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This randomized, open-label, multicenter study will evaluate the efficacy and safety of folinic acid (leucovorin), 5-fluorouracil (5-FU), oxaliplatin, and irinotecan (FOLFOXIRI) / bevacizumab regimens (concurrent and sequential) versus folinic acid (leucovorin), 5-fluorouracil, and oxaliplatin (FOLFOX) / bevacizumab in first-line in participants with metastatic colorectal cancer. Participants will be randomized to receive bevacizumab 5 milligrams per kilogram (mg/kg) intravenously every 2 weeks with either concurrent or sequential FOLFOXIRI or with FOLFOX for 4 to 6 months of induction therapy, followed by maintenance therapy with bevacizumab plus either leucovorin/5-fluorouracil or capecitabine until disease progression occurs. After disease progression, participants will receive treatment with a fluoropyrimidine-based chemotherapy plus bevacizumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Concurrent FOLFOXIRI + Bevacizumab | Experimental | Participants will receive concurrent FOLFOXIRI along with 5 mg/kg of bevacizumab with treatment cycle of 2 weeks during first 4 month induction phase (plus optional 2 months of induction for participants who exhibit good response and tolerate the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) will be administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion. |
|
| Arm B: Sequential FOLFOXIRI + Bevacizumab | Experimental | Participants will receive alternating 4-week administrations of FOLFOX/bevacizumab and folinic acid (leucovorin), 5-FU, and irinotecan (FOLFIRI) /Bevacizumab with a treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibit good response and tolerate the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) will be administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion. |
|
| Arm C: FOLFOX + Bevacizumab | Experimental | Participants will receive FOLFOX along with 5 mg/kg of bevacizumab with treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibit good response and tolerate the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) will be administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5-fluorouracil | Drug | Participants in Arm A will receive 3200 milligrams per square meter (mg/m^2) by 48-hour continuous intravenous (IV) infusion every 2 weeks, during the 4-6 months' induction followed by maintenance therapy including bolus dose of 400 mg/m^2, followed by a 46-hour continuous infusion (2400 mg/m^2) every 2 weeks per investigator's discretion. Participants in Arm B and C will receive a bolus dose of 400 mg/m^2, followed by a 46-hour continuous infusion (2400 mg/m^2) every 2 weeks during the 4-6 months of induction and maintenance per investigator's discretion. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Overall Response During First-Line Therapy (ORR1) | ORR1 was the percentage of participants with complete response (CR) or partial response (PR) during first-line therapy as assessed by investigator according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v.1.1). CR was defined as disappearance of all extranodal target lesions and all pathological lymph nodes had to have decreased to <10 millimeter (mm) in short axis. PR was defined as at least a 30% decrease in the sum of longest diameters of target lesions, taking as reference the baseline sum diameters. ORR1 = CR + PR | Randomization up to disease progression during first-line therapy or death, whichever occurs first (up to approximately 3 years) |
| Progression-Free Survival During First-Line Therapy (PFS1) | PFS1 was defined as time from randomization to the first occurrence of disease progression during first-line therapy, as assessed by the Investigator using RECIST v1.1, or death from any cause, whichever occurs first. Disease progression was defined as sum of longest diameters increased by at least 20% from the smallest value on study. The sum of longest diameters must also demonstrate an absolute increase of at least 5 mm. | Randomization up to disease progression during first-line therapy or death, whichever occurs first (up to approximately 3 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to PFS2 | Time to PFS2 was defined as time from randomization to the first occurrence of disease progression after reinduction of second-line therapy, as assessed by the Investigator using RECIST v1.1, or death from any cause, whichever occurs first. Disease progression was defined as sum of longest diameters increased by at least 20% from the smallest value on study. The sum of longest diameters must also demonstrate an absolute increase of at least 5mm. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Alabama; Mitchell Cancer Institute | Mobile | Alabama | 36604 | United States | ||
| Long Beach Memorial Medical Center; Oncology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32816630 | Derived | Cremolini C, Antoniotti C, Stein A, Bendell J, Gruenberger T, Rossini D, Masi G, Ongaro E, Hurwitz H, Falcone A, Schmoll HJ, Di Maio M. Individual Patient Data Meta-Analysis of FOLFOXIRI Plus Bevacizumab Versus Doublets Plus Bevacizumab as Initial Therapy of Unresectable Metastatic Colorectal Cancer. J Clin Oncol. 2020 Aug 20:JCO2001225. doi: 10.1200/JCO.20.01225. Online ahead of print. | |
| 30552157 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A: Concurrent FOLFOXIRI + Bevacizumab | Participants received concurrent FOLFOXIRI along with 5 mg/kg of bevacizumab with treatment cycle of 2 weeks during first 4 month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-fluorouracil (5-FU) with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| bevacizumab | Drug | Participants will receive 5 mg/kg IV every 2 weeks during the first 4-6 months induction phase, followed by 5 mg/kg IV every 2 weeks or 7.5 mg/kg IV every 3 weeks during maintenance therapy, and 2.5 mg/kg per week reinduction after disease progression. |
