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The primary objective of this study is to estimate the treatment effect on progression-free survival (PFS) of panitumumab relative to bevacizumab in combination with mFOLFOX6 chemotherapy as first-line therapy in patients with tumors expressing wild-type KRAS, unresectable mCRC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panitumumab Plus mFOLFOX6 | Experimental | Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and modified FOLFOX6 (mFOLFOX6) chemotherapy regimen consisting of oxaliplatin (85 mg/m^2), leucovorin (400 mg/m^2) and 5-fluorouracil (5-FU) (2400 mg/m^2) administered on Day 1 of every 14-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death. |
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| Bevacizumab Plus mFOLFOX6 | Active Comparator | Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 regimen consisting of oxaliplatin (85 mg/m^2), leucovorin (400 mg/m^2), followed by 5-FU (2400 mg/m^2) administered on Day 1 of every 14-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Panitumumab | Drug | Panitumumab is a fully human immunoglobulin G (IgG)2 monoclonal antibody antagonist directed against human Epidermal Growth Factor receptor (EGFr). |
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| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | PFS was defined as the time from the date of randomization to the date of first disease progression, or death within 60 days after the last evaluable tumor assessment or randomization date (whichever was later). Participants not meeting the criteria by the cutoff date were censored at the last evaluable tumor assessment date. Tumor response was evaluated by the investigator per modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 every 8 weeks until radiographic disease progression. Progression is defined as at least a 20% increase in the size of target lesions, unequivocal progression of existing non-target lesions, or any new lesions. | From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival was defined as the time from randomization to the date of death, with participants alive or lost to follow-up at the analysis data cutoff date censored at their last contact date. | From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Birmingham | Alabama | 35205 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28424871 | Background | Rivera F, Karthaus M, Hecht JR, Sevilla I, Forget F, Fasola G, Canon JL, Guan X, Demonty G, Schwartzberg LS. Final analysis of the randomised PEAK trial: overall survival and tumour responses during first-line treatment with mFOLFOX6 plus either panitumumab or bevacizumab in patients with metastatic colorectal carcinoma. Int J Colorectal Dis. 2017 Aug;32(8):1179-1190. doi: 10.1007/s00384-017-2800-1. Epub 2017 Apr 19. | |
| 24687833 |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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First patient was enrolled on 24 April 2009; last patient was enrolled on 09 December 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Panitumumab Plus mFOLFOX6 | Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and modified FOLFOX6 (mFOLFOX6) chemotherapy regimen consisting of oxaliplatin (85 mg/m^2), leucovorin (400 mg/m^2) and 5-fluorouracil (5-FU; 2400 mg/m^2) administered on Day 1 of every 14-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Bevacizumab | Drug | Bevacizumab is a humanized monoclonal IgG1 antibody that is directed against Vascular Endothelial Growth Factor (VEGF). |
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| mFOLFOX6 | Drug | mFOLFOX6 regimen is a combination therapy of oxaliplatin (85 mg/m^2) administered as a 2-hour infusion on Day 1; leucovorin (400 mg/m^2) administered as a 2-hour infusion on Day 1; followed by a loading dose of 5-fluorouracil (5-FU; 400 mg/m^2) IV bolus administered over approximately 2 to 4 minutes on Day 1, then 5- FU (2400 mg/m^2) via ambulatory pump administered for a period of 46 to 48 hours. |
|
| Percentage of Participants With an Objective Response |
Objective response was defined as having a confirmed complete response (CR) or partial response (PR) during first-line treatment, based on the investigator's review of scans using a modified-RECIST v1.0. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met. Complete Response: Disappearance of all target and non-target lesions and no new lesions. Partial Response: At least a 30% decrease in the sum of the longest diameter (SLD) of target lesions and no progression of non-target lesions and no new lesions, or the disappearance of all target lesions with persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease and no new lesions. |
| From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks. |
| Duration of Response | For participants with a confirmed objective response, the time from first confirmed objective response to radiologic disease progression per modified RECIST 1.0 criteria or death. For participants who responded and have not progressed or died, duration of response was censored at their last evaluable disease assessment date. | From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks. |
