Low-grade Serous Fallopian Tube Cancer, Low-grade Serous Ovarian Cancer, Low-grade Serous Peritoneal Cancer
Conditions
Brief summary
The MILO Study (MEK Inhibitor in Low-grade Serous Ovarian Cancer) is a Phase 3 study during which patients with recurrent or persistent low-grade serous (LGS) carcinomas of the ovary, fallopian tube or primary peritoneum will receive either investigational study drug MEK162 or a chemotherapy chosen by the physician (liposomal doxorubicin, paclitaxel or topotecan). Patients will be followed to compare the effectiveness of the study drug to that of the selected chemotherapies. Patients may be eligible to crossover from physician's choice chemotherapy to MEK162 if they meet certain inclusion criteria including centrally confirmed disease progression. Approximately 360 patients from North America, Europe and Australia will be enrolled in this study.
Interventions
multiple dose, single schedule
Patients will receive one of the following chemotherapies as determined by the physician: * Liposomal doxorubicin, anthracycline antibiotic; intravenous (multiple dose, single schedule) * Paclitaxel, mitotic inhibitor; intravenous (multiple dose, single schedule) * Topotecan, topoisomerase 1 inhibitor; intravenous (multiple dose, single schedule)
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Diagnosis of LGS carcinoma of the ovary, fallopian tube or primary peritoneum (invasive micropapillary serous carcinoma or invasive grade 1 serous carcinoma), confirmed histologically and verified by central pathology review. * Recurrent or persistent measurable disease that has progressed (defined as radiological and/or clinical progression; an increase in cancer antigen \[CA\]-125 alone is not sufficient) on or after last therapy (i.e., chemotherapy, hormonal therapy, surgery) and is not amenable to potentially curative intent surgery, as determined by the patient's treating physician. * Must have received at least 1 prior platinum-based chemotherapy regimen but have received no more than 3 lines of prior chemotherapy regimens, with no limit to the number of lines of prior hormonal therapy. Front-line therapy may include neoadjuvant and adjuvant therapy and will be counted as 1 prior systemic regimen. Biological therapy (e.g. bevacizumab) administered as a single agent is considered a prior systemic regimen and not a prior chemotherapy regimen. Maintenance therapy is not considered its own regimen but should be included with the regimen that it follows. * Available archival tumor sample (excisional or core biopsy) for confirmation of LGS carcinoma diagnosis. If adequate archival tumor sample is not available, willingness to consent to tissue biopsy. * Suitable for treatment with at least one of the physician's choice chemotherapy options (liposomal doxorubicin, paclitaxel or topotecan) as determined by the Investigator. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. * Additional criteria exist. Key
Exclusion criteria
* History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO (e.g., uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes). * Prior therapy with a MEK or BRAF inhibitor. * History of Gilbert's syndrome. * Impaired cardiovascular function or clinically significant cardiovascular diseases. * Uncontrolled or symptomatic brain metastases that are not stable or require steroids, are potentially life-threatening or have required radiation within 28 days prior to first dose of study treatment. * Concomitant malignancies or previous malignancies with less than a 5-year disease-free interval at the time of first dose of study treatment; patients with adequately resected basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or ductal carcinoma in situ may be enrolled irrespective of the time of diagnosis. * Known positive serology for the human immunodeficiency virus (HIV), active hepatitis B and/or active hepatitis C. * Prior randomization into this clinical study. * Additional criteria exist.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) | From randomization until documented progressive disease (PD) or death, whichever occurred first, for censored participants at the date of last adequate tumor assessment (up to 24 months) | PFS was defined as the time from randomization to the earliest documented disease progression date or death due to any cause whichever occurred first. Disease progression was defined as at least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including Baseline) and an absolute increase of greater than or equal to (\>=) 5 millimeter (mm). Appearance of new lesions \>=10 mm in diameter also constituted PD. If a participant did not have an event at the time of the analysis cutoff or at the start of any new therapy, PFS was censored at the date of last adequate tumor assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate Per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (RECIST V1.1) | From randomization until disease progression or death (up to 24 months) | ORR was defined as the percentage of participants achieving an overall best response of complete response (CR) or partial response (PR) (responders). CR was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures less than (\<) 10 mm, PR was defined as at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference the Baseline sum of diameters. Non-target lesions must be non-progressive disease. |
| Duration of Response (DOR) | From the first radiographic evidence of response to the first documentation of PD or death, for censored participants at their last radiological assessment (up to 24 months) | DOR was defined as the time from first radiographic evidence of response to the earliest documented progression date or death due to any cause, and was calculated on responders only. Responders with no PD or death date or subsequent anticancer therapy by the data cutoff date, were censored for DOR at their last radiological assessment. Responders who received subsequent anticancer therapy prior to PD or death were censored at their last radiological assessment prior to initiation of subsequent anticancer therapy. |
| Disease Control Rate (DCR) | Week 24 | Disease control rate was defined as percentage of participants with disease control. Disease control was defined as a best response of CR or PR, or stable disease (SD) documented at Week 24 or later. CR was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures \<10 mm, and PR is defined as at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference the Baseline sum of diameters. Non-target lesions must be non-progressive disease. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum of diameters on study. |
| Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | From the first dose of study intervention until 30 days after the last dose (up to 9 years) | An AE was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. |
| Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | From the first dose of study intervention until 30 days after the last dose (up to 9 years) | Number of participants with shifts from normal Baseline values (Grade 0) to abnormal post-baseline values on-study (shift to greater than or equal to Grade 3) were reported as per NCI-CTCAE, v4.03 graded from Grade 1 to 5. Grade 1: Mild; asymptomatic/ mild symptoms; clinical/diagnostic observations only; intervention not indicated. Grade 2: Moderate; minimal, local/noninvasive intervention indicated. Grade 3: Severe/medically significant but not immediately life-threatening; hospitalization/prolongation of hospitalization indicated. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death. Shifts in lab parameter from Grade 0 to 3, Grade 0 to 4 and Grade 0 to Low 3 and 4 and Grade 0 to High 3 and 4 (for parameters total hemoglobin, lymphocytes, white blood cells, calcium, magnesium, potassium, and sodium) were reported. |
| Overall Survival (OS) | From randomization date to the date of death, for censored participants at their last contact date (up to 24 months) | OS was defined as the time from randomization to death due to any cause. Participants who were alive at the data cutoff date were censored for overall survival at their last contact date. |
| Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Screening, every 8 weeks from randomization for the first 72 weeks (while on treatment), treatment discontinuation visit, 30-day safety follow-up visit | EORTC QLQ-OV28 contains 28 items which assess a comprehensive range of relevant issues: abdominal/gastrointestinal (GI) symptoms, peripheral neuropathy, other chemotherapy side-effects, hormonal/menopausal symptoms, body image, attitude to disease/treatment and sexual functioning. The score for each domain and component score were scaled from 0 (minimum) to 100 (maximum). Higher scores indicate lower quality of life except for sexual functioning where higher scores indicate better quality of life. |
| Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Screening, every 8 weeks from randomization for the first 72 weeks (while on treatment), treatment discontinuation visit, 30-day safety follow-up visit | FACT/GOG-NTX questionnaire consists of questions for dimensions related to physical, social, emotional, and functional well-being which contains 11 items, with responses scored on a Likert scale from 0 (not at all) to 4 (very much) designed to capture the symptoms of chemotherapy-induced peripheral neuropathy (CIPN). The summed scores of each item were reverted into standardized scores ranging from 0 to 44, with a higher score indicating a lower level of neurological toxicity and less effect on quality of life (ie, higher scores indicate better quality of life). The trial outcome index consists of two subscales from the FACT-G: Physical Well Being (7 items) and Functional Well Being (7 items), plus the Cervix Cancer-specific subscale (15 items). Each item in the trial outcome index scored using a 5-point scale (0=not at all to 4=very much). The summed scores of each item were reverted into standardized scores ranging from 0 to 116. Higher scores indicate better quality of life. |
| Predose Plasma Concentration (Ctrough) of MEK162 | Predose on Study Days 1, 57, and 113. | Ctrough of MEK162 is defined as the predose plasma concentration of MEK162. Ctrough of MEK162 was observed directly from data. |
| Maximum Observed Plasma Concentration (Cmax) of MEK162 | 2 hours ± 10 minutes postdose on Study Days 1, 57, and 113. | Cmax is maximum observed plasma concentration. Cmax of MEK162 was observed directly from data. |
| Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Screening, every 8 weeks from randomization for the first 72 weeks (while on treatment), treatment discontinuation visit, 30-day safety follow-up visit | EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a global health status/quality of life (QOL) scale, and 6 single-item scales. The global health status/QOL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for global health status/QOL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. In this study, global health status/QOL scale score was identified as the primary patient-reported outcome variable of interest. Physical functioning, emotional functioning, and social functioning scale scores were considered as secondary. Higher scores indicate better quality of life. |
Countries
Australia, Austria, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Netherlands, Norway, Poland, Spain, Sweden, United Kingdom, United States
Participant flow
Pre-assignment details
As of the data cutoff date of 20 Jan 2016 for primary completion date (PCD), a total of 303 participants were enrolled, with 201 (200 treated) in MEK162 group and 102 (94 treated) in physician's choice group. After PCD, additional 27 participants were enrolled in MEK162 group and 11 in physician's choice group. Data reported was based on the last participant last visit date (23 Aug 2022). Note: one participant was enrolled before PCD and received the first dose after PCD.
