Trial Outcomes & Findings for An Observational Study of Avastin in First Line in Elderly Patients With Metastatic Colorectal Cancer (CASSIOPEE) (NCT NCT01555762)
NCT ID: NCT01555762
Last Updated: 2019-03-05
Results Overview
Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Recruitment status
COMPLETED
Target enrollment
402 participants
Primary outcome timeframe
From the time of first dose of study treatment to the time of disease progression or death from any cause (Up to 53 months)
Results posted on
2019-03-05
Participant Flow
A total of 402 participants were enrolled from 100 French sites.
The data in the study for participant flow, baseline characteristics, outcome measure and adverse events was collected for overall participants and not as per the dose administered to participants.
Participant milestones
| Measure |
Bevacizumab
Participants received initial dose of either 5 milligram per kilogram (mg/kg) every 2 weeks or 7.5 mg/kg every 3 weeks of bevacizumab irrespective of the age subgroup.
|
|---|---|
|
Overall Study
STARTED
|
402
|
|
Overall Study
Safety Population
|
383
|
|
Overall Study
Efficacy Population
|
358
|
|
Overall Study
COMPLETED
|
128
|
|
Overall Study
NOT COMPLETED
|
274
|
Reasons for withdrawal
| Measure |
Bevacizumab
Participants received initial dose of either 5 milligram per kilogram (mg/kg) every 2 weeks or 7.5 mg/kg every 3 weeks of bevacizumab irrespective of the age subgroup.
|
|---|---|
|
Overall Study
No information on Bevacizumab intake
|
11
|
|
Overall Study
Missing start date of infusion
|
8
|
|
Overall Study
75 years old or more ticked No
|
1
|
|
Overall Study
Treatment with Bevacizumab ticked No
|
24
|
|
Overall Study
Death linked to progression of disease
|
165
|
|
Overall Study
Lost follow-up/moved house/changed team
|
35
|
|
Overall Study
Investigator's decision
|
10
|
|
Overall Study
Participant not wishing to continue
|
5
|
|
Overall Study
Missing data
|
1
|
|
Overall Study
Death linked to an adverse event
|
14
|
Baseline Characteristics
An Observational Study of Avastin in First Line in Elderly Patients With Metastatic Colorectal Cancer (CASSIOPEE)
Baseline characteristics by cohort
| Measure |
Bevacizumab
n=358 Participants
Participants received initial dose of either 5 milligram per kilogram (mg/kg) every 2 weeks or 7.5 mg/kg every 3 weeks of bevacizumab irrespective of the age subgroup.
|
|---|---|
|
Age, Continuous
|
80.5 Years
STANDARD_DEVIATION 3.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
173 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
185 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the time of first dose of study treatment to the time of disease progression or death from any cause (Up to 53 months)Population: The efficacy population (EFF) included all participants who had at least one infusion of bevacizumab, without exclusion criteria and excluding participants with no intake of chemotherapy, or intake of bevacizumab before or 2 months after chemotherapy initiation. Data in study was collected for overall participants and not as per dose administered.
Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Bevacizumab
n=358 Participants
Participants received initial dose of either 5 milligram per kilogram (mg/kg) every 2 weeks or 7.5 mg/kg every 3 weeks of bevacizumab irrespective of the age subgroup.
|
|---|---|
|
Progression-Free Survival
|
9.14 Months
Interval 8.32 to 10.16
|
SECONDARY outcome
Timeframe: From the time of first dose of study treatment to the time of death from any cause (Up to 53 months)Population: The EFF included all participants who had at least one infusion of bevacizumab, without exclusion criteria and excluding participants with no intake of chemotherapy, or intake of bevacizumab before or 2 months after chemotherapy initiation. Data in the study was collected for overall participants and not as per dose administered to participants.
Overall survival was defined as the time between the treatment start date (date of the first infusion of bevacizumab) and date of all-cause death.
