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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA016042 | U.S. NIH Grant/Contract | View source | |
| UCLA-0412086-01 | |||
| ROCHE-BO17920A |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab (Bv) may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving combination chemotherapy together with bevacizumab is more effective than combination chemotherapy alone in treating colon cancer in adjuvant setting.
PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens with or without bevacizumab to compare how well they work in treating patients who have undergone surgery for high risk stage II or stage III colon cancer.
This was an open-label Phase III, multicenter, multinational, randomized, 3-arm study designed to evaluate the efficacy and safety of bevacizumab in combination with either intermittent fluorouracil/leucovorin with oxaliplatin (FOLFOX4) or capecitabine plus oxaliplatin (XELOX) versus FOLFOX4 regimen alone, as adjuvant chemotherapy in colon carcinoma.
The treatment phase consisted of two parts of 24 weeks for a total of 48 weeks. The first part (weeks 1 to 24) consisted of treatment with either FOLFOX4, FOLFOX4 in combination with bevacizumab, or XELOX in combination with bevacizumab. The second part (weeks 25 to 48) consisted of single-agent bevacizumab for patients randomized to either bevacizumab-containing arm, but was only an observation period for patients assigned to the FOLFOX4-alone arm.
Patients were to be followed for recurrence/new occurrence of colorectal cancer and survival. Patients who experienced a confirmed recurrence, occurrence of a new colorectal cancer during therapy, or experienced unacceptable toxicity were to be taken off study treatment but remain in study follow-up. Patients that came off therapy due to a confirmed recurrence/appearance of new colorectal cancer, were to be followed for survival until the end of the study follow-up period. The primary analysis was performed 36 months after the last patient has been randomized. After the primary analysis, patients continue to be followed for survival for at least a further 2 years ie, until all patients have been followed-up for at least 5 years following randomization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FOLFOX4 | Active Comparator | Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks). Weeks 25-48: Observation only. |
|
| FOLFOX4 + Bv | Experimental | Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks). Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks). |
|
| XELOX+Bv | Experimental | Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks). Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Biological | Administered as an intravenous infusion over 30 - 90 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free Survival in Stage III Cancer Patients - Time to Event | Disease-free survival (DFS) was defined as the time from the date of randomization to the time of a recurrence, a new occurrence of colorectal cancer or death due to any cause, whichever occurred first. Patients without an event were censored at the last date the patient was known to be disease-free. Recurrence and new occurrence of colorectal cancer were based on tumor assessments made by the investigator. Patients with no tumor assessments after baseline but still alive at the time of the clinical cut-off were censored at day 1. | From first patient randomized until the data cut-off date of 30 June 2010 (36 months after the last patient randomized). |
| Disease-free Survival in Stage III Cancer Patients - Number of Events | A disease-free survival (DFS) event was composed of a recurrence, a new occurrence of colorectal cancer or death due to any cause. Recurrence and new occurrence of colorectal cancer were based on tumor assessments made by the investigator. Triggering events for DFS are reported; a patient can have both recurrence and a new occurrence of colon cancer. | From first patient randomized until the data cut-off date of 30 June 2010 (36 months after the last patient randomized). |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival in Stage III Cancer Patients - Time to Event | Overall survival was defined as the time between date of randomization and date of death due to any cause. Patients not reported as having died at the time of the analysis were censored at the date they were last known to be alive. | From first patient randomized until the clinical data cut-off date of 30 June 2010 (36 months after the last patient randomized). |
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Inclusion Criteria
Signed written informed consent obtained prior to any study specific screening procedures.
Patient willing and able to comply with the protocol.
Age ≥ 18 years-of-age.
Histologically confirmed colon carcinoma, American Joint Cancer Committee/Union Internationale Contre le Cancer (AJCC/UICC) Stage II or Stage III defined as a tumor location ≥ 15 cm from the anal verge by endoscopy or above the peritoneal reflection at surgery. The patient was not to be a candidate for (neo) adjuvant radiotherapy. Note: Stage II patients were to be considered as high-risk patients fulfilling one of the following criteria:
Curative surgery not less than 4 and not more than 8 weeks prior to randomization.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Life expectancy of ≥ 5 years.
Exclusion Criteria
Macroscopic or microscopic evidence of remaining tumour. Patients should never have had any evidence of metastatic disease (including presence of tumour cells in the ascites). The isolated finding of cytokeratin positive cells in bone marrow is not considered evidence of metastatic disease for purposes of this study.
Carcinoembryonic antigen > 1.5 x upper limit of normal (ULN) after surgery (during screening period).
For patients with colostomy, unwilling to delay revision until at least 28 days after treatment completion.