| Time to Disease Progression | Time to progression (TTP) is defined as the time from randomization to the date of radiologic disease progression per modified RECIST 1.0 criteria. Participants not meeting criteria for disease progression by the analysis data cutoff date were censored at their last evaluable disease assessment date. Progression is defined as at least a 20% increase in the size of target lesions, unequivocal progression of existing non-target lesions, or any new lesions. | From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks. |
| Time to Initial Objective Response | For participants with a confirmed objective response, the time from randomization to the date of first confirmed objective response. Assessments are based on the investigator's review of scans using a modified-RECIST v1.0. An objective response is defined as a best tumor response of complete or partial response. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met. | From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks. |
| Resection Rate | The resection rate was defined as the percentage of participants with a surgical procedure that resulted in partial reduction or complete eradication of all metastatic disease. | From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks. |
| Progression-free Survival (PFS) in Participants With Wild-type Rat Sarcoma Viral Oncogene Homolog (RAS) | PFS was defined as the time from the date of randomization to the date of first disease progression, or death within 60 days after the last evaluable tumor assessment or randomization date (whichever was later). Participants not meeting the criteria by the cutoff date were censored at the last evaluable tumor assessment date. Tumor response was evaluated by the investigator per modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 every 8 weeks until radiographic disease progression. Progression is defined as at least a 20% increase in the size of target lesions, unequivocal progression of existing non-target lesions, or any new lesions. | From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks. |
| Progression-free Survival (PFS) in Participants With Wild-type RAS / V-raf Murine Sarcoma Viral Oncogene Homolog B1 (BRAF) | PFS was defined as the time from the date of randomization to the date of first disease progression, or death within 60 days after the last evaluable tumor assessment or randomization date (whichever was later). Participants not meeting the criteria by the cutoff date were censored at the last evaluable tumor assessment date. Tumor response was evaluated by the investigator per modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 every 8 weeks until radiographic disease progression. Progression is defined as at least a 20% increase in the size of target lesions, unequivocal progression of existing non-target lesions, or any new lesions. | From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks. |
| Overall Survival in Participants With Wild-type RAS | Overall survival was defined as the time from randomization to the date of death, with participants alive or lost to follow-up at the analysis data cutoff date censored at their last contact date. | From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks. |
| Overall Survival in Participants With Wild-type RAS / BRAF | Overall survival was defined as the time from randomization to the date of death, with participants alive or lost to follow-up at the analysis data cutoff date censored at their last contact date. | From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks. |
| Percentage of Participants With an Objective Response for Participants With Wild-type RAS | Objective response was defined as having a confirmed complete response (CR) or partial response (PR) during first-line treatment, based on the investigator's review of scans using a modified-RECIST v1.0. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met. Complete Response: Disappearance of all target and non-target lesions and no new lesions. Partial Response: At least a 30% decrease in the sum of the longest diameter (SLD) of target lesions and no progression of non-target lesions and no new lesions, or the disappearance of all target lesions with persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease and no new lesions. | From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks. |
| Percentage of Participants With an Objective Response for Participants With Wild-type RAS / BRAF | Objective response was defined as having a confirmed complete response (CR) or partial response (PR) during first-line treatment, based on the investigator's review of scans using a modified-RECIST v1.0. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met. Complete Response: Disappearance of all target and non-target lesions and no new lesions. Partial Response: At least a 30% decrease in the sum of the longest diameter (SLD) of target lesions and no progression of non-target lesions and no new lesions, or the disappearance of all target lesions with persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease and no new lesions. | From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks. |