Participants by arm
| Arm | Count |
|---|---|
| MEK162 Participants received an oral dose of 45 milligram (mg) of MEK162 tablets (3 tablets of 15 mg) twice daily for each 28-day treatment cycle until disease progression, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death, whichever occurred first. Participants were followed up to 30 days after last dose of study intervention. | 227 |
| Physician's Choice Participants received chemotherapies as per treating physician's choice in accordance to the institutional standard of care. Participants received one of the three intravenous (IV) infusion therapies: Liposomal doxorubicin 40 milligram per meter square (mg/m\^2) on Day 1 of each 28-day cycle or Paclitaxel 80 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle or, Topotecan 1.25 mg/m\^2 on Days 1 through 5 of each 21-day cycle. Participants were followed up to 30 days after last dose of study intervention. | 106 |
| Total | 333 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Completed as per protocol amendment 6 | 3 | 0 |
| Overall Study | Death | 89 | 42 |
| Overall Study | Lost to Follow-up | 3 | 2 |
| Overall Study | Other | 16 | 4 |
| Overall Study | Physician Decision | 7 | 1 |
| Overall Study | Study Termination By Sponsor | 93 | 48 |
| Overall Study | Withdrawal by Subject | 17 | 16 |
Baseline characteristics
| Characteristic | MEK162 | Physician's Choice | Total |
|---|---|---|---|
| Age, Continuous | 52.26 Years STANDARD_DEVIATION 14.64 | 50.12 Years STANDARD_DEVIATION 13.35 | 51.58 Years STANDARD_DEVIATION 14.26 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 18 Participants | 9 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 200 Participants | 95 Participants | 295 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 9 Participants | 2 Participants | 11 Participants |
| Sex: Female, Male Female | 227 Participants | 106 Participants | 333 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 89 / 227 | 42 / 106 |
| other Total, other adverse events | 226 / 227 | 105 / 106 |
| serious Total, serious adverse events | 126 / 227 | 31 / 106 |
Outcome results
Primary
Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)
PFS was defined as the time from randomization to the earliest documented disease progression date or death due to any cause whichever occurred first. Disease progression was defined as at least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including Baseline) and an absolute increase of greater than or equal to (\>=) 5 millimeter (mm). Appearance of new lesions \>=10 mm in diameter also constituted PD. If a participant did not have an event at the time of the analysis cutoff or at the start of any new therapy, PFS was censored at the date of last adequate tumor assessment.
Time frame: From randomization until documented progressive disease (PD) or death, whichever occurred first, for censored participants at the date of last adequate tumor assessment (up to 24 months)
Population: Analysis population included all randomized participants as of PCD (201 participants in MEK162 group and 102 participants in physician's choice group). In the futility analysis based on PCD, the futility boundary was crossed, and therefore, no additional efficacy data was collected due to study early termination and no additional efficacy analyses were conducted.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MEK162 | Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) | 9.10 months |
| Physician's Choice | Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) | 10.58 months |
Secondary
Disease Control Rate (DCR)
Disease control rate was defined as percentage of participants with disease control. Disease control was defined as a best response of CR or PR, or stable disease (SD) documented at Week 24 or later. CR was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures \<10 mm, and PR is defined as at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference the Baseline sum of diameters. Non-target lesions must be non-progressive disease. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum of diameters on study.
Time frame: Week 24
Population: Due to the lack of follow-up data as of PCD, data for this outcome measure was not collected. In the futility analysis based on PCD, the futility boundary was crossed, and therefore, no additional efficacy data was collected due to study early termination and no additional efficacy analyses were conducted.
Secondary
Duration of Response (DOR)
DOR was defined as the time from first radiographic evidence of response to the earliest documented progression date or death due to any cause, and was calculated on responders only. Responders with no PD or death date or subsequent anticancer therapy by the data cutoff date, were censored for DOR at their last radiological assessment. Responders who received subsequent anticancer therapy prior to PD or death were censored at their last radiological assessment prior to initiation of subsequent anticancer therapy.
Time frame: From the first radiographic evidence of response to the first documentation of PD or death, for censored participants at their last radiological assessment (up to 24 months)
Population: Analysis population included all randomized participants with measurable disease at baseline per BICR with response ongoing as of PCD (23 in MEK162 group and 8 in physician's choice group). Here, Number of Participants Analyzed signifies number of participants evaluable for DOR. In the futility analysis based on PCD, the futility boundary was crossed, and therefore, no additional efficacy data was collected due to study early termination and no additional efficacy analyses were conducted.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MEK162 | Duration of Response (DOR) | 8.05 months |
| Physician's Choice | Duration of Response (DOR) | 6.67 months |
Secondary
Maximum Observed Plasma Concentration (Cmax) of MEK162
Cmax is maximum observed plasma concentration. Cmax of MEK162 was observed directly from data.
Time frame: 2 hours ± 10 minutes postdose on Study Days 1, 57, and 113.
Population: The PK set consisted of all participants who received at least 1 dose of MEK162 and had at least 1 PK blood collection with associated bioanalytical results.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| MEK162 | Maximum Observed Plasma Concentration (Cmax) of MEK162 | Week 9 (Study Day 57) | 343 ng/mL | Geometric Coefficient of Variation 0.959 |
| MEK162 | Maximum Observed Plasma Concentration (Cmax) of MEK162 | Week 1 (Study Day 1) | 339 ng/mL | Geometric Coefficient of Variation 0.544 |
| MEK162 | Maximum Observed Plasma Concentration (Cmax) of MEK162 | Week 17 (Study Day 113) | 304 ng/mL | Geometric Coefficient of Variation 0.649 |
Secondary
Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03
Number of participants with shifts from normal Baseline values (Grade 0) to abnormal post-baseline values on-study (shift to greater than or equal to Grade 3) were reported as per NCI-CTCAE, v4.03 graded from Grade 1 to 5. Grade 1: Mild; asymptomatic/ mild symptoms; clinical/diagnostic observations only; intervention not indicated. Grade 2: Moderate; minimal, local/noninvasive intervention indicated. Grade 3: Severe/medically significant but not immediately life-threatening; hospitalization/prolongation of hospitalization indicated. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death. Shifts in lab parameter from Grade 0 to 3, Grade 0 to 4 and Grade 0 to Low 3 and 4 and Grade 0 to High 3 and 4 (for parameters total hemoglobin, lymphocytes, white blood cells, calcium, magnesium, potassium, and sodium) were reported.
Time frame: From the first dose of study intervention until 30 days after the last dose (up to 9 years)
Population: The safety set included all participants who received at least 1 dose of study intervention and had at least 1 post-treatment assessment, including death. No data was collected for the crossover set due to the early stopping of the crossover period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MEK162 | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Lymphocytes: Grade 0 to Low 3 | 8 Participants |
| MEK162 | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | International Normalized Ratio: Grade 0 to 4 | 0 Participants |
| MEK162 | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Neutrophils: Grade 0 to 3 | 3 Participants |
| MEK162 | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Neutrophils: Grade 0 to 4 | 0 Participants |
| MEK162 | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Platelet Count: Grade 0 to 3 | 0 Participants |
| MEK162 | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Platelet Count: Grade 0 to 4 | 1 Participants |
| MEK162 | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Partial Thromboplastin Time: Grade 0 to 3 | 4 Participants |
| MEK162 | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Partial Thromboplastin Time: Grade 0 to 4 | 0 Participants |
| MEK162 | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Total Hemoglobin: Grade 0 to Low 3 | 10 Participants |
| MEK162 | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Total Hemoglobin: Grade 0 to Low 4 | 0 Participants |
| MEK162 | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Total Hemoglobin: Grade 0 to High 3 | 0 Participants |
| MEK162 | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Total Hemoglobin: Grade 0 to High 4 | 0 Participants |
| MEK162 | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | International Normalized Ratio: Grade 0 to 3 | 0 Participants |
| MEK162 | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Lymphocytes: Grade 0 to Low 4 | 1 Participants |
| MEK162 | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Lymphocytes: Grade 0 to High 3 | 0 Participants |
| MEK162 | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Lymphocytes: Grade 0 to High 4 | 0 Participants |
| MEK162 | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | White Blood Cells: Grade 0 to Low 3 | 0 Participants |
| MEK162 | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | White Blood Cells: Grade 0 to Low 4 | 0 Participants |
| MEK162 | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | White Blood Cells: Grade 0 to High 3 | 0 Participants |
| MEK162 | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | White Blood Cells: Grade 0 to High 4 | 0 Participants |
| MEK162 | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Albumin: Grade 0 to 3 | 1 Participants |
| MEK162 | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Albumin: Grade 0 to 4 | 0 Participants |
| MEK162 | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Alkaline Phosphatase: Grade 0 to 3 | 4 Participants |
| MEK162 | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Alkaline Phosphatase: Grade 0 to 4 | 0 Participants |
| MEK162 | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Alanine Aminotransferase/Serum Glutamic-Pyruvic Transaminase: Grade 0 to 3 | 7 Participants |
| MEK162 | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Alanine Aminotransferase/Serum Glutamic-Pyruvic Transaminase: Grade 0 to 4 | 0 Participants |
| MEK162 | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Aspartate Aminotransferase/Serum Glutamic-Oxaloacetic Transaminase: Grade 0 to 3 | 7 Participants |
| MEK162 | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Aspartate Aminotransferase/Serum Glutamic-Oxaloacetic Transaminase: Grade 0 to 4 | 0 Participants |
| MEK162 | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Creatine Kinase: Grade 0 to 3 | 52 Participants |
| MEK162 | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Creatine Kinase: Grade 0 to 4 | 12 Participants |
| MEK162 | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Serum Creatinine: Grade 0 to 3 | 1 Participants |
| MEK162 | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Serum Creatinine: Grade 0 to 4 | 0 Participants |
| MEK162 | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Total Bilirubin: Grade 0 to 3 | 1 Participants |
| MEK162 | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Total Bilirubin: Grade 0 to 4 | 0 Participants |
| MEK162 | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Calcium: Grade 0 to Low 3 | 0 Participants |
| MEK162 | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Calcium: Grade 0 to Low 4 | 1 Participants |
| MEK162 | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Calcium: Grade 0 to High 3 | 1 Participants |
