Ovarian Neoplasms
Conditions
Keywords
Peritoneal Neoplasma
Brief summary
Comparison of Nexavar with a placebo as maintenance therapy for patients with advanced Ovarian or primary Peritoneal cancers in complete remission following surgery and one regimen of chemotherapy.
Interventions
DRUGSorafenib (Nexavar, BAY43-9006)
Patients in Sorafenib arm will receive 2 Sorafenib tablets (200 mg each) twice a day and in continuous administration.
DRUGPlacebo
Patients in Placebo arm will receive 2 matching placebo tablets twice a day and in continuous administration.
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed International Federation of Gynecology and Obstetrics (FIGO) stage (67) III or IV ovarian epithelial cancer or primary peritoneal cancer at presentation. Patients must have achieved a clinical complete response (disappearance of all clinical and radiological evidence of tumor) after only one regimen (4-6 cycles) of platinum and taxane-based standard chemotherapy received after tumor debulkment. * Normal serum CA125 (cancer-associated tumor marker) level within 7 days of first dose of sorafenib. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * All scans used to document complete response must be done within 30 days prior to randomization. * Patients must be able to swallow and retain oral medication.
Exclusion criteria
* Patients with any residual cancer tissue after the completion of chemotherapy detectable by standard Computed tomography (CT) or magnetic resonance imaging (MRI). * Prior local radiotherapy, neoadjuvant chemotherapy or intraperitoneal chemotherapy. * Histologic subtypes of ovarian cancer other than epithelial (i.e. sarcoma, lymphoma, germ cell). * Major surgery, open biopsy, or significant traumatic injury within 30 days prior to randomization.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS), Based on Radiological or Pathologic Assessment | From randomization of the first patient until 32.5 months later, assessed every 8 weeks | Time from randomization to the first documented disease progression by radiological or pathologic assessment or death due to any cause whichever occurred first. For patients who had not progressed or died at the time of analysis, PFS was censored at the date of their last evaluable tumor scan. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Pathologic CA-125 (Cancer-associated Tumor Marker) Serum Level | From randomization of the first patient until 32.5 months later, assessed every 8 weeks | Time from randomization to the first documented increase of CA-125 above the upper limit of normal. Patients without pathologic CA-125 increase at the time of analysis were censored at their last date of evaluation of CA-125. |
| Overall Survival (OS) | From randomization of the first patient until 32.5 months later | The OS time was measured from the date of randomization until the date of death due to any cause. Patients who were alive at the time of analysis were censored at the date of the last contact (last time the patient was known to be alive). |
Other
| Measure | Time frame | Description |
|---|---|---|
| FOSI Total Score at Cycle 5 | At Cycle 5 (4 weeks per Cycle) | The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The FOSI total score ranges from 0 (severely symptomatic) to 32 (asymptomatic). |
| Change From Baseline in FOSI Total Score at Cycle 5 | Baseline and Cycle 5 (4 weeks per Cycle) | The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The change is calculated as score at Cycle 5 minus baseline score. The change in FOSI total score ranges from -32 (most deterioration from baseline) to 32 (most improvement from baseline). |
| FOSI Total Score at End of Treatment | At End of treatment (up to Cycle 33, 4 weeks per Cycle) | The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The FOSI total score ranges from 0 (severely symptomatic) to 32 (asymptomatic). |
| Change From Baseline in FOSI Total Score at End of Treatment | Baseline and End of treatment (up to Cycle 33, 4 weeks per Cycle) | The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The change is calculated as score at End of treatment minus baseline score. The change in FOSI total score ranges from -32 (most deterioration from baseline) to 32 (most improvement from baseline). |
| EuroQol-5D (EQ-5D) Index Score at Cycle 1/Baseline | At Cycle 1 (4 weeks per Cycle)/baseline | The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index score which ranges from -0.594 (worst) to 1 (best) when the United Kingdom (UK) weights are applied. |
| EQ-5D Index Score at Cycle 3 | At Cycle 3 (4 weeks per Cycle) | The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index score which ranges from -0.594 (worst) to 1 (best) when the United Kingdom (UK) weights are applied. |