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| capecitabine | Drug | Participants will receive 1000 or 850 mg/kg orally twice daily as per investigator's discretion on Day 1 to 14, repeated every 3 weeks in maintenance phase. |
|
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| irinotecan | Drug | Participants will receive IV infusion of 165 mg/m^2 over 1 hour every 2 weeks (Arm A) or IV infusion of 180 mg/m^2 over 1 hour in 2 x 2 weeks cycles alternating months (in Arm B), during 4-6 months induction phase. |
|
| folinic acid | Drug | Participants will receive IV infusion of 200 mg/m^² (Arm A) or 400 mg/m^2 (Arm B or C) over 2 hours every 2 weeks, during 4-6 months induction phase followed by IV infusion of 400 mg/m^2 in the maintenance therapy. |
|
|
| oxaliplatin | Drug | Participants will receive 85 mg/m^2 over 2 hours as IV infusion every 2 weeks (Arm A, C ) or 2 x 2 week cycles alternating months (Arm B), during 4-6 months induction phase . |
|
| Randomization up to disease progression during second-line therapy or death, whichever occurs first (up to approximately 3 years) |
| Overall Survival (OS) | OS was defined as the time from the date of randomization to the date of death from any cause. | Randomization until death due to any cause (up to approximately 3 years) |
| Proportion of Participants Who Underwent Liver Metastases Resections | Reported here is the proportion of participants who underwent liver metastases resections calculated as follows: number of participants who underwent liver metastases resections divided by total number of participants in each arm. | Randomization up to approximately 3 years |
| Proportion of Participants Considered by the Investigator to be Unresectable on Study Enrollment Who Subsequently Underwent Attempted Curative Resections of Metastases | The proportion of participants considered by the investigator to be unresectable at study enrollment who subsequently underwent attempted curative resections of metastases was calculated as follows: number of participants considered by the investigator to be unresectable at study enrollment who subsequently underwent attempted curative resections of metastases divided by total number of participants in each arm. This outcome represents a measure of the rate of conversion from unresectable to resectable disease. | Randomization up to approximately 3 years |
| Percentage of Participants With Adverse Events | An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | Randomization up to approximately 3 years |
| Long Beach |
| California |
| 90806 |
| United States |
| LAC-USC Medical Center | Los Angeles | California | 90033 | United States |
| USC Norris Cancer Center | Los Angeles | California | 90033 | United States |
| Pacific Cancer Care - Monterey | Monterey | California | 93940 | United States |
| Sacramento Center for Hematolo | Sacramento | California | 95816 | United States |
| Pacific Cancer Care | Salinas | California | 93901 | United States |
| Kaiser Permanente - Franklin | Denver | Colorado | 80205 | United States |
| Yale Cancer Center | New Haven | Connecticut | 06520 | United States |
| Sibley Memorial Hospital | Washington D.C. | District of Columbia | 20016 | United States |
| Florida Cancer Specialists - Fort Myers (Colonial Center Dr) | Fort Myers | Florida | 33905 | United States |
| Florida Cancer Specialist, North Region | St. Petersburg | Florida | 33705 | United States |
| University Cancer & Blood Center, LLC | Athens | Georgia | 30607 | United States |
| Emory University Clinic | Atlanta | Georgia | 30322 | United States |
| Central Georgia Cancer Care PC | Macon | Georgia | 31201 | United States |
| Summit Cancer Care PC | Savannah | Georgia | 31405 | United States |
| Ingalls Memorial Hosp | Harvey | Illinois | 60426 | United States |
| Edward Cancer Center Naperville | Naperville | Illinois | 60540 | United States |
| Edward Cancer Center Plainfield | Plainfield | Illinois | 60585 | United States |
| University of Kentucky Medical Center | Lexington | Kentucky | 40536 | United States |
| Johns Hopkins Univ; Bunting Blaustein Cancer Center | Baltimore | Maryland | 21231 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| St. Joseph Mercy Hospital; Cancer Care Center. | Ann Arbor | Michigan | 48106 | United States |
| Karmanos Cancer Institute.. | Detroit | Michigan | 48201 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Southeast Nebraska Cancer Center;; Southeast Nebraska Hematology and Oncology | Lincoln | Nebraska | 68510 | United States |
| Nebraska Methodist Hospital; Cancer Center | Omaha | Nebraska | 68114 | United States |
| Dartmouth Hitchcock Med Center | Lebanon | New Hampshire | 03756 | United States |
| Oncology Hematology Care Inc | Cincinnati | Ohio | 45242 | United States |
| University of Oklahoma; Stephenson Oklahoma Canc Ctr | Oklahoma City | Oklahoma | 73104 | United States |
| Milton S. Hershey Medical Center; Penn State Cancer Inst. | Hershey | Pennsylvania | 17033 | United States |
| Chattanooga Oncology and Hematology Associates, PC | Chattanooga | Tennessee | 37404 | United States |
| West Clinic | Germantown | Tennessee | 38138 | United States |
| Sarah Cannon Cancer Center and Research Institute | Nashville | Tennessee | 37203 | United States |
| UT Southwestern MC at Dallas | Dallas | Texas | 75390-9063 | United States |
| Ctr for Cancer and Blood Disorders | Fort Worth | Texas | 76104 | United States |
| Scott and White Hospital; Cancer Center | Temple | Texas | 76508 | United States |
| Virginia Cancer Institute | Richmond | Virginia | 23226 | United States |