| Number of Participants With Adverse Events (AEs) | Severity was graded using Common Terminology Criteria for Adverse Events (CTCAE) v3.0, with the exception of some dermatology/skin adverse events that were graded using CTCAE v3.0 with modifications. Fatal adverse events are classified as grade 5. Serious adverse events include any event that is fatal, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or other significant medical hazard. Treatment-related AEs were those that the investigator considered a reasonable possibility that might have been caused by study drug. | The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 8.0 months for Panitumumab Plus mFOLFOX arm and 7.3 months for Bevacizumab Plus mFOLFOX6 arm. |
| Huntsville |
| Alabama |
| 35805 |
| United States |
| Research Site | Berkeley | California | 94704 | United States |
| Research Site | Beverly Hills | California | 90211 | United States |
| Research Site | Burbank | California | 91505 | United States |
| Research Site | Fountain Valley | California | 92708 | United States |
| Research Site | La Verne | California | 91750 | United States |
| Research Site | Orange | California | 92868 | United States |
| Research Site | Riverside | California | 92501 | United States |
| Research Site | Roseville | California | 95661 | United States |
| Research Site | Denver | Colorado | 80218 | United States |
| Research Site | Stamford | Connecticut | 06902 | United States |
| Research Site | Waterbury | Connecticut | 06708 | United States |
| Research Site | Boynton Beach | Florida | 33435 | United States |
| Research Site | Coral Springs | Florida | 33065 | United States |
| Research Site | Daytona Beach | Florida | 32114 | United States |
| Research Site | Hollywood | Florida | 33021 | United States |
| Research Site | Lake Worth | Florida | 33467 | United States |
| Research Site | Alpharetta | Georgia | 30005 | United States |
| Research Site | Augusta | Georgia | 30901 | United States |
| Research Site | Savannah | Georgia | 31405 | United States |
| Research Site | Post Falls | Idaho | 83854 | United States |
| Research Site | Gurnee | Illinois | 60031 | United States |
| Research Site | Peoria | Illinois | 61615 | United States |
| Research Site | Indianapolis | Indiana | 46237 | United States |
| Research Site | Overland Park | Kansas | 66210 | United States |
| Research Site | Wichita | Kansas | 67214 | United States |
| Research Site | Danville | Kentucky | 40422 | United States |
| Research Site | Hazard | Kentucky | 41701 | United States |
| Research Site | Paducah | Kentucky | 42003 | United States |
| Research Site | Baltimore | Maryland | 21204 | United States |
| Research Site | Bethesda | Maryland | 20817 | United States |
| Research Site | Boston | Massachusetts | 02111 | United States |
| Research Site | Kalamazoo | Michigan | 49048 | United States |
| Research Site | Lambertville | Michigan | 48144 | United States |
| Research Site | Lansing | Michigan | 48912 | United States |
| Research Site | Mountain Lakes | New Jersey | 07046 | United States |
| Research Site | Sparta | New Jersey | 07871 | United States |
| Research Site | Albuquerque | New Mexico | 87131 | United States |
| Research Site | Buffalo | New York | 14215 | United States |
| Research Site | East Setauket | New York | 11733 | United States |
| Research Site | Staten Island | New York | 10301 | United States |
| Research Site | Huntersville | North Carolina | 28078 | United States |
| Research Site | Raleigh | North Carolina | 27607 | United States |
| Research Site | Akron | Ohio | 44304 | United States |
| Research Site | Columbus | Ohio | 43228 | United States |
| Research Site | Hershey | Pennsylvania | 17033 | United States |
| Research Site | Philadelphia | Pennsylvania | 19106 | United States |
| Research Site | Greenville | South Carolina | 29605 | United States |
| Research Site | Mt. Pleasant | South Carolina | 29464 | United States |
| Research Site | Memphis | Tennessee | 38120 | United States |
| Research Site | Austin | Texas | 78759 | United States |
| Research Site | Corpus Christi | Texas | 78463 | United States |
| Research Site | Dallas | Texas | 75231 | United States |
| Research Site | Round Rock | Texas | 78665 | United States |
| Research Site | Temple | Texas | 76508 | United States |
| Research Site | Tyler | Texas | 75702 | United States |
| Research Site | White River Junction | Vermont | 05009 | United States |
| Research Site | Chesapeake | Virginia | 23320 | United States |
| Research Site | Newport News | Virginia | 23601 | United States |
| Research Site | Newport News | Virginia | 23606 | United States |
| Research Site | Spokane | Washington | 99218 | United States |
| Research Site | Vancouver | Washington | 98684 | United States |
| Research Site | Charleroi | 6000 | Belgium |
| Research Site | Edegem | 2650 | Belgium |
| Research Site | Libramont | 6800 | Belgium |
| Research Site | Sint-Niklaas | 9100 | Belgium |
| Research Site | Calgary | Alberta | T2N 4N2 | Canada |
| Research Site | Edmonton | Alberta | T6G 1Z2 | Canada |
| Research Site | Vancouver | British Columbia | V5Z 4E6 | Canada |
| Research Site | Victoria | British Columbia | V8R 6V5 | Canada |
| Research Site | Oshawa | Ontario | L1G 2B9 | Canada |
| Research Site | Greenfield Park | Quebec | J4V 2H1 | Canada |
| Research Site | Montreal | Quebec | H2X 3J4 | Canada |
| Research Site | Québec | Quebec | G1R 2J6 | Canada |
