florida | 33136 | United States |
| Mid-Florida Hem Oncology Ctr | Orange City | Florida | 32763 | United States |
| Integrated Comm Onc Network | Orange Park | Florida | 32073 | United States |
| Hematology Onc Treasure Coast | Port Saint Lucie | Florida | 34952 | United States |
| Phoebe Putney Cancer Center | Albany | Georgia | 31701 | United States |
| Northeast Georgia Cancer Care | Athens | Georgia | 30607 | United States |
| Suburban Hem-Onc Associates | Lawrenceville | Georgia | 30045 | United States |
| Northwest Georgia Onc Centers | Marietta | Georgia | 30060 | United States |
| Chicagoland Hematology Onc | Arlington Heights | Illinois | 60005 | United States |
| Weiss-Strauss Oncology Center | Chicago | Illinois | 60640 | United States |
| LaGrange Oncology Associates | Geneva | Illinois | 54301 | United States |
| La Grange Oncology Associates | LaGrange | Illinois | 60525 | United States |
| Associates in Medical Oncology | Oak Lawn | Illinois | 60453 | United States |
| Onc Hem Assoc of Central IL | Peoria | Illinois | 61615 | United States |
| West Suburban Cancer Center | River Forest | Illinois | 60305 | United States |
| OSF St. Anthony Med Ctr | Rockford | Illinois | 61108 | United States |
| Community Hospital | Munster | Indiana | 46321 | United States |
| Providence Medical Group | Terre Haute | Indiana | 47802 | United States |
| Hematology Oncology Associates | Bettendorf | Iowa | 52722 | United States |
| Siouxland Hem-Onc Assoc LLP | Sioux City | Iowa | 51101 | United States |
| Covenant Clinic | Waterloo | Iowa | 50702 | United States |
| Gajera & Patel, PLLC | Hopkinsville | Kentucky | 42240 | United States |
| Kentuckiana Cancer Center | Louisville | Kentucky | 40202 | United States |
| University of Louisville | Louisville | Kentucky | 40202 | United States |
| Consultants in Blood Disorders | Louisville | Kentucky | 40207 | United States |
| Owensboro Medical Health Sys | Owensboro | Kentucky | 42303 | United States |
| Willis-Knighton Cancer Center | Shreveport | Louisiana | 71103 | United States |
| H&J Weinberg Cancer Institute | Baltimore | Maryland | 21237 | United States |
| Oncology Hematology Associates | Clinton | Maryland | 20735 | United States |
| Maryland Oncology/Hema PA | Columbia | Maryland | 21044 | United States |
| Frederick Memorial Hospital | Frederick | Maryland | 21701 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| Caritas St. Elizabeth Med Ctr | Boston | Massachusetts | 02135 | United States |
| Lahey Clinic Med Ctr | Burlington | Massachusetts | 01805 | United States |
| Metrowest Cancer Center | Framingham | Massachusetts | 01702 | United States |
| Baystate Medical Center | Springfield | Massachusetts | 01107 | United States |
| Spectrum Health | Grand Rapids | Michigan | 49503 | United States |
| Kalamazoo Hem & Onc | Kalamazoo | Michigan | 49048 | United States |
| Marquette General Health Sys | Marquette | Michigan | 49855 | United States |
| St. Joseph Mercy Oakland | Pontiac | Michigan | 48341 | United States |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| Virginia Piper Cancer Inst | Minneapolis | Minnesota | 55407 | United States |
| Ellis Fischel Cancer Center | Columbia | Missouri | 65203 | United States |
| Freeman Cancer Institute | Joplin | Missouri | 64804 | United States |
| Missouri Cancer Center, PC | Saint Charles | Missouri | 63301 | United States |
| St. Louis Univ Care Center | St Louis | Missouri | 63117 | United States |
| Arch Medical Services | Washington | Missouri | 63090 | United States |
| Billings Clinic | Billings | Montana | 59101 | United States |
| Big Sky Oncology | Great Falls | Montana | 59405 | United States |
| Montana Cancer Specialists | Missoula | Montana | 59802 | United States |
| NE Hematology Oncology, PC | Lincoln | Nebraska | 68506 | United States |
