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| ID | Type | Description | Link |
|---|---|---|---|
| B9E-US-S337 | Other Identifier | Eli Lilly and Company |
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The purpose of the study is to describe the tumor response rates for the two regimens being studied, and to determine how long patients live after receiving the treatment, how long patients are without return of their disease after they receive treatment, and how long the response they get from the treatment lasts. The amount and type of side effects/toxicities of each regimen will also be evaluated. The regimen including Oxaliplatin + 5FU/Folinic Acid is a current standard of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A+FFG | Experimental | Avastin + Gemcitabine + 5-Fluorouracil (5FU)/Folinic Acid |
|
| A+FOLFOX 4 | Active Comparator | Avastin + Oxaliplatin + 5-Fluorouracil (5FU)/Folinic Acid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine | Drug | 900 mg/m2 IV over 90 minutes after Folinic Acid weekly for 6 weeks every 8 weeks until progression. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Response by Response Evaluation Criteria In Solid Tumors (RECIST) | Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. | baseline to measured progressive disease (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Progressive Disease | Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause. | randomization to the date of first documented disease progression or death due to disease under study, whichever comes first (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Response - Avastin Subgroup | Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. | baseline to measured progressive disease (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tucson | Arizona |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21120580 | Result | Madajewicz S, Waterhouse DM, Ritch PS, Khan MQ, Higby DJ, Leichman CG, Malik SK, Hentschel P, Gill JF, Zhao L, Nicol SJ. Multicenter, randomized phase II trial of bevacizumab plus folinic acid, fluorouracil, gemcitabine (FFG) versus bevacizumab plus folinic acid, fluorouracil, oxaliplatin (FOLFOX4) as first-line therapy for patients with advanced colorectal cancer. Invest New Drugs. 2012 Apr;30(2):772-8. doi: 10.1007/s10637-010-9598-9. Epub 2010 Dec 1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | A+FFG | Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid) |
| FG001 | A + FOLFOX 4 | Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| avastin | Drug | 5 milligrams per kilogram (mg/kg) |
|
| 5FU/folinic acid | Drug | Folinic Acid: 100 milligrams per square meter (mg/m2) intravenous (IV) over 60 minutes (A+FFG). Folinic Acid: 200 mg/m2 as a 2-hr infusion on Days 1 and 2 of a 14-day cycle (A+FOLFOX 4). 5-Fluorouracil: 450 mg/m2 as an IV bolus in middle of Folinic Acid (A+FFG). 5-Fluorouracil: 400 mg/m2 bolus plus a 600 mg/m2 22-hour infusion on Days 1 and 2 of a 14-day cycle (A+FOLFOX 4). |
|
| oxaliplatin | Drug | 85 mg/m2 as a 2-hour infusion on Day 1 of a 14 day cycle. |
|
| Progression-Free Survival | Defined as the time from randomization to the first observation of disease progression, or death due to any cause. | randomization to the first date of progression or death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years) |
| Overall Survival | Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact. | randomization to the date of death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years) |
| Duration of Response | The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. | date of first response until the first date of documented progression or death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years) |
| Time to Progressive Disease - Avastin Subgroup | Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause. | randomization to the date of first documented disease progression or death due to disease under study, whichever comes first (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years) |
| Progression-Free Survival - Avastin Subgroup | Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause. | randomization to the first date of progression or death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years) |
| Survival at 12 Months and 24 Months - Avastin Subgroup | Percentage of participants who were alive at 12 months and 24 months. | randomization to the date of death from any cause (up to 24 months) |
| Toxicity - Avastin Subgroup | Includes all Grade 3-4 hematologic toxicities and all non-hematologic toxicities with either >=1 Grade 4 or >=2 Grade 3 adverse events | every cycle (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years) |
| Duration of Response - A+FOLFOX4 - Avastin Subgroup | The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. | date of first response until the first date of documented progression or death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years) |
| United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Beverly Hills | California | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Palm Springs | California | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Stockton | California | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kansas City | Kansas | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Springfield | Massachusetts | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Lansing | Michigan | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tupelo | Mississippi | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Stony Brook | New York | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | The Bronx | New York | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Burlington | North Carolina | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Cincinnati | Ohio | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Springfield | Ohio | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Marshfield | Wisconsin | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Milwaukee | Wisconsin | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | A+FFG | Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid) |
| BG001 | A + FOLFOX 4 | Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Diagnosis to Enrollment | Number | participants |
