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This study was designed to find out how effective and safe GW786034, is in the treatment of epithelial ovarian, fallopian tube, or primary peritoneal cancer that has not responded to standard treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pazopanib | Experimental | 800 mg GW786034 administered orally on a daily basis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GW786034 | Drug | 800 mg GW786034 administered orally on a daily basis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Best Biochemical Response (Cancer Antigen [CA-125]) | Defined using modified Gynecologic Cancer Intergroup (GCIG) criteria: 50% response=≥50% decrease from baseline CA-125 (higher of 2 pretreatment CA-125 assessments) then confirmed after 21 days. 50% CA-125 response was normalized (CA-125 >21U/mL) or non-normalized (CA-125≤1U/mL). Progressive disease (PD) =CA-125 increase ≥100% from nadir (nadir >21U/mL) or ≥42U/mL (nadir ≤21U/mL); nadir was lowest CA-125. PD was confirmed after 21 days; otherwise=unconfirmed PD. Stable disease=scenarios that do not meet 50% response or PD. CA-125 response rate was defined as % of participants with 50% response. | Baseline to response (up to 3 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Biochemical Response (CA-125) | Time to biochemical response was calculated as the date pazopanib was first dosed to the date CA-125 was first reduced by 50% or greater. The reduction in CA-125 of 50% or greater was to be confirmed by a repeat measurement (no earlier than 21 days after initial evaluation documenting decrement). This was calculated for all participants with confirmed CA-125 50% reduction. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials, MD | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Atlanta | Georgia | 30342 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20584542 | Background | Friedlander M, Hancock KC, Rischin D, Messing MJ, Stringer CA, Matthys GM, Ma B, Hodge JP, Lager JJ. A Phase II, open-label study evaluating pazopanib in patients with recurrent ovarian cancer. Gynecol Oncol. 2010 Oct;119(1):32-7. doi: 10.1016/j.ygyno.2010.05.033. Epub 2010 Jun 27. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pazopanib 800 mg | 800 milligrams (mg) pazopanib administered orally once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Baseline to response (up to 3 years) |
| Duration of Biochemical Response (CA-125) | Calculated as the date of confirmed first 50% or greater reduction in CA-125 to date of documented progression by clinical, radiographic, or biochemical criteria, whichever occurred earliest. This was calculated for all participants with confirmed CA-125 50% reduction. | Baseline to response (up to 3 years) |
| CA-125 Doubling Time Prior to and During Treatment With Pazopanib | CA-125 doubling time is defined as the time for CA-125 to double from baseline value. This measure was not reported, as no participants had a post-baseline CA-125 that was double the baseline value. Therefore, the data did not warrant a report. | Baseline to doubling of CA-125 (up to 3 years) |
| Overall Response and Stable Disease (SD) | Overall response and stable disease (SD) are based on biochemical, radiographic, and clinical assessments according to the modified criteria of Gynecologic Cancer Intergroup (GCIG) (see primary outcome). Response is presented as the percentage of participants with the given response. | Baseline to response (up to 3 years) |
| Median Progression-free Survival (PFS) | Progression-free survival analysis was performed on all participants and then stratified by CA-125 response status (having confirmed 50% reduction or not). PFS was defined as the time from the date of the first dose of study drug to the date of documented and confirmed progression by clinical, radiographic, or biochemical criteria, whichever occurred earliest, or to date of death due to any causes. | Date of the first dose of study drug to the date of documented and confirmed progression by clinical, radiographic, or biochemical criteria, whichever occurred earliest, or to date of death due to any causes (up to 2 years) |
| Overall Tumor Response | Overall tumor response following daily administration of pazopanib was defined using radiographic assessments based on Response Evaluation Criteria for Solid Tumors (RECIST) criteria for subjects with measurable disease at baseline. | Baseline to response (up to 3 years) |
| Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Diastolic Blood Pressure | Summary of shifts in diastolic blood pressure from baseline to the maximum change in the study. mmHg, millimeters of mercury. | Baseline to response (up to 3 years) |
| Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Systolic Blood Pressure | Summary of shifts in systolic blood pressure from baseline to the maximum change in the study. mmHg, millimeters of mercury. | Baseline to response (up to 3 years) |
| Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Heart Rate | Summary of shifts in heart rate from baseline to the maximum change in the study. bpm, beats per minute. | Baseline to response (up to 3 years) |
| Mean Change From Baseline to Response in Albumin | Change from baseline is calculated as the value at the time of response minus the value at Baseline. | Baseline to response (up to 3 years) |
| Mean Change From Baseline to Response in Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, and Lactate Dehydrogenase | Change from baseline is calculated as the value at the time of response minus the value at Baseline. | Baseline to response (up to 3 years) |
| Mean Change From Baseline to Response in Amylase and Lipase | Change from baseline is calculated as the value at the time of response minus the value at Baseline. | Baseline to response (up to 3 years) |
| Mean Change From Baseline to Response in Total Bilirubin and Creatinine | Change from baseline is calculated as the value at the time of response minus the value at Baseline. | Baseline to response (up to 3 years) |
| Mean Change From Baseline to Response in Calcium, Glucose, Potassium, Sodium, and Urea | Change from baseline is calculated as the value at the time of response minus the value at Baseline. | Baseline to response (up to 3 years) |