Outcome measures
| Measure |
Bevacizumab
n=358 Participants
Participants received initial dose of either 5 milligram per kilogram (mg/kg) every 2 weeks or 7.5 mg/kg every 3 weeks of bevacizumab irrespective of the age subgroup.
|
|---|---|
|
Overall Survival
|
19.00 Months
Interval 16.47 to 21.47
|
SECONDARY outcome
Timeframe: Up to 36 monthsPopulation: The EFF included all participants who had at least one infusion of bevacizumab, without exclusion criteria and excluding participants with no intake of chemotherapy, or intake of bevacizumab before or 2 months after chemotherapy initiation.
Outcome measures
| Measure |
Bevacizumab
n=358 Participants
Participants received initial dose of either 5 milligram per kilogram (mg/kg) every 2 weeks or 7.5 mg/kg every 3 weeks of bevacizumab irrespective of the age subgroup.
|
|---|---|
|
Percentage of Participants With Bevacizumab Administration
5 mg/kg/2 weeks
|
90.8 Percentage of participants
|
|
Percentage of Participants With Bevacizumab Administration
7.5 mg/kg/3 weeks
|
7.3 Percentage of participants
|
|
Percentage of Participants With Bevacizumab Administration
At least one change in dosing
|
1.7 Percentage of participants
|
|
Percentage of Participants With Bevacizumab Administration
At least one temporary discontinuation
|
12.3 Percentage of participants
|
|
Percentage of Participants With Bevacizumab Administration
Permanent discontinuation
|
82.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 53 monthsPopulation: Safety population included all participants who had at least one infusion of bevacizumab. Data in the study was collected for overall participants and not as per dose administered to participants.
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 |
Bevacizumab
n=383 Participants
Participants received initial dose of either 5 milligram per kilogram (mg/kg) every 2 weeks or 7.5 mg/kg every 3 weeks of bevacizumab irrespective of the age subgroup.
|
|---|---|
|
Percentage of Participants With Adverse Events (AEs)
|
60.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Month 6, 12, 24Population: The EFF included all participants who had at least one infusion of bevacizumab, without exclusion criteria and excluding participants with no intake of chemotherapy, or intake of bevacizumab before or 2 months after chemotherapy initiation. Data in the study was collected for overall participants and not as per dose administered to participants.
The Katz Activity of Daily Living (ADL) questionnaire scale contains 6 items evaluating in terms of autonomy or dependence the patient's ability to carry out basic activities of daily living (bathing, dressing, toileting, transfer, continence, feeding). Total score range 0 (low) to 6 (high). High score indicates participant is independent.
Outcome measures
| Measure |
Bevacizumab
n=358 Participants
Participants received initial dose of either 5 milligram per kilogram (mg/kg) every 2 weeks or 7.5 mg/kg every 3 weeks of bevacizumab irrespective of the age subgroup.
|
|---|---|
|
Percentage of Participants With Activities of Daily Living (ADL)
Baseline: Bathing (self-sufficient)
|
89.2 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Baseline: Bathing (partial help)
|
8.2 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Baseline: Bathing (washing impossible)
|
2.5 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Baseline: Dressing (self-sufficient)
|
92.9 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Baseline: Dressing (partial help)
|
4.2 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Baseline: Dressing (completely undressed)
|
2.8 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Baseline: Toileting (self-sufficient)
|
95.8 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Baseline: Toileting (needs help)
|
2.5 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Baseline: Toileting (doesn't go)
|
1.7 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Baseline: Transfer (self-sufficient)
|
90.7 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Baseline: Transfer (needs help)
|
8.2 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Baseline: Transfer (bedridden)
|
1.1 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Baseline: Cont (continent)
|
86.6 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Baseline:Cont (occasional incontinence)
|
12.3 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Baseline:Cont (permanent incontinence)
|
1.1 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Baseline: Feeding (self-sufficient)
|
96.6 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Baseline: Feeding (needs help)
|
3.4 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Month 6: Bathing (self-sufficient)
|
85.4 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Month 6: Bathing (partial help)
|
13.1 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Month 6: Bathing (washing impossible)
|
1.5 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Month 6: Dressing (self-sufficient)
|
91.9 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Month 6: Dressing (partial help)
|
6.5 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Month 6: Dressing (completely undressed)
|