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, not fully healed wounds, or anticipation of the need for major surgical procedure during the course of the study. Any central venous access device (CVAD) for chemotherapy administration must be inserted at least 2 days prior to treatment start.
Previous anti-angiogenic treatment for any malignancy; cytotoxic chemotherapy, radiotherapy or immunotherapy for colon cancer.
Other malignancies within the last 5 years (other than curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix).
Females with a positive or no pregnancy test (within 7 days before treatment start) unless childbearing potential can be otherwise excluded (postmenopausal i.e. amenorrheic for at least 2 years, hysterectomy or oophorectomy).
Lactating women.
Fertile women (< 2 years after last menstruation) and men of childbearing potential not willing to use effective means of contraception.
History or evidence upon physical examination of central nervous disease (CNS) disease (eg, primary brain tumour, seizure not controlled with standard medical therapy, any brain metastases).
History of psychiatric disability judged by the investigator to be clinically significant, precluding informed consent or interfering with compliance for oral drug intake.
Clinically significant (ie, active) cardiovascular disease. This includes, but is not limited to, the following examples: cerebrovascular accidents (≤ 6 months prior to randomization), myocardial infarction (≤ 1 year prior to randomization), uncontrolled hypertension (>150/100 mmHg) while receiving chronic medication, unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, clinically significant electrocardiogram (ECG) findings (e.g. QTc ≥ 440 msecs [male] 460 msecs [female] or ≥ 2º atrioventricular block, etc.).
Patients who suffer from serious cardiac arrhythmia requiring medication can enter the study only if they are considered to be in a stable condition regarding both the arrhythmia and their medication. Patients with pacemakers are allowed to enter the study only if they are considered as being in a stable condition. In case of doubt, the investigator should obtain a consultation with a local cardiologist.
Lack of physical integrity of the upper gastro-intestinal tract, malabsorption syndrome, or inability to take oral medication.
Interstitial pneumonia or extensive symptomatic fibrosis of the lungs.
Known peripheral neuropathy ≥ Common terminology criteria for adverse events (CTCAE) version 3.0 Grade 1. Absence of deep tendon reflexes as the sole neurological abnormality does not render the patient ineligible.
Organ allografts requiring immunosuppressive therapy.
Serious, non-healing wound, ulcer, or bone fracture.
Evidence of bleeding diathesis or coagulopathy.
Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic purposes.
Chronic, daily treatment with high-dose aspirin (> 325 mg/day) or clopidogrel (> 75 mg/day).
Chronic treatment with corticosteroids (dose of ≥ 10 mg/day methylprednisolone equivalent) (excluding inhaled steroids).
Serious intercurrent infections (uncontrolled or requiring treatment).
Known dihydropyrimidine dehydrogenase deficiency.
Current or recent (within the 28 days prior to randomization) treatment with another investigational drug or participation in another investigational study.
Patients with known allergy to Chinese hamster ovary cell proteins or other recombinant human or humanized antibodies or to any excipients of bevacizumab formulation, platinum compounds or to any other components of the study drugs.
History or presence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or patient at high risk from treatment complications.
Presence of proteinuria at baseline as defined by:
- Patients with > 1 g of protein/24 hour by a 24-hour urine collection.
Any laboratory values at baseline are as follows:
Haematology:
Biochemistry:
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| Name | Affiliation | Role |
|---|---|---|
| Joel Randolph Hecht, MD | Jonsson Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jonsson Comprehensive Cancer Center at UCLA | Los Angeles | California | 90095-1781 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36306483 | Derived | Gallois C, Shi Q, Meyers JP, Iveson T, Alberts SR, de Gramont A, Sobrero AF, Haller DG, Oki E, Shields AF, Goldberg RM, Kerr R, Lonardi S, Yothers G, Kelly C, Boukovinas I, Labianca R, Sinicrope FA, Souglakos I, Yoshino T, Meyerhardt JA, Andre T, Papamichael D, Taieb J. Prognostic Impact of Early Treatment and Oxaliplatin Discontinuation in Patients With Stage III Colon Cancer: An ACCENT/IDEA Pooled Analysis of 11 Adjuvant Trials. J Clin Oncol. 2023 Feb 1;41(4):803-815. doi: 10.1200/JCO.21.02726. Epub 2022 Oct 28. | |
| 33356421 |
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Randomization was stratified according to geographic region and disease stage (high-risk stage II or stage III N1 or stage III N2). The primary analysis population consisted of patients with Stage III disease.