| Seattle Cancer Care Alliance - Evergreen Health | Kirkland | Washington | 98034 | United States |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| Medical Oncology Associates | Spokane | Washington | 99208 | United States |
| Vince Lombardi Cancer Center | Green Bay | Wisconsin | 54311 | United States |
| Medical College of Wisconsin; Dept Froedtert Clin Can Ctr | Milwaukee | Wisconsin | 53226 | United States |
| Aurora Research Institute | Wauwatosa | Wisconsin | 53226 | United States |
| Cheyenne Oncology & Hematology Associates | Cheyenne | Wyoming | 82001 | United States |
| Derived |
| Hurwitz HI, Tan BR, Reeves JA, Xiong H, Somer B, Lenz HJ, Hochster HS, Scappaticci F, Palma JF, Price R, Lee JJ, Nicholas A, Sommer N, Bendell J. Phase II Randomized Trial of Sequential or Concurrent FOLFOXIRI-Bevacizumab Versus FOLFOX-Bevacizumab for Metastatic Colorectal Cancer (STEAM). Oncologist. 2019 Jul;24(7):921-932. doi: 10.1634/theoncologist.2018-0344. Epub 2018 Dec 14. |
| FG001 | Arm B: Sequential FOLFOXIRI + Bevacizumab | Participants received alternating 4-week administrations of FOLFOX/bevacizumab and folinic acid (leucovorin), 5-FU, and irinotecan (FOLFIRI) /Bevacizumab with a treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion. |
| FG002 | Arm C: FOLFOX + Bevacizumab | Participants received FOLFOX along with 5 mg/kg of bevacizumab with treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion. |
| COMPLETED |
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| NOT COMPLETED |
|
|
Intent to Treat (ITT) population was defined as all randomized participants regardless of whether they received any dose of study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A: Concurrent FOLFOXIRI + Bevacizumab | Participants received concurrent FOLFOXIRI along with 5 mg/kg of bevacizumab with treatment cycle of 2 weeks during first 4 month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-fluorouracil (5-FU) with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion. |
| BG001 | Arm B: Sequential FOLFOXIRI + Bevacizumab | Participants received alternating 4-week administrations of FOLFOX/bevacizumab and folinic acid (leucovorin), 5-FU, and irinotecan (FOLFIRI) /Bevacizumab with a treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion. |
| BG002 | Arm C: FOLFOX + Bevacizumab | Participants received FOLFOX along with 5 mg/kg of bevacizumab with treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| 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 |
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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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Overall Response During First-Line Therapy (ORR1) | ORR1 was the percentage of participants with complete response (CR) or partial response (PR) during first-line therapy as assessed by investigator according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v.1.1). CR was defined as disappearance of all extranodal target lesions and all pathological lymph nodes had to have decreased to <10 millimeter (mm) in short axis. PR was defined as at least a 30% decrease in the sum of longest diameters of target lesions, taking as reference the baseline sum diameters. ORR1 = CR + PR | ITT population was defined as all randomized participants regardless of whether they received any dose of study treatment. | Posted | Number | Percentage of participants | Randomization up to disease progression during first-line therapy or death, whichever occurs first (up to approximately 3 years) |
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| Primary | Progression-Free Survival During First-Line Therapy (PFS1) | PFS1 was defined as time from randomization to the first occurrence of disease progression during first-line therapy, as assessed by the Investigator using RECIST v1.1, or death from any cause, whichever occurs first. Disease progression was defined as sum of longest diameters increased by at least 20% from the smallest value on study. The sum of longest diameters must also demonstrate an absolute increase of at least 5 mm. | ITT population was defined as all randomized participants regardless of whether they received any dose of study treatment. | Posted | Median | 90% Confidence Interval | months | Randomization up to disease progression during first-line therapy or death, whichever occurs first (up to approximately 3 years) |
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| Secondary | Time to PFS2 | Time to PFS2 was defined as time from randomization to the first occurrence of disease progression after reinduction of second-line therapy, as assessed by the Investigator using RECIST v1.1, or death from any cause, whichever occurs first. Disease progression was defined as sum of longest diameters increased by at least 20% from the smallest value on study. The sum of longest diameters must also demonstrate an absolute increase of at least 5mm. | ITT population was defined as all randomized participants regardless of whether they received any dose of study treatment. | Posted | Median | 90% Confidence Interval | months | Randomization up to disease progression during second-line therapy or death, whichever occurs first (up to approximately 3 years) |
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| Secondary | Overall Survival (OS) | OS was defined as the time from the date of randomization to the date of death from any cause. | ITT population was defined as all randomized participants regardless of whether they received any dose of study treatment. | Posted | Median | 90% Confidence Interval | months | Randomization until death due to any cause (up to approximately 3 years) |