| MEK162 | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Calcium: Grade 0 to High 4 | 0 Participants |
| MEK162 | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Magnesium: Grade 0 to Low 3 | 2 Participants |
| MEK162 | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Magnesium: Grade 0 to Low 4 | 0 Participants |
| MEK162 | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Magnesium: Grade 0 to High 3 | 1 Participants |
| MEK162 | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Magnesium: Grade 0 to High 4 | 0 Participants |
| MEK162 | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Potassium: Grade 0 to Low 3 | 10 Participants |
| MEK162 | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Potassium: Grade 0 to Low 4 | 0 Participants |
| MEK162 | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Potassium: Grade 0 to High 3 | 3 Participants |
| MEK162 | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Potassium: Grade 0 to High 4 | 0 Participants |
| MEK162 | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Sodium: Grade 0 to Low 3 | 5 Participants |
| MEK162 | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Sodium: Grade 0 to Low 4 | 1 Participants |
| MEK162 | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Sodium: Grade 0 to High 3 | 3 Participants |
| MEK162 | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Sodium: Grade 0 to High 4 | 1 Participants |
| Physician's Choice | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Calcium: Grade 0 to High 4 | 0 Participants |
| Physician's Choice | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | International Normalized Ratio: Grade 0 to 3 | 0 Participants |
| Physician's Choice | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Alanine Aminotransferase/Serum Glutamic-Pyruvic Transaminase: Grade 0 to 4 | 0 Participants |
| Physician's Choice | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | International Normalized Ratio: Grade 0 to 4 | 0 Participants |
| Physician's Choice | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Sodium: Grade 0 to High 3 | 0 Participants |
| Physician's Choice | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Neutrophils: Grade 0 to 3 | 7 Participants |
| Physician's Choice | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Aspartate Aminotransferase/Serum Glutamic-Oxaloacetic Transaminase: Grade 0 to 3 | 1 Participants |
| Physician's Choice | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Neutrophils: Grade 0 to 4 | 1 Participants |
| Physician's Choice | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Magnesium: Grade 0 to Low 3 | 1 Participants |
| Physician's Choice | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Platelet Count: Grade 0 to 3 | 0 Participants |
| Physician's Choice | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Aspartate Aminotransferase/Serum Glutamic-Oxaloacetic Transaminase: Grade 0 to 4 | 0 Participants |
| Physician's Choice | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Platelet Count: Grade 0 to 4 | 0 Participants |
| Physician's Choice | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Potassium: Grade 0 to High 3 | 2 Participants |
| Physician's Choice | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Partial Thromboplastin Time: Grade 0 to 3 | 2 Participants |
| Physician's Choice | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Creatine Kinase: Grade 0 to 3 | 0 Participants |
| Physician's Choice | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Partial Thromboplastin Time: Grade 0 to 4 | 0 Participants |
| Physician's Choice | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Magnesium: Grade 0 to Low 4 | 0 Participants |
| Physician's Choice | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Total Hemoglobin: Grade 0 to Low 3 | 2 Participants |
| Physician's Choice | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Creatine Kinase: Grade 0 to 4 | 0 Participants |
| Physician's Choice | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Total Hemoglobin: Grade 0 to Low 4 | 0 Participants |
| Physician's Choice | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Sodium: Grade 0 to Low 4 | 0 Participants |
| Physician's Choice | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Total Hemoglobin: Grade 0 to High 3 | 0 Participants |
| Physician's Choice | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Serum Creatinine: Grade 0 to 3 | 0 Participants |
| Physician's Choice | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Total Hemoglobin: Grade 0 to High 4 | 0 Participants |
| Physician's Choice | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Magnesium: Grade 0 to High 3 | 0 Participants |
| Physician's Choice | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Lymphocytes: Grade 0 to Low 3 | 3 Participants |
| Physician's Choice | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Serum Creatinine: Grade 0 to 4 | 0 Participants |
| Physician's Choice | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Lymphocytes: Grade 0 to Low 4 | 0 Participants |
| Physician's Choice | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Potassium: Grade 0 to High 4 | 0 Participants |
| Physician's Choice | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Lymphocytes: Grade 0 to High 3 | 0 Participants |
| Physician's Choice | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Total Bilirubin: Grade 0 to 3 | 0 Participants |
| Physician's Choice | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Lymphocytes: Grade 0 to High 4 | 0 Participants |
| Physician's Choice | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Magnesium: Grade 0 to High 4 | 0 Participants |
| Physician's Choice | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | White Blood Cells: Grade 0 to Low 3 | 1 Participants |
| Physician's Choice | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Total Bilirubin: Grade 0 to 4 | 0 Participants |
| Physician's Choice | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | White Blood Cells: Grade 0 to Low 4 | 1 Participants |
| Physician's Choice | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Sodium: Grade 0 to High 4 | 0 Participants |
| Physician's Choice | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | White Blood Cells: Grade 0 to High 3 | 0 Participants |
| Physician's Choice | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Calcium: Grade 0 to Low 3 | 1 Participants |
| Physician's Choice | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | White Blood Cells: Grade 0 to High 4 | 0 Participants |
| Physician's Choice | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Potassium: Grade 0 to Low 3 | 4 Participants |
| Physician's Choice | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Albumin: Grade 0 to 3 | 1 Participants |
| Physician's Choice | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Calcium: Grade 0 to Low 4 | 1 Participants |
| Physician's Choice | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Albumin: Grade 0 to 4 | 0 Participants |
| Physician's Choice | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Sodium: Grade 0 to Low 3 | 2 Participants |
| Physician's Choice | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Alkaline Phosphatase: Grade 0 to 3 | 1 Participants |
| Physician's Choice | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Calcium: Grade 0 to High 3 | 0 Participants |
| Physician's Choice | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Alkaline Phosphatase: Grade 0 to 4 | 0 Participants |
| Physician's Choice | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Potassium: Grade 0 to Low 4 | 0 Participants |
| Physician's Choice | Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Alanine Aminotransferase/Serum Glutamic-Pyruvic Transaminase: Grade 0 to 3 | 1 Participants |
Secondary
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: From the first dose of study intervention until 30 days after the last dose (up to 9 years)
Population: The safety set included all participants who received at least 1 dose of study intervention and had at least 1 post-treatment assessment, including death. No data was collected for the crossover set due to the early stopping of the crossover period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MEK162 | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 227 Participants |
| MEK162 | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 126 Participants |
| Physician's Choice | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 105 Participants |
| Physician's Choice | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 31 Participants |
Secondary
Objective Response Rate Per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (RECIST V1.1)
ORR was defined as the percentage of participants achieving an overall best response of complete response (CR) or partial response (PR) (responders). CR was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures less than (\<) 10 mm, PR was defined as at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference the Baseline sum of diameters. Non-target lesions must be non-progressive disease.
Time frame: From randomization until disease progression or death (up to 24 months)
Population: Analysis population included all randomized participants with measurable disease at baseline per BICR as of PCD (198 participants in MEK162 group and 101 participants in physician's choice group). In the futility analysis based on PCD, the futility boundary was crossed, and therefore, no additional efficacy data was collected due to study early termination and no additional efficacy analyses were conducted.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MEK162 | Objective Response Rate Per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (RECIST V1.1) | 16 percentage of participants |
| Physician's Choice | Objective Response Rate Per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (RECIST V1.1) | 13 percentage of participants |
Secondary
Overall Survival (OS)
OS was defined as the time from randomization to death due to any cause. Participants who were alive at the data cutoff date were censored for overall survival at their last contact date.
Time frame: From randomization date to the date of death, for censored participants at their last contact date (up to 24 months)
Population: Analysis population included all randomized participants as of PCD (201 participants in MEK162 group and 102 participants in physician's choice group). In the futility analysis based on PCD, the futility boundary was crossed, and therefore, no additional efficacy data was collected due to study early termination and no additional efficacy analyses were conducted.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MEK162 | Overall Survival (OS) | 25.33 months |
| Physician's Choice | Overall Survival (OS) | 20.83 months |
Secondary
Predose Plasma Concentration (Ctrough) of MEK162
Ctrough of MEK162 is defined as the predose plasma concentration of MEK162. Ctrough of MEK162 was observed directly from data.
Time frame: Predose on Study Days 1, 57, and 113.
Population: The pharmacokinetics (PK) set consisted of all participants who received at least 1 dose of MEK162 and had at least 1 PK blood collection with associated bioanalytical results.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| MEK162 | Predose Plasma Concentration (Ctrough) of MEK162 | Week 1 (Study Day 1) | 42.2 nanograms per milliliter (ng/mL) | — |
| MEK162 | Predose Plasma Concentration (Ctrough) of MEK162 | Week 9 (Study Day 57) | 69.3 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 1.54 |
| MEK162 | Predose Plasma Concentration (Ctrough) of MEK162 | Week 17 (Study Day 113) | 56.5 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 1.68 |
Secondary
Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30)
EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a global health status/quality of life (QOL) scale, and 6 single-item scales. The global health status/QOL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for global health status/QOL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. In this study, global health status/QOL scale score was identified as the primary patient-reported outcome variable of interest. Physical functioning, emotional functioning, and social functioning scale scores were considered as secondary. Higher scores indicate better quality of life.