| Research Site | Berlin | 13125 | Germany |
| Research Site | Bielefeld | 33611 | Germany |
| Research Site | Magdeburg | 39104 | Germany |
| Research Site | München | 81737 | Germany |
| Research Site | München | 81925 | Germany |
| Research Site | Passau | 94032 | Germany |
| Research Site | Regensburg | 93049 | Germany |
| Research Site | Würzburg | 97070 | Germany |
| Research Site | Alba (CN) | 12051 | Italy |
| Research Site | Fano | 61032 | Italy |
| Research Site | Genova | 16132 | Italy |
| Research Site | Mantua | 46100 | Italy |
| Research Site | Udine | 33100 | Italy |
| Research Site | Varese | 21100 | Italy |
| Research Site | Málaga | AndalucÃ-a | 29010 | Spain |
| Research Site | Santander | Cantabria | 39008 | Spain |
| Research Site | Sabadell | Cataluña | 08208 | Spain |
| Research Site | Elche | Comunidad | 03203 | Spain |
| Research Site | A Coruña | Galicia | 15006 | Spain |
| Research Site | San Sebastián de Los Reyes | Madrid | 28702 | Spain |
| Background |
| Schwartzberg LS, Rivera F, Karthaus M, Fasola G, Canon JL, Hecht JR, Yu H, Oliner KS, Go WY. PEAK: a randomized, multicenter phase II study of panitumumab plus modified fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) or bevacizumab plus mFOLFOX6 in patients with previously untreated, unresectable, wild-type KRAS exon 2 metastatic colorectal cancer. J Clin Oncol. 2014 Jul 20;32(21):2240-7. doi: 10.1200/JCO.2013.53.2473. Epub 2014 Mar 31. |
| 28449055 | Background | Boeckx N, Koukakis R, Op de Beeck K, Rolfo C, Van Camp G, Siena S, Tabernero J, Douillard JY, Andre T, Peeters M. Primary tumor sidedness has an impact on prognosis and treatment outcome in metastatic colorectal cancer: results from two randomized first-line panitumumab studies. Ann Oncol. 2017 Aug 1;28(8):1862-1868. doi: 10.1093/annonc/mdx119. |
| 27592068 | Background | Heinemann V, Rivera F, O'Neil BH, Stintzing S, Koukakis R, Terwey JH, Douillard JY. A study-level meta-analysis of efficacy data from head-to-head first-line trials of epidermal growth factor receptor inhibitors versus bevacizumab in patients with RAS wild-type metastatic colorectal cancer. Eur J Cancer. 2016 Nov;67:11-20. doi: 10.1016/j.ejca.2016.07.019. Epub 2016 Sep 1. |
| 30614531 | Background | Modest DP, Rivera F, Bachet JB, de Braud F, Pietrantonio F, Koukakis R, Demonty G, Douillard JY. Panitumumab-based maintenance after oxaliplatin discontinuation in metastatic colorectal cancer: A retrospective analysis of two randomised trials. Int J Cancer. 2019 Jul 15;145(2):576-585. doi: 10.1002/ijc.32110. Epub 2019 Jan 24. |
| 29531837 | Background | Peeters M, Forget F, Karthaus M, Valladares-Ayerbes M, Zaniboni A, Demonty G, Guan X, Rivera F. Exploratory pooled analysis evaluating the effect of sequence of biological therapies on overall survival in patients with RAS wild-type metastatic colorectal carcinoma. ESMO Open. 2018 Feb 24;3(2):e000297. doi: 10.1136/esmoopen-2017-000297. eCollection 2018. |
| 31515083 | Background | Taieb J, Geissler M, Rivera F, Karthaus M, Wilson R, Loupakis F, Price T, Tracy M, Burdon P, Peeters M. Relationship Between Tumor Response and Tumor-Related Symptoms in RAS Wild-Type Metastatic Colorectal Cancer: Retrospective Analyses From 3 Panitumumab Trials. Clin Colorectal Cancer. 2019 Dec;18(4):245-256.e5. doi: 10.1016/j.clcc.2019.07.009. Epub 2019 Jul 29. |
| 29080924 | Background | Taieb J, Rivera F, Siena S, Karthaus M, Valladares-Ayerbes M, Gallego J, Geissler M, Koukakis R, Demonty G, Peeters M. Exploratory analyses assessing the impact of early tumour shrinkage and depth of response on survival outcomes in patients with RAS wild-type metastatic colorectal cancer receiving treatment in three randomised panitumumab trials. J Cancer Res Clin Oncol. 2018 Feb;144(2):321-335. doi: 10.1007/s00432-017-2534-z. Epub 2017 Oct 28. |
| 29627309 | Background | Boeckx N, Koukakis R, Op de Beeck K, Rolfo C, Van Camp G, Siena S, Tabernero J, Douillard JY, Andre T, Peeters M. Effect of Primary Tumor Location on Second- or Later-line Treatment Outcomes in Patients With RAS Wild-type Metastatic Colorectal Cancer and All Treatment Lines in Patients With RAS Mutations in Four Randomized Panitumumab Studies. Clin Colorectal Cancer. 2018 Sep;17(3):170-178.e3. doi: 10.1016/j.clcc.2018.03.005. Epub 2018 Mar 8. |
| 30013091 | Background | Peeters M, Price T, Taieb J, Geissler M, Rivera F, Canon JL, Pentheroudakis G, Koukakis R, Burdon P, Siena S. Relationships between tumour response and primary tumour location, and predictors of long-term survival, in patients with RAS wild-type metastatic colorectal cancer receiving first-line panitumumab therapy: retrospective analyses of the PRIME and PEAK clinical trials. Br J Cancer. 2018 Aug;119(3):303-312. doi: 10.1038/s41416-018-0165-z. Epub 2018 Jul 17. |
| 34172397 | Background | Sartore-Bianchi A, Garcia-Alfonso P, Geissler M, Kohne CH, Peeters M, Price T, Valladares-Ayerbes M, Zhang Y, Burdon P, Taieb J, Modest DP. Relationships Between Kohne Category/Baseline Tumor Load and Early Tumor Shrinkage, Depth of Response, and Outcomes in Metastatic Colorectal Cancer. Clin Colorectal Cancer. 2021 Dec;20(4):305-313. doi: 10.1016/j.clcc.2021.05.007. Epub 2021 May 25. |