| Mean Change From Baseline to Response in Thyroxine | Change from baseline is calculated as the value at the time of response minus the value at Baseline. | Baseline to response (up to 3 years) |
| Mean Change From Baseline to Response in Thyroid Stimulating Hormone | Change from baseline is calculated as the value at the time of response minus the value at Baseline. | Baseline to response (up to 3 years) |
| Mean Change From Baseline to Response in Hemoglobin and Hematocrit | Change from baseline is calculated as the value at the time of response minus the value at Baseline. | Baseline to response (up to 3 years) |
| Mean Change From Baseline to Response in Lymphocytes, Neutrophils, Platelet Count, and White Blood Count | Change from baseline is calculated as the value at the time of response minus the value at Baseline. | Baseline to response (up to 3 years) |
| Austin |
| Texas |
| 78731 |
| United States |
| GSK Investigational Site | Bedford | Texas | 76022 | United States |
| GSK Investigational Site | Dallas | Texas | 75246 | United States |
| GSK Investigational Site | Fort Worth | Texas | 76104 | United States |
| GSK Investigational Site | Randwick | New South Wales | 2031 | Australia |
| GSK Investigational Site | Herston | Queensland | 4029 | Australia |
| GSK Investigational Site | Melbourne | 3084 | Australia |
| GSK Investigational Site | Singapore | 119074 | Singapore |
| GSK Investigational Site | Singapore | 229899 | Singapore |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pazopanib 800 mg | 800 milligrams (mg) pazopanib administered orally once daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Best Biochemical Response (Cancer Antigen [CA-125]) | Defined using modified Gynecologic Cancer Intergroup (GCIG) criteria: 50% response=≥50% decrease from baseline CA-125 (higher of 2 pretreatment CA-125 assessments) then confirmed after 21 days. 50% CA-125 response was normalized (CA-125 >21U/mL) or non-normalized (CA-125≤1U/mL). Progressive disease (PD) =CA-125 increase ≥100% from nadir (nadir >21U/mL) or ≥42U/mL (nadir ≤21U/mL); nadir was lowest CA-125. PD was confirmed after 21 days; otherwise=unconfirmed PD. Stable disease=scenarios that do not meet 50% response or PD. CA-125 response rate was defined as % of participants with 50% response. | All participants | Posted | Number | percentage of participants | Baseline to response (up to 3 years) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Biochemical Response (CA-125) | Time to biochemical response was calculated as the date pazopanib was first dosed to the date CA-125 was first reduced by 50% or greater. The reduction in CA-125 of 50% or greater was to be confirmed by a repeat measurement (no earlier than 21 days after initial evaluation documenting decrement). This was calculated for all participants with confirmed CA-125 50% reduction. | All participants with confirmed CA-125 50% reduction | Posted | Median | Full Range | days | Baseline to response (up to 3 years) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Biochemical Response (CA-125) | Calculated as the date of confirmed first 50% or greater reduction in CA-125 to date of documented progression by clinical, radiographic, or biochemical criteria, whichever occurred earliest. This was calculated for all participants with confirmed CA-125 50% reduction. | All participants with confirmed CA-125 50% reduction | Posted | Median | 95% Confidence Interval | days | Baseline to response (up to 3 years) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | CA-125 Doubling Time Prior to and During Treatment With Pazopanib | CA-125 doubling time is defined as the time for CA-125 to double from baseline value. This measure was not reported, as no participants had a post-baseline CA-125 that was double the baseline value. Therefore, the data did not warrant a report. | All participants with confirmed CA-125 50% reduction | Posted | Baseline to doubling of CA-125 (up to 3 years) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Response and Stable Disease (SD) | Overall response and stable disease (SD) are based on biochemical, radiographic, and clinical assessments according to the modified criteria of Gynecologic Cancer Intergroup (GCIG) (see primary outcome). Response is presented as the percentage of participants with the given response. | All participants | Posted | Number | percentage of participants | Baseline to response (up to 3 years) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Median Progression-free Survival (PFS) | Progression-free survival analysis was performed on all participants and then stratified by CA-125 response status (having confirmed 50% reduction or not). PFS was defined as the time from the date of the first dose of study drug to the date of documented and confirmed progression by clinical, radiographic, or biochemical criteria, whichever occurred earliest, or to date of death due to any causes. | All participants with PFS | Posted | Median | 95% Confidence Interval | days | Date of the first dose of study drug to the date of documented and confirmed progression by clinical, radiographic, or biochemical criteria, whichever occurred earliest, or to date of death due to any causes (up to 2 years) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Tumor Response | Overall tumor response following daily administration of pazopanib was defined using radiographic assessments based on Response Evaluation Criteria for Solid Tumors (RECIST) criteria for subjects with measurable disease at baseline. | All participants | Posted | Number | participants | Baseline to response (up to 3 years) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Diastolic Blood Pressure | Summary of shifts in diastolic blood pressure from baseline to the maximum change in the study. mmHg, millimeters of mercury. | All participants. Data are presented for only those participants who provided measurements at baseline and maximum shift post-baseline. | Posted | Number | participants | Baseline to response (up to 3 years) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Systolic Blood Pressure | Summary of shifts in systolic blood pressure from baseline to the maximum change in the study. mmHg, millimeters of mercury. | All participants. Data are presented for only those participants who provided measurements at baseline and maximum shift post-baseline. | Posted | Number | participants | Baseline to response (up to 3 years) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Heart Rate | Summary of shifts in heart rate from baseline to the maximum change in the study. bpm, beats per minute. | All participants | Posted | Number | participants | Baseline to response (up to 3 years) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline to Response in Albumin | Change from baseline is calculated as the value at the time of response minus the value at Baseline. | All participants. Data are presented for only those participants who provided chemistry measurements at both baseline and the time of response. | Posted | Mean | Standard Deviation | grams per liter (g/L) | Baseline to response (up to 3 years) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline to Response in Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, and Lactate Dehydrogenase | Change from baseline is calculated as the value at the time of response minus the value at Baseline. | All participants. Data are presented for only those participants who provided chemistry measurements at both baseline and the time of response. | Posted | Mean | Standard Deviation | International Units per liter (IU/L) | Baseline to response (up to 3 years) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline to Response in Amylase and Lipase | Change from baseline is calculated as the value at the time of response minus the value at Baseline. | All participants. Data are presented for only those participants who provided chemistry measurements at both baseline and the time of response. | Posted | Mean | Standard Deviation | Units per liter (U/L) | Baseline to response (up to 3 years) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline to Response in Total Bilirubin and Creatinine | Change from baseline is calculated as the value at the time of response minus the value at Baseline. | All participants. Data are presented for only those participants who provided chemistry measurements at both baseline and the time of response. | Posted | Mean | Standard Deviation | micromoles per liter (umol/l) | Baseline to response (up to 3 years) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline to Response in Calcium, Glucose, Potassium, Sodium, and Urea | Change from baseline is calculated as the value at the time of response minus the value at Baseline. | All participants. Data are presented for only those participants who provided chemistry measurements at both baseline and the time of response. | Posted | Mean | Standard Deviation | millimoles per liter (mmol/l) | Baseline to response (up to 3 years) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline to Response in Thyroxine | Change from baseline is calculated as the value at the time of response minus the value at Baseline. | All participants. Data are presented for only those participants who provided chemistry measurements at both baseline and the time of response. | Posted | Mean | Standard Deviation | nanomoles per liter (nmol/l) | Baseline to response (up to 3 years) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline to Response in Thyroid Stimulating Hormone | Change from baseline is calculated as the value at the time of response minus the value at Baseline. | All participants. Data are presented for only those participants who provided chemistry measurements at both baseline and the time of response. | Posted | Mean | Standard Deviation | milliunits per liter (MU/L) | Baseline to response (up to 3 years) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline to Response in Hemoglobin and Hematocrit | Change from baseline is calculated as the value at the time of response minus the value at Baseline. | All participants. Data are presented for only those participants who provided hematology measurements at both baseline and the time of response. | Posted | Mean | Standard Deviation | g/L | Baseline to response (up to 3 years) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline to Response in Lymphocytes, Neutrophils, Platelet Count, and White Blood Count | Change from baseline is calculated as the value at the time of response minus the value at Baseline. | All participants. Data are presented for only those participants who provided hematology measurements at both baseline and the time of response. | Posted | Mean | Standard Deviation | giga (10^9) per liter (GI/L) | Baseline to response (up to 3 years) |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pazopanib 800 mg | 800 milligrams (mg) pazopanib administered orally once daily | 6 | 36 | 35 | 36 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Breast cancer situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal distensions | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Systematic Assessment |
| |
| Edema peripheral | General disorders | MedDRA | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA | Systematic Assessment |
| |
| Pain | General disorders | MedDRA | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA | Systematic Assessment |
| |
| Blood alkaline phosphastase | Investigations | MedDRA | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hair color changes | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Lymph node pain | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| C516667 | pazopanib |
Not provided
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| Progressive Disease |
|
| Unconfirmed Progressive Disease |
|
| Unknown |
|
|
|
| Counts |
|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Complete Response |
| |||||
| Partial Response |
| |||||
| Stable Disease |
| |||||
| Progressive Disease |
| |||||
| Unknown |
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| BL, 44-100 bpm; shift to post-BL, <44 bpm |
| |||||
| BL, 44-100 bpm; shift to post-BL, 44-100 bpm |
| |||||
| BL, 44-100 bpm; shift to post-BL, 101-120 bpm |
| |||||
| BL, 44-100 bpm; shift to post-BL, >120 bpm |
| |||||
| BL, 101-120 bpm; shift to post-BL, <44 bpm |
| |||||
| BL, 101-120 bpm; shift to post-BL, 44-100 bpm |
| |||||
| BL, 101-120 bpm; shift to post-BL, 101-120 bpm |
| |||||
| BL, 101-120 bpm; shift to post-BL, >120 bpm |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
|
|
|
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Hemoglobin |
| |||||
| Hematocrit |
|
|