| Nebraska Methodist Hospital | Omaha | Nebraska | 68114 | United States |
| Comp Cancer Centers of Nevada | Las Vegas | Nevada | 89109 | United States |
| Ctr for Cancer & Hem Disease | Cherry Hill | New Jersey | 08003 | United States |
| Forte, Attas & Schleider | Englewood | New Jersey | 07631 | United States |
| Hunterdon Medical Center | Flemington | New Jersey | 08822 | United States |
| Central State Medical Center | Freehold | New Jersey | 07728 | United States |
| St. Barnabas Health Care Sys | Livingston | New Jersey | 07039 | United States |
| Mountainside Hospital | Montclair | New Jersey | 07042 | United States |
| Morristown Memorial Hospital | Morristown | New Jersey | 07962 | United States |
| Hematology Oncology Assoc SJ | Mount Holly | New Jersey | 08060 | United States |
| Jersey Shore Medical Center | Neptune City | New Jersey | 07754 | United States |
| Cancer Institute of New Jersey | New Brunswick | New Jersey | 08901 | United States |
| The Valley Hospital | Paramus | New Jersey | 07652 | United States |
| Overlook Hospital | Summit | New Jersey | 07902 | United States |
| Holy Name Hospital | Teaneck | New Jersey | 07666 | United States |
| San Juan Onco Assoc | Farmington | New Mexico | 87401 | United States |
| Zale P Bernstein MD - PP | Buffalo | New York | 14215 | United States |
| Bassett Cancer Center | Cooperstown | New York | 13326 | United States |
| Adriondack Cancer Care | Glen Falls | New York | 12801 | United States |
| BRANY | Great Neck | New York | 11021 | United States |
| Queens Cancer Center | Jamaica | New York | 11432 | United States |
| Crystal Run Health Care | Middletown | New York | 10941 | United States |
| NYU Medical Center | New York | New York | 10016 | United States |
| Mem Sloan Kettering Cancer Ctr | New York | New York | 10021 | United States |
| SUNY Upstate | Syracuse | New York | 13210 | United States |
| Presbyterian Hospital | Charlotte | North Carolina | 28204 | United States |
| NorthEast Medical Center | Concord | North Carolina | 28025 | United States |
| Moses Cone Reg Cncr Ctr | Greensboro | North Carolina | 27403 | United States |
| Emerywood Hematology Oncology | High Point | North Carolina | 27262 | United States |
| Carolina BioOncology Institute | Huntersville | North Carolina | 28078 | United States |
| Kinston Medical Specialists | Kinston | North Carolina | 28501 | United States |
| Beaufort County Hospital | Washington | North Carolina | 27889 | United States |
| Summa Health System | Akron | Ohio | 44304 | United States |
| Akron General Medical Center | Akron | Ohio | 44307 | United States |
| Aultman Hospital | Canton | Ohio | 44710 | United States |
| Gabrail Cancer Center | Canton | Ohio | 44718 | United States |
| Onc/Hem Care Clin Trials LLC | Cincinnati | Ohio | 45242 | United States |
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
| Mid Ohio Onc Hematology Inc | Columbus | Ohio | 43213 | United States |
| Riverside Methodist Hospital | Columbus | Ohio | 43214 | United States |
| Dayton Clinical Oncology Prog | Dayton | Ohio | 45429 | United States |
| Ohio Cancer Specialists | Mansfield | Ohio | 44907 | United States |
| Signal Point Hem/Oncology Inc | Middletown | Ohio | 45042 | United States |
| Toledo Community Hospital | Toledo | Ohio | 43623 | United States |
| Forum Health Cancer Care Ctr | Youngstown | Ohio | 44501 | United States |
| Providence Portland Med Center | Portland | Oregon | 97213 | United States |
| Ephrata Cancer Center | Ephrata | Pennsylvania | 17543 | United States |
| Armstrong County Memorial Hosp | Kittanning | Pennsylvania | 16201 | United States |
| Hem Onc Assoc Phys Lancaster | Lancaster | Pennsylvania | 17604 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Scranton Hematology Oncology | Scranton | Pennsylvania | 18510 | United States |