Time frame: Screening, every 8 weeks from randomization for the first 72 weeks (while on treatment), treatment discontinuation visit, 30-day safety follow-up visit
Population: Analysis population included all randomized participants (228 participants in MEK162 group, 113 participants in physician's choice group).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Social functioning Score at Week 17 | 75.6 Scores on a scale | Standard Deviation 21.8 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Emotional functioning Score at Week 25 | 76.7 Scores on a scale | Standard Deviation 20 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Emotional functioning Score at Week 33 | 75.1 Scores on a scale | Standard Deviation 21.6 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Emotional functioning Score at Week 41 | 74.7 Scores on a scale | Standard Deviation 22 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Emotional functioning Score at Week 49 | 77.6 Scores on a scale | Standard Deviation 18.6 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Emotional functioning Score at Week 57 | 77.7 Scores on a scale | Standard Deviation 18.7 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Emotional functioning Score at Week 65 | 77.1 Scores on a scale | Standard Deviation 17.6 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Emotional functioning Score at Week 73 | 73.4 Scores on a scale | Standard Deviation 22.5 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Emotional functioning Score at Treatment Discontinuation Visit | 63.6 Scores on a scale | Standard Deviation 28.2 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Emotional functioning Score at 30-Day Safety Follow-up | 70.5 Scores on a scale | Standard Deviation 24.7 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Social functioning Score at Screening | 79.9 Scores on a scale | Standard Deviation 23.9 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Social functioning Score at Week 9 | 69.5 Scores on a scale | Standard Deviation 26 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Emotional functioning Score at Week 17 | 73.9 Scores on a scale | Standard Deviation 20.2 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Social functioning Score at Week 25 | 78.7 Scores on a scale | Standard Deviation 21.3 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Social functioning Score at Week 33 | 76.0 Scores on a scale | Standard Deviation 23.8 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Social functioning Score at Week 41 | 73.4 Scores on a scale | Standard Deviation 25 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Social functioning Score at Week 49 | 78.5 Scores on a scale | Standard Deviation 20.6 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Social functioning Score at Week 57 | 74.0 Scores on a scale | Standard Deviation 24.2 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Social functioning Score at Week 65 | 78.3 Scores on a scale | Standard Deviation 23.9 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Social functioning Score at Week 73 | 75.5 Scores on a scale | Standard Deviation 25.4 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Social functioning Score at Treatment Discontinuation Visit | 63.5 Scores on a scale | Standard Deviation 32.7 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Social functioning Score at 30-Day Safety Follow-up | 71.1 Scores on a scale | Standard Deviation 27.9 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Global health status/QOL Score at Screening | 67.2 Scores on a scale | Standard Deviation 19.9 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Global health status/QOL Score at Week 9 | 57.4 Scores on a scale | Standard Deviation 19.4 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Global health status/QOL Score at Week 17 | 58.4 Scores on a scale | Standard Deviation 19.9 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Global health status/QOL Score at Week 25 | 60.5 Scores on a scale | Standard Deviation 18.7 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Global health status/QOL Score at Week 33 | 60.4 Scores on a scale | Standard Deviation 20 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Global health status/QOL Score at Week 41 | 60.4 Scores on a scale | Standard Deviation 18.6 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Global health status/QOL Score at Week 49 | 60.9 Scores on a scale | Standard Deviation 19.4 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Global health status/QOL Score at Week 57 | 62.4 Scores on a scale | Standard Deviation 18.3 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Global health status/QOL Score at Week 65 | 60.8 Scores on a scale | Standard Deviation 18.9 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Global health status/QOL Score at Week 73 | 62.0 Scores on a scale | Standard Deviation 19.7 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Global health status/QOL Score at Treatment Discontinuation Visit | 47.0 Scores on a scale | Standard Deviation 21.4 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Global health status/QOL Score at 30-Day Safety Follow-up | 59.8 Scores on a scale | Standard Deviation 19.1 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Physical functioning Score at Screening | 80.2 Scores on a scale | Standard Deviation 19.2 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Physical functioning Score at Week 9 | 74.8 Scores on a scale | Standard Deviation 20.3 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Physical functioning Score at Week 17 | 75.3 Scores on a scale | Standard Deviation 19.5 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Physical functioning Score at Week 25 | 75.5 Scores on a scale | Standard Deviation 20.8 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Physical functioning Score at Week 33 | 76.6 Scores on a scale | Standard Deviation 19.6 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Physical functioning Score at Week 41 | 75.1 Scores on a scale | Standard Deviation 19.9 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Physical functioning Score at Week 49 | 77.5 Scores on a scale | Standard Deviation 18 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Physical functioning Score at Week 57 | 74.8 Scores on a scale | Standard Deviation 19.4 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Physical functioning Score at Week 65 | 77.2 Scores on a scale | Standard Deviation 19.7 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Physical functioning Score at Week 73 | 77.2 Scores on a scale | Standard Deviation 21.1 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Physical functioning Score at Treatment Discontinuation Visit | 66.6 Scores on a scale | Standard Deviation 23.8 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Physical functioning Score at 30-Day Safety Follow-up | 71.7 Scores on a scale | Standard Deviation 21.5 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Emotional functioning Score at Screening | 75.8 Scores on a scale | Standard Deviation 21.2 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Emotional functioning Score at Week 9 | 73.1 Scores on a scale | Standard Deviation 21.6 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Emotional functioning Score at Screening | 71.7 Scores on a scale | Standard Deviation 24 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Emotional functioning Score at Week 17 | 77.7 Scores on a scale | Standard Deviation 19.1 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Global health status/QOL Score at Week 17 | 65.4 Scores on a scale | Standard Deviation 17.5 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Emotional functioning Score at Week 25 | 78.7 Scores on a scale | Standard Deviation 20.9 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Physical functioning Score at Week 17 | 79.4 Scores on a scale | Standard Deviation 20.9 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Emotional functioning Score at Week 33 | 81.6 Scores on a scale | Standard Deviation 20.4 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Global health status/QOL Score at Week 25 | 65.4 Scores on a scale | Standard Deviation 19.6 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Emotional functioning Score at Week 41 | 79.0 Scores on a scale | Standard Deviation 24.9 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Physical functioning Score at Week 65 | 81.8 Scores on a scale | Standard Deviation 20.2 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Emotional functioning Score at Week 49 | 79.2 Scores on a scale | Standard Deviation 24 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Global health status/QOL Score at Week 33 | 63.7 Scores on a scale | Standard Deviation 18.9 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Emotional functioning Score at Week 57 | 81.8 Scores on a scale | Standard Deviation 26.6 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Physical functioning Score at Week 25 | 80.2 Scores on a scale | Standard Deviation 19.9 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Emotional functioning Score at Week 65 | 80.3 Scores on a scale | Standard Deviation 28.7 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Global health status/QOL Score at Week 41 | 73.0 Scores on a scale | Standard Deviation 18.5 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Emotional functioning Score at Week 73 | 69.8 Scores on a scale | Standard Deviation 31.5 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Physical functioning Score at 30-Day Safety Follow-up | 78.6 Scores on a scale | Standard Deviation 23.4 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Emotional functioning Score at Treatment Discontinuation Visit | 70.3 Scores on a scale | Standard Deviation 23.2 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Global health status/QOL Score at Week 49 | 69.9 Scores on a scale | Standard Deviation 17.9 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Emotional functioning Score at 30-Day Safety Follow-up | 82.0 Scores on a scale | Standard Deviation 17.4 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Physical functioning Score at Week 33 | 81.5 Scores on a scale | Standard Deviation 23.3 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Social functioning Score at Screening | 79.0 Scores on a scale | Standard Deviation 24.8 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Global health status/QOL Score at Week 57 | 76.6 Scores on a scale | Standard Deviation 20.9 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Social functioning Score at Week 9 | 76.2 Scores on a scale | Standard Deviation 28 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Physical functioning Score at Week 73 | 78.3 Scores on a scale | Standard Deviation 25.6 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Social functioning Score at Week 17 | 77.7 Scores on a scale | Standard Deviation 23.9 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Global health status/QOL Score at Week 65 | 65.9 Scores on a scale | Standard Deviation 22.8 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Social functioning Score at Week 25 | 76.6 Scores on a scale | Standard Deviation 23.2 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Physical functioning Score at Week 41 | 83.7 Scores on a scale | Standard Deviation 21.9 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Social functioning Score at Week 33 | 79.0 Scores on a scale | Standard Deviation 26.5 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Global health status/QOL Score at Week 73 | 67.7 Scores on a scale | Standard Deviation 21.6 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Social functioning Score at Week 41 | 83.3 Scores on a scale | Standard Deviation 25.5 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Emotional functioning Score at Week 9 | 75.8 Scores on a scale | Standard Deviation 22.9 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Social functioning Score at Week 49 | 81.5 Scores on a scale | Standard Deviation 16.1 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Global health status/QOL Score at Treatment Discontinuation Visit | 60.9 Scores on a scale | Standard Deviation 25.6 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Social functioning Score at Week 57 | 77.1 Scores on a scale | Standard Deviation 27.1 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Physical functioning Score at Week 49 | 83.7 Scores on a scale | Standard Deviation 20.5 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Social functioning Score at Week 65 | 72.7 Scores on a scale | Standard Deviation 31.9 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Global health status/QOL Score at 30-Day Safety Follow-up | 69.3 Scores on a scale | Standard Deviation 18 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Social functioning Score at Week 73 | 75.0 Scores on a scale | Standard Deviation 28.2 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Physical functioning Score at Treatment Discontinuation Visit | 71.0 Scores on a scale | Standard Deviation 25 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Social functioning Score at Treatment Discontinuation Visit | 66.7 Scores on a scale | Standard Deviation 31.2 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Physical functioning Score at Screening | 82.6 Scores on a scale | Standard Deviation 18.7 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Social functioning Score at 30-Day Safety Follow-up | 78.1 Scores on a scale | Standard Deviation 27.2 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Physical functioning Score at Week 57 | 83.3 Scores on a scale | Standard Deviation 20.7 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Global health status/QOL Score at Screening | 66.4 Scores on a scale | Standard Deviation 24.5 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Physical functioning Score at Week 9 | 81.4 Scores on a scale | Standard Deviation 18.4 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | Global health status/QOL Score at Week 9 | 66.4 Scores on a scale | Standard Deviation 20.4 |
Secondary
Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28)
EORTC QLQ-OV28 contains 28 items which assess a comprehensive range of relevant issues: abdominal/gastrointestinal (GI) symptoms, peripheral neuropathy, other chemotherapy side-effects, hormonal/menopausal symptoms, body image, attitude to disease/treatment and sexual functioning. The score for each domain and component score were scaled from 0 (minimum) to 100 (maximum). Higher scores indicate lower quality of life except for sexual functioning where higher scores indicate better quality of life.