| ||||||||||||||||
| Eastern Cooperative Oncology Group (ECOG) Performance Status | Classifies patients according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death). | Number | participants |
| |||||||||||||||
| Primary Tumor Site | Number | participants |
| ||||||||||||||||
| Prior Adjuvant Therapy | Number | participants |
| ||||||||||||||||
| Race/Ethnicity | Number | participants |
| ||||||||||||||||
| Site of Metastasis | Metastasis could occur in multiple sites. | Number | participants |
| |||||||||||||||
| Tumor Stage | Patients could experience multiple tumors. | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Tumor Response by Response Evaluation Criteria In Solid Tumors (RECIST) | Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. | Intent-to-Treat Population | Posted | Number | participants | baseline to measured progressive disease (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years) |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Time to Progressive Disease | Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause. | Intent to treat population. Five patients in A+FFG and 5 patients in A+FOLFOX4 were censored. | Posted | Median | 95% Confidence Interval | months | randomization to the date of first documented disease progression or death due to disease under study, whichever comes first (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival | Defined as the time from randomization to the first observation of disease progression, or death due to any cause. | Intent to treat population. Three patients in A+FFG and 4 patients in A+FOLFOX4 were censored. | Posted | Median | 95% Confidence Interval | months | randomization to the first date of progression or death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact. | Intent to treat population. Eight patients in A+FFG and 12 patients in A+FOLFOX4 were censored. | Posted | Median | 95% Confidence Interval | months | randomization to the date of death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years) |
|
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| Other Pre-specified | Tumor Response - Avastin Subgroup | Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. | The original treatment regimens were FFG and FOLFOX. Due to FDA approval of Avastin, protocol was amended to add Avastin to treatment regimens. This is the population of patients who received Avastin with the original treatment. | Posted | Number | participants | baseline to measured progressive disease (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years) |
|
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Time to Progressive Disease - Avastin Subgroup | Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause. | The original treatment regimens were FFG and FOLFOX. Due to FDA approval of Avastin, protocol was amended to add Avastin to treatment regimens. This is the population of patients who received Avastin with the original treatment. Three patients in A+FFG - Avastin subgroup and 4 patients in A+FOLFOX4 - Avastin subgroup were censored. | Posted | Median | 95% Confidence Interval | months | randomization to the date of first documented disease progression or death due to disease under study, whichever comes first (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years) |
|
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Progression-Free Survival - Avastin Subgroup | Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause. | The original treatment regimens were FFG and FOLFOX. Due to FDA approval of Avastin, protocol was amended to add Avastin to treatment regimens. This is the population of patients who received Avastin with the original treatment. Three patients in A+FFG - Avastin subgroup and 3 patients in A+FOLFOX4 - Avastin subgroup were censored. | Posted | Median | 95% Confidence Interval | months | randomization to the first date of progression or death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years) |
|
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Survival at 12 Months and 24 Months - Avastin Subgroup | Percentage of participants who were alive at 12 months and 24 months. | The original treatment regimens were FFG (Arm A) and FOLFOX (Arm B). Due to FDA approval of Avastin, protocol was amended to add Avastin to treatment regimens. This is the population of patients who received Avastin with the original treatment. | Posted | Number | 95% Confidence Interval | percentage of participants alive | randomization to the date of death from any cause (up to 24 months) |
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| Other Pre-specified | Toxicity - Avastin Subgroup | Includes all Grade 3-4 hematologic toxicities and all non-hematologic toxicities with either >=1 Grade 4 or >=2 Grade 3 adverse events | The original treatment regimens were FFG and FOLFOX. Due to FDA approval of Avastin, protocol was amended to add Avastin to treatment regimens. This is the population of patients who received Avastin with the original treatment. | Posted | Number | participants | every cycle (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years) |
|
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| Secondary | Duration of Response | The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. | Intent to treat population who were responders (had best overall response of either complete response or partial response). Zero patients in A+FFG and 2 patients in A+FOLFOX4 were censored. | Posted | Median | 95% Confidence Interval | months | date of first response until the first date of documented progression or death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years) |
|
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| Other Pre-specified | Duration of Response - A+FOLFOX4 - Avastin Subgroup | The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. | The original treatment regimens were FFG and FOLFOX. Due to FDA approval of Avastin, protocol was amended to add Avastin to treatment regimens. This is the population of patients who received Avastin with the original treatment. Results were not calculable for the A+FFG-Avastin subgroup. Two patients were censored in the A+FOLFOX4-Avastin subgroup. | Posted | Median | 95% Confidence Interval | months | date of first response until the first date of documented progression or death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years) |