| Assoc in Hematology Oncology | Upland | Pennsylvania | 19013 | United States |
| Lankenau Medical Office Bldg | Wynnewood | Pennsylvania | 19096 | United States |
| Charleston Cancer Center | Charleston | South Carolina | 29406 | United States |
| Palmetto Hematology Oncology | Spartanburg | South Carolina | 29303 | United States |
| Erlanger Health Systems | Chattanooga | Tennessee | 37403 | United States |
| The Jones Clinic | Germantown | Tennessee | 38138 | United States |
| Jackson-Madsion County Hosp | Jackson | Tennessee | 38301 | United States |
| Clopton Clinic | Memphis | Tennessee | 38138 | United States |
| Sarah Cannon Cancer Center | Nashville | Tennessee | 37203-1632 | United States |
| Vanderbilt University Medical | Nashville | Tennessee | 37232 | United States |
| Lone Star Oncology Consultants | Austin | Texas | 78759 | United States |
| Coastal Bend Cancer Center | Corpus Christi | Texas | 78404 | United States |
| Texas Cancer Associates | Dallas | Texas | 75231 | United States |
| Texas Hematology Oncology | Dallas | Texas | 75234 | United States |
| JPS Center for Cancer Care | Fort Worth | Texas | 76104 | United States |
| Univ of Texas Medical Branch | Galveston | Texas | 77555 | United States |
| Wilford Hall Medical Center | Lackland Air Force Base | Texas | 78236 | United States |
| SW Vermont Healthcare Onc Asoc | Bennington | Vermont | 05201 | United States |
| Vermont Ctr Cancer Medicine | Colchester | Vermont | 05446 | United States |
| Community Cancer Center | Rutland | Vermont | 05701 | United States |
| Peninsula Cancer Institute | Newport News | Virginia | 23606 | United States |
| SW Virginia Hem Onc | Roanoke | Virginia | 24014 | United States |
| Cascade Cancer Center | Kirkland | Washington | 98034 | United States |
| Northwest Medical Specialists | Tacoma | Washington | 98405 | United States |
| Univ Physicians Internal Med | Huntington | West Virginia | 25701 | United States |
| West Virginia University | Morgantown | West Virginia | 26506 | United States |
| Oncology Alliance | Glendale | Wisconsin | 53212 | United States |
| Dean Clinic | Madison | Wisconsin | 53715 | United States |
| Medical Consultants LTD | Milwaukee | Wisconsin | 53215 | United States |
| All Saints Cancer Center | Racine | Wisconsin | 53405 | United States |
| Hospital Pirovano | Buenos Aires | 1430 | Argentina |
| Hospital Britanico | Buenos Aires | C1284AEB | Argentina |
| Hospital Toru | Buenos Aires | C1427ARN | Argentina |
| CEMIC | Buenos Aires | C1431FWO | Argentina |
| Centro Oncologico de Cordoba | Córdoba | X5000AAI | Argentina |
| COIR | Mendoza | 5500 | Argentina |
| Instituto Medico Privado | Resistencia | 3900 | Argentina |
| Clinica Oncologica de Rosario | Rosario | S2000dsk | Argentina |
| ISIS Clinica Especializada | Sante Fe | S3000FFU | Argentina |
| Holy Spirit Hospital Northside | Chermside, QLD | 4032 | Australia |
| Sunshine Coast Cancer Centre | Nambour, QLD | 4560 | Australia |
| Sir Charles Gairdner Hospital | Nedlands, WA | 6009 | Australia |
| Burnside War Memorial Hospital | Toorak Gardens, SA | 5065 | Australia |
| Cliniques Univ St Luc | Brussels | 1200 | Belgium |
| CHR Citadelle Liege | Liège | 4000 | Belgium |
| Instituto de cancer Arnaldo | São Paulo | São Paulo | 01221-020 | Brazil |
| Instituto Nacional do Cancer | Rio de Janeiro | 20-231-050 | Brazil |
| Hospital Das Clinicas | São Paulo | 05403-01 | Brazil |
| Regional Oncodispensary | Plovdiv | 4004 | Bulgaria |
| Regional Oncodispensary | Rousse | 7000 | Bulgaria |
| Regional Oncodispensary | Shumen | 9700 | Bulgaria |
| Regional Oncodispensary | Sofia | 1233 | Bulgaria |
| UMHAT "Queen Joanna" | Sofia | 1527 | Bulgaria |
| National Specialized Hospital | Sofia | 1756 | Bulgaria |
| Regional Oncodispensary | Stara Zagora | 6003 | Bulgaria |
| MHAT "St Marina" | Varna | 9010 | Bulgaria |