Time frame: Screening, every 8 weeks from randomization for the first 72 weeks (while on treatment), treatment discontinuation visit, 30-day safety follow-up visit
Population: Analysis population included all randomized participants (228 participants in MEK162 group, 113 participants in physician's choice group).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Abdominal/GI Score at Week 41 | 26.9 Scores on a scale | Standard Deviation 20.3 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Attitude to disease/treatment Score at Screening | 48.0 Scores on a scale | Standard Deviation 28.6 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Hormonal Score at Screening | 22.0 Scores on a scale | Standard Deviation 25.5 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Attitude to disease/treatment Score at Week 9 | 49.5 Scores on a scale | Standard Deviation 25.5 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Peripheral neuropathy Score at Screening | 16.6 Scores on a scale | Standard Deviation 26.1 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Attitude to disease/treatment Score at Week 17 | 46.1 Scores on a scale | Standard Deviation 24.2 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Hormonal Score at Week 9 | 10.2 Scores on a scale | Standard Deviation 15.5 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Attitude to disease/treatment Score at Week 25 | 39.0 Scores on a scale | Standard Deviation 22.2 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Abdominal/GI Score at Week 17 | 26.7 Scores on a scale | Standard Deviation 19.6 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Attitude to disease/treatment Score at Week 33 | 41.8 Scores on a scale | Standard Deviation 22.9 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Hormonal Score at Week 17 | 9.3 Scores on a scale | Standard Deviation 16.8 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Attitude to disease/treatment Score at Week 41 | 44.3 Scores on a scale | Standard Deviation 23.1 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Peripheral neuropathy Score at Week 9 | 26.7 Scores on a scale | Standard Deviation 29.9 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Attitude to disease/treatment Score at Week 49 | 37.2 Scores on a scale | Standard Deviation 19.7 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Hormonal Score at Week 25 | 6.2 Scores on a scale | Standard Deviation 11.5 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Attitude to disease/treatment Score at Week 57 | 38.8 Scores on a scale | Standard Deviation 20 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Abdominal/GI Score at Week 49 | 23.5 Scores on a scale | Standard Deviation 20.5 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Attitude to disease/treatment Score at Week 65 | 37.4 Scores on a scale | Standard Deviation 21.6 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Hormonal Score at Week 33 | 11.6 Scores on a scale | Standard Deviation 20 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Attitude to disease/treatment Score at Week 73 | 37.7 Scores on a scale | Standard Deviation 25.3 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Peripheral neuropathy Score at Week 17 | 27.1 Scores on a scale | Standard Deviation 28.8 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Attitude to disease/treatment Score at Treatment Discontinuation Visit | 55.8 Scores on a scale | Standard Deviation 27.5 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Hormonal Score at Week 41 | 13.4 Scores on a scale | Standard Deviation 22.9 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Attitude to disease/treatment Score at 30-Day Safety Follow-up | 49.3 Scores on a scale | Standard Deviation 27 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Sexuality Score at 30-Day Safety Follow-up | 15.6 Scores on a scale | Standard Deviation 19.8 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Chemotherapy Side Effects Score at Screening | 17.7 Scores on a scale | Standard Deviation 16 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Hormonal Score at Week 49 | 13.8 Scores on a scale | Standard Deviation 22.3 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Chemotherapy Side Effects Score at Week 9 | 28.6 Scores on a scale | Standard Deviation 16.4 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Peripheral neuropathy Score at Week 25 | 30.2 Scores on a scale | Standard Deviation 31 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Chemotherapy Side Effects Score at Week 17 | 27.1 Scores on a scale | Standard Deviation 15.3 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Hormonal Score at Week 57 | 11.2 Scores on a scale | Standard Deviation 16.6 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Chemotherapy Side Effects Score at Week 25 | 27.7 Scores on a scale | Standard Deviation 17.5 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Abdominal/GI Score at Week 57 | 26.1 Scores on a scale | Standard Deviation 20.4 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Chemotherapy Side Effects Score at Week 33 | 28.8 Scores on a scale | Standard Deviation 18.4 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Hormonal Score at Week 65 | 9.8 Scores on a scale | Standard Deviation 15.8 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Chemotherapy Side Effects Score at Week 41 | 30.1 Scores on a scale | Standard Deviation 19.2 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Peripheral neuropathy Score at Week 33 | 30.4 Scores on a scale | Standard Deviation 28.7 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Chemotherapy Side Effects Score at Week 49 | 29.5 Scores on a scale | Standard Deviation 16.5 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Hormonal Score at Week 73 | 8.1 Scores on a scale | Standard Deviation 13.3 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Chemotherapy Side Effects Score at Week 57 | 27.9 Scores on a scale | Standard Deviation 19.5 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Abdominal/GI Score at Week 25 | 22.1 Scores on a scale | Standard Deviation 18.6 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Chemotherapy Side Effects Score at Week 65 | 25.5 Scores on a scale | Standard Deviation 19.1 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Hormonal Score at Treatment Discontinuation Visit | 14.8 Scores on a scale | Standard Deviation 21.7 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Chemotherapy Side Effects Score at Week 73 | 27.7 Scores on a scale | Standard Deviation 19.4 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Peripheral neuropathy Score at Week 41 | 25.2 Scores on a scale | Standard Deviation 30.1 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Chemotherapy Side Effects Score at Treatment Discontinuation Visit | 30.4 Scores on a scale | Standard Deviation 19.6 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Hormonal Score at 30-Day Safety Follow-up | 22.4 Scores on a scale | Standard Deviation 27.8 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Chemotherapy Side Effects Score at 30-Day Safety Follow-up | 27.5 Scores on a scale | Standard Deviation 19.5 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Abdominal/GI Score at Week 65 | 26.0 Scores on a scale | Standard Deviation 19.4 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Other Score at Screening | 11.8 Scores on a scale | Standard Deviation 16.5 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Body image Score at Screening | 28.9 Scores on a scale | Standard Deviation 29.3 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Other Score at Week 9 | 22.0 Scores on a scale | Standard Deviation 17.4 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Peripheral neuropathy Score at Week 49 | 25.0 Scores on a scale | Standard Deviation 24.1 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Other Score at Week 17 | 26.1 Scores on a scale | Standard Deviation 22.2 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Body image Score at Week 9 | 42.1 Scores on a scale | Standard Deviation 32.1 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Other Score at Week 25 | 22.9 Scores on a scale | Standard Deviation 21.1 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Abdominal/GI Score at Week 9 | 29.3 Scores on a scale | Standard Deviation 20.1 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Other Score at Week 33 | 22.3 Scores on a scale | Standard Deviation 21.3 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Body image Score at Week 17 | 40.1 Scores on a scale | Standard Deviation 29.6 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Other Score at Week 41 | 19.1 Scores on a scale | Standard Deviation 20.2 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Peripheral neuropathy Score at Week 57 | 22.5 Scores on a scale | Standard Deviation 27.9 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Other Score at Week 49 | 19.0 Scores on a scale | Standard Deviation 18.6 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Body image Score at Week 25 | 37.4 Scores on a scale | Standard Deviation 29.1 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Other Score at Week 57 | 16.3 Scores on a scale | Standard Deviation 15.5 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Abdominal/GI Score at Week 33 | 27.2 Scores on a scale | Standard Deviation 20.3 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Other Score at Week 65 | 15.4 Scores on a scale | Standard Deviation 12.9 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Body image Score at Week 33 | 36.2 Scores on a scale | Standard Deviation 25.7 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Other Score at Week 73 | 15.7 Scores on a scale | Standard Deviation 15 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Peripheral neuropathy Score at Week 65 | 18.7 Scores on a scale | Standard Deviation 24.8 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Other Score at Treatment Discontinuation Visit | 22.1 Scores on a scale | Standard Deviation 16.9 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Body image Score at Week 41 | 40.4 Scores on a scale | Standard Deviation 26.8 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Abdominal/GI Score at Treatment Discontinuation Visit | 31.6 Scores on a scale | Standard Deviation 22 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Other Score at 30-Day Safety Follow-up | 17.2 Scores on a scale | Standard Deviation 17 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Body image Score at Week 49 | 36.2 Scores on a scale | Standard Deviation 25.8 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Sexuality Score at Screening | 20.2 Scores on a scale | Standard Deviation 20.3 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Peripheral neuropathy Score at Week 73 | 17.2 Scores on a scale | Standard Deviation 27.2 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Sexuality Score at Week 9 | 18.7 Scores on a scale | Standard Deviation 20.4 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Sexuality Score at Week 17 | 19.6 Scores on a scale | Standard Deviation 20.3 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Body image Score at Week 57 | 36.1 Scores on a scale | Standard Deviation 27 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Sexuality Score at Week 25 | 21.8 Scores on a scale | Standard Deviation 21.5 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Abdominal/GI Score at Screening | 22.8 Scores on a scale | Standard Deviation 18.6 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Sexuality Score at Week 33 | 25.8 Scores on a scale | Standard Deviation 23 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Body image Score at Week 65 | 33.7 Scores on a scale | Standard Deviation 28 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Sexuality Score at Week 41 | 21.3 Scores on a scale | Standard Deviation 20 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Peripheral neuropathy Score at Treatment Discontinuation Visit | 28.5 Scores on a scale | Standard Deviation 32.4 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Sexuality Score at Week 49 | 23.0 Scores on a scale | Standard Deviation 21.9 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Body image Score at Week 73 | 27.8 Scores on a scale | Standard Deviation 23.4 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Sexuality Score at Week 57 | 21.8 Scores on a scale | Standard Deviation 21.8 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Abdominal/GI Score at 30-Day Safety Follow-up | 31.8 Scores on a scale | Standard Deviation 24.6 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Sexuality Score at Week 65 | 21.3 Scores on a scale | Standard Deviation 20.7 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Body image Score at Treatment Discontinuation Visit | 46.9 Scores on a scale | Standard Deviation 32.9 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Sexuality Score at Week 73 | 20.8 Scores on a scale | Standard Deviation 21.6 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Peripheral neuropathy Score at 30-Day Safety Follow-up | 28.9 Scores on a scale | Standard Deviation 29.8 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Sexuality Score at Treatment Discontinuation Visit | 14.2 Scores on a scale | Standard Deviation 19.4 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Body image Score at 30-Day Safety Follow-up | 35.0 Scores on a scale | Standard Deviation 30.5 |