| Change From Baseline in EQ-5D Index Score at Cycle 3 | Baseline and Cycle 3 (4 weeks per Cycle) | The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index. The change is calculated as score at Cycle 3 minus baseline score. The change in EQ-5D index ranges from -1.594 (most deterioration from baseline) to 1.594 (most improvement from baseline). |
| EQ-5D Index Score at Cycle 5 | At Cycle 5 (4 weeks per Cycle) | The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index score which ranges from -0.594 (worst) to 1 (best) when the United Kingdom (UK) weights are applied. |
| Change From Baseline in EQ-5D Index Score at Cycle 5 | Baseline and Cycle 5 (4 weeks per Cycle) | The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index. The change is calculated as score at Cycle 5 minus baseline score. The change in EQ-5D index ranges from -1.594 (most deterioration from baseline) to 1.594 (most improvement from baseline). |
| Functional Assessment of Cancer Therapy (FACT)/National Comprehensive Cancer Network (NCCN) Ovarian Symptom Index (FOSI) Total Score at Cycle 1/Baseline | At Cycle 1 (4 weeks per Cycle)/baseline | The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The FOSI total score ranges from 0 (severely symptomatic) to 32 (asymptomatic). |
| Change From Baseline in EQ-5D Index Score at End of Treatment | Baseline and End of treatment (up to Cycle 33, 4 weeks per Cycle) | The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index. The change is calculated as score at End of treatment minus baseline score. The change in EQ-5D index ranges from -1.594 (most deterioration from baseline) to 1.594 (most improvement from baseline). |
| EQ-5D Visual Analogue Scale (VAS) Score at Cycle 1/Baseline | At Cycle 1 (4 weeks per Cycle)/baseline | The EQ-5D also contains a VAS, which records the respondent's self-rated health status on a vertical graduated scale. The scale ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). |
| EQ-5D VAS Score at Cycle 3 | At Cycle 3 (4 weeks per Cycle) | The EQ-5D also contains a VAS, which records the respondent's self-rated health status on a vertical graduated scale. The scale ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). |
| Change From Baseline in EQ-5D VAS Score at Cycle 3 | Baseline and Cycle 3 (4 weeks per Cycle) | The EQ-5D also contains a VAS, which records the respondent's self-rated health status on a vertical graduated scale. The change is calculated as score at Cycle 3 minus baseline score. The change in EQ-5D VAS ranges from -100 (most deterioration from baseline) to 100 (most improvement from baseline). |
| EQ-5D VAS Score at Cycle 5 | At Cycle 5 (4 weeks per Cycle) | The EQ-5D also contains a VAS, which records the respondent's self-rated health status on a vertical graduated scale. The scale ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). |
| Change From Baseline in EQ-5D VAS Score at Cycle 5 | Baseline and Cycle 5 (4 weeks per Cycle) | The EQ-5D also contains a VAS, which records the respondent's self-rated health status on a vertical graduated scale. The change is calculated as score at Cycle 5 minus baseline score. The change in EQ-5D VAS ranges from -100 (most deterioration from baseline) to 100 (most improvement from baseline). |
| EQ-5D VAS Score at End of Treatment | At End of treatment (up to Cycle 33, 4 weeks per Cycle) | The EQ-5D also contains a VAS, which records the respondent's self-rated health status on a vertical graduated scale. The scale ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). |
| Change From Baseline in EQ-5D VAS Score at End of Treatment | Baseline and End of treatment (up to Cycle 33, 4 weeks per Cycle) | The EQ-5D also contains a VAS, which records the respondent's self-rated health status on a vertical graduated scale. The change is calculated as score at End of treatment minus baseline score. The change in EQ-5D VAS ranges from -100 (most deterioration from baseline) to 100 (most improvement from baseline). |
| EQ-5D Index Score at End of Treatment | At End of treatment (up to Cycle 33, 4 weeks per Cycle) | The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index score which ranges from -0.594 (worst) to 1 (best) when the United Kingdom (UK) weights are applied. |
| FOSI Total Score at Cycle 3 | At Cycle 3 (4 weeks per Cycle) | The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The FOSI total score ranges from 0 (severely symptomatic) to 32 (asymptomatic). |
| Change From Baseline in FOSI Total Score at Cycle 3 | Baseline and Cycle 3 (4 weeks per Cycle) | The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The change is calculated as score at Cycle 3 minus baseline score. The change in FOSI total score ranges from -32 (most deterioration from baseline) to 32 (most improvement from baseline). |
Countries