| 26049686 | Derived | Peeters M, Kafatos G, Taylor A, Gastanaga VM, Oliner KS, Hechmati G, Terwey JH, van Krieken JH. Prevalence of RAS mutations and individual variation patterns among patients with metastatic colorectal cancer: A pooled analysis of randomised controlled trials. Eur J Cancer. 2015 Sep;51(13):1704-13. doi: 10.1016/j.ejca.2015.05.017. Epub 2015 Jun 3. |
| FG001 | Bevacizumab Plus mFOLFOX6 | Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 regimen consisting of oxaliplatin (85 mg/m^2), leucovorin (400 mg/m^2), followed by 5-FU (2400 mg/m^2) administered on Day 1 of every 14-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death. |
| Received Study Treatment |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Panitumumab Plus mFOLFOX6 | Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle. |
| BG001 | Bevacizumab Plus mFOLFOX6 | Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Prior Adjuvant Oxaliplatin Therapy | Number | participants |
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| RAS and BRAF Mutation Status | This analysis was performed on tumors from 136 and 137 participants in each treatment group respectively. BRAF = v-raf murine sarcoma viral oncogene homolog B1; RAS = rat sarcoma viral oncogene homolog, and includes Kirsten rat sarcoma-2 viral oncogene (KRAS) exons 2, 3 & 4 and neuroblastoma RAS viral (v-ras) oncogene (NRAS) exons 2, 3, and 4. Participants may appear in more than one category. | Number | participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Progression-free Survival (PFS) | PFS was defined as the time from the date of randomization to the date of first disease progression, or death within 60 days after the last evaluable tumor assessment or randomization date (whichever was later). Participants not meeting the criteria by the cutoff date were censored at the last evaluable tumor assessment date. Tumor response was evaluated by the investigator per modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 every 8 weeks until radiographic disease progression. Progression is defined as at least a 20% increase in the size of target lesions, unequivocal progression of existing non-target lesions, or any new lesions. | Intent-to-treat (ITT) analysis set (all randomized participants) | Posted | Median | 95% Confidence Interval | months | From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks. |
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| Secondary | Overall Survival | Overall survival was defined as the time from randomization to the date of death, with participants alive or lost to follow-up at the analysis data cutoff date censored at their last contact date. | Intent-to-treat analysis set | Posted | Median | 95% Confidence Interval | months | From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks. |
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| Secondary | Percentage of Participants With an Objective Response | Objective response was defined as having a confirmed complete response (CR) or partial response (PR) during first-line treatment, based on the investigator's review of scans using a modified-RECIST v1.0. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met. Complete Response: Disappearance of all target and non-target lesions and no new lesions. Partial Response: At least a 30% decrease in the sum of the longest diameter (SLD) of target lesions and no progression of non-target lesions and no new lesions, or the disappearance of all target lesions with persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease and no new lesions. | Evaluable for Local Tumor Response Analysis Set, defined as the subset of participants in the ITT Analysis Set who had at least 1 unidimensionally measurable lesion per modified RECIST 1.0 per the local investigator. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks. |
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| Secondary | Duration of Response | For participants with a confirmed objective response, the time from first confirmed objective response to radiologic disease progression per modified RECIST 1.0 criteria or death. For participants who responded and have not progressed or died, duration of response was censored at their last evaluable disease assessment date. | Evaluable for Local Tumor Response Analysis Set: Responders | Posted | Median | 95% Confidence Interval | months | From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks. |
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| Secondary | Time to Disease Progression | Time to progression (TTP) is defined as the time from randomization to the date of radiologic disease progression per modified RECIST 1.0 criteria. Participants not meeting criteria for disease progression by the analysis data cutoff date were censored at their last evaluable disease assessment date. Progression is defined as at least a 20% increase in the size of target lesions, unequivocal progression of existing non-target lesions, or any new lesions. | Intent-to-treat analysis set | Posted | Median | 95% Confidence Interval | months | From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks. |