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| ID | Title | Description |
|---|---|---|
| FG000 | FOLFOX4 | Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-fluorouracil (5-FU), given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks). Weeks 25-48: Observation only. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Capecitabine | Drug | Film-coated tablets |
|
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| 5-Fluorouracil (5-FU) | Drug | Administered as either a bolus injection or continuous intravenous infusion over 22 hours. |
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| Leucovorin calcium | Drug | Administered as a 200 mg/m^2 infusion over 2 hours. |
|
| Oxaliplatin | Drug | Administered as an intravenous infusion over 2 hours. |
|
| Overall Survival in Stage III Cancer Patients - Number of Events | An overall survival event was death due to any cause. | From first patient randomized until the clinical data cut-off date of 30 June 2010 (36 months after the last patient randomized). |
| Overall Survival in Stage III Cancer Patients - Time to Event: Final Analysis | Overall survival was defined as the time between date of randomization and date of death due to any cause. Patients not reported as having died at the time of the clinical cut-off date (30 June 2012) were censored at the date they were last known to be alive. | From first patient randomized until the final data cut-off date of 30 June 2012 (5 years after the last patient randomized). |
| Overall Survival in Stage III Cancer Patients - Number of Events: Final Analysis | An overall survival event was death due to any cause. | From first patient randomized until the final data cut-off date of 30 June 2012 (5 years after the last patient randomized). |
| Derived |
| Cohen R, Taieb J, Fiskum J, Yothers G, Goldberg R, Yoshino T, Alberts S, Allegra C, de Gramont A, Seitz JF, O'Connell M, Haller D, Wolmark N, Erlichman C, Zaniboni A, Lonardi S, Kerr R, Grothey A, Sinicrope FA, Andre T, Shi Q. Microsatellite Instability in Patients With Stage III Colon Cancer Receiving Fluoropyrimidine With or Without Oxaliplatin: An ACCENT Pooled Analysis of 12 Adjuvant Trials. J Clin Oncol. 2021 Feb 20;39(6):642-651. doi: 10.1200/JCO.20.01600. Epub 2020 Dec 23. |
| 33074326 | Derived | Chibaudel B, Henriques J, Rakez M, Brenner B, Kim TW, Martinez-Villacampa M, Gallego-Plazas J, Cervantes A, Shim K, Jonker D, Guerin-Meyer V, Mineur L, Banzi C, Dewdney A, Dejthevaporn T, Bloemendal HJ, Roth A, Moehler M, Aranda E, Van Cutsem E, Tabernero J, Schmoll HJ, Hoff PM, Andre T, de Gramont A. Association of Bevacizumab Plus Oxaliplatin-Based Chemotherapy With Disease-Free Survival and Overall Survival in Patients With Stage II Colon Cancer: A Secondary Analysis of the AVANT Trial. JAMA Netw Open. 2020 Oct 1;3(10):e2020425. doi: 10.1001/jamanetworkopen.2020.20425. |
| 32085892 | Derived | Salem ME, Yin J, Goldberg RM, Pederson LD, Wolmark N, Alberts SR, Taieb J, Marshall JL, Lonardi S, Yoshino T, Kerr RS, Yothers G, Grothey A, Andre T, De Gramont A, Shi Q. Evaluation of the change of outcomes over a 10-year period in patients with stage III colon cancer: pooled analysis of 6501 patients treated with fluorouracil, leucovorin, and oxaliplatin in the ACCENT database. Ann Oncol. 2020 Apr;31(4):480-486. doi: 10.1016/j.annonc.2019.12.007. Epub 2020 Jan 16. |
| 31959341 | Derived | Andre T, Vernerey D, Im SA, Bodoky G, Buzzoni R, Reingold S, Rivera F, McKendrick J, Scheithauer W, Ravit G, Fountzilas G, Yong WP, Isaacs R, Osterlund P, Liang JT, Creemers GJ, Rakez M, Van Cutsem E, Cunningham D, Tabernero J, de Gramont A. Bevacizumab as adjuvant treatment of colon cancer: updated results from the S-AVANT phase III study by the GERCOR Group. Ann Oncol. 2020 Feb;31(2):246-256. doi: 10.1016/j.annonc.2019.12.006. Epub 2019 Dec 18. |
| 31268130 | Derived | Taieb J, Shi Q, Pederson L, Alberts S, Wolmark N, Van Cutsem E, de Gramont A, Kerr R, Grothey A, Lonardi S, Yoshino T, Yothers G, Sinicrope FA, Zaanan A, Andre T. Prognosis of microsatellite instability and/or mismatch repair deficiency stage III colon cancer patients after disease recurrence following adjuvant treatment: results of an ACCENT pooled analysis of seven studies. Ann Oncol. 2019 Sep 1;30(9):1466-1471. doi: 10.1093/annonc/mdz208. |
| 23168362 | Derived | de Gramont A, Van Cutsem E, Schmoll HJ, Tabernero J, Clarke S, Moore MJ, Cunningham D, Cartwright TH, Hecht JR, Rivera F, Im SA, Bodoky G, Salazar R, Maindrault-Goebel F, Shacham-Shmueli E, Bajetta E, Makrutzki M, Shang A, Andre T, Hoff PM. Bevacizumab plus oxaliplatin-based chemotherapy as adjuvant treatment for colon cancer (AVANT): a phase 3 randomised controlled trial. Lancet Oncol. 2012 Dec;13(12):1225-33. doi: 10.1016/S1470-2045(12)70509-0. Epub 2012 Nov 16. |
| FG001 | FOLFOX4 + Bv | Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks). Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks). |
| FG002 | XELOX+Bv | Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks). Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks). |
| Received Treatment |
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| Stage III Disease Population |
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| COMPLETED |
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| NOT COMPLETED |
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Baseline Measures are based on the Intent-to-Treat - Stage III Disease Patient Population.