Belgium, Canada, Finland, France, Germany, Hong Kong, Italy, Japan, Netherlands, Poland, Singapore, South Korea, Spain, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sorafenib (Nexavar, BAY43-9006) Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid) | 123 |
| Placebo Participants received 2 matching placebo tablets per oral twice daily | 123 |
| Total | 246 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Double-blind Treatment | Adverse Event | 49 | 9 |
| Double-blind Treatment | Non-compliant with study medication | 2 | 0 |
| Double-blind Treatment | Physician Decision | 6 | 26 |
| Double-blind Treatment | Protocol Violation | 0 | 4 |
| Double-blind Treatment | Withdrawal by Subject | 20 | 9 |
| Follow-up | Lost to Follow-up | 2 | 1 |
| Follow-up | Withdrawal by Subject | 3 | 0 |
Baseline characteristics
| Characteristic | Sorafenib (Nexavar, BAY43-9006) | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 56.9 Years STANDARD_DEVIATION 10.4 | 54.4 Years STANDARD_DEVIATION 10.3 | 55.7 Years STANDARD_DEVIATION 10.4 |
| Age, Customized ≥ 65 - < 75 years | 23 Participants | 23 Participants | 46 Participants |
| Age, Customized < 65 years | 95 Participants | 99 Participants | 194 Participants |
| Age, Customized ≥ 75 years | 5 Participants | 1 Participants | 6 Participants |
| Performance status, Eastern Cooperative Oncology Group (ECOG) 0=Fully active without restriction | 89 Participants | 92 Participants | 181 Participants |
| Performance status, Eastern Cooperative Oncology Group (ECOG) 1=Restricted in physically strenuous activity | 32 Participants | 30 Participants | 62 Participants |
| Performance status, Eastern Cooperative Oncology Group (ECOG) 2=Ambulatory, capable of all selfcare | 1 Participants | 0 Participants | 1 Participants |
| Performance status, Eastern Cooperative Oncology Group (ECOG) Missing | 1 Participants | 1 Participants | 2 Participants |
| Previous Intra-peritoneal (IP) chemotherapy No | 118 Participants | 119 Participants | 237 Participants |
| Previous Intra-peritoneal (IP) chemotherapy Yes | 5 Participants | 4 Participants | 9 Participants |
| Sex: Female, Male Female | 123 Participants | 123 Participants | 246 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Surgical cytoreduction Missing | 8 Participants | 8 Participants | 16 Participants |
| Surgical cytoreduction Optimal | 105 Participants | 105 Participants | 210 Participants |
| Surgical cytoreduction Suboptimal | 10 Participants | 10 Participants | 20 Participants |
| Type of cancer Ovarian cancer | 115 Participants | 114 Participants | 229 Participants |
| Type of cancer Peritoneal cancer | 8 Participants | 9 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 121 / 123 | 105 / 123 |
| serious Total, serious adverse events | 26 / 123 | 25 / 123 |
Outcome results
Primary
Progression-free Survival (PFS), Based on Radiological or Pathologic Assessment
Time from randomization to the first documented disease progression by radiological or pathologic assessment or death due to any cause whichever occurred first. For patients who had not progressed or died at the time of analysis, PFS was censored at the date of their last evaluable tumor scan.
Time frame: From randomization of the first patient until 32.5 months later, assessed every 8 weeks
Population: Full analysis set (FAS)=all randomized participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | Progression-free Survival (PFS), Based on Radiological or Pathologic Assessment | 386 Days |
| Placebo | Progression-free Survival (PFS), Based on Radiological or Pathologic Assessment | 478 Days |
Comparison: Sample size based on the primary efficacy endpoint of PFS. Clinically meaningful improvement defined as 65% increase in median PFS. With one-sided alpha of 0.10, power of 90% and a randomization ratio of 1:1 between Sorafenib and Placebo, a total of 105 PFS events were required.p-value: 0.65595% CI: [0.72, 1.63]Log Rank
Secondary
Overall Survival (OS)
The OS time was measured from the date of randomization until the date of death due to any cause. Patients who were alive at the time of analysis were censored at the date of the last contact (last time the patient was known to be alive).
Time frame: From randomization of the first patient until 32.5 months later
Population: FAS=all randomized participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | Overall Survival (OS) | NA Days |
| Placebo | Overall Survival (OS) | NA Days |
p-value: 0.8495% CI: [0.69, 3.23]Log Rank
Secondary
Time to First Pathologic CA-125 (Cancer-associated Tumor Marker) Serum Level
Time from randomization to the first documented increase of CA-125 above the upper limit of normal. Patients without pathologic CA-125 increase at the time of analysis were censored at their last date of evaluation of CA-125.
