Trial Outcomes & Findings for An Observational Study on Bevacizumab (Avastin) as First-Line Treatment in Colorectal Cancer Participants With Potentially Resectable Liver Metastases (NCT NCT01343901)
NCT ID: NCT01343901
Last Updated: 2017-04-25
Results Overview
Secondary resection involves removal of all detectable metastases at surgery including participants with missing metastases left in place. Percentage of participants without detectable metastatic disease after secondary resection removing all detectable metastases at surgery (including participants with disappeared metastases left in place \[missing metastases\]) was reported. Metastases was detected using computed tomography (CT) scan or magnetic resonance imaging (MRI).
Recruitment status
COMPLETED
Target enrollment
210 participants
Primary outcome timeframe
Baseline up to 36 months
Results posted on
2017-04-25
Participant Flow
Participant milestones
| Measure |
Bevacizumab
All participants with metastatic colorectal cancer (mCRC) with exclusively liver or liver and lung metastases for whom bevacizumab (Avastin) was administered as part of first line treatment for potentially resectable liver metastases as per treating physician discretion. All concomitant medications as used in daily routine clinical practice were allowed.
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|---|---|
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Overall Study
STARTED
|
210
|
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Overall Study
Efficacy Population
|
205
|
|
Overall Study
COMPLETED
|
97
|
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Overall Study
NOT COMPLETED
|
113
|
Reasons for withdrawal
| Measure |
Bevacizumab
All participants with metastatic colorectal cancer (mCRC) with exclusively liver or liver and lung metastases for whom bevacizumab (Avastin) was administered as part of first line treatment for potentially resectable liver metastases as per treating physician discretion. All concomitant medications as used in daily routine clinical practice were allowed.
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|---|---|
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Overall Study
Death
|
85
|
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Overall Study
Physician Decision
|
4
|
|
Overall Study
Lost to Follow-up
|
12
|
|
Overall Study
Management by another medical team
|
11
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Overall Study
Participant decision
|
1
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Baseline Characteristics
An Observational Study on Bevacizumab (Avastin) as First-Line Treatment in Colorectal Cancer Participants With Potentially Resectable Liver Metastases
Baseline characteristics by cohort
| Measure |
Bevacizumab
n=205 Participants
All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician's discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
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|---|---|
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Age, Continuous
|
65.83 years
STANDARD_DEVIATION 9.63 • n=5 Participants
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Sex: Female, Male
Female
|
73 Participants
n=5 Participants
|
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Sex: Female, Male
Male
|
132 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 36 monthsPopulation: Efficacy population. Here number of participants analyzed represents the number of participants evaluable for this outcome measure.
Secondary resection involves removal of all detectable metastases at surgery including participants with missing metastases left in place. Percentage of participants without detectable metastatic disease after secondary resection removing all detectable metastases at surgery (including participants with disappeared metastases left in place \[missing metastases\]) was reported. Metastases was detected using computed tomography (CT) scan or magnetic resonance imaging (MRI).
Outcome measures
| Measure |
Bevacizumab
n=104 Participants
All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician's discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
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|---|---|
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Percentage of Participants Without Detectable Metastatic Disease After Secondary Resection Post Surgery
|
84.6 Percentage of participants
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PRIMARY outcome
Timeframe: Baseline up to 36 monthsPopulation: Efficacy population. Here number of participants analyzed represents the number of participants evaluable for this outcome measure.
The percentage of participants with no detectable metastatic disease after a complete response without surgery (missing metastasis) was reported.
Outcome measures
| Measure |
Bevacizumab
n=90 Participants
All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician's discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
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|---|---|
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Percentage of Participants Without Detectable Metastatic Disease After a Complete Response Without Surgery
|
4.4 Percentage of participants
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SECONDARY outcome
Timeframe: Day 0Population: Efficacy population. Here number of participants analyzed represents the number of participants evaluable for this outcome and 'n' represents the number of participants available for assessment at a given category.
Percentage of participants who had any concurrent disease (comorbidity) at Day 0 was reported. Comorbidities included gastrointestinal disease, hypertension, other cardiovascular disease, and other medical history and comorbidities (other than those specified above). Same participant may be counted in more than one category.
Outcome measures
| Measure |
Bevacizumab
n=204 Participants
All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician's discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
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|---|---|
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Percentage of Participants With at Least One Disease and Comorbidity at Day 0
Other medical history and comorbidities (n=204)
|
52.9 Percentage of participants
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Percentage of Participants With at Least One Disease and Comorbidity at Day 0
Gastrointestinal disease (n=201)
|
7.5 Percentage of participants
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Percentage of Participants With at Least One Disease and Comorbidity at Day 0
Hypertension (n=202)
|
41.6 Percentage of participants
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Percentage of Participants With at Least One Disease and Comorbidity at Day 0
Other cardiovascular disease (n=202)
|
13.9 Percentage of participants
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SECONDARY outcome
Timeframe: Day 0Population: Efficacy population. Here number of participants analysed represents the number of participants evaluable for this outcome measure.