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| ID | Title | Description |
|---|---|---|
| BG000 | FOLFOX4 | Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-fluorouracil (5-FU), given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks). Weeks 25-48: Observation only. |
| BG001 | FOLFOX4 + Bv | Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks). Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks). |
| BG002 | XELOX+Bv | Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks). Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks). |
| 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, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Disease-free Survival in Stage III Cancer Patients - Time to Event | Disease-free survival (DFS) was defined as the time from the date of randomization to the time of a recurrence, a new occurrence of colorectal cancer or death due to any cause, whichever occurred first. Patients without an event were censored at the last date the patient was known to be disease-free. Recurrence and new occurrence of colorectal cancer were based on tumor assessments made by the investigator. Patients with no tumor assessments after baseline but still alive at the time of the clinical cut-off were censored at day 1. | The primary population for efficacy analyses was the intent to treat population (ITT; all randomized patients) with stage III disease. | Posted | Median | 95% Confidence Interval | months | From first patient randomized until the data cut-off date of 30 June 2010 (36 months after the last patient randomized). |
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| Secondary | Overall Survival in Stage III Cancer Patients - Time to Event | Overall survival was defined as the time between date of randomization and date of death due to any cause. Patients not reported as having died at the time of the analysis were censored at the date they were last known to be alive. | ITT patients with Stage III disease. | Posted | Median | 95% Confidence Interval | months | From first patient randomized until the clinical data cut-off date of 30 June 2010 (36 months after the last patient randomized). |
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| Primary | Disease-free Survival in Stage III Cancer Patients - Number of Events | A disease-free survival (DFS) event was composed of a recurrence, a new occurrence of colorectal cancer or death due to any cause. Recurrence and new occurrence of colorectal cancer were based on tumor assessments made by the investigator. Triggering events for DFS are reported; a patient can have both recurrence and a new occurrence of colon cancer. | The primary population for efficacy analyses was the intent to treat population (ITT; all randomized patients) with stage III disease. | Posted | Number | participants | From first patient randomized until the data cut-off date of 30 June 2010 (36 months after the last patient randomized). |
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| Secondary | Overall Survival in Stage III Cancer Patients - Number of Events | An overall survival event was death due to any cause. | ITT patients with Stage III disease. | Posted | Number | participants | From first patient randomized until the clinical data cut-off date of 30 June 2010 (36 months after the last patient randomized). |
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| Secondary | Overall Survival in Stage III Cancer Patients - Time to Event: Final Analysis | Overall survival was defined as the time between date of randomization and date of death due to any cause. Patients not reported as having died at the time of the clinical cut-off date (30 June 2012) were censored at the date they were last known to be alive. | ITT patients with Stage III disease. | Posted | Median | 95% Confidence Interval | months | From first patient randomized until the final data cut-off date of 30 June 2012 (5 years after the last patient randomized). |
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| Secondary | Overall Survival in Stage III Cancer Patients - Number of Events: Final Analysis | An overall survival event was death due to any cause. | ITT patients with Stage III disease. | Posted | Number | participants | From first patient randomized until the final data cut-off date of 30 June 2012 (5 years after the last patient randomized). |
|
All adverse events occurring between the date of first drug intake and 28 days after last drug intake, regardless of which treatment group the patient was randomized to.