Time frame: From randomization of the first patient until 32.5 months later, assessed every 8 weeks
Population: Per protocol set (PPS)=all randomized participants who had normal CA-125 serum level at baseline and at least one post-baseline CA-125 assessment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | Time to First Pathologic CA-125 (Cancer-associated Tumor Marker) Serum Level | 337 Days |
| Placebo | Time to First Pathologic CA-125 (Cancer-associated Tumor Marker) Serum Level | 617 Days |
p-value: 0.95195% CI: [0.93, 2.2]Log Rank
Other Pre-specified
Change From Baseline in EQ-5D Index Score at Cycle 3
The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index. The change is calculated as score at Cycle 3 minus baseline score. The change in EQ-5D index ranges from -1.594 (most deterioration from baseline) to 1.594 (most improvement from baseline).
Time frame: Baseline and Cycle 3 (4 weeks per Cycle)
Population: PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | Change From Baseline in EQ-5D Index Score at Cycle 3 | -0.068 Scores on a scale | Standard Deviation 0.225 |
| Placebo | Change From Baseline in EQ-5D Index Score at Cycle 3 | -0.003 Scores on a scale | Standard Deviation 0.201 |
Other Pre-specified
Change From Baseline in EQ-5D Index Score at Cycle 5
The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index. The change is calculated as score at Cycle 5 minus baseline score. The change in EQ-5D index ranges from -1.594 (most deterioration from baseline) to 1.594 (most improvement from baseline).
Time frame: Baseline and Cycle 5 (4 weeks per Cycle)
Population: PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 5
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | Change From Baseline in EQ-5D Index Score at Cycle 5 | -0.045 Scores on a scale | Standard Deviation 0.222 |
| Placebo | Change From Baseline in EQ-5D Index Score at Cycle 5 | 0.016 Scores on a scale | Standard Deviation 0.18 |
Other Pre-specified
Change From Baseline in EQ-5D Index Score at End of Treatment
The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index. The change is calculated as score at End of treatment minus baseline score. The change in EQ-5D index ranges from -1.594 (most deterioration from baseline) to 1.594 (most improvement from baseline).
Time frame: Baseline and End of treatment (up to Cycle 33, 4 weeks per Cycle)
Population: PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at end of treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | Change From Baseline in EQ-5D Index Score at End of Treatment | -0.064 Scores on a scale | Standard Deviation 0.243 |
| Placebo | Change From Baseline in EQ-5D Index Score at End of Treatment | -0.054 Scores on a scale | Standard Deviation 0.274 |
Other Pre-specified
Change From Baseline in EQ-5D VAS Score at Cycle 3
The EQ-5D also contains a VAS, which records the respondent's self-rated health status on a vertical graduated scale. The change is calculated as score at Cycle 3 minus baseline score. The change in EQ-5D VAS ranges from -100 (most deterioration from baseline) to 100 (most improvement from baseline).
Time frame: Baseline and Cycle 3 (4 weeks per Cycle)
Population: PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | Change From Baseline in EQ-5D VAS Score at Cycle 3 | -2.225 Scores on a scale | Standard Deviation 15.594 |
| Placebo | Change From Baseline in EQ-5D VAS Score at Cycle 3 | 2.688 Scores on a scale | Standard Deviation 10.736 |
Other Pre-specified
Change From Baseline in EQ-5D VAS Score at Cycle 5
The EQ-5D also contains a VAS, which records the respondent's self-rated health status on a vertical graduated scale. The change is calculated as score at Cycle 5 minus baseline score. The change in EQ-5D VAS ranges from -100 (most deterioration from baseline) to 100 (most improvement from baseline).
Time frame: Baseline and Cycle 5 (4 weeks per Cycle)
Population: PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 5
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | Change From Baseline in EQ-5D VAS Score at Cycle 5 | -0.947 Scores on a scale | Standard Deviation 15.901 |
| Placebo | Change From Baseline in EQ-5D VAS Score at Cycle 5 | 3.543 Scores on a scale | Standard Deviation 14.151 |
Other Pre-specified
Change From Baseline in EQ-5D VAS Score at End of Treatment
The EQ-5D also contains a VAS, which records the respondent's self-rated health status on a vertical graduated scale. The change is calculated as score at End of treatment minus baseline score. The change in EQ-5D VAS ranges from -100 (most deterioration from baseline) to 100 (most improvement from baseline).