Previous therapies included neoadjuvant treatment (chemotherapy or chemotherapy + radiotherapy) and adjuvant treatment (FOLFOX \[folinic acid+5-fluorouracil+oxaliplatin\], LV5FU2 \[leucovorin+5-Fluorouracil\], capecitabine, or any other adjuvant treatment). Only participants who received neoadjuvant treatment and adjuvant treatment was reported.
Outcome measures
| Measure |
Bevacizumab
n=55 Participants
All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician's discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
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|---|---|
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Percentage of Participants With Different Previous Therapies at Day 0
With Neoadjuvant Treatment
|
29.1 Percentage of participants
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Percentage of Participants With Different Previous Therapies at Day 0
With Adjuvant Treatment
|
52.7 Percentage of participants
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SECONDARY outcome
Timeframe: Baseline up to 36 monthsPopulation: Efficacy population. Here number of participants analyzed represents the number of participants evaluable for this outcome measure.
Outcome measures
| Measure |
Bevacizumab
n=191 Participants
All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician's discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
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|---|---|
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Mean Number of Cumulated Cycles of Bevacizumab Over the Study Period
|
14.40 Cycles
Standard Deviation 10.80
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SECONDARY outcome
Timeframe: Baseline up to 36 monthsPopulation: Efficacy population. Here number of participants analyzed represents the number of participants evaluable for this outcome measure.
Outcome measures
| Measure |
Bevacizumab
n=181 Participants
All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician's discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
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|---|---|
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Percentage of Participants Who Received at Least One Chemotherapy Over the Study Period
|
96.1 Percentage of participants
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SECONDARY outcome
Timeframe: Baseline up to 36 monthsPopulation: Analysis population consisted of participants with disappeared metastasis left in place with or without surgery. Here number of participants analyzed represents the number of participants evaluable for this outcome and 'n' represents the number of participants available for assessment at a given category.
Percentage of participants who had any concurrent disease (comorbidity) was reported. Comorbidities included gastrointestinal disease, other cardiovascular disease, and other medical history and comorbidities (other than those which are specified above). Same participant may be counted in more than one category.
Outcome measures
| Measure |
Bevacizumab
n=92 Participants
All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician's discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
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|---|---|
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Percentage of Participants With at Least One Comorbidity Post Bevacizumab Treatment
Gastrointestinal disease
|
8.0 Percentage of participants
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Percentage of Participants With at Least One Comorbidity Post Bevacizumab Treatment
Other cardiovascular disease
|
10.9 Percentage of participants
|
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Percentage of Participants With at Least One Comorbidity Post Bevacizumab Treatment
Other medical history and comorbidities
|
54.9 Percentage of participants
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Percentage of Participants With at Least One Comorbidity Post Bevacizumab Treatment
Respiratory, thoracic and mediastinum disorders
|
4.0 Percentage of participants
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SECONDARY outcome
Timeframe: Baseline until disease progression or death, whichever occurred first, assessed up to 36 monthsPopulation: Efficacy population
Disease progression is defined at least a 20 percent (%) increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 millimeter (mm) or persistence of non-target lesions, or appearance of one or more new lesions.
Outcome measures
| Measure |
Bevacizumab
n=205 Participants
All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician's discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
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|---|---|
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Percentage of Participants With Disease Progression or Death
|
82.9 Percentage of participants
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SECONDARY outcome
Timeframe: Baseline until disease progression or death, whichever occurred first, assessed up to 36 monthsPopulation: Efficacy population.
Progression-free survival defined as the time elapsed between the Avastin start date and the date of first progressive disease (PD) or death. Kaplan-Meier estimate was used for evaluation. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions or appearance of one or more new lesions.
Outcome measures
| Measure |
Bevacizumab
n=205 Participants
All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician's discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
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|---|---|
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Progression-free Survival (PFS)
|
11.50 Months
Interval 10.38 to 12.35
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SECONDARY outcome
Timeframe: Baseline until disease progression or death, whichever occurred first, assessed up to 36 monthsPopulation: Efficacy population. Here number of participants analyzed signifies efficacy population with surgery removing all the detectable metastases.
Relapse was defined as the presence of metastases post last surgery removing all detectable metastases (A1 criterion \[participants without detectable metastatic disease {DMD} after secondary resection removing all detectable metastases at surgery {including participants with missing metastases}\]) and the date of first PD or death. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions, or appearance of one or more new lesions.