| Regional Oncodispensary | Veliko Tarnovo | 5000 | Bulgaria |
| Princess Margaret Hospital | Hong Kong | Hong Kong |
| Queen Elizabeth Hospital | Hong Kong | Hong Kong |
| Queen Mary Hospital | Hong Kong | Hong Kong |
| Tuen Mun Hospital | Hong Kong | Hong Kong |
| Hadassah Medical Center | Jerusalem | 91120 | Israel |
| Sourasky Medical Center | Tel Aviv | 64239 | Israel |
| Sheba Medical Center | Tel Litwinsky | 52621 | Israel |
| Azienda Ospedaliera Univ | Genova | 16132 | Italy |
| Ist Nazion per Ricerca Cancro | Genova | 16132 | Italy |
| Univ degli Studi di Napoli | Naples | 80131 | Italy |
| Azienda Ospedaliera | Parma | 43100 | Italy |
| Azienda Osper di Perugia | Perugia | 06159 | Italy |
| Divisione Onc Med dell'Azienda | Udine | 33100 | Italy |
| Torre Medica Cristobal Colon | Acapulco | 39670 | Mexico |
| Inst Nacional de Cancerologia | Distrito Federal | 14080 | Mexico |
| ISSSTE Merida | Mérida | 97500 | Mexico |
| Hospital de Especialidades | Torreon, Coahuila | 27200 | Mexico |
| Philippine General Hospital | Manila | Luzon | 1000 | Philippines |
| The Medical City | Pasig | Luzon | 1605 | Philippines |
| Veterans Memorial Medical Ctr | Quezon City | Luzon | 1114 | Philippines |
| Perpetual Succour Hospital | Cebu City | Visayas | 6000 | Philippines |
| Univ of Santo Tomas Hospital | Manila | 1008 | Philippines |
| St Luke's Medical Center | Quezon City | 1102 | Philippines |
| Centrul de Onc Medical Lasi | Iași | 700106 | Romania |
| Spitalul Clinic Judetean Sibiu | Sibiu | 550245 | Romania |
| Spitalul Judetean de Urgente | Suceava | 720237 | Romania |
| National Cancer Center | Singapore | 169610 | Singapore |
| Corporacio Sanitaria Parc | Sabadell | Barcelona | 08208 | Spain |
| Hospital de Cruces | Barakaldo | 48903 | Spain |
| Hospital del Mar | Barcelona | 08003 | Spain |
| Hospital Clinic i Provincial | Barcelona | 08036 | Spain |
| Hospital Universitario | San Cristóbal de La Laguna | 38320 | Spain |
| Instituto Valenciano Oncologia | Valencia | 46009 | Spain |
| Hospital Clinico Universitario | Valencia | 46010 | Spain |
| Taichung Veterans Gen Hosp | Dawan | 407 | Taiwan |
| China Medical Univ Hosp | Taichung | 404 | Taiwan |
| National Taiwan University | Taipei | 112 | Taiwan |
| Bumrungrad International Hosp | Bangkok | 10110 | Thailand |
| National Cancer Institute | Bangkok | 10400 | Thailand |
| Pramongkutklao Hospital | Bangkok | 10400 | Thailand |
| Siriraj Hospital | Bangkok | 10700 | Thailand |
| Maharaj Nakorn Chiang Mai Hosp | Chiang Mai | 50200 | Thailand |
| Bristol Heamatology & Onc Ctr | Bristol | BS2 8ED | United Kingdom |
| Bevacizumab + Placebo |
Participants who completed four cycles of chemotherapy + bevacizumab received Bevacizumab 15 milligram per kilogram (mg/kg) intravenously (IV) on Day 1 of every 21-day cycle along with matched Placebo to Erlotinib orally daily. |
| FG002 | Bevacizumab + Erlotinib | Participants who completed four cycles of chemotherapy + bevacizumab received received IV dose of Bevacizumab 15 mg/kg on Day 1 of every 21-day cycle along with Erlotinib as 150 mg per day orally daily. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Post Chemotherapy Phase |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Bevacizumab + Placebo | Participants received Bevacizumab 15 milligram per kilogram (mg/kg) intravenously (IV) on Day 1 of every 21-day cycle along with matched Placebo to Erlotinib orally daily |