Time frame: Baseline and End of treatment (up to Cycle 33, 4 weeks per Cycle)
Population: PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at end of treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | Change From Baseline in EQ-5D VAS Score at End of Treatment | -2.147 Scores on a scale | Standard Deviation 18.054 |
| Placebo | Change From Baseline in EQ-5D VAS Score at End of Treatment | 0.348 Scores on a scale | Standard Deviation 17.481 |
Other Pre-specified
Change From Baseline in FOSI Total Score at Cycle 3
The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The change is calculated as score at Cycle 3 minus baseline score. The change in FOSI total score ranges from -32 (most deterioration from baseline) to 32 (most improvement from baseline).
Time frame: Baseline and Cycle 3 (4 weeks per Cycle)
Population: PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | Change From Baseline in FOSI Total Score at Cycle 3 | 0.086 Scores on a scale | Standard Deviation 3.387 |
| Placebo | Change From Baseline in FOSI Total Score at Cycle 3 | 0.460 Scores on a scale | Standard Deviation 3.128 |
Other Pre-specified
Change From Baseline in FOSI Total Score at Cycle 5
The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The change is calculated as score at Cycle 5 minus baseline score. The change in FOSI total score ranges from -32 (most deterioration from baseline) to 32 (most improvement from baseline).
Time frame: Baseline and Cycle 5 (4 weeks per Cycle)
Population: PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 5
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | Change From Baseline in FOSI Total Score at Cycle 5 | -0.223 Scores on a scale | Standard Deviation 3.53 |
| Placebo | Change From Baseline in FOSI Total Score at Cycle 5 | 0.659 Scores on a scale | Standard Deviation 3.38 |
Other Pre-specified
Change From Baseline in FOSI Total Score at End of Treatment
The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The change is calculated as score at End of treatment minus baseline score. The change in FOSI total score ranges from -32 (most deterioration from baseline) to 32 (most improvement from baseline).
Time frame: Baseline and End of treatment (up to Cycle 33, 4 weeks per Cycle)
Population: PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at end of treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | Change From Baseline in FOSI Total Score at End of Treatment | -0.733 Scores on a scale | Standard Deviation 4.089 |
| Placebo | Change From Baseline in FOSI Total Score at End of Treatment | -1.088 Scores on a scale | Standard Deviation 4.067 |
Other Pre-specified
EQ-5D Index Score at Cycle 3
The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index score which ranges from -0.594 (worst) to 1 (best) when the United Kingdom (UK) weights are applied.
Time frame: At Cycle 3 (4 weeks per Cycle)
Population: PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | EQ-5D Index Score at Cycle 3 | 0.727 Scores on a scale | Standard Deviation 0.219 |
| Placebo | EQ-5D Index Score at Cycle 3 | 0.767 Scores on a scale | Standard Deviation 0.232 |
Other Pre-specified
EQ-5D Index Score at Cycle 5
The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index score which ranges from -0.594 (worst) to 1 (best) when the United Kingdom (UK) weights are applied.
Time frame: At Cycle 5 (4 weeks per Cycle)
Population: PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 5
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | EQ-5D Index Score at Cycle 5 | 0.744 Scores on a scale | Standard Deviation 0.217 |
| Placebo | EQ-5D Index Score at Cycle 5 | 0.813 Scores on a scale | Standard Deviation 0.159 |
Other Pre-specified
EQ-5D Index Score at End of Treatment
The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index score which ranges from -0.594 (worst) to 1 (best) when the United Kingdom (UK) weights are applied.
Time frame: At End of treatment (up to Cycle 33, 4 weeks per Cycle)
Population: PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at end of treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | EQ-5D Index Score at End of Treatment | 0.731 Scores on a scale | Standard Deviation 0.235 |
| Placebo | EQ-5D Index Score at End of Treatment | 0.741 Scores on a scale | Standard Deviation 0.25 |
Other Pre-specified
EQ-5D VAS Score at Cycle 3
The EQ-5D also contains a VAS, which records the respondent's self-rated health status on a vertical graduated scale. The scale ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).
Time frame: At Cycle 3 (4 weeks per Cycle)
Population: PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | EQ-5D VAS Score at Cycle 3 | 73.042 Scores on a scale | Standard Deviation 14.701 |
| Placebo | EQ-5D VAS Score at Cycle 3 | 77.899 Scores on a scale | Standard Deviation 16.503 |
Other Pre-specified
EQ-5D VAS Score at Cycle 5
The EQ-5D also contains a VAS, which records the respondent's self-rated health status on a vertical graduated scale. The scale ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).