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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 | FOLFOX4 | Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with Leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks). Weeks 25-48: Observation only. | 226 | 1,126 | 1,112 | 1,126 | ||
| EG001 | FOLFOX4 + Bv | Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks). Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks). | 297 | 1,145 | 1,127 | 1,145 | ||
| EG002 | XELOX+Bv | Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks). Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks). | 284 | 1,135 | 1,117 | 1,135 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Abdominal adhesions | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Gastrointestinal obstruction | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Small intestinal perforation | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Peritonitis | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Gastrointestinal necrosis | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Mechanical ileus | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Abdominal rigidity | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Acute abdomen | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Caecitis | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Duodenitis | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Enterocolitis haemorrhagic | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Erosive oesophagitis | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Gastric volvulus | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Gastrointestinal perforation | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hiatus hernia, obstructive | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Ileal perforation | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Intestinal angina | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Intestinal dilatation | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Intestinal fistula | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Intestinal prolapse | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Intestinal strangulation | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Mallory-Weiss syndrome | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Mesenteric vein thrombosis | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Neutropenic colitis | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Rectal perforation | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Volvulus of small bowel | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Abdominal wall abscess | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Neutropenic infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Pelvic abscess | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Abdominal infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Aspergillosis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Campylobacter infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Candida sepsis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Catheter site cellulitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Cholecystitis infective | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Clostridial infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Enteritis infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Gastroenteritis norovirus | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Hepatitis viral | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Herpes zoster ophthalmic | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Incision site cellulitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Intervertebral discitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Intestinal fistual infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Klebsiella bacteraemia | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Klebsiella infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Lower respiratory tract infection viral | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Orchitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Overgrowth bacterial | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Perineal abscess | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Postoperative abscess | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Psoas abscess | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Puncture site infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Wound abscess | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Subclavian vein thrombosis | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Arterial stenosis | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Arterial thrombosis | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Arterial thrombosis limb | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Axillary vein thrombosis | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pelvic venous thrombosis | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Thrombophlebitis superficial | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Extravasation | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Medical device complication | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Thrombosis in device | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Adhesion | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Device leakage | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Device malfunction | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hernia obstructive | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hyperpyrexia | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Infusion site thrombosis | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Performance status decreased | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Sudden cardiac death | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Visceral pain | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Idiopathic thrombocytopenia purpura | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dysaesthesia pharynx | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Laryngospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pulmonary artery thrombosis | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dysaesthesia | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Leukoaraiosis | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Monoparesis | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Neurotoxicity | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Orthostatic intolerance | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Post herpetic neuralgia | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Reversible ischaemic neurological deficit | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Reversible posterior leukoencephalopathy syndrome | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Sensory disturbance | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Speech disorder | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Arteriospasm coronary | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Cardiac asthma | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Paroxysmal arrhythmia | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pericardial haemorrhage | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Sinus arrest | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Procedural site reaction | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Accident at work | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Anastomotic stenosis | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Brachial plexus injury | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Drug toxicity | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Post procedural fistula | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Anaphylactic shock | Immune system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Anaphylactiod reaction | Immune system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Cytolytic hepatitis | Hepatobiliary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hepatitis toxic | Hepatobiliary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Ureteric stenosis | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Acute prerenal failure | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Nephrogenic diabetes insipidus | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Nephrotic syndrome | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Intervertebral disc protusion | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Musculoskeletal disorder | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA (13.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (13.0) | Systematic Assessment |
| |
| Blood glucose fluctuation | Investigations | MedDRA (13.0) | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (13.0) | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Palmar-Plantar | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Alcoholism | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Retinal vein thrombosis | Eye disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Uveitis | Eye disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Systematic Assessment |
| |
| Benign lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Systematic Assessment |
| |
| Female genital tract fistula | Reproductive system and breast disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pregnancy of partner | Social circumstances | MedDRA (13.0) | Systematic Assessment |
| |
| Central venous catheter removal | Surgical and medical procedures | MedDRA (13.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dysaesthesia | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Neurotoxicity | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Temperature intolerance | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Palmar-Plantar Erythrodysaesthesia Syndrome | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dysaesthesia pharynx | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (13.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (13.0) | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffman-LaRoche | 800-821-8590 |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D003110 | Colonic 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 |
|---|---|
| D000068258 | Bevacizumab |
| D000069287 | Capecitabine |
| D005472 | Fluorouracil |
| D002955 | Leucovorin |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| 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
| 40-65 |
|
| >=65 |
|
| Male |
|
| Asian |
|
| Black or African American |
|
| White |
|
| Other |
|
| OG002 | XELOX+Bv | Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks). Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks). |
|
|
| OG002 | XELOX+Bv | Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks). Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks). |
|
|
| OG002 | XELOX+Bv | Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks). Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks). |
|
|
| OG002 | XELOX+Bv | Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks). Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks). |
|
|
| OG002 | XELOX+Bv | Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks). Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks). |
|
|