| BG001 | Bevacizumab + Erlotinib | Participants received Bevacizumab 15 mg/kg IV on Day 1 of every 21-day cycle along with Erlotinib as 150 mg per day orally daily |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression-free Survival (PFS) | PFS was defined as the length of time from randomization until documented disease progression or death from any cause, whichever occurred earlier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Data presented until cut-off date 18 July 2008. | Intent to treat (ITT) population included all participants who were randomized during the post-chemotherapy phase. | Posted | Median | 95% Confidence Interval | months | Approximately 3 years |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Prospectively Identified Treatment Emergent Adverse Events (TEAE) During Chemotherapy Phase | Treatment-emergent adverse events were events between administration of study drug and up to 30 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.. Number of participants who had Grade >=3TEAEs of pulmonary hemorrhage, gastrointestinal (GI) perforation, arterial thromboembolic (ATE) events, proteinuria, congestive heart failure (CHF), and hypertension were presented. Data presented up to data cutoff 18 July 2008. | Safety-evaluable enrolled participants: All participants who enrolled and received at least one dose of chemotherapy or Bevacizumab. N= Number of participants analyzed. | Posted | Number | participants | Approximately 3 years |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Prospectively Identified Treatment Emergent Adverse Events (TEAE) During Post-Chemotherapy Phase | Treatment-related adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state and are judged by the investigator to be possibly, probably or definitely related to study medication. Pulmonary hemorrhage, GI perforation, ATE events, proteinuria, CHF, and hypertension were prospectively identified TEAEs of grade >=3. Data presented until cut-off date 28 January 2009. | Safety-evaluable randomized Participants: All randomized Participants who received at least one complete or partial dose of Bevacizumab + Erlotinib or Bevacizumab + Placebo. N= Number of participants analyzed. | Posted | Number | participants | Approximately 3 years |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Any Adverse Events During Post-Chemotherapy Phase | An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event. Data presented up to data cutoff 19 June 2009. | Safety-evaluable randomized Participants: All randomized Participants who received at least one complete or partial dose of Bevacizumab + Erlotinib or Bevacizumab + Placebo. N= Number of participants analyzed. At the time of the 28 January 2009 data cutoff, an additional 25 patients had been randomized. | Posted | Number | participants | Approximately 3.5 years |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Study Treatment Discontinuation for Reasons Other Than Disease Progression in Chemotherapy Phase | Participants who experienced disease progression were discontinued from the study. Data presented up to data cutoff (18 July 2008). | Enrolled participants: All participants who were enrolled in the study. N= Number of participants analyzed. | Posted | Number | participants | Approximately 3 years |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Study Treatment Discontinuation | Participants in post-chemotherapy phase were discontinued from the study for the reasons other than disease progression. Data presented Up to data cutoff 18 July 2008. | Intent to treat (ITT) population included all participants who were randomized during the post-chemotherapy phase.. N= Number of participants analyzed. | Posted | Number | participants | Approximately 3 years |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival was defined as the length of time from randomization to death. | Intent-to-treat population included all participants who were randomized during the post-chemotherapy phase. | Posted | Median | 95% Confidence Interval | months | Approximately 3.5 years |
|
|
Up to 30 days after discontinuation of study treatment
Safety-evaluable randomized participants who had received at least one complete or partial dose of bevacizumab or erlotinib/placebo.