1.5 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Month 6: Toileting (self-sufficient)
|
95.0 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Month 6: Toileting (needs help)
|
4.6 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Month 6: Toileting (doesn't go)
|
0.4 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Month 6: Transfer (self-sufficient)
|
91.2 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Month 6: Transfer (needs help)
|
8.8 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Month 6: Cont (continent)
|
89.6 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Month 6: Cont (occasional incontinence)
|
10.0 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Month 6: Cont (permanent incontinence)
|
0.4 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Month 6: Feeding (self-sufficient)
|
94.6 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Month 6: Feeding (needs help)
|
5.4 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Month 12: Bathing (self-sufficient)
|
83.1 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Month 12: Bathing (partial help)
|
11.4 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Month 12: Bathing (washing impossible)
|
5.5 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Month 12: Dressing (self-sufficient)
|
88 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Month 12: Dressing (partial help)
|
7.0 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Month 12: Dressing (completely undressed)
|
5.0 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Month 12: Toileting (self-sufficient)
|
91.5 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Month 12: Toileting (needs help)
|
6.5 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Month 12: Toileting (doesn't go)
|
2.0 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Month 12: Transfer (self-sufficient)
|
85.1 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Month 12: Transfer (needs help)
|
11.9 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Month 12: Transfer (bedridden)
|
3.0 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Month 12: Cont (continent)
|
89.3 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Month 12: Cont (occasional incontinence)
|
9.1 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Month 12: Cont (permanent incontinence)
|
1.5 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Month 12: Feeding (self-sufficient)
|
91.4 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Month 12: Feeding (needs help)
|
7.1 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Month 12: Feeding (complete help)
|
1.5 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Month 24: Bathing (self-sufficient)
|
89.4 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Month 24: Bathing (partial help)
|
6.7 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Month 24: Bathing (washing impossible)
|
3.8 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Month 24: Dressing (self-sufficient)
|
91.3 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Month 24: Dressing (partial help)
|
3.8 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Month 24: Dressing (completely undressed)
|
4.8 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Month 24: Toileting (self-sufficient)
|
93.3 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Month 24: Toileting (needs help)
|
6.7 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Month 24: Transfer (self-sufficient)
|
86.5 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Month 24: Transfer (needs help)
|
13.5 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Month 24: Cont (continent)
|
90.4 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Month 24: Cont (occasional incontinence)
|
9.6 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Month 24: Feeding (self-sufficient)
|
91.3 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Month 24: Feeding (needs help)
|
6.7 Percentage of participants
|
|
Percentage of Participants With Activities of Daily Living (ADL)
Month 24: Feeding (complete help)
|
1.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Month 6, 12, 24Population: The EFF included all participants who had at least one infusion of bevacizumab, without exclusion criteria and excluding participants with no intake of chemotherapy, or intake of bevacizumab before or 2 months after chemotherapy initiation. Data in the study was collected for overall participants and not as per dose administered to participants.
The Lawton Instrumental Activities of Daily Living Scale (IADL) is an appropriate instrument to assess independent living skills. The instrument is most useful for identifying how a participant is functioning at the present time and for identifying improvement or deterioration over time. There are 8 domains of function measured with the Lawton IADL scale (telephone use, shopping, cooking, housekeeping, laundry, mode of transportation, responsibility of own medications, and ability to handle finances). Participants are scored according to their level of functioning from 0 (low function, dependent) to 8 (high function, independent). Higher score for each domain represents better functional performance of the older people.
Outcome measures
| Measure |
Bevacizumab
n=358 Participants
Participants received initial dose of either 5 milligram per kilogram (mg/kg) every 2 weeks or 7.5 mg/kg every 3 weeks of bevacizumab irrespective of the age subgroup.
|
|---|---|
|
Lawton Instrumental Activities of Daily Living Score (IADL)
Baseline
|
0.9 units on a scale
Standard Deviation 1.1
|
|
Lawton Instrumental Activities of Daily Living Score (IADL)
Month 6
|
1.0 units on a scale
Standard Deviation 1.2
|
|
Lawton Instrumental Activities of Daily Living Score (IADL)
Month 12
|
1.0 units on a scale
Standard Deviation 1.2
|
|
Lawton Instrumental Activities of Daily Living Score (IADL)
Month 24
|
0.8 units on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Baseline, Month 6, 12, 24Population: The EFF included all participants who had at least one infusion of bevacizumab, without exclusion criteria and excluding participants with no intake of chemotherapy, or intake of bevacizumab before or 2 months after chemotherapy initiation. Data in the study was collected for overall participants and not as per dose administered to participants.
Balducci score defines an algorithm for the individual participant according to age, ADL and modified IADL 4-items scores, estimated performance status and comorbidities, particularly cardiovascular, cancer, depression or anemia. Balducci score is categorized in the following- Type 1 (Harmonious), Type 2 (Intermediate) and Type 3 (Frail). Type 1 indicates better results and Type 3 indicates worse outcomes.
Outcome measures
| Measure |
Bevacizumab
n=358 Participants
Participants received initial dose of either 5 milligram per kilogram (mg/kg) every 2 weeks or 7.5 mg/kg every 3 weeks of bevacizumab irrespective of the age subgroup.
|
|---|---|
|
Percentage of Participants With Balducci Score
Month 24: Don't know
|
27.3 Percentage of participants
|
|
Percentage of Participants With Balducci Score
Baseline: Don't know
|
36.8 Percentage of participants
|
|
Percentage of Participants With Balducci Score
Baseline: Type 1 (Harmonious)
|
38.8 Percentage of participants
|
|
Percentage of Participants With Balducci Score
Baseline: Type 2 (Intermediate)
|
21.1 Percentage of participants
|
|
Percentage of Participants With Balducci Score
Baseline: Type 3 (Frail)
|
3.4 Percentage of participants
|
|
Percentage of Participants With Balducci Score
Month 6: Don't know
|
37.3 Percentage of participants
|
|
Percentage of Participants With Balducci Score
Month 6: Type 1 (Harmonious)
|
36.9 Percentage of participants
|
|
Percentage of Participants With Balducci Score
Month 6: Type 2 (Intermediate)
|
22.3 Percentage of participants
|
|
Percentage of Participants With Balducci Score
Month 6: Type 3 (Frail)
|
3.5 Percentage of participants
|
|
Percentage of Participants With Balducci Score
Month 12: Don't know
|
33.0 Percentage of participants
|
|
Percentage of Participants With Balducci Score
Month 12: Type 1 (Harmonious)
|
39.8 Percentage of participants
|
|
Percentage of Participants With Balducci Score
Month 12: Type 2 (Intermediate)
|
19.4 Percentage of participants
|
|
Percentage of Participants With Balducci Score
Month 12: Type 3 (Frail)
|
7.8 Percentage of participants
|
|
Percentage of Participants With Balducci Score
Month 24: Type 1 (Harmonious)
|
50.5 Percentage of participants
|
|
Percentage of Participants With Balducci Score
Month 24: Type 2 (Intermediate)
|
16.2 Percentage of participants
|
|
Percentage of Participants With Balducci Score
Month 24: Type 3 (Frail)
|
6.1 Percentage of participants
|
Adverse Events
Bevacizumab
Serious events: 98 serious events
Other events: 169 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bevacizumab
n=383 participants at risk
Participants received initial dose of either 5 milligram per kilogram (mg/kg) every 2 weeks or 7.5 mg/kg every 3 weeks of bevacizumab irrespective of the age subgroup.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
3.9%
15/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Vascular disorders
Jugular Vein Thrombosis
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Vascular disorders
Phlebitis
|
0.52%
2/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Vascular disorders
Subclavian Vein Thrombosis
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Vascular disorders
Venous Thrombosis Limb
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.8%
7/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Gastrointestinal disorders
Haematemesis
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Gastrointestinal disorders
Ileal Fistula
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Gastrointestinal disorders
Intestinal Ischaemia
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Nervous system disorders
Haemorrhagic Stroke
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Nervous system disorders
Ischaemic Stroke
|
0.52%
2/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Nervous system disorders
Leukoencephalopathy
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.0%
4/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Infections and infestations
Anal Abscess
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Injury, poisoning and procedural complications
Anastomotic Fistula
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Renal and urinary disorders
Haematuria
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.52%
2/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Gastrointestinal disorders
Rectal Obstruction
|
0.52%
2/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Gastrointestinal disorders
Subileus
|
0.52%
2/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Gastrointestinal disorders
Anal Fissure
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Gastrointestinal disorders
Constipation