|
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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 | A+FFG | Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid) | 11 | 42 | 40 | 42 | ||
| EG001 | A + FOLFOX 4 | Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid) | 8 | 42 | 41 | 42 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 7 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 7 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 7 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 7 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 7 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 7 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 7 | Systematic Assessment |
| |
| Perirectal abscess | Gastrointestinal disorders | MedDRA 7 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 7 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 7 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 7 | Systematic Assessment |
| |
| Catheter related infection | Infections and infestations | MedDRA 7 | Systematic Assessment |
| |
| Pelvic abscess | Infections and infestations | MedDRA 7 | Systematic Assessment |
| |
| Pneumonia primary atypical | Infections and infestations | MedDRA 7 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 7 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 7 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 7 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 7 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 7 | Systematic Assessment |
| |
| Syncope vasovagal | Nervous system disorders | MedDRA 7 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 7 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 7 | Systematic Assessment |
| |
| Thrombophlebitis superficial | Vascular disorders | MedDRA 7 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 7 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 7 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 7 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 7 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 7 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 7 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 7 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 7 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 7 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 7 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 7 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 7 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 7 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 7 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 7 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 7 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 7 | Systematic Assessment |
| |
| Rigors | General disorders | MedDRA 7 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 7 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 7 | Systematic Assessment |
| |
| Haematocrit decreased | Investigations | MedDRA 7 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 7 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 7 | Systematic Assessment |
| |
| Neutrophil percentage decreased | Investigations | MedDRA 7 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 7 | Systematic Assessment |
| |
| Red blood cell count decreased | Investigations | MedDRA 7 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 7 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 7 | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA 7 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 7 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 7 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 7 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 7 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 7 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 7 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 7 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 7 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 7 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 7 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 7 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 7 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 7 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 7 | Systematic Assessment |
| |
| Neuropathy | Nervous system disorders | MedDRA 7 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 7 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 7 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 7 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 7 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 7 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 7 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 7 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 7 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 7 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 7 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 7 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 7 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 7 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 7 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 7 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 1-800-545-5979 |
| 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 |
|---|---|
| D000093542 | Gemcitabine |
| D000068258 | Bevacizumab |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| 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 |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Male |
|
| >=6 months |
|
| 1 - Ambulatory, Restricted Strenuous Activity |
|
| Rectum |
|
| Other |
|
| No |
|
| African descent |
|
| Asian |
|
| Hispanic |
|
| Lung |
|
| Abdominal |
|
| Regional lymph nodes |
|
| Distant lymph nodes |
|
| Genitourinary |
|
| Other |
|
| Regional lymph nodes |
|
| Distant metastasis |
|
| Overall Response Rate (CR+PR) |
|
| Stable Disease (SD) |
|
| Disease Control Rate (CR+PR+SD) |
|
| Progressive Disease |
|
| Unknown |
|
|
|
|
|
|
| Participants |
|
|
|
|
|
|
|