Time frame: At Cycle 5 (4 weeks per Cycle)
Population: PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 5
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | EQ-5D VAS Score at Cycle 5 | 75.404 Scores on a scale | Standard Deviation 14.177 |
| Placebo | EQ-5D VAS Score at Cycle 5 | 79.915 Scores on a scale | Standard Deviation 16.339 |
Other Pre-specified
EQ-5D VAS Score at End of Treatment
The EQ-5D also contains a VAS, which records the respondent's self-rated health status on a vertical graduated scale. The scale ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).
Time frame: At End of treatment (up to Cycle 33, 4 weeks per Cycle)
Population: PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at end of treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | EQ-5D VAS Score at End of Treatment | 71.413 Scores on a scale | Standard Deviation 16.686 |
| Placebo | EQ-5D VAS Score at End of Treatment | 76.246 Scores on a scale | Standard Deviation 16.017 |
Other Pre-specified
EQ-5D Visual Analogue Scale (VAS) Score at Cycle 1/Baseline
The EQ-5D also contains a VAS, which records the respondent's self-rated health status on a vertical graduated scale. The scale ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).
Time frame: At Cycle 1 (4 weeks per Cycle)/baseline
Population: PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at least one post-baseline assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | EQ-5D Visual Analogue Scale (VAS) Score at Cycle 1/Baseline | 75.235 Scores on a scale | Standard Deviation 14.494 |
| Placebo | EQ-5D Visual Analogue Scale (VAS) Score at Cycle 1/Baseline | 75.868 Scores on a scale | Standard Deviation 16.725 |
Other Pre-specified
EuroQol-5D (EQ-5D) Index Score at Cycle 1/Baseline
The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index score which ranges from -0.594 (worst) to 1 (best) when the United Kingdom (UK) weights are applied.
Time frame: At Cycle 1 (4 weeks per Cycle)/baseline
Population: PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at least one post-baseline assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | EuroQol-5D (EQ-5D) Index Score at Cycle 1/Baseline | 0.804 Scores on a scale | Standard Deviation 0.168 |
| Placebo | EuroQol-5D (EQ-5D) Index Score at Cycle 1/Baseline | 0.779 Scores on a scale | Standard Deviation 0.218 |
Other Pre-specified
FOSI Total Score at Cycle 3
The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The FOSI total score ranges from 0 (severely symptomatic) to 32 (asymptomatic).
Time frame: At Cycle 3 (4 weeks per Cycle)
Population: PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | FOSI Total Score at Cycle 3 | 25.871 Scores on a scale | Standard Deviation 3.166 |
| Placebo | FOSI Total Score at Cycle 3 | 26.105 Scores on a scale | Standard Deviation 3.414 |
Other Pre-specified
FOSI Total Score at Cycle 5
The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The FOSI total score ranges from 0 (severely symptomatic) to 32 (asymptomatic).
Time frame: At Cycle 5 (4 weeks per Cycle)
Population: PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 5
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | FOSI Total Score at Cycle 5 | 25.496 Scores on a scale | Standard Deviation 3.83 |
| Placebo | FOSI Total Score at Cycle 5 | 26.634 Scores on a scale | Standard Deviation 2.922 |
Other Pre-specified
FOSI Total Score at End of Treatment
The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The FOSI total score ranges from 0 (severely symptomatic) to 32 (asymptomatic).
Time frame: At End of treatment (up to Cycle 33, 4 weeks per Cycle)
Population: PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at end of treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | FOSI Total Score at End of Treatment | 25.011 Scores on a scale | Standard Deviation 3.832 |
| Placebo | FOSI Total Score at End of Treatment | 24.528 Scores on a scale | Standard Deviation 3.579 |
Other Pre-specified
Functional Assessment of Cancer Therapy (FACT)/National Comprehensive Cancer Network (NCCN) Ovarian Symptom Index (FOSI) Total Score at Cycle 1/Baseline
The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The FOSI total score ranges from 0 (severely symptomatic) to 32 (asymptomatic).
Time frame: At Cycle 1 (4 weeks per Cycle)/baseline
Population: Patient-reported outcomes (PRO) analysis set=the FAS population with evaluable PRO assessments at baseline and at least one post-baseline assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | Functional Assessment of Cancer Therapy (FACT)/National Comprehensive Cancer Network (NCCN) Ovarian Symptom Index (FOSI) Total Score at Cycle 1/Baseline | 25.909 Scores on a scale | Standard Deviation 3.174 |
| Placebo | Functional Assessment of Cancer Therapy (FACT)/National Comprehensive Cancer Network (NCCN) Ovarian Symptom Index (FOSI) Total Score at Cycle 1/Baseline | 25.658 Scores on a scale | Standard Deviation 3.968 |