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| Secondary | Proportion of Participants Who Underwent Liver Metastases Resections | Reported here is the proportion of participants who underwent liver metastases resections calculated as follows: number of participants who underwent liver metastases resections divided by total number of participants in each arm. | ITT population was defined as all randomized participants regardless of whether they received any dose of study treatment. | Posted | Number | 90% Confidence Interval | Proportion of participants | Randomization up to approximately 3 years |
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| Secondary | Proportion of Participants Considered by the Investigator to be Unresectable on Study Enrollment Who Subsequently Underwent Attempted Curative Resections of Metastases | The proportion of participants considered by the investigator to be unresectable at study enrollment who subsequently underwent attempted curative resections of metastases was calculated as follows: number of participants considered by the investigator to be unresectable at study enrollment who subsequently underwent attempted curative resections of metastases divided by total number of participants in each arm. This outcome represents a measure of the rate of conversion from unresectable to resectable disease. | ITT population was defined as all randomized participants regardless of whether they received any dose of study treatment. | Posted | Number | 90% Confidence Interval | Proportion of participants | Randomization up to approximately 3 years |
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| Secondary | Percentage of Participants With Adverse Events | An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | Safety population was defined as all randomized participants who received at least one partial or complete dose of study medication. | Posted | Number | Percentage of participants | Randomization up to approximately 3 years |
|
From baseline up to approximately 3 years.
Safety population was defined as all randomized participants who received at least one partial or complete dose of study medication.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A: Concurrent FOLFOXIRI + Bevacizumab | Participants received concurrent FOLFOXIRI along with 5 mg/kg of bevacizumab with treatment cycle of 2 weeks during first 4 month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-fluorouracil (5-FU) with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion. | 39 | 91 | 91 | 91 | ||
| EG001 | Arm B: Sequential FOLFOXIRI + Bevacizumab | Participants received alternating 4-week administrations of FOLFOX/bevacizumab and folinic acid (leucovorin), 5-FU, and irinotecan (FOLFIRI) /Bevacizumab with a treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion. | 42 | 90 | 89 | 90 | ||
| EG002 | Arm C: FOLFOX + Bevacizumab | Participants received FOLFOX along with 5 mg/kg of bevacizumab with treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion. | 43 | 90 | 89 | 90 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Arteriospasm coronary | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Rectal perforation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Rectal Haemorrhage | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Gastrointestinal perforation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Large intestinal stenosis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Obstruction gastric | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Rectal obstruction | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Medical device pain | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hepatic haemorrhage | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Carbuncle | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Liver abscess | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Necrotising fasciitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Pelvic abscess | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Pneumococcal sepsis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Rectal abscess | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Stoma site infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Cystitis radiation | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Postoperative respiratory failure | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Procedural complication | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Stoma obstruction | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Stoma site pain | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Lactic acidosis | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Soft tissue necrosis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Tumour compression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Central nervous system lesion | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Embolic stroke | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Acute prerenal failure | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Urinary bladder rupture | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Laryngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Wound drainage | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Air embolism | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Abdominal distention | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Temperature intolerance | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Deceased appetite | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Nail discolouration | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Sinus operation | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
This trial was terminated on 12 November 2015, because the primary objective was not met.