| MEK162 | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Abdominal/GI Score at Week 73 | 23.0 Scores on a scale | Standard Deviation 20.3 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Sexuality Score at 30-Day Safety Follow-up | 26.1 Scores on a scale | Standard Deviation 25.8 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Abdominal/GI Score at Screening | 25.7 Scores on a scale | Standard Deviation 22.5 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Abdominal/GI Score at Week 9 | 22.3 Scores on a scale | Standard Deviation 17.7 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Abdominal/GI Score at Week 17 | 20.3 Scores on a scale | Standard Deviation 15.9 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Abdominal/GI Score at Week 25 | 20.9 Scores on a scale | Standard Deviation 17.2 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Abdominal/GI Score at Week 33 | 15.6 Scores on a scale | Standard Deviation 18.3 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Abdominal/GI Score at Week 41 | 18.7 Scores on a scale | Standard Deviation 23 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Abdominal/GI Score at Week 49 | 17.6 Scores on a scale | Standard Deviation 20.7 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Abdominal/GI Score at Week 57 | 18.4 Scores on a scale | Standard Deviation 19.3 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Abdominal/GI Score at Week 65 | 23.7 Scores on a scale | Standard Deviation 23.1 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Abdominal/GI Score at Week 73 | 31.3 Scores on a scale | Standard Deviation 29.1 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Abdominal/GI Score at Treatment Discontinuation Visit | 24.1 Scores on a scale | Standard Deviation 20.4 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Abdominal/GI Score at 30-Day Safety Follow-up | 17.5 Scores on a scale | Standard Deviation 22.1 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Peripheral neuropathy Score at Screening | 14.5 Scores on a scale | Standard Deviation 22.4 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Peripheral neuropathy Score at Week 9 | 19.5 Scores on a scale | Standard Deviation 23.5 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Peripheral neuropathy Score at Week 17 | 20.9 Scores on a scale | Standard Deviation 21.6 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Peripheral neuropathy Score at Week 25 | 21.0 Scores on a scale | Standard Deviation 24.2 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Peripheral neuropathy Score at Week 33 | 21.4 Scores on a scale | Standard Deviation 24.4 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Peripheral neuropathy Score at Week 41 | 14.0 Scores on a scale | Standard Deviation 16.4 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Peripheral neuropathy Score at Week 49 | 16.7 Scores on a scale | Standard Deviation 18.1 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Peripheral neuropathy Score at Week 57 | 15.6 Scores on a scale | Standard Deviation 23.9 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Peripheral neuropathy Score at Week 65 | 22.7 Scores on a scale | Standard Deviation 26.1 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Peripheral neuropathy Score at Week 73 | 25.0 Scores on a scale | Standard Deviation 30.9 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Peripheral neuropathy Score at Treatment Discontinuation Visit | 22.6 Scores on a scale | Standard Deviation 24.4 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Peripheral neuropathy Score at 30-Day Safety Follow-up | 23.7 Scores on a scale | Standard Deviation 32.5 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Hormonal Score at Screening | 23.3 Scores on a scale | Standard Deviation 28.4 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Hormonal Score at Week 9 | 23.7 Scores on a scale | Standard Deviation 28.9 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Hormonal Score at Week 17 | 23.1 Scores on a scale | Standard Deviation 28.1 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Hormonal Score at Week 25 | 23.2 Scores on a scale | Standard Deviation 26.2 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Hormonal Score at Week 33 | 23.4 Scores on a scale | Standard Deviation 29 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Hormonal Score at Week 41 | 21.3 Scores on a scale | Standard Deviation 29.9 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Hormonal Score at Week 49 | 25.9 Scores on a scale | Standard Deviation 34.4 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Hormonal Score at Week 57 | 33.3 Scores on a scale | Standard Deviation 38 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Hormonal Score at Week 65 | 25.8 Scores on a scale | Standard Deviation 38.3 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Hormonal Score at Week 73 | 14.6 Scores on a scale | Standard Deviation 28.8 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Hormonal Score at Treatment Discontinuation Visit | 26.7 Scores on a scale | Standard Deviation 34 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Hormonal Score at 30-Day Safety Follow-up | 14.9 Scores on a scale | Standard Deviation 21.4 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Body image Score at Screening | 31.4 Scores on a scale | Standard Deviation 31.9 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Body image Score at Week 9 | 36.0 Scores on a scale | Standard Deviation 30.1 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Body image Score at Week 17 | 32.6 Scores on a scale | Standard Deviation 29.9 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Body image Score at Week 25 | 27.7 Scores on a scale | Standard Deviation 25.4 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Body image Score at Week 33 | 28.6 Scores on a scale | Standard Deviation 29.1 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Body image Score at Week 41 | 30.0 Scores on a scale | Standard Deviation 31.2 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Body image Score at Week 49 | 25.9 Scores on a scale | Standard Deviation 32.5 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Body image Score at Week 57 | 16.7 Scores on a scale | Standard Deviation 26.5 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Body image Score at Week 65 | 25.8 Scores on a scale | Standard Deviation 30.2 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Body image Score at Week 73 | 33.3 Scores on a scale | Standard Deviation 34.5 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Body image Score at Treatment Discontinuation Visit | 37.0 Scores on a scale | Standard Deviation 32 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Body image Score at 30-Day Safety Follow-up | 23.7 Scores on a scale | Standard Deviation 26.8 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Attitude to disease/treatment Score at Screening | 51.4 Scores on a scale | Standard Deviation 29.1 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Attitude to disease/treatment Score at Week 9 | 47.6 Scores on a scale | Standard Deviation 26.5 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Attitude to disease/treatment Score at Week 17 | 51.6 Scores on a scale | Standard Deviation 26.1 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Attitude to disease/treatment Score at Week 25 | 44.1 Scores on a scale | Standard Deviation 26.5 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Attitude to disease/treatment Score at Week 33 | 44.4 Scores on a scale | Standard Deviation 24.8 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Attitude to disease/treatment Score at Week 41 | 40.4 Scores on a scale | Standard Deviation 23.1 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Attitude to disease/treatment Score at Week 49 | 38.9 Scores on a scale | Standard Deviation 23.6 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Attitude to disease/treatment Score at Week 57 | 32.6 Scores on a scale | Standard Deviation 27.1 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Attitude to disease/treatment Score at Week 65 | 45.5 Scores on a scale | Standard Deviation 28.7 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Attitude to disease/treatment Score at Week 73 | 51.4 Scores on a scale | Standard Deviation 43.6 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Attitude to disease/treatment Score at Treatment Discontinuation Visit | 53.8 Scores on a scale | Standard Deviation 29.3 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Attitude to disease/treatment Score at 30-Day Safety Follow-up | 50.3 Scores on a scale | Standard Deviation 24.9 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Chemotherapy Side Effects Score at Screening | 17.1 Scores on a scale | Standard Deviation 14.7 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Chemotherapy Side Effects Score at Week 9 | 22.6 Scores on a scale | Standard Deviation 16.2 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Chemotherapy Side Effects Score at Week 17 | 24.1 Scores on a scale | Standard Deviation 15.2 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Chemotherapy Side Effects Score at Week 25 | 25.3 Scores on a scale | Standard Deviation 18.1 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Chemotherapy Side Effects Score at Week 33 | 24.1 Scores on a scale | Standard Deviation 17.1 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Chemotherapy Side Effects Score at Week 41 | 23.5 Scores on a scale | Standard Deviation 20.8 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Chemotherapy Side Effects Score at Week 49 | 23.0 Scores on a scale | Standard Deviation 18.6 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Chemotherapy Side Effects Score at Week 57 | 23.1 Scores on a scale | Standard Deviation 18.3 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Chemotherapy Side Effects Score at Week 65 | 25.5 Scores on a scale | Standard Deviation 15.4 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Chemotherapy Side Effects Score at Week 73 | 29.2 Scores on a scale | Standard Deviation 20.5 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Chemotherapy Side Effects Score at Treatment Discontinuation Visit | 28.0 Scores on a scale | Standard Deviation 19.4 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Chemotherapy Side Effects Score at 30-Day Safety Follow-up | 17.9 Scores on a scale | Standard Deviation 14.7 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Other Score at Screening | 14.5 Scores on a scale | Standard Deviation 19.6 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Other Score at Week 9 | 23.3 Scores on a scale | Standard Deviation 20.6 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Other Score at Week 17 | 20.1 Scores on a scale | Standard Deviation 19.1 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Other Score at Week 25 | 18.7 Scores on a scale | Standard Deviation 17.5 