Trial Outcomes & Findings for An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer (RELEVANT) (NCT NCT01697449)
NCT ID: NCT01697449
Last Updated: 2015-10-16
Results Overview
An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.
COMPLETED
191 participants
Up to 65 months
2015-10-16
Participant Flow
Participant milestones
| Measure |
Colorectal Cancer (CRC) Cohort
Participants with metastatic CRC (resectable/unresectable at baseline) received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent.
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|---|---|
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Overall Study
STARTED
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191
|
|
Overall Study
COMPLETED
|
101
|
|
Overall Study
NOT COMPLETED
|
90
|
Reasons for withdrawal
| Measure |
Colorectal Cancer (CRC) Cohort
Participants with metastatic CRC (resectable/unresectable at baseline) received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent.
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|---|---|
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Overall Study
Disease progression
|
47
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Overall Study
Adverse Event
|
7
|
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Overall Study
Lost to Follow-up
|
5
|
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Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Death
|
2
|
|
Overall Study
Other
|
1
|
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Overall Study
Missing
|
25
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Baseline Characteristics
An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer (RELEVANT)
Baseline characteristics by cohort
| Measure |
CRC Cohort
n=191 Participants
Participants with metastatic CRC (resectable/unresectable at baseline) received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent.
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|---|---|
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Age, Continuous
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59.31 years
STANDARD_DEVIATION 10.23 • n=5 Participants
|
|
Sex: Female, Male
Female
|
71 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
120 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Up to 65 monthsPopulation: All participants who received at least 1 dose of study drug and underwent subsequent safety assessment were considered for the safety analysis.
An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.
Outcome measures
| Measure |
CRC Cohort
n=191 Participants
Participants with metastatic CRC (resectable/unresectable at baseline) received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent.
|
Unresectable CRC at Baseline
Participants with unresectable metastatic CRC at baseline received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent..
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|---|---|---|
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Percentage of Participants With At Least One Adverse Event (AE)
|
15.2 percentage of participants
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—
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SECONDARY outcome
Timeframe: Up to 65 monthsPopulation: All participants who received at least 1 dose of study drug were included in this analysis.
Per RECIST, CR was defined as the disappearance of all target and non-target lesions and normalization of tumor marker level; PR was defined as at least a 30 percentage (%) decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter; SD for target lesions was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started and SD for non-target lesions defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and nontarget lesions) or the unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
CRC Cohort
n=162 Participants
Participants with metastatic CRC (resectable/unresectable at baseline) received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent.
|
Unresectable CRC at Baseline
n=29 Participants
Participants with unresectable metastatic CRC at baseline received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent..
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|---|---|---|
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Percentage of Participants With Clinical Benefit of Complete Response [CR], Partial Response [PR] or Stable Disease [SD] Per Response Evaluation Criteria in Solid Tumors (RECIST)
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72 percentage of participants
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69 percentage of participants
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SECONDARY outcome
Timeframe: Up to 65 monthsPopulation: Included participants whose CRC was identified as unresectable at baseline.
Outcome measures
| Measure |
CRC Cohort
n=29 Participants
Participants with metastatic CRC (resectable/unresectable at baseline) received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent.
|
Unresectable CRC at Baseline
Participants with unresectable metastatic CRC at baseline received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent..
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|---|---|---|
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Percentage of Participants Who Were Resectable Postbaseline Among the Participants Who Were Unresectable at Baseline
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34.5 percentage of participants
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—
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SECONDARY outcome
Timeframe: Up to 65 monthsPopulation: Included participants who received at least 1 dose of study drug and had postbaseline tumor assessment.
Per RECIST, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and nontarget lesions) or the unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
CRC Cohort
n=170 Participants
Participants with metastatic CRC (resectable/unresectable at baseline) received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent.
|
Unresectable CRC at Baseline
Participants with unresectable metastatic CRC at baseline received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent..
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|---|---|---|
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Percentage of Participants With Disease Progression or Death
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76.5 percentage of participants
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—
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SECONDARY outcome
Timeframe: Up to 65 monthsPopulation: Included participants who received at least 1 dose of study drug and had postbaseline tumor assessment.
PFS was defined as the time from the date of informed consent until the date when the participant had progression of disease or died due to any cause. Participants who left the study for reasons other than progression of the disease were censored at the time of their last tumor assessment. Per RECIST, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and non-target lesions) or the unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
CRC Cohort
n=170 Participants
Participants with metastatic CRC (resectable/unresectable at baseline) received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent.
|
Unresectable CRC at Baseline
Participants with unresectable metastatic CRC at baseline received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent..
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|---|---|---|
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Progression Free Survival (PFS)
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9 months
Interval 8.24 to 9.75
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—
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Adverse Events
CRC Cohort
Serious adverse events
| Measure |
CRC Cohort
n=191 participants at risk
Participants with metastatic CRC (resectable/unresectable at baseline) received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent.
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|---|---|
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Infections and infestations
Tuberculosis
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0.52%
1/191 • Up to 65 months
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
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0.52%
1/191 • Up to 65 months
|
|
Blood and lymphatic system disorders
Neutropenia
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2.6%
5/191 • Up to 65 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
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0.52%
1/191 • Up to 65 months
|
|
Vascular disorders
Deep vein thrombosis
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0.52%
1/191 • Up to 65 months
|
|
Vascular disorders
Embolism
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0.52%
1/191 • Up to 65 months
|
|
Vascular disorders
Hypertension
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1.6%
3/191 • Up to 65 months
|
|
Vascular disorders
Peripheral Artery Thrombosis
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0.52%
1/191 • Up to 65 months
|
|
Vascular disorders
Thrombophlebitis
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0.52%
1/191 • Up to 65 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
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0.52%
1/191 • Up to 65 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
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0.52%
1/191 • Up to 65 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
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0.52%
1/191 • Up to 65 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.52%
1/191 • Up to 65 months
|
|
Gastrointestinal disorders
Diarrhoea
|
1.0%
2/191 • Up to 65 months
|
|
Gastrointestinal disorders
Gastrointestinal Necrosis
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0.52%
1/191 • Up to 65 months
|
|
Gastrointestinal disorders
Ileus
|
0.52%
1/191 • Up to 65 months
|
|
Renal and urinary disorders
Acute Kidney Injury
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0.52%
1/191 • Up to 65 months
|
|
General disorders
Fatigue
|
1.0%
2/191 • Up to 65 months
|
|
General disorders
Impaired Healing
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0.52%
1/191 • Up to 65 months
|
|
General disorders
Sudden Death
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0.52%
1/191 • Up to 65 months
|
|
Investigations
Body Temperature Increased
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0.52%
1/191 • Up to 65 months
|
|
Injury, poisoning and procedural complications
Post Procedural Complication
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0.52%
1/191 • Up to 65 months
|
Other adverse events
| Measure |
CRC Cohort
n=191 participants at risk
Participants with metastatic CRC (resectable/unresectable at baseline) received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent.
|
|---|---|
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Blood and lymphatic system disorders
Neutropenia
|
0.52%
1/191 • Up to 65 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.52%
1/191 • Up to 65 months
|
|
Vascular disorders
Hypertension
|
0.52%
1/191 • Up to 65 months
|
|
General disorders
Disease progression
|
0.52%
1/191 • Up to 65 months
|
|
Gastrointestinal disorders
Constipation
|
0.52%
1/191 • Up to 65 months
|
|
Gastrointestinal disorders
Diarrhoea
|
1.0%
2/191 • Up to 65 months
|
|
Renal and urinary disorders
Proteinuria
|
1.0%
2/191 • Up to 65 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER