Renal Cell Cancer
Conditions
Brief summary
This single arm study will assess progression free survival, tumor response and safety of Avastin in combination with interferon alfa-2a (IFN) as first line treatment in patients with metastatic clear cell renal cell carcinoma. Patients will receive Avastin (10mg/kg iv) every 2 weeks in combination with a low dose of interferon alfa-2a (3 MIU sc three times per week (t.i.w.). The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
Interventions
DRUGbevacizumab [Avastin]
10mg/kg iv infusion every 2 weeks
3 MIU sc t.i.w.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patients, \>=18 years of age; * metastatic RCC with majority (\>50%) of conventional clear-cell type; * prior total nephrectomy for primary RCC; * at least one measurable or non-measurable lesions; * ECOG performance score of 0 or 2.
Exclusion criteria
* prior systemic treatment for metastatic RCC; * current or previously treated but non-stable CNS metastases or spinal cord compression; * major surgery (including open biopsy) or radiation therapy within 28 days prior to enrollment; * significant cardiovascular disease within 6 months prior to enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) - Percentage of Participants Estimated to be Progression Free at 12 and 24 Months | 12 and 24 months | PFS at 12 and 24 months is an estimate of the percentages of participants expected to be progression free at 12 and 24 months based on Kaplan-Meier survival analysis of the PFS data. PFS was defined as the time period from the first postbaseline tumor assessment to evidence of disease progression or death from any cause, whichever occurred first. Disease progression included evaluation solely due to symptomatic deterioration or death due to any reason. Censoring at start of any subsequent antineoplastic therapy was not performed. |
| PFS - Percentage of Participants With an Event | Baseline, every 8 weeks to Week 32 then every 12 weeks to disease progression or a maximum of 2 years from enrollment of last participant | PFS was defined as the time period from the first postbaseline assessment tumor assessment to evidence of disease progression or death from any cause, whichever occurred first. Disease progression included evaluation solely due to symptomatic deterioration or death due to any reason. Censoring at start of any subsequent antineoplastic therapy was not performed. |
| PFS - Time to Event | Baseline, every 8 weeks to Week 32 then every 12 weeks to disease progression or a maximum of 2 years from enrollment of last participant | PFS was defined as the time period from the first postbaseline assessment tumor assessment to evidence of disease progression or death from any cause, whichever occurred first. Disease progression included evaluation solely due to symptomatic deterioration or death due to any reason. Censoring at start of any subsequent antineoplastic therapy was not performed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS - Time to Event | Day 0, every 2 weeks until disease progression or end of treatment visit (28 days after last bevacizumab infusion, every 3 months during follow-up, or a maximum of 2 years from enrollment of last participant | OS was defined as the time period from the first bevacizumab infusion to death from any cause. Censoring at start of any subsequent antineoplastic therapy was not performed. |
| Percentage of Participants With a Best Overall Response of Complete Reponse (CR) or Partial Response (PR) | Baseline, every 8 weeks to Week 32 then every 12 weeks to disease progression or a maximum of 2 years from enrollment of last participant | Percentage of participants with objective response, termed responders, based assessment of confirmed CR or confirmed PR according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses were those that persisted on repeat imaging study greater than or equal to (≥)4 weeks after initial documentation of response. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis less than \[\<\]10 millimeters \[mm\]). No new lesions. PR was defined as ≥30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. |
| EQ-5D - Visual Analog Scale (VAS) | Screening/Baseline, Cycle 7, Cycle 25, Cycle 43, Cycle 61, and EOT | EQ-5D: participant-rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 millimeters (mm) (best imaginable health state); higher scores indicate a better health state. Participants were asked to rate their health state and mark the line; the distance from the left edge was recorded. For change from baseline a negative value represents a worsening in the health state and a positive value represents an improvement in the health state. |
| Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Screening/Baseline, Cycle 7, Cycle 25, Cycle 43, Cycle 61, and End of Treatment (EOT) | EQ-5D is a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). Answers from the questionnaire for each dimension (mobility, self-care, usual activity, pain/discomfort, and anxiety/depression) was classified into one of 2 categories: 'no problems' or 'any problems', and the percentage of participants in each category was determined. |
| Overall Survival (OS) - Percentage of Participants Estimated to be Alive at 12 and 24 Months | Day 0, every 2 weeks until disease progression or end of treatment visit (28 days after last bevacizumab infusion, every 3 months during follow-up, or a maximum of 2 years from enrollment of last participant | OS at 12 and 24 months is the estimate of the percentages of participants expected to alive at 12 and 24 months based on Kaplan-Meier survival analysis of the survival data. Median OS was defined as the time period from the first bevacizumab infusion to death from any cause. Censoring at start of any subsequent antineoplastic therapy was not performed. |
| OS - Percentage of Participants With an Event | Day 0, every 2 weeks until disease progression or end of treatment visit (28 days after last bevacizumab infusion, every 3 months during follow-up, or a maximum of 2 years from enrollment of last participant | OS was defined as the time period from the first bevacizumab infusion to death from any cause. Censoring at start of any subsequent antineoplastic therapy was not performed. |
Countries
Czechia, Estonia, Finland, Germany, Greece, Italy, Lithuania, Netherlands, Russia, Sweden, Switzerland, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bevacizumab + Interferon Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal. | 146 |
| Total | 146 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 61 |
| Overall Study | Investigator's decision | 2 |
| Overall Study | Other | 7 |
| Overall Study | Participant noncompliance | 1 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 14 |
Baseline characteristics
| Characteristic | Bevacizumab + Interferon |
|---|---|
| Age, Continuous | 61.1 years STANDARD_DEVIATION 10.37 |
| Sex: Female, Male Female | 48 Participants |
| Sex: Female, Male Male | 98 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 113 / 146 |
| serious Total, serious adverse events | 26 / 146 |
Outcome results
Primary
PFS - Percentage of Participants With an Event
PFS was defined as the time period from the first postbaseline assessment tumor assessment to evidence of disease progression or death from any cause, whichever occurred first. Disease progression included evaluation solely due to symptomatic deterioration or death due to any reason. Censoring at start of any subsequent antineoplastic therapy was not performed.
Time frame: Baseline, every 8 weeks to Week 32 then every 12 weeks to disease progression or a maximum of 2 years from enrollment of last participant
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bevacizumab + Interferon | PFS - Percentage of Participants With an Event | 69.2 percentage of participants |
Primary
PFS - Time to Event
PFS was defined as the time period from the first postbaseline assessment tumor assessment to evidence of disease progression or death from any cause, whichever occurred first. Disease progression included evaluation solely due to symptomatic deterioration or death due to any reason. Censoring at start of any subsequent antineoplastic therapy was not performed.
Time frame: Baseline, every 8 weeks to Week 32 then every 12 weeks to disease progression or a maximum of 2 years from enrollment of last participant
Population: ITT population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bevacizumab + Interferon | PFS - Time to Event | 15.3 months |
Primary
Progression-Free Survival (PFS) - Percentage of Participants Estimated to be Progression Free at 12 and 24 Months
PFS at 12 and 24 months is an estimate of the percentages of participants expected to be progression free at 12 and 24 months based on Kaplan-Meier survival analysis of the PFS data. PFS was defined as the time period from the first postbaseline tumor assessment to evidence of disease progression or death from any cause, whichever occurred first. Disease progression included evaluation solely due to symptomatic deterioration or death due to any reason. Censoring at start of any subsequent antineoplastic therapy was not performed.
Time frame: 12 and 24 months
Population: ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bevacizumab + Interferon | Progression-Free Survival (PFS) - Percentage of Participants Estimated to be Progression Free at 12 and 24 Months | 12 months | 58.2 percentage of participants |
| Bevacizumab + Interferon | Progression-Free Survival (PFS) - Percentage of Participants Estimated to be Progression Free at 12 and 24 Months | 24 months | 28.9 percentage of participants |
Secondary
EQ-5D - Visual Analog Scale (VAS)
EQ-5D: participant-rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 millimeters (mm) (best imaginable health state); higher scores indicate a better health state. Participants were asked to rate their health state and mark the line; the distance from the left edge was recorded. For change from baseline a negative value represents a worsening in the health state and a positive value represents an improvement in the health state.
Time frame: Screening/Baseline, Cycle 7, Cycle 25, Cycle 43, Cycle 61, and EOT
Population: ITT population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bevacizumab + Interferon | EQ-5D - Visual Analog Scale (VAS) | Cycle 25 (n=68) | 72.4 mm | Standard Deviation 15.46 |
| Bevacizumab + Interferon | EQ-5D - Visual Analog Scale (VAS) | Change at Cycle 61 (n=22) | -1.7 mm | Standard Deviation 20.41 |
| Bevacizumab + Interferon | EQ-5D - Visual Analog Scale (VAS) | Baseline (n=140) | 71.2 mm | Standard Deviation 17.27 |
| Bevacizumab + Interferon | EQ-5D - Visual Analog Scale (VAS) | Cycle 7 (n=103) | 71.8 mm | Standard Deviation 13.63 |
| Bevacizumab + Interferon | EQ-5D - Visual Analog Scale (VAS) | Change at Cycle 7 (n=99) | -1.8 mm | Standard Deviation 14.54 |
| Bevacizumab + Interferon | EQ-5D - Visual Analog Scale (VAS) | Change at Cycle 25 (n=67) | -2.3 mm | Standard Deviation 17.84 |
| Bevacizumab + Interferon | EQ-5D - Visual Analog Scale (VAS) | Cycle 43 (n=36) | 71.3 mm | Standard Deviation 17.12 |
| Bevacizumab + Interferon | EQ-5D - Visual Analog Scale (VAS) | Change at Cycle 43 (n=36) | -0.9 mm | Standard Deviation 20.12 |
| Bevacizumab + Interferon | EQ-5D - Visual Analog Scale (VAS) | Cycle 61 (n=22) | 70.5 mm | Standard Deviation 15.74 |
| Bevacizumab + Interferon | EQ-5D - Visual Analog Scale (VAS) | EOT (n=79) | 65.2 mm | Standard Deviation 19.72 |
| Bevacizumab + Interferon | EQ-5D - Visual Analog Scale (VAS) | Change at EOT (n=77) | -7.7 mm | Standard Deviation 15.73 |
Secondary
OS - Percentage of Participants With an Event
OS was defined as the time period from the first bevacizumab infusion to death from any cause. Censoring at start of any subsequent antineoplastic therapy was not performed.
Time frame: Day 0, every 2 weeks until disease progression or end of treatment visit (28 days after last bevacizumab infusion, every 3 months during follow-up, or a maximum of 2 years from enrollment of last participant
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bevacizumab + Interferon | OS - Percentage of Participants With an Event | 41.8 percentage of participants |
Secondary
OS - Time to Event
OS was defined as the time period from the first bevacizumab infusion to death from any cause. Censoring at start of any subsequent antineoplastic therapy was not performed.
Time frame: Day 0, every 2 weeks until disease progression or end of treatment visit (28 days after last bevacizumab infusion, every 3 months during follow-up, or a maximum of 2 years from enrollment of last participant
Population: ITT population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bevacizumab + Interferon | OS - Time to Event | 30.7 months |
Secondary
Overall Survival (OS) - Percentage of Participants Estimated to be Alive at 12 and 24 Months
OS at 12 and 24 months is the estimate of the percentages of participants expected to alive at 12 and 24 months based on Kaplan-Meier survival analysis of the survival data. Median OS was defined as the time period from the first bevacizumab infusion to death from any cause. Censoring at start of any subsequent antineoplastic therapy was not performed.
Time frame: Day 0, every 2 weeks until disease progression or end of treatment visit (28 days after last bevacizumab infusion, every 3 months during follow-up, or a maximum of 2 years from enrollment of last participant
Population: ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bevacizumab + Interferon | Overall Survival (OS) - Percentage of Participants Estimated to be Alive at 12 and 24 Months | 12 months | 84.1 percentage of participants |
| Bevacizumab + Interferon | Overall Survival (OS) - Percentage of Participants Estimated to be Alive at 12 and 24 Months | 24 months | 59.6 percentage of participants |
Secondary
Percentage of Participants With a Best Overall Response of Complete Reponse (CR) or Partial Response (PR)
Percentage of participants with objective response, termed responders, based assessment of confirmed CR or confirmed PR according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses were those that persisted on repeat imaging study greater than or equal to (≥)4 weeks after initial documentation of response. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis less than \[\<\]10 millimeters \[mm\]). No new lesions. PR was defined as ≥30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.
Time frame: Baseline, every 8 weeks to Week 32 then every 12 weeks to disease progression or a maximum of 2 years from enrollment of last participant
Population: ITT population; only participants with measurable disease were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bevacizumab + Interferon | Percentage of Participants With a Best Overall Response of Complete Reponse (CR) or Partial Response (PR) | 28.8 percentage of participants |
Secondary
Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit
EQ-5D is a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). Answers from the questionnaire for each dimension (mobility, self-care, usual activity, pain/discomfort, and anxiety/depression) was classified into one of 2 categories: 'no problems' or 'any problems', and the percentage of participants in each category was determined.
Time frame: Screening/Baseline, Cycle 7, Cycle 25, Cycle 43, Cycle 61, and End of Treatment (EOT)
Population: ITT population; number (n) equals (=) number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Mobility, any problems, Baseline (n=142) | 31.0 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Mobility, no problems, Cycle 7 (n=106) | 64.2 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Self-care, any problems, Cycle 61 (n=22) | 22.7 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Self-care, any problems, EOT (n=80) | 36.3 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Pain/discomfort, any problems, Cycle 25 (n=69) | 46.4 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Pain/discomfort, any problems, EOT (n=80) | 66.3 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Anxiety/depression, any problems, Cycle 25 (n=69) | 37.7 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Anxiety/depression, any problems, EOT (n=80) | 55.0 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Usual activity, any problems, Baseline (n=145) | 39.3 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Usual activity, no problems, Cycle 7 (n=106) | 53.8 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Usual activity, any problems, Cycle 7 (n=106) | 46.2 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Mobility, no problems, Baseline (n=142) | 69.0 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Mobility, any problems, Cycle 7 (n=106) | 35.8 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Mobility, no problems, Cycle 25 (n=69) | 58.0 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Mobility, any problems, Cycle 25 (n=69) | 42.0 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Mobility, no problems, Cycle 43 (n=36) | 38.9 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Mobility, any problems, Cycle 43 (n=36) | 61.1 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Mobility, no problems, Cycle 61 (n=22) | 40.9 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Mobility, any problems, Cycle 61 (n=22) | 59.1 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Mobility, no problems, EOT (n=82) | 41.3 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Mobility, any problems, EOT (n=82) | 58.8 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Self-care, no problems, Baseline (n=145) | 82.8 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Usual activity, no problems, Cycle 25 (n=69) | 46.4 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Self-care, any problems, Baseline (n=145) | 17.2 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Self-care, no problems, Cycle 7 (n=106) | 81.1 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Self-care, any problems, Cycle 7 (n=106) | 18.9 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Usual activity, any problems, Cycle 25 (n=69) | 53.6 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Usual activity, no problems, Cycle 43 (n=36) | 33.3 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Self-care, no problems, Cycle 25 (n=69) | 81.2 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Self-care, any problems, Cycle 25 (n=69) | 18.8 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Self-care, no problems, Cycle 43 (n=36) | 69.4 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Usual activity, any problems, Cycle 43 (n=36) | 66.7 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Usual activity, no problems, Cycle 61 (n=22) | 45.5 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Self-care, any problems, Cycle 43 (n=36) | 30.6 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Self-care, no problems, Cycle 61 (n=22) | 77.3 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Self-care, no problems, EOT (n=80) | 63.8 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Usual activity, any problems, Cycle 61 (n=22) | 54.5 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Usual activity, no problems, EOT (n=78) | 33.3 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Usual activity, any problems, EOT (n=78) | 66.7 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Pain/discomfort, no problems, Baseline (n=145) | 48.3 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Usual activity, no problems, Baseline (n=145) | 60.7 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Anxiety/depression, no problems, EOT (n=80) | 45.0 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Pain/discomfort, any problems, Baseline (n=145) | 51.7 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Pain/discomfort, no problems, Cycle 7 (n=106) | 49.1 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Pain/discomfort, any problems, Cycle 7 (n=106) | 50.9 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Pain/discomfort, no problems, Cycle 25 (n=69) | 53.6 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Pain/discomfort, no problems, Cycle 43 (n=36) | 50.0 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Pain/discomfort, any problems, Cycle 43 (n=36) | 50.0 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Pain/discomfort, no problems, Cycle 61 (n=22) | 50.0 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Pain/discomfort, any problems, Cycle 61 (n=22) | 50.0 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Pain/discomfort, no problems, EOT (n=80) | 33.8 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Anxiety/depression, no problems, Baseline (n=144) | 45.8 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Anxiety/depression, any problems, Baseline (n=144) | 54.2 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Anxiety/depression, no problems, Cycle 7 (n=106) | 55.7 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Anxiety/depression, any problems, Cycle 7 (n=106) | 44.3 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Anxiety/depression, no problems, Cycle 25 (n=69) | 62.3 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Anxiety/depression, no problems, Cycle 43 (n=36) | 61.1 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Anxiety/depression, any problems, Cycle 43 (n=36) | 38.9 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Anxiety/depression, no problems, Cycle 61 (n=22) | 59.1 percentage of participants |
| Bevacizumab + Interferon | Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit | Anxiety/depression, any problems, Cycle 61 (n=22) | 40.9 percentage of participants |