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Other Score at Week 33 | 16.7 Scores on a scale | Standard Deviation 19.4 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Other Score at Week 41 | 14.3 Scores on a scale | Standard Deviation 15.1 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Other Score at Week 49 | 12.8 Scores on a scale | Standard Deviation 13.6 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Other Score at Week 57 | 16.8 Scores on a scale | Standard Deviation 17 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Other Score at Week 65 | 22.0 Scores on a scale | Standard Deviation 24.5 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Other Score at Week 73 | 22.2 Scores on a scale | Standard Deviation 22 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Sexuality Score at Week 9 | 18.1 Scores on a scale | Standard Deviation 21.9 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Other Score at Treatment Discontinuation Visit | 22.7 Scores on a scale | Standard Deviation 20.1 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Other Score at 30-Day Safety Follow-up | 14.6 Scores on a scale | Standard Deviation 20.4 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Sexuality Score at Screening | 19.2 Scores on a scale | Standard Deviation 21.9 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Sexuality Score at Week 17 | 18.3 Scores on a scale | Standard Deviation 21.6 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Sexuality Score at Week 25 | 22.0 Scores on a scale | Standard Deviation 23.8 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Sexuality Score at Week 33 | 21.3 Scores on a scale | Standard Deviation 21.7 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Sexuality Score at Week 41 | 19.2 Scores on a scale | Standard Deviation 23.1 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Sexuality Score at Week 49 | 20.6 Scores on a scale | Standard Deviation 23 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Sexuality Score at Week 57 | 18.9 Scores on a scale | Standard Deviation 24.7 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Sexuality Score at Week 65 | 12.5 Scores on a scale | Standard Deviation 15.8 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Sexuality Score at Week 73 | 11.9 Scores on a scale | Standard Deviation 16.6 |
| Physician's Choice | Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) | Sexuality Score at Treatment Discontinuation Visit | 23.2 Scores on a scale | Standard Deviation 23 |
Secondary
Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX)
FACT/GOG-NTX questionnaire consists of questions for dimensions related to physical, social, emotional, and functional well-being which contains 11 items, with responses scored on a Likert scale from 0 (not at all) to 4 (very much) designed to capture the symptoms of chemotherapy-induced peripheral neuropathy (CIPN). The summed scores of each item were reverted into standardized scores ranging from 0 to 44, with a higher score indicating a lower level of neurological toxicity and less effect on quality of life (ie, higher scores indicate better quality of life). The trial outcome index consists of two subscales from the FACT-G: Physical Well Being (7 items) and Functional Well Being (7 items), plus the Cervix Cancer-specific subscale (15 items). Each item in the trial outcome index scored using a 5-point scale (0=not at all to 4=very much). The summed scores of each item were reverted into standardized scores ranging from 0 to 116. Higher scores indicate better quality of life.
Time frame: Screening, every 8 weeks from randomization for the first 72 weeks (while on treatment), treatment discontinuation visit, 30-day safety follow-up visit
Population: Analysis population included all randomized participants (228 participants in MEK162 group, 113 participants in physician's choice group).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Social Well-being Score at Week 49 | 20.6 Scores on a scale | Standard Deviation 4.6 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Physical Well-being Score at Week 9 | 19.0 Scores on a scale | Standard Deviation 5.7 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Physical Well-being Score at Week 17 | 20.1 Scores on a scale | Standard Deviation 4.9 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Physical Well-being Score at Week 25 | 20.4 Scores on a scale | Standard Deviation 5.2 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Physical Well-being Score at Week 33 | 20.2 Scores on a scale | Standard Deviation 5.1 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Physical Well-being Score at Week 41 | 19.9 Scores on a scale | Standard Deviation 5.5 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Physical Well-being Score at Week 49 | 20.5 Scores on a scale | Standard Deviation 4.9 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Physical Well-being Score at Week 57 | 20.8 Scores on a scale | Standard Deviation 4.6 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Physical Well-being Score at Week 65 | 21.3 Scores on a scale | Standard Deviation 4.7 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Physical Well-being Score at Week 73 | 21.8 Scores on a scale | Standard Deviation 4.5 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Physical Well-being Score at Treatment Discontinuation Visit | 17.8 Scores on a scale | Standard Deviation 6.7 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Physical Well-being Score at 30-Day Safety Follow-up | 19.6 Scores on a scale | Standard Deviation 6.5 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Social Well-being Score at Screening | 20.7 Scores on a scale | Standard Deviation 4.8 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Social Well-being Score at Week 9 | 20.0 Scores on a scale | Standard Deviation 4.6 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Social Well-being Score at Week 17 | 19.7 Scores on a scale | Standard Deviation 5.1 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Social Well-being Score at Week 25 | 20.3 Scores on a scale | Standard Deviation 4.6 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Social Well-being Score at Week 33 | 20.3 Scores on a scale | Standard Deviation 5.5 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Social Well-being Score at Week 41 | 20.7 Scores on a scale | Standard Deviation 5 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Physical Well-being Score at Screening | 21.7 Scores on a scale | Standard Deviation 5.1 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Social Well-being Score at Week 57 | 20.0 Scores on a scale | Standard Deviation 5.9 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Social Well-being Score at Week 65 | 20.5 Scores on a scale | Standard Deviation 5.4 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Social Well-being Score at Week 73 | 20.0 Scores on a scale | Standard Deviation 6.1 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Peripheral neuropathy Score at Treatment Discontinuation Visit | 19.3 Scores on a scale | Standard Deviation 4.7 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Peripheral neuropathy Score at 30-Day Safety Follow-up | 20.5 Scores on a scale | Standard Deviation 4.3 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Emotional Well-being Score at Screening | 16.1 Scores on a scale | Standard Deviation 5.1 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Emotional Well-being Score at Week 9 | 16.5 Scores on a scale | Standard Deviation 4.7 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Emotional Well-being Score at Week 17 | 17.2 Scores on a scale | Standard Deviation 4.2 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Emotional Well-being Score at Week 25 | 17.3 Scores on a scale | Standard Deviation 4.4 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Emotional Well-being Score at Week 33 | 17.3 Scores on a scale | Standard Deviation 4.3 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Emotional Well-being Score at Week 41 | 16.9 Scores on a scale | Standard Deviation 4.4 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Emotional Well-being Score at Week 49 | 17.4 Scores on a scale | Standard Deviation 3.8 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Emotional Well-being Score at Week 57 | 17.5 Scores on a scale | Standard Deviation 4.1 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Emotional Well-being Score at Week 65 | 18.1 Scores on a scale | Standard Deviation 3.8 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Emotional Well-being Score at Week 73 | 18.3 Scores on a scale | Standard Deviation 3.2 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Emotional Well-being Score at Treatment Discontinuation Visit | 14.5 Scores on a scale | Standard Deviation 5.9 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Emotional Well-being Score at 30-Day Safety Follow-up | 15.4 Scores on a scale | Standard Deviation 5.4 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Functional Well-being Score at Screening | 18.0 Scores on a scale | Standard Deviation 6 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Functional Well-being Score at Week 9 | 16.2 Scores on a scale | Standard Deviation 6.2 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Functional Well-being Score at Week 17 | 16.9 Scores on a scale | Standard Deviation 5.7 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Functional Well-being Score at Week 25 | 17.4 Scores on a scale | Standard Deviation 5.3 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Functional Well-being Score at Week 33 | 17.5 Scores on a scale | Standard Deviation 5.7 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Functional Well-being Score at Week 41 | 17.5 Scores on a scale | Standard Deviation 5.3 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Functional Well-being Score at Week 49 | 18.0 Scores on a scale | Standard Deviation 5 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Functional Well-being Score at Week 57 | 17.0 Scores on a scale | Standard Deviation 6.3 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Functional Well-being Score at Week 65 | 18.3 Scores on a scale | Standard Deviation 5.7 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Functional Well-being Score at Week 73 | 18.7 Scores on a scale | Standard Deviation 5.4 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Functional Well-being Score at Treatment Discontinuation Visit | 15.0 Scores on a scale | Standard Deviation 6 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Functional Well-being Score at 30-Day Safety Follow-up | 16.5 Scores on a scale | Standard Deviation 6.1 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Neurotoxicity Subscale Score at Screening | 38.0 Scores on a scale | Standard Deviation 6.4 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Neurotoxicity Subscale Score at Week 9 | 36.2 Scores on a scale | Standard Deviation 6.5 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Neurotoxicity Subscale Score at Week 17 | 35.9 Scores on a scale | Standard Deviation 7.1 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Neurotoxicity Subscale Score at Week 25 | 35.1 Scores on a scale | Standard Deviation 7.6 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Neurotoxicity Subscale Score at Week 33 | 35.2 Scores on a scale | Standard Deviation 6.8 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Neurotoxicity Subscale Score at Week 41 | 35.6 Scores on a scale | Standard Deviation 7.2 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Neurotoxicity Subscale Score at Week 49 | 35.1 Scores on a scale | Standard Deviation 7.1 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Neurotoxicity Subscale Score at Week 57 | 35.9 Scores on a scale | Standard Deviation 7.3 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Neurotoxicity Subscale Score at Week 65 | 36.6 Scores on a scale | Standard Deviation 7.4 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Neurotoxicity Subscale Score at Week 73 | 37.5 Scores on a scale | Standard Deviation 6.7 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Neurotoxicity Subscale Score at Treatment Discontinuation Visit | 34.6 Scores on a scale | Standard Deviation 7.8 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Neurotoxicity Subscale Score at 30-Day Safety Follow-up | 34.7 Scores on a scale | Standard Deviation 9 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Trial Outcome Index Score at Screening | 78.0 Scores on a scale | Standard Deviation 13.6 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Trial Outcome Index Score at Week 9 | 71.5 Scores on a scale | Standard Deviation 14.4 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Trial Outcome Index Score at Week 17 | 72.9 Scores on a scale | Standard Deviation 13.5 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Trial Outcome Index Score at Week 25 | 72.8 Scores on a scale | Standard Deviation 15 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Trial Outcome Index Score at Week 33 | 72.9 Scores on a scale | Standard Deviation 14.7 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Trial Outcome Index Score at Week 41 | 73.3 Scores on a scale | Standard Deviation 13.8 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Trial Outcome Index Score at Week 49 | 74.1 Scores on a scale | Standard Deviation 13.4 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Trial Outcome Index Score at Week 57 | 74.4 Scores on a scale | Standard Deviation 13.9 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Trial Outcome Index Score at Week 65 | 77.2 Scores on a scale | Standard Deviation 13.5 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Trial Outcome Index Score at Week 73 | 77.9 Scores on a scale | Standard Deviation 14.2 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Trial Outcome Index Score at Treatment Discontinuation Visit | 67.5 Scores on a scale | Standard Deviation 16.5 |
