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This 2-arm study assessed the efficacy and safety of bevacizumab (Avastin) in combination with capecitabine (Xeloda), compared with capecitabine alone, in elderly patients with metastatic colorectal cancer. Patients were randomized to receive either bevacizumab (7.5 mg/kg intravenously on Day 1 of each 3-week cycle) in combination with capecitabine (1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle) or capecitabine (1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle) alone.
No notable trends or interactions in laboratory values, electrocardiogram, or vital signs suggesting an effect in either direction for capecitabine/bevacizumab combination therapy or capecitabine monotherapy were observed during the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bevacizumab + capecitabine | Experimental | Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle. |
|
| Capecitabine | Active Comparator | Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | Treatment continued until unacceptable toxicity, withdrawal of consent, disease progression, or a decision to terminate at the discretion of the Investigator if medically indicated. Bevacizumab was supplied in single-use vials. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | Progression-free survival was defined as the time in months from the date of randomization to the date of disease progression or death from any cause, whichever occurred first. All measurable lesions (maximum of 5 per organ and 10 in total, those with the longest diameter and suitability for accurate repeated measurements) were identified as target lesions (TL). A sum of the longest diameter for all TLs was calculated and reported as the baseline sum longest diameter (SLD). All other lesions were identified as non-TLs and recorded at baseline. PD was defined as ≥ 20% increase in the sum of the longest diameter of TLs, taking as reference the smallest SLD recorded since treatment started, the unequivocal progression of existing non-TLs, or the appearance of 1 or more new lesions. | Baseline to the end of the study (up to 5 years 8 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Best Overall Response (BOR) | BOR was defined as the best response (complete response [CR], partial response [PR], stable disease [SD], progressive disease [PD], not evaluable [NE], or not assessed [NA]) recorded from the start of study treatment until disease progression (PD) or death. CR was defined as the disappearance of all target (TL) and non-target lesions (non-TL). PR was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD, or the persistence of 1 or more non-TLs. For TLs, SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since treatment started. For non-TLs, SD was defined as the persistence of 1 or more lesions. PD was defined as ≥ 20% increase in the sum of the longest diameter of TLs, taking as reference the smallest SLD recorded since treatment started, the unequivocal progression of existing non-TLs, or the appearance of 1 or more new lesions. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Innsbruck | 6020 | Austria | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24028813 | Derived | Cunningham D, Lang I, Marcuello E, Lorusso V, Ocvirk J, Shin DB, Jonker D, Osborne S, Andre N, Waterkamp D, Saunders MP; AVEX study investigators. Bevacizumab plus capecitabine versus capecitabine alone in elderly patients with previously untreated metastatic colorectal cancer (AVEX): an open-label, randomised phase 3 trial. Lancet Oncol. 2013 Oct;14(11):1077-1085. doi: 10.1016/S1470-2045(13)70154-2. Epub 2013 Sep 10. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bevacizumab + Capecitabine | Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle. |
| FG001 | Capecitabine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Capecitabine | Drug | Treatment continued until unacceptable toxicity, withdrawal of consent, disease progression, or a decision to terminate at the discretion of the Investigator if medically indicated. Capecitabine was supplied as tablets. |
|
|
| Baseline to the end of the study (up to 5 years 8 months) |
| Duration of Response | Duration of response was defined as the time in months from the first confirmed complete response (CR) or partial response (PR) until disease progression or death from any cause, whichever occurred first. CR was defined as the disappearance of all target (TL) and non-target lesions (non-TL). PR was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD, or the persistence of 1 or more non-TLs. | Baseline to the end of the study (up to 5 years 8 months) |
| Time to Response | Time to response was defined as the time in months from the date of first study treatment to the date of the first documentation of complete response (CR) or partial response (PR), whichever occurred first. CR was defined as the disappearance of all target (TL) and non-target lesions (non-TL). PR was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD, or the persistence of 1 or more non-TLs. Participants who did not have a confirmed response were censored at the date of the last evaluable tumor assessment, or if that was unavailable, at the date of the first dose of study medication. | Baseline to the end of the study (up to 5 years 8 months) |
| Overall Survival | Overall survival was defined as the time in months from randomization to death from any cause. | Baseline to the end of the study (up to 5 years 8 months) |