Outcome measures
| Measure |
Bevacizumab
n=88 Participants
All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician's discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
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|---|---|
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Percentage of Participants With Disease Relapse
|
76.1 Percentage of participants
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SECONDARY outcome
Timeframe: Baseline until disease progression or death, whichever occurred first, assessed up to 36 monthsPopulation: Efficacy population. Here number of participants analyzed signifies efficacy population with surgery removing all the detectable metastases.
RFS was defined as the time elapsed between the last surgery removing all detectable metastases (A1 criterion \[participants without DMD after secondary resection removing all detectable metastases at surgery {including participants with missing metastases}\]) and the date of first PD or death. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions, or appearance of one or more new lesions.
Outcome measures
| Measure |
Bevacizumab
n=88 Participants
All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician's discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
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|---|---|
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Relapse-free Survival (RFS)
|
11.10 Months
Interval 7.82 to 14.62
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SECONDARY outcome
Timeframe: Baseline until death; assessed up to 36 monthsPopulation: Efficacy population
Outcome measures
| Measure |
Bevacizumab
n=205 Participants
All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician's discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
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|---|---|
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Percentage of Participants Who Died
|
41.0 Percentage of participants
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SECONDARY outcome
Timeframe: Baseline until death, assessed up to 36 monthsPopulation: Efficacy population
OS time is defined as time between start of therapy and date of death. Kaplan-Meier estimate was used for evaluation.
Outcome measures
| Measure |
Bevacizumab
n=205 Participants
All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician's discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
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|---|---|
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Overall Survival (OS)
|
NA months
Survival time was not reached due to high number of censored participants.
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SECONDARY outcome
Timeframe: Baseline up to 36 monthsPopulation: Efficacy population. Here number of participants analyzed represents the overall number of participants evaluable for this outcome and 'n' represents the number of participants available for assessment at a given category.
For the non-detectable liver and lung metastases the categorization based on rate of viable cells were as follows (no viable cells =0%, minimum =1 to 49%, maximum =50 to 100%).
Outcome measures
| Measure |
Bevacizumab
n=104 Participants
All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician's discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
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|---|---|
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Percentage of Participants With Histologically Viable Tumor Cells With Resected Non Detectable Hepatic and Pulmonary Metastases Post Surgery
Hepatic metastases:No viable cell (0%)(n=70)
|
4.3 Percentage of participants
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Percentage of Participants With Histologically Viable Tumor Cells With Resected Non Detectable Hepatic and Pulmonary Metastases Post Surgery
Hepatic metastases:Minimum (1 - 49 %)(n=70)
|
8.6 Percentage of participants
|
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Percentage of Participants With Histologically Viable Tumor Cells With Resected Non Detectable Hepatic and Pulmonary Metastases Post Surgery
Hepatic metastases:Maximum (>=50%)(n=70)
|
7.1 Percentage of participants
|
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Percentage of Participants With Histologically Viable Tumor Cells With Resected Non Detectable Hepatic and Pulmonary Metastases Post Surgery
Hepatic metastases:Not Applicable(n=70)
|
80.0 Percentage of participants
|
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Percentage of Participants With Histologically Viable Tumor Cells With Resected Non Detectable Hepatic and Pulmonary Metastases Post Surgery
Pulmonary metastases:Maximum (>=50%)(n=80)
|
1.3 Percentage of participants
|
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Percentage of Participants With Histologically Viable Tumor Cells With Resected Non Detectable Hepatic and Pulmonary Metastases Post Surgery
Pulmonary metastases:Not Applicable(n=80)
|
98.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 0Population: Efficacy population. Here number of participants analyzed represents the number of participants evaluable for this outcome measure.
Outcome measures
| Measure |
Bevacizumab
n=195 Participants
All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician's discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
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|---|---|
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Number of Cumulated Cycles of First Line Bevacizumab at Day 0
|
10.20 cycles
Standard Deviation 7.79
|
SECONDARY outcome
Timeframe: Day 0Population: Efficacy population. Here, number of participants analyzed represents the number of participants evaluable for this outcome measure.
Outcome measures
| Measure |
Bevacizumab
n=196 Participants
All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician's discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
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|---|---|
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Percentage of Participants With Different Doses of First Line Bevacizumab at Day 0
5 milligrams per kilogram (mg/kg)/2 weeks
|
94.9 Percentage of participants
|
|
Percentage of Participants With Different Doses of First Line Bevacizumab at Day 0
7.5 mg/kg/3 weeks
|
3.1 Percentage of participants
|
|
Percentage of Participants With Different Doses of First Line Bevacizumab at Day 0
10 mg/kg/2 weeks
|
2.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 0Population: Efficacy population. Here number of participants analyzed represents the number of participants evaluable for this outcome measure.