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 | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D005472 | Fluorouracil |
| D000068258 | Bevacizumab |
| D000069287 | Capecitabine |
| D000077146 | Irinotecan |
| D002955 | Leucovorin |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| 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 |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Male |
|
Participants received alternating 4-week administrations of FOLFOX/bevacizumab and folinic acid (leucovorin), 5-FU, and irinotecan (FOLFIRI) /Bevacizumab with a treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion. |
| OG002 | Arm C: FOLFOX + Bevacizumab | Participants received FOLFOX along with 5 mg/kg of bevacizumab with treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion. |
| OG003 | Arms A + B: Pooled FOLFOXIRI + Bevacizumab | This analysis set combines Arms A and B and represents participants who received either concurrent or sequential FOLFOXIRI with 5 mg/kg of bevacizumab during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion. |
|
|
|
Participants received alternating 4-week administrations of FOLFOX/bevacizumab and folinic acid (leucovorin), 5-FU, and irinotecan (FOLFIRI) /Bevacizumab with a treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion. |
| OG002 | Arm C: FOLFOX + Bevacizumab | Participants received FOLFOX along with 5 mg/kg of bevacizumab with treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion. |
| OG003 | Arms A + B: Pooled FOLFOXIRI + Bevacizumab | This analysis set combines Arms A and B and represents participants who received either concurrent or sequential FOLFOXIRI with 5 mg/kg of bevacizumab during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion. |
|
|
| OG002 | Arm C: FOLFOX + Bevacizumab | Participants received FOLFOX along with 5 mg/kg of bevacizumab with treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion. |
| OG003 | Arms A + B: Pooled FOLFOXIRI + Bevacizumab | This analysis set combines Arms A and B and represents participants who received either concurrent or sequential FOLFOXIRI with 5 mg/kg of bevacizumab during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion. |
|
|
| OG002 | Arm C: FOLFOX + Bevacizumab | Participants received FOLFOX along with 5 mg/kg of bevacizumab with treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion. |
| OG003 | Arms A + B: Pooled FOLFOXIRI + Bevacizumab | This analysis set combines Arms A and B and represents participants who received either concurrent or sequential FOLFOXIRI with 5 mg/kg of bevacizumab during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion. |
|
|
| OG001 |
| Arm B: Sequential FOLFOXIRI + Bevacizumab |
Participants received alternating 4-week administrations of FOLFOX/bevacizumab and folinic acid (leucovorin), 5-FU, and irinotecan (FOLFIRI) /Bevacizumab with a treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion. |
| OG002 | Arm C: FOLFOX + Bevacizumab | Participants received FOLFOX along with 5 mg/kg of bevacizumab with treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion. |
| OG003 | Arms A + B: Pooled FOLFOXIRI + Bevacizumab | This analysis set combines Arms A and B and represents participants who received either concurrent or sequential FOLFOXIRI with 5 mg/kg of bevacizumab during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion. |
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Participants received alternating 4-week administrations of FOLFOX/bevacizumab and folinic acid (leucovorin), 5-FU, and irinotecan (FOLFIRI) /Bevacizumab with a treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion. |
| OG002 | Arm C: FOLFOX + Bevacizumab | Participants received FOLFOX along with 5 mg/kg of bevacizumab with treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion. |
| OG003 | Arms A + B: Pooled FOLFOXIRI + Bevacizumab | This analysis set combines Arms A and B and represents participants who received either concurrent or sequential FOLFOXIRI with 5 mg/kg of bevacizumab during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion. |
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