| MEK162 | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Trial Outcome Index Score at 30-Day Safety Follow-up | 70.8 Scores on a scale | Standard Deviation 17.5 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Trial Outcome Index Score at Week 57 | 80.1 Scores on a scale | Standard Deviation 17.1 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Physical Well-being Score at Screening | 21.6 Scores on a scale | Standard Deviation 5.7 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Functional Well-being Score at Screening | 18.3 Scores on a scale | Standard Deviation 6.5 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Physical Well-being Score at Week 9 | 21.4 Scores on a scale | Standard Deviation 5.5 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Neurotoxicity Subscale Score at Week 49 | 37.6 Scores on a scale | Standard Deviation 7.9 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Physical Well-being Score at Week 17 | 21.5 Scores on a scale | Standard Deviation 5.2 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Functional Well-being Score at Week 9 | 18.1 Scores on a scale | Standard Deviation 6 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Physical Well-being Score at Week 25 | 21.3 Scores on a scale | Standard Deviation 6.1 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Trial Outcome Index Score at Week 25 | 75.7 Scores on a scale | Standard Deviation 16.1 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Physical Well-being Score at Week 33 | 21.2 Scores on a scale | Standard Deviation 6.3 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Functional Well-being Score at Week 17 | 17.3 Scores on a scale | Standard Deviation 5.8 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Physical Well-being Score at Week 41 | 22.6 Scores on a scale | Standard Deviation 6.6 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Neurotoxicity Subscale Score at Week 57 | 37.3 Scores on a scale | Standard Deviation 7.4 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Physical Well-being Score at Week 49 | 22.6 Scores on a scale | Standard Deviation 6.2 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Functional Well-being Score at Week 25 | 17.7 Scores on a scale | Standard Deviation 5.8 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Physical Well-being Score at Week 57 | 22.4 Scores on a scale | Standard Deviation 6.1 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Trial Outcome Index Score at 30-Day Safety Follow-up | 79.8 Scores on a scale | Standard Deviation 15.7 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Physical Well-being Score at Week 65 | 20.2 Scores on a scale | Standard Deviation 7.2 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Functional Well-being Score at Week 33 | 18.8 Scores on a scale | Standard Deviation 6.1 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Physical Well-being Score at Week 73 | 20.8 Scores on a scale | Standard Deviation 8.4 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Neurotoxicity Subscale Score at Week 65 | 35.5 Scores on a scale | Standard Deviation 7.1 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Physical Well-being Score at Treatment Discontinuation Visit | 19.4 Scores on a scale | Standard Deviation 7.4 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Functional Well-being Score at Week 41 | 19.8 Scores on a scale | Standard Deviation 7.4 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Physical Well-being Score at 30-Day Safety Follow-up | 23.1 Scores on a scale | Standard Deviation 4.7 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Trial Outcome Index Score at Week 33 | 76.6 Scores on a scale | Standard Deviation 17.4 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Social Well-being Score at Screening | 20.7 Scores on a scale | Standard Deviation 4.9 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Functional Well-being Score at Week 49 | 19.1 Scores on a scale | Standard Deviation 6.3 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Social Well-being Score at Week 9 | 20.3 Scores on a scale | Standard Deviation 5 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Neurotoxicity Subscale Score at Week 73 | 34.3 Scores on a scale | Standard Deviation 8.8 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Social Well-being Score at Week 17 | 20.6 Scores on a scale | Standard Deviation 4.4 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Functional Well-being Score at Week 57 | 20.4 Scores on a scale | Standard Deviation 6.6 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Social Well-being Score at Week 25 | 20.2 Scores on a scale | Standard Deviation 4.6 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Trial Outcome Index Score at Week 65 | 74.6 Scores on a scale | Standard Deviation 16.4 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Social Well-being Score at Week 33 | 21.0 Scores on a scale | Standard Deviation 5 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Functional Well-being Score at Week 65 | 18.9 Scores on a scale | Standard Deviation 6.1 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Social Well-being Score at Week 41 | 21.3 Scores on a scale | Standard Deviation 4.9 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Neurotoxicity Subscale Score at Treatment Discontinuation Visit | 36.0 Scores on a scale | Standard Deviation 7.3 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Social Well-being Score at Week 49 | 21.4 Scores on a scale | Standard Deviation 4.8 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Functional Well-being Score at Week 73 | 19.8 Scores on a scale | Standard Deviation 5.8 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Social Well-being Score at Week 57 | 21.5 Scores on a scale | Standard Deviation 5.1 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Trial Outcome Index Score at Week 41 | 80.1 Scores on a scale | Standard Deviation 18 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Social Well-being Score at Week 65 | 20.6 Scores on a scale | Standard Deviation 5.4 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Functional Well-being Score at Treatment Discontinuation Visit | 17.0 Scores on a scale | Standard Deviation 7 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Social Well-being Score at Week 73 | 22.1 Scores on a scale | Standard Deviation 5 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Neurotoxicity Subscale Score at 30-Day Safety Follow-up | 37.8 Scores on a scale | Standard Deviation 7.5 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Peripheral neuropathy Score at Treatment Discontinuation Visit | 20.7 Scores on a scale | Standard Deviation 4.5 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Functional Well-being Score at 30-Day Safety Follow-up | 18.8 Scores on a scale | Standard Deviation 6.5 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Peripheral neuropathy Score at 30-Day Safety Follow-up | 21.0 Scores on a scale | Standard Deviation 4.9 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Trial Outcome Index Score at Treatment Discontinuation Visit | 72.1 Scores on a scale | Standard Deviation 18 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Emotional Well-being Score at Screening | 15.4 Scores on a scale | Standard Deviation 5 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Neurotoxicity Subscale Score at Screening | 39.0 Scores on a scale | Standard Deviation 6 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Emotional Well-being Score at Week 9 | 16.4 Scores on a scale | Standard Deviation 4.7 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Trial Outcome Index Score at Screening | 78.9 Scores on a scale | Standard Deviation 15.3 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Emotional Well-being Score at Week 17 | 17.0 Scores on a scale | Standard Deviation 4.1 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Neurotoxicity Subscale Score at Week 9 | 37.8 Scores on a scale | Standard Deviation 6.4 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Emotional Well-being Score at Week 25 | 17.5 Scores on a scale | Standard Deviation 3.9 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Trial Outcome Index Score at Week 49 | 79.3 Scores on a scale | Standard Deviation 17.6 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Emotional Well-being Score at Week 33 | 18.0 Scores on a scale | Standard Deviation 4.8 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Neurotoxicity Subscale Score at Week 17 | 37.1 Scores on a scale | Standard Deviation 5.9 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Emotional Well-being Score at Week 41 | 18.0 Scores on a scale | Standard Deviation 4.9 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Trial Outcome Index Score at Week 9 | 77.3 Scores on a scale | Standard Deviation 15.2 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Emotional Well-being Score at Week 49 | 18.1 Scores on a scale | Standard Deviation 4.6 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Neurotoxicity Subscale Score at Week 25 | 36.6 Scores on a scale | Standard Deviation 6.1 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Emotional Well-being Score at Week 57 | 19.2 Scores on a scale | Standard Deviation 3.2 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Trial Outcome Index Score at Week 73 | 74.8 Scores on a scale | Standard Deviation 20.9 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Emotional Well-being Score at Week 65 | 17.7 Scores on a scale | Standard Deviation 3.6 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Neurotoxicity Subscale Score at Week 33 | 36.6 Scores on a scale | Standard Deviation 7.5 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Emotional Well-being Score at Week 73 | 17.3 Scores on a scale | Standard Deviation 5.8 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Trial Outcome Index Score at Week 17 | 76.0 Scores on a scale | Standard Deviation 14.2 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Emotional Well-being Score at Treatment Discontinuation Visit | 15.4 Scores on a scale | Standard Deviation 5.6 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Neurotoxicity Subscale Score at Week 41 | 37.7 Scores on a scale | Standard Deviation 5.9 |
| Physician's Choice | Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) | Emotional Well-being Score at 30-Day Safety Follow-up | 17.3 Scores on a scale | Standard Deviation 4.7 |