Outcome measures
| Measure |
Bevacizumab
n=195 Participants
All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician's discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
|
|---|---|
|
Total Duration of First Line Bevacizumab Treatment at Day 0
|
4.67 months
Interval 0.5 to 33.2
|
SECONDARY outcome
Timeframe: Day 0Population: Efficacy population. Here number of participants analyzed represents the number of participants evaluable for this outcome measure.
Outcome measures
| Measure |
Bevacizumab
n=201 Participants
All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician's discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
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|---|---|
|
Percentage of Participants With Unresectability Criteria
Oncological Reason (n=201)
|
81.6 Percentage of participants
|
|
Percentage of Participants With Unresectability Criteria
Technical Reason (n=191)
|
12.0 Percentage of participants
|
|
Percentage of Participants With Unresectability Criteria
Both Oncological and Technical Reason (n=191)
|
10.5 Percentage of participants
|
Adverse Events
Bevacizumab
Serious events: 71 serious events
Other events: 75 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bevacizumab
n=210 participants at risk
All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician's discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
1.9%
4/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Gastrointestinal disorders
Subileus
|
1.4%
3/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.95%
2/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.95%
2/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Gastrointestinal disorders
Vomiting
|
0.95%
2/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Gastrointestinal disorders
Colonic fistula
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Gastrointestinal disorders
Jejunal perforation
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Gastrointestinal disorders
Melaena
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Infections and infestations
Infectious peritonitis
|
1.9%
4/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Infections and infestations
Septic shock
|
1.9%
4/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Infections and infestations
Sepsis
|
1.4%
3/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Infections and infestations
Device related infection
|
0.95%
2/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Infections and infestations
Erysipelas
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Infections and infestations
Gastroenteritis
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Infections and infestations
Infection
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Infections and infestations
Pseudomonal sepsis
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Infections and infestations
Sepsis syndrome
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
General disorders
General physical health deterioration
|
2.9%
6/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
General disorders
Chills
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
General disorders
Death
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
General disorders
Hyperthermia
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
General disorders
Mucosal inflammation
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
General disorders
Pain
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
General disorders
Pyrexia
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.8%
8/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.95%
2/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Vascular disorders
Aortic thrombosis
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Vascular disorders
Haematoma
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Vascular disorders
Hypertensive crisis
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Vascular disorders
Phlebitis
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Vascular disorders
Transient ischaemic attack
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.95%
2/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Blood and lymphatic system disorders
Febrile bone marrow aplasia
|
0.95%
2/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.95%
2/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Injury, poisoning and procedural complications
Fall
|
0.95%
2/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Injury, poisoning and procedural complications
Vascular injury
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Renal and urinary disorders
Renal failure
|
0.95%
2/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Renal and urinary disorders
Bladder dilatation
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Renal and urinary disorders
Bladder obstruction
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Renal and urinary disorders
Haematuria
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Renal and urinary disorders
Renal failure acute
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Hepatobiliary disorders
Biliary fistula
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Hepatobiliary disorders
Biloma
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Hepatobiliary disorders
Chronic hepatic failure
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Hepatobiliary disorders
Hepatic atrophy
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Nervous system disorders
Aphasia
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Nervous system disorders
Dizziness
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Nervous system disorders
Nervous system disorder
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Cardiac disorders
Cardiac arrest
|
0.95%
2/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Cardiac disorders
Cardiac failure
|
0.95%
2/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Cardiac disorders
Atrial fibrillation
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour perforation
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Psychiatric disorders
Completed suicide
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Blood and lymphatic system disorders
Thrombocytopenic purpura
|
0.48%
1/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
Other adverse events
| Measure |
Bevacizumab
n=210 participants at risk
All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician's discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
|
|---|---|
|
General disorders
Asthenia
|
21.0%
44/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
General disorders
Mucosal inflammation
|
10.5%
22/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Gastrointestinal disorders
Diarrhoea
|
17.6%
37/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Gastrointestinal disorders
Nausea
|
13.3%
28/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Gastrointestinal disorders
Vomiting
|
7.6%
16/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Gastrointestinal disorders
Constipation
|
5.7%
12/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Nervous system disorders
Paraesthesia
|
9.5%
20/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Nervous system disorders
Neuropathy peripheral
|
7.6%
16/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.2%
13/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Blood and lymphatic system disorders
Anaemia
|
5.7%
12/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
|
Vascular disorders
Hypertension
|
5.7%
12/210 • Baseline up to 36 months
Safety population included all participants with at least one dose of bevacizumab.
|
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