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Gastrointestinal disorders
Faecaloma
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Gastrointestinal disorders
Gastrointestinal Disorder
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Gastrointestinal disorders
Gastrointestinal Toxicity
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Gastrointestinal disorders
Intestinal Perforation
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Gastrointestinal disorders
Vomiting
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.52%
2/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Oedema
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial Obstruction
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopneumopathy
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Respiratory, thoracic and mediastinal disorders
Lung Disorder
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Infections and infestations
Sepsis
|
1.0%
4/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Infections and infestations
Device Related Infection
|
0.52%
2/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Infections and infestations
Diverticulitis
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Infections and infestations
Endocarditis
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Infections and infestations
Herpes Zoster
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Infections and infestations
Infection
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Infections and infestations
Lung Infection
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Infections and infestations
Ophthalmic Herpes Zoster
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Infections and infestations
Peritonitis
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Infections and infestations
Pneumonia
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Infections and infestations
Pseudomonal Sepsis
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Infections and infestations
Septic Shock
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Infections and infestations
Subcutaneous Abscess
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Infections and infestations
Urinary Tract Infection
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
General disorders
General Physical Health Deterioration
|
2.9%
11/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
General disorders
Asthenia
|
0.78%
3/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
General disorders
Death
|
0.52%
2/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
General disorders
Face Oedema
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.78%
3/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Vascular disorders
Vena Cava Thrombosis
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.52%
2/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.78%
3/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Metabolism and nutrition disorders
Metabolic Alkalosis
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Metabolism and nutrition disorders
Metabolic Disorder
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Renal and urinary disorders
Renal Failure
|
0.52%
2/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.52%
2/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Renal and urinary disorders
Dysuria
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Nervous system disorders
Presyncope
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Cardiac disorders
Cardiac Failure
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Cardiac disorders
Myocardial Infarction
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Investigations
Prothrombin Time Ratio Decreased
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Investigations
White Blood Cell Count Decreased
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal Carcinoma
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Perforation
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Psychiatric disorders
Confusional State
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Psychiatric disorders
Psychiatric Symptom
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Congenital, familial and genetic disorders
Dihydropyrimidine Dehydrogenase Deficiency
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Hepatobiliary disorders
Hepatic Failure
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Surgical and medical procedures
Hepatectomy
|
0.26%
1/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
Other adverse events
| Measure |
Bevacizumab
n=383 participants at risk
Participants received initial dose of either 5 milligram per kilogram (mg/kg) every 2 weeks or 7.5 mg/kg every 3 weeks of bevacizumab irrespective of the age subgroup.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.8%
30/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.2%
20/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Gastrointestinal disorders
Diarrhoea
|
20.4%
78/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Gastrointestinal disorders
Nausea
|
9.7%
37/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
General disorders
Asthenia
|
17.8%
68/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Gastrointestinal disorders
Vomiting
|
5.5%
21/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
General disorders
Fatigue
|
5.5%
21/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
General disorders
Mucosal inflammation
|
6.8%
26/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.5%
25/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Nervous system disorders
Neuropathy peripheral
|
7.6%
29/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
|
Vascular disorders
Hypertension
|
6.3%
24/383 • Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
|
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