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 | Bevacizumab + Placebo | Participants who completed four cycles of chemotherapy + bevacizumab received Bevacizumab 15 milligram per kilogram (mg/kg) intravenously (IV) on Day 1 of every 21-day cycle along with matched Placebo to Erlotinib orally daily. | 63 | 367 | 288 | 367 | ||
| EG001 | Bevacizumab + Erlotinib | Participants who completed four cycles of chemotherapy + bevacizumab received received IV dose of Bevacizumab 15 mg/kg on Day 1 of every 21-day cycle along with Erlotinib as 150 mg per day orally daily. | 86 | 368 | 341 | 368 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Atrial tachycardia | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Sinus arrhythmia | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Gastrointestinal inflammation | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Oesophageal fistula | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Death | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hyperthermia | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Performance status decreased | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hepatitis acute | Hepatobiliary disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Encephalitic infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Escherichia infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Incision site infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Staphylococcal abscess | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Device failure | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Mouth injury | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Procedural complication | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Traumatic brain injury | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Wound complication | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Blood sodium decreased | Investigations | MedDRA (12.0) | Systematic Assessment |
| |
| Heart rate increased | Investigations | MedDRA (12.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (12.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Metastases to meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Metastases to spine | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Embolic stroke | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Cerebellar infarction | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Cerebral artery embolism | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Cranial neuropathy | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Leukoencephalopathy | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Reversible posterior leukoencephalopathy syndrome | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hallucinations, mixed | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Bronchial haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (12.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roche Trial Information Hotline | F. Hoffmann-La Roche AG | +41 616878333 | global.trial_information@roche.com |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D000069347 | Erlotinib Hydrochloride |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Unwillingness or inability to comply |
|
| Need for concomitant/ancillary therapy |
|
| Patient's decision to discontinue |
|
| Unrelated intercurrent illness |
|
| Lost to Follow-up |
|
| Physician Decision |
|
| Sponsor's decision to terminate study |
|
| Not treated |
|
| Male |
|
| OG002 | Carboplatin + Docetaxel | Participants received IV dose of Carboplatin at a dose based on the AUC of of 6 mg/mL × min and Docetaxel 75 mg/m^2, respectively followed by Bevacizumab on Day 1 of each 21-day cycle up to 4 cycles. |
| OG003 | Cisplatin + Gemcitabine | Participants received IV dose of Cisplatin 80 mg/m^2 on Day 1 of each 21-day cycle and Gemcitabine 1000-1250 mg/m^2 on Day 1 and Day 8 followed by Bevacizumab of each 21-day cycle up to 4 cycles. |
| OG004 | Other | Included participants who received Cisplatin + Docetaxel or Cisplatin + vinorelbine, participants who received only one of the two chemotherapies planned followed by Bevacizumab of each 21-day cycle up to 4 cycles. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| OG003 | Cisplatin + Gemcitabine | Participants received IV dose of Cisplatin 80 mg/m^2 on Day 1 of each 21-day cycle and Gemcitabine 1000-1250 mg/m^2 on Day 1 and Day 8 followed by Bevacizumab of each 21-day cycle up to 4 cycles. |
| OG004 | Other | Included participants who received Cisplatin + Docetaxel or Cisplatin + vinorelbine, participants who received only one of the two chemotherapies planned followed by Bevacizumab of each 21-day cycle up to 4 cycles. |
|
|
|
|
|