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| Secondary | Time to Initial Objective Response | For participants with a confirmed objective response, the time from randomization to the date of first confirmed objective response. Assessments are based on the investigator's review of scans using a modified-RECIST v1.0. An objective response is defined as a best tumor response of complete or partial response. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met. | Evaluable for Local Tumor Response Analysis Set: Responders | Posted | Median | Inter-Quartile Range | months | From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks. |
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| Secondary | Resection Rate | The resection rate was defined as the percentage of participants with a surgical procedure that resulted in partial reduction or complete eradication of all metastatic disease. | Intent-to-treat analysis set | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) in Participants With Wild-type Rat Sarcoma Viral Oncogene Homolog (RAS) | PFS was defined as the time from the date of randomization to the date of first disease progression, or death within 60 days after the last evaluable tumor assessment or randomization date (whichever was later). Participants not meeting the criteria by the cutoff date were censored at the last evaluable tumor assessment date. Tumor response was evaluated by the investigator per modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 every 8 weeks until radiographic disease progression. Progression is defined as at least a 20% increase in the size of target lesions, unequivocal progression of existing non-target lesions, or any new lesions. | Wild-type RAS Efficacy Analysis Set, defined as a subset of Wild-type KRAS Exon 2 Efficacy Analysis Set including all randomized participants with wild-type KRAS exon 2, 3, 4, NRAS exon 2, 3, and 4. | Posted | Median | 95% Confidence Interval | months | From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) in Participants With Wild-type RAS / V-raf Murine Sarcoma Viral Oncogene Homolog B1 (BRAF) | PFS was defined as the time from the date of randomization to the date of first disease progression, or death within 60 days after the last evaluable tumor assessment or randomization date (whichever was later). Participants not meeting the criteria by the cutoff date were censored at the last evaluable tumor assessment date. Tumor response was evaluated by the investigator per modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 every 8 weeks until radiographic disease progression. Progression is defined as at least a 20% increase in the size of target lesions, unequivocal progression of existing non-target lesions, or any new lesions. | Wild-type RAS/BRAF Efficacy Analysis Set was defined as a subset of Wild-type KRAS Exon 2 Efficacy Analysis Set with wild-type KRAS exon 2, 3, and 4, NRAS exon 2, 3, 4, and BRAF exon 15. | Posted | Median | 95% Confidence Interval | months | From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival in Participants With Wild-type RAS | Overall survival was defined as the time from randomization to the date of death, with participants alive or lost to follow-up at the analysis data cutoff date censored at their last contact date. | Wild-type RAS Efficacy Analysis Set, defined as a subset of Wild-type KRAS Exon 2 Efficacy Analysis Set including all randomized participants with wild-type KRAS exon 2, 3, 4, NRAS exon 2, 3, and 4. | Posted | Median | 95% Confidence Interval | months | From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival in Participants With Wild-type RAS / BRAF | Overall survival was defined as the time from randomization to the date of death, with participants alive or lost to follow-up at the analysis data cutoff date censored at their last contact date. | Wild-type RAS/BRAF Efficacy Analysis Set was defined as a subset of Wild-type KRAS Exon 2 Efficacy Analysis Set with wild-type KRAS exon 2, 3, and 4, NRAS exon 2, 3, 4, and BRAF exon 15. | Posted | Median | 95% Confidence Interval | months | From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With an Objective Response for Participants With Wild-type RAS | Objective response was defined as having a confirmed complete response (CR) or partial response (PR) during first-line treatment, based on the investigator's review of scans using a modified-RECIST v1.0. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met. Complete Response: Disappearance of all target and non-target lesions and no new lesions. Partial Response: At least a 30% decrease in the sum of the longest diameter (SLD) of target lesions and no progression of non-target lesions and no new lesions, or the disappearance of all target lesions with persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease and no new lesions. | Wild-type RAS Investigator Tumor Response Analysis Set, defined as the subset of participants in the Wild-type RAS Efficacy Analysis Set who had at least 1 unidimensionally measurable lesion per modified RECIST 1.0 per the local investigator. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With an Objective Response for Participants With Wild-type RAS / BRAF | Objective response was defined as having a confirmed complete response (CR) or partial response (PR) during first-line treatment, based on the investigator's review of scans using a modified-RECIST v1.0. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met. Complete Response: Disappearance of all target and non-target lesions and no new lesions. Partial Response: At least a 30% decrease in the sum of the longest diameter (SLD) of target lesions and no progression of non-target lesions and no new lesions, or the disappearance of all target lesions with persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease and no new lesions. | Wild-type RAS/BRAF Investigator Tumor Response Analysis Set, defined as the subset of participants in the Wild-type RAS/BRAF Efficacy Analysis Set who had at least 1 unidimensionally measurable lesion per modified RECIST 1.0 per the local investigator. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events (AEs) | Severity was graded using Common Terminology Criteria for Adverse Events (CTCAE) v3.0, with the exception of some dermatology/skin adverse events that were graded using CTCAE v3.0 with modifications. Fatal adverse events are classified as grade 5. Serious adverse events include any event that is fatal, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or other significant medical hazard. Treatment-related AEs were those that the investigator considered a reasonable possibility that might have been caused by study drug. | Safety analysis set, which included all randomized participants who received at least 1 dose of protocol treatment (ie, panitumumab, bevacizumab, or any component of mFOLFOX6). | Posted | Number | participants | The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 8.0 months for Panitumumab Plus mFOLFOX arm and 7.3 months for Bevacizumab Plus mFOLFOX6 arm. |
|
The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 8.0 months for Panitumumab Plus Chemotherapy arm and 7.3 months for Bevacizumab Plus Chemotherapy arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
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 | Panitumumab Plus mFOLFOX6 | Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle. | 61 | 139 | 139 | 139 | ||
| EG001 | Bevacizumab Plus mFOLFOX6 | Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle. | 53 | 139 | 139 | 139 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Gastrointestinal perforation | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Rectal perforation | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Small intestinal perforation | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Adverse drug reaction | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Thrombosis in device | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Escherichia bacteraemia | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Herpes zoster oticus | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Infusion site infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Meningoencephalitis herpetic | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Orchitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Perirectal abscess | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Face injury | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Wound haemorrhage | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Eastern Cooperative Oncology Group performance status worsened | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Trismus | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Colorectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Vertebrobasilar insufficiency | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Mood altered | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Substance abuse | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Ureteric obstruction | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Epididymitis | Reproductive system and breast disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pulmonary venous thrombosis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Nail bed inflammation | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Intra-abdominal haematoma | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Superior vena cava syndrome | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Thrombophlebitis superficial | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Temperature intolerance | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dysaesthesia | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Neurotoxicity | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Exfoliative rash | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypertrichosis | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Skin toxicity | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results aftercompletion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D015179 | Colorectal Neoplasms |
| D012004 | Rectal Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077544 | Panitumumab |
| D000068258 | Bevacizumab |
| 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 |
Not provided
Not provided
| Male |
|
| Black or African American |
|
| Hispanic or Latino |
|
| Asian |
|
| Japanese |
|
| No |
|
| RAS Wild-type |
|
| RAS/BRAF wild-type |
|
| Testing not performed |
|
| Sample acceptance failure |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
|
|
|
Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
|
|
|
|
|