| Eastern Cooperative Oncology Group (ECOG) Performance Status | The ECOG performance status is a scale used to quantify cancer patients' general well-being and activities of daily life. The scale ranges from 0 to 5, with 0 denoting perfect health and 5 indicating death. The 6 categories are 0=Asymptomatic (Fully active, able to carry on all predisease activities without restriction), 1=Symptomatic but completely ambulatory (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature), 2=Symptomatic, < 50% in bed during the day (Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours), 3=Symptomatic, > 50% in bed, but not bedbound (Capable of only limited self-care, confined to bed or chair 50% or more of waking hours), 4=Bedbound (Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair), 5=Death. Reported is the percentage of participants in each of the 6 ECOG performance status categories. | Baseline to the Safety Follow-up which occurred 28 days after the last dose of treatment (up to 5 years 8 months). |
| Percentage of Participants Requiring Additional Treatment for Malignancy | Reported is the percentage of participants requiring additional treatment for malignancy in the survival follow-up period. | Baseline to the end of the study (up to 5 years 8 months) |
| Duration of Follow-up | Duration of follow-up is defined as the time in days from randomization until disease progression or death, or time to censoring for overall survival. | Baseline to the end of the study (up to 5 years 8 months) |
| AEs, Laboratory Parameters, Vital Signs | Throughout study |
| Linz |
| 4010 |
| Austria |
| Salzburg | 5020 | Austria |
| Vienna | 1160 | Austria |
| Vienna | 1220 | Austria |
| Calgary | Alberta | T2N 4N2 | Canada |
| Vancouver | British Columbia | V5Z 4E6 | Canada |
| Halifax | Nova Scotia | B3H 2Y9 | Canada |
| London | Ontario | N6A 4L6 | Canada |
| Ottawa | Ontario | K1H 8L6 | Canada |
| Toronto | Ontario | M4N 3M5 | Canada |
| Toronto | Ontario | M5B 1W8 | Canada |
| Montreal | Quebec | H3T 1E2 | Canada |
| Larissa | 41 110 | Greece |
| Piraeus | 18537 | Greece |
| Budapest | 1083 | Hungary |
| Budapest | 1122 | Hungary |
| Győr | 9023 | Hungary |
| Zalaegerszeg-Pozva | 8900 | Hungary |
| Lecce | Apulia | 73100 | Italy |
| Reggio Emilia | Emilia-Romagna | 42100 | Italy |
| Rome | Lazio | 00144 | Italy |
| Florence | Tuscany | 50139 | Italy |
| León | 37000 | Mexico |
| Mexico City | 14000 | Mexico |
| Mexico City | 14140 | Mexico |
| Mexico City | 16200 | Mexico |
| Puebla City | 72530 | Mexico |
| Apeldoorn | 7334 DZ | Netherlands |
| Eindhoven | 5623 EJ | Netherlands |
| Utrecht | 3527 CE | Netherlands |
| Krakow | 30-501 | Poland |
| Krakow | 31-826 | Poland |
| Warsaw | 02-097 | Poland |
| Ljubljana | 1000 | Slovenia |
| Gyeonggi-do | 410-769 | South Korea |
| Incheon | 405-760 | South Korea |
| Seoul | 110-744 | South Korea |
| Seoul | 135-710 | South Korea |
| Barcelona | Barcelona | 08041 | Spain |
| Jaén | Jaen | 23007 | Spain |
| Las Palmas de Gran Canaria | Las Palmas | 35016 | Spain |
| Leganés | Madrid | 28911 | Spain |
| Madrid | Madrid | 28040 | Spain |
| Murcia | Murcia | 30120 | Spain |
| Zaragoza | Zaragoza | 50009 | Spain |
| Bristol | BS2 8ED | United Kingdom |
| Colchester | CO3 3NB | United Kingdom |
| Glasgow | G12 0YN | United Kingdom |
| Leicester | LE1 5WW | United Kingdom |
| London | W2 1NY | United Kingdom |
| Manchester | M20 4BX | United Kingdom |
| Nottingham | NG5 1PB | United Kingdom |
| Rhyl | LL18 5UJ | United Kingdom |
| Sutton | SM2 5PT | United Kingdom |
Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-treat population: All participants randomized into the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Bevacizumab + Capecitabine | Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle. |
| BG001 | Capecitabine | Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression-free Survival | Progression-free survival was defined as the time in months from the date of randomization to the date of disease progression or death from any cause, whichever occurred first. All measurable lesions (maximum of 5 per organ and 10 in total, those with the longest diameter and suitability for accurate repeated measurements) were identified as target lesions (TL). A sum of the longest diameter for all TLs was calculated and reported as the baseline sum longest diameter (SLD). All other lesions were identified as non-TLs and recorded at baseline. PD was defined as ≥ 20% increase in the sum of the longest diameter of TLs, taking as reference the smallest SLD recorded since treatment started, the unequivocal progression of existing non-TLs, or the appearance of 1 or more new lesions. | Intent-to-treat population: All participants randomized into the study. | Posted | Median | 95% Confidence Interval | Months | Baseline to the end of the study (up to 5 years 8 months) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Best Overall Response (BOR) | BOR was defined as the best response (complete response [CR], partial response [PR], stable disease [SD], progressive disease [PD], not evaluable [NE], or not assessed [NA]) recorded from the start of study treatment until disease progression (PD) or death. CR was defined as the disappearance of all target (TL) and non-target lesions (non-TL). PR was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD, or the persistence of 1 or more non-TLs. For TLs, SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since treatment started. For non-TLs, SD was defined as the persistence of 1 or more lesions. PD was defined as ≥ 20% increase in the sum of the longest diameter of TLs, taking as reference the smallest SLD recorded since treatment started, the unequivocal progression of existing non-TLs, or the appearance of 1 or more new lesions. | Intent-to-treat population: All participants randomized into the study. Only participants with a response were included in the analysis. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline to the end of the study (up to 5 years 8 months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response | Duration of response was defined as the time in months from the first confirmed complete response (CR) or partial response (PR) until disease progression or death from any cause, whichever occurred first. CR was defined as the disappearance of all target (TL) and non-target lesions (non-TL). PR was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD, or the persistence of 1 or more non-TLs. | Intent-to-treat population: All participants randomized into the study. Only participants with a complete response or partial response were included in the analysis. | Posted | Median | 95% Confidence Interval | Months | Baseline to the end of the study (up to 5 years 8 months) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Response | Time to response was defined as the time in months from the date of first study treatment to the date of the first documentation of complete response (CR) or partial response (PR), whichever occurred first. CR was defined as the disappearance of all target (TL) and non-target lesions (non-TL). PR was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD, or the persistence of 1 or more non-TLs. Participants who did not have a confirmed response were censored at the date of the last evaluable tumor assessment, or if that was unavailable, at the date of the first dose of study medication. | Intent-to-treat population: All participants randomized into the study. | Posted | Median | 95% Confidence Interval | Months | Baseline to the end of the study (up to 5 years 8 months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival was defined as the time in months from randomization to death from any cause. | Intent-to-treat population: All participants randomized into the study. | Posted | Median | 95% Confidence Interval | Months | Baseline to the end of the study (up to 5 years 8 months) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Eastern Cooperative Oncology Group (ECOG) Performance Status | The ECOG performance status is a scale used to quantify cancer patients' general well-being and activities of daily life. The scale ranges from 0 to 5, with 0 denoting perfect health and 5 indicating death. The 6 categories are 0=Asymptomatic (Fully active, able to carry on all predisease activities without restriction), 1=Symptomatic but completely ambulatory (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature), 2=Symptomatic, < 50% in bed during the day (Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours), 3=Symptomatic, > 50% in bed, but not bedbound (Capable of only limited self-care, confined to bed or chair 50% or more of waking hours), 4=Bedbound (Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair), 5=Death. Reported is the percentage of participants in each of the 6 ECOG performance status categories. | Intent-to-treat population: All participants randomized into the study. | Posted | Number | Percentage of participants | Baseline to the Safety Follow-up which occurred 28 days after the last dose of treatment (up to 5 years 8 months). |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Requiring Additional Treatment for Malignancy | Reported is the percentage of participants requiring additional treatment for malignancy in the survival follow-up period. | Intent-to-treat population: All participants randomized into the study. | Posted | Number | Percentage of participants | Baseline to the end of the study (up to 5 years 8 months) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Follow-up | Duration of follow-up is defined as the time in days from randomization until disease progression or death, or time to censoring for overall survival. | Intent-to-treat population: All participants randomized into the study. | Posted | Mean | Standard Deviation | Days | Baseline to the end of the study (up to 5 years 8 months) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | AEs, Laboratory Parameters, Vital Signs | Not Posted | Throughout study |
Not provided
Safety population: All participants who had at least 1 dose of study medication.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bevacizumab + Capecitabine | Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle. | 40 | 134 | 129 | 134 | ||
| EG001 | Capecitabine | Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle. | 42 | 136 | 130 | 136 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Colonic obstruction | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Mechanical ileus | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Death | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Cellulitis gangrenous | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Peripheral artery thrombosis | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Vena cava thrombosis | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
| |
| Impacted fracture | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Systematic Assessment |
| |
| Metastases to lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Amaurosis fugax | Eye disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Female genital tract fistula | Reproductive system and breast disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Hepatitis acute | Hepatobiliary disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Bone operation | Surgical and medical procedures | MedDRA (12.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Palmar-Plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (12.1) | 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 | Hoffmann-La Roche | 800 821-8590 |
| 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 |
|---|---|
| D000068258 | Bevacizumab |
| D000069287 | Capecitabine |
| 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 |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
| Male |
|
| Capecitabine |
Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle. |
|
|
|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
| Capecitabine |
Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle. |
|
|
|
|